On the month, the Nasdaq rose 4.8%, its best percentage gain since October 2003 when it shot up 8.2%. The S&P 500, meanwhile, climbed 3.2% in October. The broad gauge has also not put in a better October performance since 2003 when it rose 5.5%.
"It's been a very good month," said Joe Liro, equity strategist at Stone & McCarthy Research Associates. "First and foremost the decline in energy prices has taken a lot of pressure off in a number of areas. It makes the outlook of the economy more secure as it reduces the chances that we could slip into a recession while the Fed is also under less pressure to increase interest rates."
The Federal Reserve has left its key short-term interest rate unchanged at 5.25% since August after raising it seventeen times in a row in a bid to quell inflationary pressures in the economy, due in no small extent to higher energy prices.
Stock market gains, said Liro, have also been fueled by third-quarter earnings
reports that have "exceeded expectations once again."
"And finally, we've started to see a little bit more [new] money flowing into the market although nothing like the flows in previous bull markets," he said.
In Tuesday trading, investor sentiment was somewhat dented by a report showing an unexpected dip in consumer confidence as well as a manufacturing report that came in weaker than expected.
By sector, home builders, transportation stocks and pharmaceutical companies came under pressure.
Tuesday, October 31, 2006
Good Read about Stem Cells
DID YOU SEE THE SIZE OF THOSE HEADLINES? "Stem Cells Used to Create Artificial Liver," the New York Times screamed on its front page. "Breakthrough! Stem Cells to One Day Create Organ for Liver Transplant," was how the Washington Post put it. "Stem Cell Breakthrough Demonstrates Viability of New Science," yelled the Los Angeles Times. "Stem Cell Hope for People with Liver Disease," agreed USA Today. The story was so big that Katie Couric narrated a special report, expressing her profound gratitude for the hope these dedicated stem-cell scientists had brought to suffering humanity.
What's that? You didn't see those headlines? You say you somehow missed the story? Well, don't blame yourself. You are not out of touch. The above headlines never appeared, the stories have not been written.
Don't get me wrong: The breakthrough described in the fictional headlines is real. British scientists have created an artificial liver--from scratch--using stem cells. The research does offer tremendous hope for the alleviation of human suffering. But you probably didn't hear about this amazing achievement because the stem cells the scientists used to build a human liver did not come from embryos: They came from umbilical cord blood.
This made their scientific achievement politically incorrect. A story that doesn't validate the stem-cell mantra that embryonic stem cells offer the "best hope" for future cures isn't worth much attention. Even the most important adult or umbilical cord blood stem-cell breakthroughs usually receive only minor, inside-the-paper coverage. This is the primary reason why so many people
still don't know about the many advances being made on a continual basis in human research with ethical, adult and umbilical cord blood stem cells.
HERE'S THE STORY: Two scientists from Newcastle University, Nico Forraz and Colin McGuckin, have built dime-sized human livers using stem cells found in umbilical cord blood. The livers are already sufficient for use in drug testing--perhaps in place of using some animals and humans as research subjects. The scientists believe that within five years, stem-cell generated liver tissue could be sufficiently perfected for use in treating human diseases caused by injury, disease, and alcohol abuse. Perhaps in 15 years, the technique could even be employed to manufacture whole human livers suitable for transplantation.
Contrast this general media's shunning of this major story with its sensationalistic reporting several weeks ago of the bogus story that scientists had obtained embryonic stem cells without destroying embryos. That story, unlike the umbilical-cord-blood-stem-cells-into-liver breakthrough, got front-page play and major television coverage. It was deemed news because it was seen as undermining President Bush's stem-cell policy.
Indeed, if this new breakthrough had been accomplished with embryonic stem cells instead of umbilical cord blood stem cells, the headlines would have been enormous. The second paragraph of the stories would have accused President Bush of holding up potentially life-saving cures. Notable scientists and bioethicists would have been touting the new dawn of regenerative medicine that was coming into being, despite Bush's resistance.
Instead, we hear the sound of silence--thanks to the news blockade that doesn't care much about stem-cell breakthroughs unless they come from destroyed embryos.
What's that? You didn't see those headlines? You say you somehow missed the story? Well, don't blame yourself. You are not out of touch. The above headlines never appeared, the stories have not been written.
Don't get me wrong: The breakthrough described in the fictional headlines is real. British scientists have created an artificial liver--from scratch--using stem cells. The research does offer tremendous hope for the alleviation of human suffering. But you probably didn't hear about this amazing achievement because the stem cells the scientists used to build a human liver did not come from embryos: They came from umbilical cord blood.
This made their scientific achievement politically incorrect. A story that doesn't validate the stem-cell mantra that embryonic stem cells offer the "best hope" for future cures isn't worth much attention. Even the most important adult or umbilical cord blood stem-cell breakthroughs usually receive only minor, inside-the-paper coverage. This is the primary reason why so many people
still don't know about the many advances being made on a continual basis in human research with ethical, adult and umbilical cord blood stem cells.
HERE'S THE STORY: Two scientists from Newcastle University, Nico Forraz and Colin McGuckin, have built dime-sized human livers using stem cells found in umbilical cord blood. The livers are already sufficient for use in drug testing--perhaps in place of using some animals and humans as research subjects. The scientists believe that within five years, stem-cell generated liver tissue could be sufficiently perfected for use in treating human diseases caused by injury, disease, and alcohol abuse. Perhaps in 15 years, the technique could even be employed to manufacture whole human livers suitable for transplantation.
Contrast this general media's shunning of this major story with its sensationalistic reporting several weeks ago of the bogus story that scientists had obtained embryonic stem cells without destroying embryos. That story, unlike the umbilical-cord-blood-stem-cells-into-liver breakthrough, got front-page play and major television coverage. It was deemed news because it was seen as undermining President Bush's stem-cell policy.
Indeed, if this new breakthrough had been accomplished with embryonic stem cells instead of umbilical cord blood stem cells, the headlines would have been enormous. The second paragraph of the stories would have accused President Bush of holding up potentially life-saving cures. Notable scientists and bioethicists would have been touting the new dawn of regenerative medicine that was coming into being, despite Bush's resistance.
Instead, we hear the sound of silence--thanks to the news blockade that doesn't care much about stem-cell breakthroughs unless they come from destroyed embryos.
Monday, October 30, 2006
General Science News: Male contraceptive gets results
Scientists are developing a male contraceptive drug which stops the development process of sperm.
Tests on rats show blocking connections to cells which "nurture" developing sperm makes the animals infertile.
The US and Italian researchers say they used relatively low doses of the molecule and found no obvious side effects, and the effect was reversible.
But they told Nature Medicine that work was now needed to see if their approach is equally effective and safe in men.
High dosage
When sperm are being made in the body in a process called spermatogenesis they sit next to other cells, called Sertoli cells, which nurse and help them grow.
If the connection between these two cell types is broken, infertility can result in men.
In the study authors used a recently developed molecule called Adjudin to dislodge the developing sperm from the Sertoli cells.
However Adjudin is also known to be toxic at high doses.
To get round this, the researchers linked it chemically to a hormone, called FSH, which acts in the testicles where sperm are made.
The FSH, which the researchers made inactive so it would merely act as a carrier and not cause any effect itself, delivered Adjudin to where it was needed, allowing much lower doses to be given.
This made the developing sperm cells "fall off" too early, before they were properly mature, resulting in complete but temporary loss of fertility in the rats.
More research is needed to assess if the same approach could work in humans.
But the researchers, led by Dr Dolores Mruk, from the Center For Biomedical Research in New York, said: "We anticipate that this compound could become a male contraceptive for human use."
Tests on rats show blocking connections to cells which "nurture" developing sperm makes the animals infertile.
The US and Italian researchers say they used relatively low doses of the molecule and found no obvious side effects, and the effect was reversible.
But they told Nature Medicine that work was now needed to see if their approach is equally effective and safe in men.
High dosage
When sperm are being made in the body in a process called spermatogenesis they sit next to other cells, called Sertoli cells, which nurse and help them grow.
If the connection between these two cell types is broken, infertility can result in men.
In the study authors used a recently developed molecule called Adjudin to dislodge the developing sperm from the Sertoli cells.
However Adjudin is also known to be toxic at high doses.
To get round this, the researchers linked it chemically to a hormone, called FSH, which acts in the testicles where sperm are made.
The FSH, which the researchers made inactive so it would merely act as a carrier and not cause any effect itself, delivered Adjudin to where it was needed, allowing much lower doses to be given.
This made the developing sperm cells "fall off" too early, before they were properly mature, resulting in complete but temporary loss of fertility in the rats.
More research is needed to assess if the same approach could work in humans.
But the researchers, led by Dr Dolores Mruk, from the Center For Biomedical Research in New York, said: "We anticipate that this compound could become a male contraceptive for human use."
Sirna soars after buyout deal afterhours!!!!
Sirna Therapeutics Inc. shares almost doubled late Monday after Merck & Co. Inc. agreed to pay $1.1 billion cash to acquire the biotechnology company, expanding its portfolio of drug development platforms.
Shares of Sirna surged $6.28 to change hands for $12.73 in after-hours trading. Merck's offer of $13 per share was a 102% premium over Sirna's closing price of $6.45.
The San Francisco-based company develops therapeutics using RNA interference, which aims to treat diseases by disrupting the expression of disease-causing genes.
"RNAi is a powerful enabler of drug discovery in cells, in animals, and in humans. We can potentially use this technology to target the activity of genes which control the activity of cancer cells, and so produce their destruction without damaging normal cells," Stephen Friend, executive vice president and franchise head of Merck's oncology and neuroscience in its research division, said in a statement.
Andrew Fire and Craig Mello were recently awarded the Nobel Prize in Medicine for their discovery of RNAi.
Merck began researching RNAi in 2001, when it bought Rosetta Inpharmatics Inc.
Sirna's lead product candidate is for the treatment of the wet-form of age related macular degeneration, the leading cause of blindness in the elderly, known as Sirna-027. It's being developed in collaboration with Allergan Inc. It has a separate alliance with GlaxoSmithKline PLC to develop compounds for the treatment of respiratory diseases.
"We had been talking with Merck about a drug development collaboration," said Jim Niedel, managing director of New Leaf Venture Partners, and out of those talks arose the acquisition talks. New Leaf manages the healthcare portfolio of The Sprout Group and holds about 25% of Sirna's shares, Niedel said.
See my post from 10-3-06 where I explain how RNAi works.
Shares of Sirna surged $6.28 to change hands for $12.73 in after-hours trading. Merck's offer of $13 per share was a 102% premium over Sirna's closing price of $6.45.
The San Francisco-based company develops therapeutics using RNA interference, which aims to treat diseases by disrupting the expression of disease-causing genes.
"RNAi is a powerful enabler of drug discovery in cells, in animals, and in humans. We can potentially use this technology to target the activity of genes which control the activity of cancer cells, and so produce their destruction without damaging normal cells," Stephen Friend, executive vice president and franchise head of Merck's oncology and neuroscience in its research division, said in a statement.
Andrew Fire and Craig Mello were recently awarded the Nobel Prize in Medicine for their discovery of RNAi.
Merck began researching RNAi in 2001, when it bought Rosetta Inpharmatics Inc.
Sirna's lead product candidate is for the treatment of the wet-form of age related macular degeneration, the leading cause of blindness in the elderly, known as Sirna-027. It's being developed in collaboration with Allergan Inc. It has a separate alliance with GlaxoSmithKline PLC to develop compounds for the treatment of respiratory diseases.
"We had been talking with Merck about a drug development collaboration," said Jim Niedel, managing director of New Leaf Venture Partners, and out of those talks arose the acquisition talks. New Leaf manages the healthcare portfolio of The Sprout Group and holds about 25% of Sirna's shares, Niedel said.
See my post from 10-3-06 where I explain how RNAi works.
Emisphere Technologies, Inc. Shares Fall On Mixed Results From Diabetes Drug
TARRYTOWN, N.Y.--Emisphere Technologies, Inc. (“Emisphere”, NASDAQ: EMIS) announced today results from its 90-day, Phase 2 study of its oral insulin product utilizing its eligen® oral delivery technology. The four-arm study evaluated the safety and efficacy of low and high fixed doses of oral insulin tablets versus placebo in patients with Type 2 Diabetes Mellitus on existing oral metformin monotherapy. The trial focused on the safety of oral insulin, specifically noting incidents of hypoglycemia, as well as the occurrence of insulin antibodies. The study met the Company’s objectives for both safety and efficacy.
The eligen technology is basically a packaging mechanism as a drug carrier:
"Drug molecules exist in many different shapes, or conformations. Some conformations can be transported across the cell membranes while others are too large or too charged to do so. The eligen technology uses the body’s natural passive transcellular transport process to enable large or highly charged molecules to cross cell membranes. Once the drug molecule crosses the membrane, the EMISPHERE delivery agent dissociates from the drug molecule, which then reestablishes its natural conformation and returns to its therapeutically active state."
EMIS closed down 24% today to $6.77- ouch.
The eligen technology is basically a packaging mechanism as a drug carrier:
"Drug molecules exist in many different shapes, or conformations. Some conformations can be transported across the cell membranes while others are too large or too charged to do so. The eligen technology uses the body’s natural passive transcellular transport process to enable large or highly charged molecules to cross cell membranes. Once the drug molecule crosses the membrane, the EMISPHERE delivery agent dissociates from the drug molecule, which then reestablishes its natural conformation and returns to its therapeutically active state."
EMIS closed down 24% today to $6.77- ouch.
Update from post on 10-25-06! The vampire bats are back from the dead:
Forest Laboratories, Inc. (FRX) And PAION Vampire Bat Drug Back From Dead; Drug Trial Resumes
--(BUSINESS WIRE)--Biopharmaceutical company PAION AG (FSE: PA8) today announced that the independent Data Monitoring Committee (DMC) for the DIAS-2 Phase III study met and informed the Steering Committee, PAION and its development partner for Desmoteplase, Forest Laboratories, Inc. (New York, USA), that it has reviewed the cumulative data from the study provided by the Companies and recommended to resume patient enrollment into DIAS-2 with no modification of the protocol. At this meeting, the DMC reviewed data from 170 randomized patients. The DIAS-2 study is evaluating PAION's drug candidate Desmoteplase in patients with acute ischaemic stroke. The Companies continue to expect that enrollment will be completed by the end of 2006 and that study results will be available by the middle of 2007.
"We are reassured by the DMC's recommendation and are looking forward to complete the study as an important milestone in the development of this potentially breakthrough stroke medication," states PAION's CEO Dr Wolfgang Soehngen. "We wish to thank our clinical investigators for their continued support in conducting the clinical trial and the positive feedback that we received during the ongoing stroke conference in Cape Town. We also appreciate the confidence of our shareholders and the analysts who cover PAION as they have provided a balanced description of the situation in PAION."
FRX is up $1.01 at this hour.
--(BUSINESS WIRE)--Biopharmaceutical company PAION AG (FSE: PA8) today announced that the independent Data Monitoring Committee (DMC) for the DIAS-2 Phase III study met and informed the Steering Committee, PAION and its development partner for Desmoteplase, Forest Laboratories, Inc. (New York, USA), that it has reviewed the cumulative data from the study provided by the Companies and recommended to resume patient enrollment into DIAS-2 with no modification of the protocol. At this meeting, the DMC reviewed data from 170 randomized patients. The DIAS-2 study is evaluating PAION's drug candidate Desmoteplase in patients with acute ischaemic stroke. The Companies continue to expect that enrollment will be completed by the end of 2006 and that study results will be available by the middle of 2007.
"We are reassured by the DMC's recommendation and are looking forward to complete the study as an important milestone in the development of this potentially breakthrough stroke medication," states PAION's CEO Dr Wolfgang Soehngen. "We wish to thank our clinical investigators for their continued support in conducting the clinical trial and the positive feedback that we received during the ongoing stroke conference in Cape Town. We also appreciate the confidence of our shareholders and the analysts who cover PAION as they have provided a balanced description of the situation in PAION."
FRX is up $1.01 at this hour.
Point Therapeutics shares rise on osteosarcoma trial data
SAN FRANCISCO-- Point Therapeutics Inc. (POTP)shares jumped 22% to $1.53 in Monday morning trade after the Boston-based biopharmaceutical company said new data in an osteosarcoma model demonstrated that mice treated with talabostat, the company's lead product candidate, had a four-fold decrease in the number of primary tumors compared to saline treatment. In a separate experiment, the company said mice treated with talabostat had a 20-fold decrease in the number of metastatic lung nodules. The studies were presented at the annual meeting of the International Society for Biological Therapy of Cancer Development in Los Angeles. In one experiment, talabostat was shown to decrease the growth of primary tumors. Mice were injected intramuscularly with a murine osteosarcoma cell line and treatment with either talabostat or saline began the following day. Mice treated with talabostat had a marked reduction in the development of primary tumors. Only two out of 10 mice treated with talabostat went on to form tumors whereas eight out 10 mice treated with saline formed tumors.
REMEMBER THAT THIS IS PRECLINICAL DATA--NOT IN HUMANS OR EVEN PHASE 1.
What is talabostat and how does it work?
Talabostat (valine-proline-boronic acid) is a potent and long-acting inhibitor of dipeptidyl peptidases, or matrix metalloproteases, MMP's. MMPs have been under intense research for cancer targets for many years.
So what are dipeptidyl peptidases? They are enzymes that cut proteins on the extracellular matrix and proteins that surround tumors that are solid. Here is a good example of a compound being tested, it worked, they ran with it and they really do not know the exact mechanism of action other than the basic pharmacokinetics.
POTP is up 16% today to $1.45 in heavy trading.
REMEMBER THAT THIS IS PRECLINICAL DATA--NOT IN HUMANS OR EVEN PHASE 1.
What is talabostat and how does it work?
Talabostat (valine-proline-boronic acid) is a potent and long-acting inhibitor of dipeptidyl peptidases, or matrix metalloproteases, MMP's. MMPs have been under intense research for cancer targets for many years.
So what are dipeptidyl peptidases? They are enzymes that cut proteins on the extracellular matrix and proteins that surround tumors that are solid. Here is a good example of a compound being tested, it worked, they ran with it and they really do not know the exact mechanism of action other than the basic pharmacokinetics.
POTP is up 16% today to $1.45 in heavy trading.
Asian stocks were mixed to lower Monday
Asian stocks were mixed to lower Monday, with Japan's Nikkei 225 Index losing ground after weak quarterly U.S. GDP data weighed on exporters such as Toyota Motor and Honda Motor while NTT Docomo Inc. fell back after posting disappointing half-year profit figures.
U.S. stock indexes ended weaker Friday after the government reported the economy grew at a slower-than-expected annual rate of 1.6% in the third quarter, below economists' expectations of 2%.
Japan's Nikkei 225 Index fell 1.6% in early-afternoon trading to 16,407.18.
Data released ahead of trading showed Japanese industrial production fell 0.7% while inventories rose slightly in September from a month earlier, according to the Nikkei daily, citing figures from the Ministry of Economy, Trade and Industry.
Elsewhere around Asia, Australia's S&P/ASX 200 was up 0.6% and South Korea's Kospi was down 0.9%. Taiwan's Weighted Price Index was down 1%. Markets in Hong Kong were closed for a public holiday.
"Although the yen looks inexpensive based on the current account surplus to GDP and interest rates in Japan are on the rise, investors have continued to borrow in yen and invest in higher nominal interest rates overseas," Sean Darby, regional Asia economist with Nomura, wrote in a note to clients. "The heavy borrowing in yen has driven risk appetite to insatiable levels, while pushing the vulnerability of equity markets towards a sharp correction as positions are closed at year-end."
U.S. stock indexes ended weaker Friday after the government reported the economy grew at a slower-than-expected annual rate of 1.6% in the third quarter, below economists' expectations of 2%.
Japan's Nikkei 225 Index fell 1.6% in early-afternoon trading to 16,407.18.
Data released ahead of trading showed Japanese industrial production fell 0.7% while inventories rose slightly in September from a month earlier, according to the Nikkei daily, citing figures from the Ministry of Economy, Trade and Industry.
Elsewhere around Asia, Australia's S&P/ASX 200 was up 0.6% and South Korea's Kospi was down 0.9%. Taiwan's Weighted Price Index was down 1%. Markets in Hong Kong were closed for a public holiday.
"Although the yen looks inexpensive based on the current account surplus to GDP and interest rates in Japan are on the rise, investors have continued to borrow in yen and invest in higher nominal interest rates overseas," Sean Darby, regional Asia economist with Nomura, wrote in a note to clients. "The heavy borrowing in yen has driven risk appetite to insatiable levels, while pushing the vulnerability of equity markets towards a sharp correction as positions are closed at year-end."
Sunday, October 29, 2006
Market outlook mixed for next week; Economy slows
As an extremely strong month draws to a close, stock investors are in a bit of a pickle.
On one hand, there are many reasons to keep the rally going. On the other hand, the rally's been going so long, it might be time to step back.
Strong earnings, low oil prices and the likelihood that the Federal Reserve is done raising rates for now should all keep equities buoyant. But countering that is the reality of the slowing economy and the threat that it poses to corporate earnings.
"The economy is slowing and it will begin to undermine earnings," said Ned Riley, chief investment strategist at Riley Asset Management. "But the market may have already accounted for that and seems to be focused on other things."
25 Rules to Grow Rich By
Riley said that in the short term, stocks should be able to keep pushing higher, particularly if this week's economic and earnings news proves supportive. (See charts for details).
"We're still in the earnings period, and that will continue to be the main driver in the short term," said Brett Gallagher, head of equities at Julius Baer. "We've had strong results and the market has reacted well, as expected."
However, "technically, we're overdone," Gallagher said, referring to the fact that on a technical market level, stocks are probably due for a retreat - and one that's bigger than Friday's selloff. This tug of war between the strong fundamentals and the likelihood of a pullback could keep markets choppy in the near future, he added.
That was certainly the case last week, where stocks rallied for four days straight, only to do an about-face Friday, after a report showed economic growth in the third quarter slowed far more than expected, due largely to the slowing housing market.
While the selloff no doubt unsettled some investors, it certainly wasn't surprising.
On one hand, there are many reasons to keep the rally going. On the other hand, the rally's been going so long, it might be time to step back.
Strong earnings, low oil prices and the likelihood that the Federal Reserve is done raising rates for now should all keep equities buoyant. But countering that is the reality of the slowing economy and the threat that it poses to corporate earnings.
"The economy is slowing and it will begin to undermine earnings," said Ned Riley, chief investment strategist at Riley Asset Management. "But the market may have already accounted for that and seems to be focused on other things."
25 Rules to Grow Rich By
Riley said that in the short term, stocks should be able to keep pushing higher, particularly if this week's economic and earnings news proves supportive. (See charts for details).
"We're still in the earnings period, and that will continue to be the main driver in the short term," said Brett Gallagher, head of equities at Julius Baer. "We've had strong results and the market has reacted well, as expected."
However, "technically, we're overdone," Gallagher said, referring to the fact that on a technical market level, stocks are probably due for a retreat - and one that's bigger than Friday's selloff. This tug of war between the strong fundamentals and the likelihood of a pullback could keep markets choppy in the near future, he added.
That was certainly the case last week, where stocks rallied for four days straight, only to do an about-face Friday, after a report showed economic growth in the third quarter slowed far more than expected, due largely to the slowing housing market.
While the selloff no doubt unsettled some investors, it certainly wasn't surprising.
Saturday, October 28, 2006
Man , another HCV polymerase inhibitor!
Pharmasset announced today that a "Late Breaker" presentation describing the results of Study 303, a 48 week follow-on study to the Korean Phase 3 drug registration trial of Clevudine for the treatment of Hepatitis B, will be presented at the 57th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) being held in Boston, Massachusetts from October 27-31, 2006. The Clevudine abstract can be viewed on the AASLD website at http://www.aasld.org.
Clevudine is a nucleoside analogue that has shown potent anti-HBV activity in both in vitro and late-stage clinical studies in over 600 HBV-infected patients. The poster presentation at AASLD will describe the results of a study conducted by Bukwang Pharmaceuticals. In this study, Clevudine demonstrated potent antiviral activity in e-antigen positive (HBeAg+) and e-antigen negative (HBeAg-) patient populations, along with a marked 12-week post-treatment antiviral effect or sustained virological response (SVR) in both patient populations. Clevudine was generally well tolerated throughout the course of this study. Clevudine received conditional drug approval from the Korean Food & Drug Administration in July 2006, and the product launch in Korea is anticipated by the end of 2006.
"In this study, 31% of HBeAg+ patients and 92% of HBeAg -- patients have undetectable HBV 12 weeks after the end of treatment," stated Schaefer Price, Pharmasset's President & CEO. "The duration of Clevudine's post-treatment effect is unique. To our knowledge, Clevudine is the only HBV therapeutic agent, investigational or approved, that has demonstrated potentially clinically meaningful SVR levels at 12 weeks and 24 weeks post-treatment. We look forward to initiating our U.S. and European registration studies of Clevudine in 2007."
Clevudine acts directly on the HBV-polymerase to reduce its ability to incorporate nucleosides into new viral DNA chains. In preclinical animal models, Clevudine also demonstrated the ability to significantly reduce covalently closed circular DNA, or cccDNA, the form of HBV that is believed to be responsible for the persistence of an HBV infection.
Clevudine is a nucleoside analogue that has shown potent anti-HBV activity in both in vitro and late-stage clinical studies in over 600 HBV-infected patients. The poster presentation at AASLD will describe the results of a study conducted by Bukwang Pharmaceuticals. In this study, Clevudine demonstrated potent antiviral activity in e-antigen positive (HBeAg+) and e-antigen negative (HBeAg-) patient populations, along with a marked 12-week post-treatment antiviral effect or sustained virological response (SVR) in both patient populations. Clevudine was generally well tolerated throughout the course of this study. Clevudine received conditional drug approval from the Korean Food & Drug Administration in July 2006, and the product launch in Korea is anticipated by the end of 2006.
"In this study, 31% of HBeAg+ patients and 92% of HBeAg -- patients have undetectable HBV 12 weeks after the end of treatment," stated Schaefer Price, Pharmasset's President & CEO. "The duration of Clevudine's post-treatment effect is unique. To our knowledge, Clevudine is the only HBV therapeutic agent, investigational or approved, that has demonstrated potentially clinically meaningful SVR levels at 12 weeks and 24 weeks post-treatment. We look forward to initiating our U.S. and European registration studies of Clevudine in 2007."
Clevudine acts directly on the HBV-polymerase to reduce its ability to incorporate nucleosides into new viral DNA chains. In preclinical animal models, Clevudine also demonstrated the ability to significantly reduce covalently closed circular DNA, or cccDNA, the form of HBV that is believed to be responsible for the persistence of an HBV infection.
Stocks seen higher but data may bring in cool front
Employment report for October due Friday; earnings growth rate rises to 17%
U.S. stocks are expected to edge higher next week as investors struggle to decide whether to take their cues from strong corporate earnings or signs that economic growth is moderating.
Some analysts said the strength of earnings - nearly three-quarters of major
companies have reported higher-than-expected profit for the third quarter -- should provide support for the market next week. Others said the recent rally has left the major indexes vulnerable and that any weakness in the raft of economic reports due could send stocks lower or keep them range-bound.
"The market is projecting at least no Fed [action], modest economic growth and diminishing inflation numbers. Any economic report that deviates significantly from that is going to shake up the market," said Paul Nolte, director of investments at Hinsdale Associates.
Investors will have to parse data including October payrolls, snapshots of September's inflation, manufacturing and construction reports as well as monthly retail sales data from chain stores.
But the economic data won't completely steal the spotlight from the strength that corporate earnings have shown so far this season and from the pile of results still to be released, analysts said.
"In the third week of earnings season, we're still coming out with more positive surprises...and usually those taper off by this time," said Marc Pado, U.S. market strategist at Cantor Fitzgerald.
Major results on deck next week include Verizon Communications, Procter & Gamble, Humana Inc., Time Warner Inc., and Clear Channel Communications, which said earlier this week that it's considering strategic alternatives.
As of Friday, have reported results, with 94 reports scheduled for next week.
So far, according to Thomson Financial, 74% of companies have beat earnings estimates, 11% have matched, and 15% have fallen short of expectations.
The blended growth rate, which combines reported and estimated figures, is now up to 17.4% from 15.3% at the beginning of the quarter. That's the highest growth rate since the fourth quarter of 2004.
"Those are very strong numbers versus expectations," said John Butters, senior research analyst at Thomson Financial, since typically 60% of companies at this point in an earnings season post results above expectations, 20% match, and 20% come in below.
Companies are also beating estimates by 6.4%, above the long-term average of 3.2%.
U.S. stocks are expected to edge higher next week as investors struggle to decide whether to take their cues from strong corporate earnings or signs that economic growth is moderating.
Some analysts said the strength of earnings - nearly three-quarters of major
companies have reported higher-than-expected profit for the third quarter -- should provide support for the market next week. Others said the recent rally has left the major indexes vulnerable and that any weakness in the raft of economic reports due could send stocks lower or keep them range-bound.
"The market is projecting at least no Fed [action], modest economic growth and diminishing inflation numbers. Any economic report that deviates significantly from that is going to shake up the market," said Paul Nolte, director of investments at Hinsdale Associates.
Investors will have to parse data including October payrolls, snapshots of September's inflation, manufacturing and construction reports as well as monthly retail sales data from chain stores.
But the economic data won't completely steal the spotlight from the strength that corporate earnings have shown so far this season and from the pile of results still to be released, analysts said.
"In the third week of earnings season, we're still coming out with more positive surprises...and usually those taper off by this time," said Marc Pado, U.S. market strategist at Cantor Fitzgerald.
Major results on deck next week include Verizon Communications, Procter & Gamble, Humana Inc., Time Warner Inc., and Clear Channel Communications, which said earlier this week that it's considering strategic alternatives.
As of Friday, have reported results, with 94 reports scheduled for next week.
So far, according to Thomson Financial, 74% of companies have beat earnings estimates, 11% have matched, and 15% have fallen short of expectations.
The blended growth rate, which combines reported and estimated figures, is now up to 17.4% from 15.3% at the beginning of the quarter. That's the highest growth rate since the fourth quarter of 2004.
"Those are very strong numbers versus expectations," said John Butters, senior research analyst at Thomson Financial, since typically 60% of companies at this point in an earnings season post results above expectations, 20% match, and 20% come in below.
Companies are also beating estimates by 6.4%, above the long-term average of 3.2%.
Friday, October 27, 2006
More bad news for Aspreva: MMF fails to meet Phase III endpoints
Aspreva Pharmaceuticals Announces Preliminary Results of Phase III Trial of CellCept for Myasthenia Gravis
Aspreva Pharmaceuticals Corporation today announced that based on a preliminary review of the data, CellCept® (mycophenolate mofetil or MMF) in treating myasthenia gravis (MG) failed to meet both primary and secondary endpoints in its phase III trial.
The randomized, double-blind, placebo-controlled clinical trial was designed to evaluate the efficacy and safety of MMF in maintaining or improving symptom control with reduced doses of corticosteroids in patients with myasthenia gravis over a treatment period of 36 weeks. The primary endpoints in the trial included minimal disease activity while maintaining a designated low steroid and cholinesterase inhibitor doses.
The preliminary analysis of the results from Aspreva's phase III trial indicates that MMF failed to meet both the primary and secondary endpoints. Aspreva's analysis also showed that MMF appeared to be generally well tolerated by the patients in the study. The most frequent adverse events were diarrhea, muscle spasms and other symptoms related to the disease.
As previously announced, Aspreva will hold a conference call and webcast beginning at 5:00 pm Eastern Time (2:00 p.m. Pacific Time) on Wednesday, November 1st, and will use this opportunity to discuss these results and to release its full financial and business results for the third quarter 2006.
Myasthenia gravis is a disease of the immune system attacking the own body. Antibodies to the acetylcholine receptor (a transmitter of cell signals) at the neuromuscular junction block the transmission of nerve impulses that normally acetylcholine would provide. This causes a progressive weakness to the patient.
MMF is an immunosupressive drug that prevents T and B lymphocytes from being able to proliferate and grow and stops antibody production from B cells.
(NASDAQ: ASPV; TSX: ASV)closed todays trading down 14% to $18.99.
Aspreva Pharmaceuticals Corporation today announced that based on a preliminary review of the data, CellCept® (mycophenolate mofetil or MMF) in treating myasthenia gravis (MG) failed to meet both primary and secondary endpoints in its phase III trial.
The randomized, double-blind, placebo-controlled clinical trial was designed to evaluate the efficacy and safety of MMF in maintaining or improving symptom control with reduced doses of corticosteroids in patients with myasthenia gravis over a treatment period of 36 weeks. The primary endpoints in the trial included minimal disease activity while maintaining a designated low steroid and cholinesterase inhibitor doses.
The preliminary analysis of the results from Aspreva's phase III trial indicates that MMF failed to meet both the primary and secondary endpoints. Aspreva's analysis also showed that MMF appeared to be generally well tolerated by the patients in the study. The most frequent adverse events were diarrhea, muscle spasms and other symptoms related to the disease.
As previously announced, Aspreva will hold a conference call and webcast beginning at 5:00 pm Eastern Time (2:00 p.m. Pacific Time) on Wednesday, November 1st, and will use this opportunity to discuss these results and to release its full financial and business results for the third quarter 2006.
Myasthenia gravis is a disease of the immune system attacking the own body. Antibodies to the acetylcholine receptor (a transmitter of cell signals) at the neuromuscular junction block the transmission of nerve impulses that normally acetylcholine would provide. This causes a progressive weakness to the patient.
MMF is an immunosupressive drug that prevents T and B lymphocytes from being able to proliferate and grow and stops antibody production from B cells.
(NASDAQ: ASPV; TSX: ASV)closed todays trading down 14% to $18.99.
Dow Ends Down 73 on Slow Economic Growth; BioTech down 0.5% as well
NEW YORK (AP) -- Stocks pulled back Friday after the Commerce Department reported that the economy grew at the slowest pace in more than three years and stirred concern that a desired soft landing in the economy might prove elusive.
Investors have bid up stocks sharply in October on the notion that the economy is slowing, but not in a way that would threaten corporate profits and consumer spending. Investors are also counting on a gradual slowdown to reduce the threat of inflation and convince the Federal Reserve to lower short-term interest rates.
While investors expected Friday's advance reading on gross domestic product would show slowing growth, the report underscored concern that a cooling housing market could spill over into other parts of the economy.
"I think that the market actually was poised for profit-taking and consolidation," said Quincy Krosby, chief investment strategist at The Hartford. She contends the GDP report gave investors an excuse to catch their breath after the recent run-up and called the pullback a healthy pause.
Dow Ends Down 73, Nasdaq Drops 28 After GDP Report Shows Slowest Growth in More Than 3 Years
Investors have bid up stocks sharply in October on the notion that the economy is slowing, but not in a way that would threaten corporate profits and consumer spending. Investors are also counting on a gradual slowdown to reduce the threat of inflation and convince the Federal Reserve to lower short-term interest rates.
While investors expected Friday's advance reading on gross domestic product would show slowing growth, the report underscored concern that a cooling housing market could spill over into other parts of the economy.
"I think that the market actually was poised for profit-taking and consolidation," said Quincy Krosby, chief investment strategist at The Hartford. She contends the GDP report gave investors an excuse to catch their breath after the recent run-up and called the pullback a healthy pause.
Dow Ends Down 73, Nasdaq Drops 28 After GDP Report Shows Slowest Growth in More Than 3 Years
Vertex Pharmaceuticals Incorporated (VRTX) Reports Good Data For Investigational Hepatitis C Drug Telaprevir (VX-950) In Most Patients; Stock Jumps
Researchers will present new data this week suggesting that both wild-type hepatitis C virus and resistant variants were suppressed in patients when pegylated interferon (peginterferon alfa-2a; peg-IFN) was added to telaprevir (VX-950), Vertex's investigational hepatitis C virus (HCV) protease inhibitor, in a Phase 1b clinical study. In addition, clinical investigators will report that 24 of 26 patients who received telaprevir (VX-950) in two early-stage clinical trials had undetectable HCV RNA after receiving follow-on combination therapy with peg-IFN and ribavirin (RBV) through 24 weeks of treatment, a therapeutic regimen following the conclusion of the clinical trials. Clinical investigators will also report that some of these patients have stopped therapy, and that a proportion of them continued to have undetectable HCV RNA after stopping therapy.
The data will be presented while attending the 57th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) and were released in accordance with media guidelines established by the conference. Telaprevir (VX-950) is an investigational drug candidate being developed as part of a global Phase 2b clinical development program by Vertex Pharmaceuticals Incorporated .
Combination of Telaprevir (VX-950) and Peg-IFN Suppressed Both Wild-type Virus and Resistance Variants in 14-day Clinical Study.
REMEMBER from a few days ago; Peg-IFN is pegylated interferon beta which is a proimflammatory cytokine the body makes in response to viral infections. The peg is an added structure that makes the cytokine more stable when injected into the body. It makes patients very ill, with flu like symptoms, fever and malaise.
VX-950 is a small molecule inhibitor of the hepatitis C NS3•4A protease. It was derived through structure-based drug design methodology, evolving from the natural NS5A-NS5B substrate. Inhibition of the polyprotein processing in liver cells as measured by the HCV replicon assay has been demonstrated. Long story short, it keeps the virus from replicating.
VRTX stock is trading very heavily and is up to $39.68 or an increase of 14% as of 12:53PM ET .
The data will be presented while attending the 57th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) and were released in accordance with media guidelines established by the conference. Telaprevir (VX-950) is an investigational drug candidate being developed as part of a global Phase 2b clinical development program by Vertex Pharmaceuticals Incorporated .
Combination of Telaprevir (VX-950) and Peg-IFN Suppressed Both Wild-type Virus and Resistance Variants in 14-day Clinical Study.
REMEMBER from a few days ago; Peg-IFN is pegylated interferon beta which is a proimflammatory cytokine the body makes in response to viral infections. The peg is an added structure that makes the cytokine more stable when injected into the body. It makes patients very ill, with flu like symptoms, fever and malaise.
VX-950 is a small molecule inhibitor of the hepatitis C NS3•4A protease. It was derived through structure-based drug design methodology, evolving from the natural NS5A-NS5B substrate. Inhibition of the polyprotein processing in liver cells as measured by the HCV replicon assay has been demonstrated. Long story short, it keeps the virus from replicating.
VRTX stock is trading very heavily and is up to $39.68 or an increase of 14% as of 12:53PM ET .
Idenix Sees Positive HCV Study Results
Idenix Pharma Says Interim Data Show Valopicitabine Effective in Midstage Hepatitis Study
CAMBRIDGE, Mass.-- Idenix Pharmaceuticals Inc. said Friday interim data from a midstage study showed its hepatitis C drug candidate suppressed the virus with a low rate of side effects after 24 weeks of treatment.
The protocol for the Phase IIb clinical trial was amended in March after patients in the higher dose portion of the study showed signs of gastrointestinal side effects. The study cut out the 800 milligram dosing and continued with 200-milligram and 400-milligram dosing levels, involving 173 patients.
The 24-week data showed that 68 percent of patients receiving valopicitabine in combination with a pegylated interferon achieved viral clearance. The full study will continue for another 24 weeks.
Idenix is collaborating with Novartis Pharma AG to develop the drug.
Shares of Idenix rose 9 cents to $9.97 on the Nasdaq in morning trading.
More on the pharmacology later in the morning!
CAMBRIDGE, Mass.-- Idenix Pharmaceuticals Inc. said Friday interim data from a midstage study showed its hepatitis C drug candidate suppressed the virus with a low rate of side effects after 24 weeks of treatment.
The protocol for the Phase IIb clinical trial was amended in March after patients in the higher dose portion of the study showed signs of gastrointestinal side effects. The study cut out the 800 milligram dosing and continued with 200-milligram and 400-milligram dosing levels, involving 173 patients.
The 24-week data showed that 68 percent of patients receiving valopicitabine in combination with a pegylated interferon achieved viral clearance. The full study will continue for another 24 weeks.
Idenix is collaborating with Novartis Pharma AG to develop the drug.
Shares of Idenix rose 9 cents to $9.97 on the Nasdaq in morning trading.
More on the pharmacology later in the morning!
Nightly Asian Markey Update:
Asian stocks were mixed in early trading Friday, with Hong Kong's blue-chip Hang Seng Index setting a record intraday high while Japan's Nikkei Average edged lower on weakness in blue-chip financial Mitsubishi UFJ, although gains in Honda Motor Corp. Nissan Motors and electronics giant Sony Corp. helped to cushion broader losses.
The Hang Seng, lifted mainly by gains in China Mobile , was up as much as 0.4% to 18,425.34, surpassing its previous intraday record of 18,397 set on March 28, 2000. China Mobile, the second-biggest Hong Kong blue-chip, rose as much as 1%.
The Hang Seng, lifted mainly by gains in China Mobile , was up as much as 0.4% to 18,425.34, surpassing its previous intraday record of 18,397 set on March 28, 2000. China Mobile, the second-biggest Hong Kong blue-chip, rose as much as 1%.
Thursday, October 26, 2006
Nasdaq joins the party while Biotech finishes up 1.3%
Falling oil prices and rallying tech shares recharged the rally Thursday, pushing the Dow to another record high, the S&P 500 to an almost 6-year high and the Nasdaq to its highest point in 5-1/2 years.
The tech-fueled Nasdaq composite (up 20.51 to 2,377.10, Charts) nearly 1 percent, according to early tallies, taking out its 2006 closing high and ending at its highest point since February 2001.
The Dow Jones industrial average (up 28.50 to 12,163.18, Charts) added 0.2 percent, closing at a new record high, after touching a new trading high of 12,165.26 in the afternoon. The blue-chip barometer has now closed at a new record for 13 of the last 18 sessions.
The broader S&P 500 (up 6.54 to 1,388.76, Charts) index added around 0.5 percent, ending at the highest point since November 2000.
Stocks advanced at the open on some upbeat earnings news, declined after the new home sales report, and then recharged in the afternoon, led by the technology and financial sectors.
"It's been a steady increase since the morning," said Joseph Saluzzi, co-head of equity trading at Themis Trading. "We sold off after the housing number, but since then we've stepped up nicely, with oil prices falling and technology leading."
The tech-fueled Nasdaq composite (up 20.51 to 2,377.10, Charts) nearly 1 percent, according to early tallies, taking out its 2006 closing high and ending at its highest point since February 2001.
The Dow Jones industrial average (up 28.50 to 12,163.18, Charts) added 0.2 percent, closing at a new record high, after touching a new trading high of 12,165.26 in the afternoon. The blue-chip barometer has now closed at a new record for 13 of the last 18 sessions.
The broader S&P 500 (up 6.54 to 1,388.76, Charts) index added around 0.5 percent, ending at the highest point since November 2000.
Stocks advanced at the open on some upbeat earnings news, declined after the new home sales report, and then recharged in the afternoon, led by the technology and financial sectors.
"It's been a steady increase since the morning," said Joseph Saluzzi, co-head of equity trading at Themis Trading. "We sold off after the housing number, but since then we've stepped up nicely, with oil prices falling and technology leading."
Renovis stock collapses on NXY-059 Phase III efficacy results
SOUTH SAN FRANCISCO, Calif., Oct. 26 /PRNewswire-FirstCall/ -- Renovis, Inc. announced today that a pivotal Phase III study of NXY-059 (SAINT II) conducted by its exclusive licensee, AstraZeneca, did not demonstrate a statistically significant reduction on the primary endpoint of stroke-related disability in patients treated with NXY-059, as assessed versus placebo using the modified Rankin Scale (mRS) (p=0.33, odds ratio 0.94).
On a secondary endpoint in the SAINT II study, treatment with NXY-059 did not result in a statistically significant improvement in neurological status versus placebo on the National Institute of Health Stroke Scale (NIHSS) (p=0.70). There was also no evidence of NXY-059 lowering the incidence of symptomatic intracranial hemorrhage when administered with the approved thrombolytic agent, rt-PA (p=0.56). The incidence and profile of adverse events in patients in SAINT II receiving NXY-059 was similar to placebo. The mortality rate was also comparable in the treatment and placebo groups.
"We are obviously very disappointed by the lack of efficacy shown by NXY-059 in the SAINT II study," commented Corey S. Goodman, Ph.D., President and Chief Executive Officer of Renovis. "Stroke is an area of enormous medical need and we had hoped that NXY-059 might become an important new treatment option for patients and physicians. Unfortunately, the data are clear and although we will continue to review the results from SAINT I and SAINT II, we understand AstraZeneca's decision to discontinue development of NXY-059."
WHAT IS NXY-059 and HOW DOES IT WORK?
Increased free radical formation contributes to the damage caused to the brain by acute ischemia. NXY-059 is a nitrone-based free radical trapping agent in development for acute stroke. Free radicals are generated during brain ischemia and are implicated in the pathological events that lead to brain damage. Beneficial effects have been demonstrated both early and late, whether assessed by infarct volume measured histologically or by functional testing. Neuroprotection has been confirmed in more than one species, including primates, and validated in independent laboratories. Nitroxides and nitrones are stabilized forms of the biological messenger nitric oxide. They also have some unique properties. e.g. unlike other antioxidants, they generally neither act as proxidants, nor do they propagate free radical chain reactions. They inhibit superoxides.
Renovis (Nasdaq: RNVS)is down $10.62 which is roughly 75% in late afternoon trading.
On a secondary endpoint in the SAINT II study, treatment with NXY-059 did not result in a statistically significant improvement in neurological status versus placebo on the National Institute of Health Stroke Scale (NIHSS) (p=0.70). There was also no evidence of NXY-059 lowering the incidence of symptomatic intracranial hemorrhage when administered with the approved thrombolytic agent, rt-PA (p=0.56). The incidence and profile of adverse events in patients in SAINT II receiving NXY-059 was similar to placebo. The mortality rate was also comparable in the treatment and placebo groups.
"We are obviously very disappointed by the lack of efficacy shown by NXY-059 in the SAINT II study," commented Corey S. Goodman, Ph.D., President and Chief Executive Officer of Renovis. "Stroke is an area of enormous medical need and we had hoped that NXY-059 might become an important new treatment option for patients and physicians. Unfortunately, the data are clear and although we will continue to review the results from SAINT I and SAINT II, we understand AstraZeneca's decision to discontinue development of NXY-059."
WHAT IS NXY-059 and HOW DOES IT WORK?
Increased free radical formation contributes to the damage caused to the brain by acute ischemia. NXY-059 is a nitrone-based free radical trapping agent in development for acute stroke. Free radicals are generated during brain ischemia and are implicated in the pathological events that lead to brain damage. Beneficial effects have been demonstrated both early and late, whether assessed by infarct volume measured histologically or by functional testing. Neuroprotection has been confirmed in more than one species, including primates, and validated in independent laboratories. Nitroxides and nitrones are stabilized forms of the biological messenger nitric oxide. They also have some unique properties. e.g. unlike other antioxidants, they generally neither act as proxidants, nor do they propagate free radical chain reactions. They inhibit superoxides.
Renovis (Nasdaq: RNVS)is down $10.62 which is roughly 75% in late afternoon trading.
Market update 2:00PM
BioTech stocks graph
Absent a convincing means to more aggressively lift stocks higher earlier, further deterioration in oil prices is finally acting as an incentive for buyers to keep the rally going. Crude oil is now down 2.0% at $60.15/bbl, losing ground in sympathy with a sell-off in natural gas futures. After surging 12% over the last two sessions, natural gas for November delivery is now down 3% amid record inventories and the Nov. contract expiring tomorrow.DJ30 +19.29 NASDAQ +14.32 SP500 +4.84 NASDAQ Dec/Adv/Vol 1221/1730/1.49 bln NYSE Dec/Adv/Vol 1207/1990/1.04 bln
Biotech is up at this hour:
Biotechnology
Composite Value: 1123.9
Today's Change: +1.30%
S&P 500: +0.33%
Absent a convincing means to more aggressively lift stocks higher earlier, further deterioration in oil prices is finally acting as an incentive for buyers to keep the rally going. Crude oil is now down 2.0% at $60.15/bbl, losing ground in sympathy with a sell-off in natural gas futures. After surging 12% over the last two sessions, natural gas for November delivery is now down 3% amid record inventories and the Nov. contract expiring tomorrow.DJ30 +19.29 NASDAQ +14.32 SP500 +4.84 NASDAQ Dec/Adv/Vol 1221/1730/1.49 bln NYSE Dec/Adv/Vol 1207/1990/1.04 bln
Biotech is up at this hour:
Biotechnology
Composite Value: 1123.9
Today's Change: +1.30%
S&P 500: +0.33%
EntreMed launches lung cancer trial for MKC-1
EntreMed has launched a first round of human trials on lung cancer patients for a drug already in clinical tests to battle other forms of cancer.
The Rockville company is starting Phase I trials of MKC-1, its small-molecule drug to treat lung cancer -- the same drug it began testing in Phase I for leukemia one month ago and in Phase II trials for advanced breast cancer 10 months ago.
The lung-cancer trial is taking place at various medical centers, but the lead institution is Indiana University Cancer Center, which is also a site for EntreMed's trials of another drug candidate, Panzem, which treats advanced breast and prostate cancer.
MKC-1 will be administered to volunteers in conjunction with another federally approved drug that blocks folic acid activity and helps treat lung cancer as well.
EntreMed will determine the effectiveness of MKC-1 in that combination in a Phase I trial, followed by a Phase II trial with up to 60 patients, including those who need further treatment after the first phase.
Earlier this year, EntreMed started Phase I and Phase II trials of Panzem.
MKC-1 is a small molecule cell cycle inhibitor (think mitosis). Specifically, MKC-1 arrests cellular mitosis by inhibiting a novel intracellular target important in cellular trafficking that has been shown to be involved in cell division. MKC-1 binds to tubulin and thus inhibits the mitotic phase of the cell cycle.
A Phase 2 clinical trial of MKC-1 in metastatic breast cancer patients commenced in January of this year and a Phase 1 study of MKC-1 in hematological(blood) cancers commenced in September. The Company anticipates that a second Phase 2 trial with MKC-1 in non-small cell lung cancer will commence in the fourth quarter of 2006.
EntreMed (NASDAQ:ENMD) is on average volume at 1.99 in afternoon trading.
The Rockville company is starting Phase I trials of MKC-1, its small-molecule drug to treat lung cancer -- the same drug it began testing in Phase I for leukemia one month ago and in Phase II trials for advanced breast cancer 10 months ago.
The lung-cancer trial is taking place at various medical centers, but the lead institution is Indiana University Cancer Center, which is also a site for EntreMed's trials of another drug candidate, Panzem, which treats advanced breast and prostate cancer.
MKC-1 will be administered to volunteers in conjunction with another federally approved drug that blocks folic acid activity and helps treat lung cancer as well.
EntreMed will determine the effectiveness of MKC-1 in that combination in a Phase I trial, followed by a Phase II trial with up to 60 patients, including those who need further treatment after the first phase.
Earlier this year, EntreMed started Phase I and Phase II trials of Panzem.
MKC-1 is a small molecule cell cycle inhibitor (think mitosis). Specifically, MKC-1 arrests cellular mitosis by inhibiting a novel intracellular target important in cellular trafficking that has been shown to be involved in cell division. MKC-1 binds to tubulin and thus inhibits the mitotic phase of the cell cycle.
A Phase 2 clinical trial of MKC-1 in metastatic breast cancer patients commenced in January of this year and a Phase 1 study of MKC-1 in hematological(blood) cancers commenced in September. The Company anticipates that a second Phase 2 trial with MKC-1 in non-small cell lung cancer will commence in the fourth quarter of 2006.
EntreMed (NASDAQ:ENMD) is on average volume at 1.99 in afternoon trading.
Wednesday, October 25, 2006
Late night update: Nikkei advances; Honda shares rise on earnings
Asian stocks were broadly higher Thursday, led by markets in Taiwan and Japan as blue-chip Honda Motor Corp. rose after lifting its full-year earnings forecast while Inpex Holdings Inc. and other energy companies advanced on higher oil prices.
Investors also took heart after the Federal Reserve decided Wednesday to hold the key U.S. interest rate steady at 5.25%.
Japan's Nikkei 225 Stock Average (JP:1804610: news, chart, profile) rose as much as 1% to 16,857.58 in the afternoon session. The broader Topix index rose 0.8% to 1,666.60.
Off biotech but you have to diversify.
Investors also took heart after the Federal Reserve decided Wednesday to hold the key U.S. interest rate steady at 5.25%.
Japan's Nikkei 225 Stock Average (JP:1804610: news, chart, profile) rose as much as 1% to 16,857.58 in the afternoon session. The broader Topix index rose 0.8% to 1,666.60.
Off biotech but you have to diversify.
Sanofi-Aventis cutting jobs in France:
Drugmaker Sanofi-Aventis plans to cut 504 jobs in France, blaming government measures to cut healthcare spending which have put a lid on growth in its home country.
Could it have anything to do with those 30 hour work weeks in France?
SNY closed up today 11 cents.
Sanofi-Aventis, through its subsidiaries, engages in the research, development, manufacture, and marketing of pharmaceutical products and human vaccines worldwide.
Could it have anything to do with those 30 hour work weeks in France?
SNY closed up today 11 cents.
Sanofi-Aventis, through its subsidiaries, engages in the research, development, manufacture, and marketing of pharmaceutical products and human vaccines worldwide.
Forest Laboratories Release: Patient Recruitment For Desmoteplase Phase IIB/III Stroke Study DIAS-2 Placed On Hold
NEW YORK, Oct.25 -- Forest Laboratories, Inc. and its development partner for desmoteplase, PAION AG (Aachen, Germany), today announced that the Steering Committee of the Phase IIB/III stroke study, DIAS-2, has decided in agreement with the Companies to place patient recruitment temporarily on hold until further data have been analyzed. The DIAS-2 study is evaluating PAION's drug candidate desmoteplase in patients with acute ischemic stroke.
The Steering Committee followed a recommendation by the independent Data Monitoring Committee (DMC). The DMC had requested additional data in order to facilitate the evaluation of a potential safety signal, which was not specified further by the DMC. The DMC had notified the Steering Committee in its statement that no conclusion on the safety or efficacy of desmoteplase should be drawn based upon this recommendation. The requested data has been processed and will be provided to the DMC within the next day.
What the heck is desmoteplase?
Desmoteplase is a specific plasminogen activator that is a genetically engineered version of a clot-dissolving protein found in the saliva of vampire bats. So what's that? Plamsinogen is the inactive precursor protein of plasmin which is a serine protease that dissolves blood clots in the body.
Currently in Phase III, Desmoteplase has been successfully tested in two independent Phase II studies for the treatment of acute ischaemic stroke between 3 and 9 hours after onset of symptoms and has received fast-track designation from the U.S. Food and Drug Administration.
Forest laboratories (NYSE: FRX) ended trading today down 2.7% at $48.08.
The Steering Committee followed a recommendation by the independent Data Monitoring Committee (DMC). The DMC had requested additional data in order to facilitate the evaluation of a potential safety signal, which was not specified further by the DMC. The DMC had notified the Steering Committee in its statement that no conclusion on the safety or efficacy of desmoteplase should be drawn based upon this recommendation. The requested data has been processed and will be provided to the DMC within the next day.
What the heck is desmoteplase?
Desmoteplase is a specific plasminogen activator that is a genetically engineered version of a clot-dissolving protein found in the saliva of vampire bats. So what's that? Plamsinogen is the inactive precursor protein of plasmin which is a serine protease that dissolves blood clots in the body.
Currently in Phase III, Desmoteplase has been successfully tested in two independent Phase II studies for the treatment of acute ischaemic stroke between 3 and 9 hours after onset of symptoms and has received fast-track designation from the U.S. Food and Drug Administration.
Forest laboratories (NYSE: FRX) ended trading today down 2.7% at $48.08.
Off topic: crude oil volitility
crude oil very volatile this morning.....all over the place. check out http://profit-from-ethanol.blogspot.com/ for some useful info
Charges cost Elan
Elan Corp. said Wednesday that its third-quarter net loss widened to $117 million, from $67.1 million a year ago, after taking a $10.9 million stock based compensation charge and paying a $15 million license fee to Transition Therapeutics. Elan said it's encouraged by the initial results from the relaunch of its Tysabri drug for multiple scleroris. Elan added its confident that revenue, excluding Tysarbi, will exceed $500 million in 2006 and that its EBITDA loss will less than previous guidance.
ELN closed up at 15.70 on tuesday in after hours trading ( on a volume of 1700 LOL)
Natalizumab [earlier post note the suffix] is being marketed under the name of Tysabri. In early news releases, the company had proposed the name of Antegren, but changed the name before launch.
This is a compound of several antibodies in the pipeline targeting different steps in the immune dysfunction that leads to the clinical condition we call MS.
The exact mechanism of action by which natalizumab exerts its effects is not fully defined. MS is believed to develop when activated inflammatory cells, including T cells, cross the blood brain barrier. No one is sure how the inflammatory cells are activated, but the result is the presence of highly active inflammatory cells within the CNS causing destruction of the "insulating" myelin sheath around nerves. Once damaged, the nerves cease functioning normally and the neurologic effects become the symptoms of MS.
Before the inflammatory cells can cross into the CNS, they must bind to the lining of the blood vessels, the endothelium. Natalizumab is thought to work by preventing this binding and hence stopping the migration of the damaging cells.
Structurally, natalizumab is a recombinant humanized IgG4κ monoclonal antibody produced in murine myeloma cells (mouse cells but the Fc receptor replaced by human one).
This binding basically disrupts the attachment of leukocytes to the blood vessels and prevents the migration of these activated leukocytes into the inflamed area; in the case of MS this is the central nervous system. Simply put, if the T cells establish a foothold on the endothelium, leukocytes cannot migrate through. Natalizumab prevents the foothold from occurring.
ELN closed up at 15.70 on tuesday in after hours trading ( on a volume of 1700 LOL)
Natalizumab [earlier post note the suffix] is being marketed under the name of Tysabri. In early news releases, the company had proposed the name of Antegren, but changed the name before launch.
This is a compound of several antibodies in the pipeline targeting different steps in the immune dysfunction that leads to the clinical condition we call MS.
The exact mechanism of action by which natalizumab exerts its effects is not fully defined. MS is believed to develop when activated inflammatory cells, including T cells, cross the blood brain barrier. No one is sure how the inflammatory cells are activated, but the result is the presence of highly active inflammatory cells within the CNS causing destruction of the "insulating" myelin sheath around nerves. Once damaged, the nerves cease functioning normally and the neurologic effects become the symptoms of MS.
Before the inflammatory cells can cross into the CNS, they must bind to the lining of the blood vessels, the endothelium. Natalizumab is thought to work by preventing this binding and hence stopping the migration of the damaging cells.
Structurally, natalizumab is a recombinant humanized IgG4κ monoclonal antibody produced in murine myeloma cells (mouse cells but the Fc receptor replaced by human one).
This binding basically disrupts the attachment of leukocytes to the blood vessels and prevents the migration of these activated leukocytes into the inflamed area; in the case of MS this is the central nervous system. Simply put, if the T cells establish a foothold on the endothelium, leukocytes cannot migrate through. Natalizumab prevents the foothold from occurring.
Asian Markets follow U.S. ; Up early Wednesday; Toyota Up
Asian stocks were higher Wednesday as a rebound in crude-oil prices lifted Inpex Holdings and other energy shares [dictated by the US Markey Rally tuesday] while Toyota Motor Corp. touched a new all-time high, although broader gains in Japanese blue-chips were limited ahead of a slew of earnings reports due later in the day.
Japan's Nikkei 225 Stock Average ended the morning session up 0.1% to 16,802.54. The broader Topix index ended nearly flat at 1,662.19.
Shares of Toyota rose 1% to 7,100 yen, after closing above 7,000 yen for the first time in the previous session. On Tuesday the automaker announced global production surged 8.7% in the six-month, April-to-September period from the same period a year ago.
Elsewhere around Asia, Australia's S&P/ASX 200 rose 0.4%. Singapore's Straits Times Index was up 0.5% and Taiwan's Weighted Price Index reversed early gains to trade lower 0.2%. South Korea's Kopsi was up 0.4% and Shanghai's Composite Index was up 0.7%. Markets in Malaysia were closed for a public holiday.
Hong Kong's Hang Seng Index fell 0.2% to 18,117.06. The China Enterprises Index traded nearly flat at 7,495.14.
"The market is waiting for the outcome of the Federal Reserve meeting" said Philip Chan, research director at CSC Securities in Hong Kong. "The focus will be on the accompanying statement and whether the Fed expects further inflation pressure or whether it expects inflation pressure is well contained; depending on the statement, the market expectation on the interest rate outlook could change substantially."
Chan added rate-sensitive property shares were under pressure owing to uncertainty over interest-rate outlook.
U.S. Federal Reserve policy makers will conclude their two-day meeting later today. The Fed is widely expected to hold the fed-funds rate unchanged at 5.25%.
Shares of Honda Motor Co. Ltd. were up 0.2%. Leading industrial blue-chips Honda, NEC Electronics and Sharp Corp., among others, were due to report earnings in Japan Wednesday.
Inpex Holdings (JP:1605: news, chart, profile) , Japan's largest oil-development company, rose 1.3% while Australian oil and gas producer Woodside Petroleum (AU:WPL: news, chart, profile) advanced 1.3%.
Shares of the world's largest mining company, BHP Billiton, rose 0.7% a day after reporting a quarterly slump in production of copper and other metals owing mainly to a strike at its Chilean operations.
Shares of Nippon Steel Corp. (JP:5401: news, chart, profile) were up 0.8% after the business daily Nihon Keizai Shimbun said the group is on track to report better-than-expected earnings on booming sales of specialized steel products to the automotive industry.
Japan's Nikkei 225 Stock Average ended the morning session up 0.1% to 16,802.54. The broader Topix index ended nearly flat at 1,662.19.
Shares of Toyota rose 1% to 7,100 yen, after closing above 7,000 yen for the first time in the previous session. On Tuesday the automaker announced global production surged 8.7% in the six-month, April-to-September period from the same period a year ago.
Elsewhere around Asia, Australia's S&P/ASX 200 rose 0.4%. Singapore's Straits Times Index was up 0.5% and Taiwan's Weighted Price Index reversed early gains to trade lower 0.2%. South Korea's Kopsi was up 0.4% and Shanghai's Composite Index was up 0.7%. Markets in Malaysia were closed for a public holiday.
Hong Kong's Hang Seng Index fell 0.2% to 18,117.06. The China Enterprises Index traded nearly flat at 7,495.14.
"The market is waiting for the outcome of the Federal Reserve meeting" said Philip Chan, research director at CSC Securities in Hong Kong. "The focus will be on the accompanying statement and whether the Fed expects further inflation pressure or whether it expects inflation pressure is well contained; depending on the statement, the market expectation on the interest rate outlook could change substantially."
Chan added rate-sensitive property shares were under pressure owing to uncertainty over interest-rate outlook.
U.S. Federal Reserve policy makers will conclude their two-day meeting later today. The Fed is widely expected to hold the fed-funds rate unchanged at 5.25%.
Shares of Honda Motor Co. Ltd. were up 0.2%. Leading industrial blue-chips Honda, NEC Electronics and Sharp Corp., among others, were due to report earnings in Japan Wednesday.
Inpex Holdings (JP:1605: news, chart, profile) , Japan's largest oil-development company, rose 1.3% while Australian oil and gas producer Woodside Petroleum (AU:WPL: news, chart, profile) advanced 1.3%.
Shares of the world's largest mining company, BHP Billiton, rose 0.7% a day after reporting a quarterly slump in production of copper and other metals owing mainly to a strike at its Chilean operations.
Shares of Nippon Steel Corp. (JP:5401: news, chart, profile) were up 0.8% after the business daily Nihon Keizai Shimbun said the group is on track to report better-than-expected earnings on booming sales of specialized steel products to the automotive industry.
Tuesday, October 24, 2006
AstraZeneca wins approval from FDA for liquid Nexium
AstraZeneca today announced that a new formulation for its prescription proton pump inhibitor NEXIUM ® (esomeprazole magnesium) has been approved by the US Food and Drug Administration (FDA). NEXIUM For Delayed-Release Oral Suspension is now approved for the treatment of GERD, including symptomatic gastroesophageal reflux disease, healing and maintenance of healing of erosive esophagitis (EE), and risk reduction of NSAID-associated gastric (stomach) ulcers.
Each packet of NEXIUM For Delayed-Release Oral Suspension contains either 20 mg or 40 mg of esomeprazole, the same active ingredient used in NEXIUM Delayed-Release Capsules. The esomeprazole granules and inactive granules used in this formulation are mixed with water to form a suspension and are given by oral, nasogastric or gastric administration.
"Some patients with acid-related diseases have difficulties swallowing their oral medication when it is a solid pill," said Doug Levine, M.D., Executive Director, Clinical Development Leader for NEXIUM. "This new prescription option to swallow an oral suspension of NEXIUM or to have it administered via a stomach tube provides these patients with an alternative method of administration that they can take instead of the NEXIUM capsule."
The new formulation of NEXIUM For Delayed-Release Oral Suspension will be available in the first quarter of 2007.
Nexium works by inhibiting gastric acid secretion in the gut by binding to H-2 receptors.
(NYSE: AZN - News)
AZN closed trading today down 36 cents to 65.22.
Each packet of NEXIUM For Delayed-Release Oral Suspension contains either 20 mg or 40 mg of esomeprazole, the same active ingredient used in NEXIUM Delayed-Release Capsules. The esomeprazole granules and inactive granules used in this formulation are mixed with water to form a suspension and are given by oral, nasogastric or gastric administration.
"Some patients with acid-related diseases have difficulties swallowing their oral medication when it is a solid pill," said Doug Levine, M.D., Executive Director, Clinical Development Leader for NEXIUM. "This new prescription option to swallow an oral suspension of NEXIUM or to have it administered via a stomach tube provides these patients with an alternative method of administration that they can take instead of the NEXIUM capsule."
The new formulation of NEXIUM For Delayed-Release Oral Suspension will be available in the first quarter of 2007.
Nexium works by inhibiting gastric acid secretion in the gut by binding to H-2 receptors.
(NYSE: AZN - News)
AZN closed trading today down 36 cents to 65.22.
ViroPharma and Wyeth Initiate Dosing in Phase 2 Study of HCV-796 in Treatment Naive Patients and Non-Responders
ViroPharma Incorporated today announced that patient dosing has commenced in a Phase 2 study of HCV-796, a unique orally dosed hepatitis C viral polymerase inhibitor that interferes with the replication of hepatitis C virus (HCV). The Phase 2 study is being conducted with Wyeth Pharmaceuticals, a division of Wyeth ViroPharma's partner in development of HCV-796.
The objectives of this trial are to assess the safety, tolerability, pharmacokinetic profile, and antiviral activity of HCV-796, when used in combination with pegylated interferon alfa-2b plus ribavirin compared to the current standard of care in treatment-naive subjects with HCV genotype 1 infection and in patients with HCV genotype 1 infection who were non-responders to prior HCV therapy. The companies will add an additional dose or doses of HCV-796 to the trial to further elucidate the dose response.
"Following the strength of the Phase 1 data, we have initiated a Phase 2 program to assess the efficacy of the compound as part of a triple therapy combination, and to continue to add to our safety database," commented Stephen Villano, M.D., ViroPharma's vice president of clinical research and development. "Hepatitis C is one of the most important unmet medical needs today. In the U.S., up to 70 percent of the estimated 3.2 million chronically infected persons will develop chronic liver disease, which is the single leading factor contributing to the need for a liver transplant in the U.S. each year. The current standard of care presents a problem for patients in terms of its cure rate and tolerability, and we believe that with continued clinical success HCV-796 could become part of combination therapies that we hope will produce a much higher cure rate for patients in the future."
More viral replication inhibitors (polymerases) here. Interferon is a naturally occuring cytokine protein that the body makes in response to viral infections; it is pegylated to make it more stable for sustained action once inside the body, usually injected into the abdomen. It is supposed to target other immune cells to kill virally infected cells. The side effects are hardly worth the benefits, thus the high interest in other mechanisms of action for HCV. Ribavirin is a standard treatment.
Wyeth (NYSE: WYE) is up at this hour 13 cents while ViroPharma (Nasdaq: VPHM) is unchanged in afternoon trading.
The objectives of this trial are to assess the safety, tolerability, pharmacokinetic profile, and antiviral activity of HCV-796, when used in combination with pegylated interferon alfa-2b plus ribavirin compared to the current standard of care in treatment-naive subjects with HCV genotype 1 infection and in patients with HCV genotype 1 infection who were non-responders to prior HCV therapy. The companies will add an additional dose or doses of HCV-796 to the trial to further elucidate the dose response.
"Following the strength of the Phase 1 data, we have initiated a Phase 2 program to assess the efficacy of the compound as part of a triple therapy combination, and to continue to add to our safety database," commented Stephen Villano, M.D., ViroPharma's vice president of clinical research and development. "Hepatitis C is one of the most important unmet medical needs today. In the U.S., up to 70 percent of the estimated 3.2 million chronically infected persons will develop chronic liver disease, which is the single leading factor contributing to the need for a liver transplant in the U.S. each year. The current standard of care presents a problem for patients in terms of its cure rate and tolerability, and we believe that with continued clinical success HCV-796 could become part of combination therapies that we hope will produce a much higher cure rate for patients in the future."
More viral replication inhibitors (polymerases) here. Interferon is a naturally occuring cytokine protein that the body makes in response to viral infections; it is pegylated to make it more stable for sustained action once inside the body, usually injected into the abdomen. It is supposed to target other immune cells to kill virally infected cells. The side effects are hardly worth the benefits, thus the high interest in other mechanisms of action for HCV. Ribavirin is a standard treatment.
Wyeth (NYSE: WYE) is up at this hour 13 cents while ViroPharma (Nasdaq: VPHM) is unchanged in afternoon trading.
Monday, October 23, 2006
Replidyne stock crashes on FDA non approval letter
LOUISVILLE, Colo. and NEW YORK, Oct. 23-- Replidyne, Inc. and Forest Laboratories, Inc. reported today the U.S. Food and Drug Administration (FDA) has issued a non- approvable letter for Replidyne's new drug application (NDA) for faropenem medoxomil, a novel oral, community antibiotic. Replidyne submitted the NDA in December 2005 for four adult indications: acute bacterial sinusitis (ABS), community-acquired pneumonia (CAP), acute exacerbation of chronic bronchitis (AECB) and uncomplicated skin and skin structure infections (SSSI). The NDA as filed was based on the results of eleven Phase III clinical trials for these indications and a safety data base of more than 5,000 patients treated with faropenem.
According to the non-approvable letter, the FDA recommends further clinical studies for all indications. For ABS and AECB, superiority studies may be needed and for CAP, studies requiring additional microbiologic evaluation. In its letter the FDA did not raise any safety concerns or chemistry, manufacturing or controls (CMC) issues related to the product. Replidyne and Forest intend to discuss the clinical plans with the FDA including the number of trials needed for each indication, and expect that a minimum of two years will be required for completion of the clinical studies.
Historically the FDA has not required superiority design studies such as placebo-controlled studies for approval for antibiotics, but the Companies believe that recent public FDA deliberations over the need for placebo- controlled studies for antibiotics were a factor in its decision. Further, recent FDA statements have reflected a preference for superiority studies in ABS.
Faropenem medoxomil is in the penecillin class of antibiotics as based on their four-membered lactam ring. It is an inhibitor of bacterial cell wall synthesis, which maintains the shape of the cell.
RDYN (NASDAQ)closed down in trading today 45% to $5.59. OUCH!
According to the non-approvable letter, the FDA recommends further clinical studies for all indications. For ABS and AECB, superiority studies may be needed and for CAP, studies requiring additional microbiologic evaluation. In its letter the FDA did not raise any safety concerns or chemistry, manufacturing or controls (CMC) issues related to the product. Replidyne and Forest intend to discuss the clinical plans with the FDA including the number of trials needed for each indication, and expect that a minimum of two years will be required for completion of the clinical studies.
Historically the FDA has not required superiority design studies such as placebo-controlled studies for approval for antibiotics, but the Companies believe that recent public FDA deliberations over the need for placebo- controlled studies for antibiotics were a factor in its decision. Further, recent FDA statements have reflected a preference for superiority studies in ABS.
Faropenem medoxomil is in the penecillin class of antibiotics as based on their four-membered lactam ring. It is an inhibitor of bacterial cell wall synthesis, which maintains the shape of the cell.
RDYN (NASDAQ)closed down in trading today 45% to $5.59. OUCH!
Tapestry Pharma up 36% in morning trading:
TAPESTRY PHARMA INC (NasdaqCM:TPPH)
Last Trade: 1.99
Trade Time: 12:31PM ET
Change: 0.52 (35.37%)
Not much in the way of data here, just looking for reasons this stock is shooting up today.
Tapestry Pharmaceuticals, Inc., together with its subsidiaries, develops therapies for the treatment of cancer. Its development stages therapeutic candidate products include TPI 287 IV, a Phase I product for prostate, nonsmall cell lung, and breast cancers; TPI 287 oral formulation, a preclinical development stage product for prostate, nonsmall cell lung, pancreatic, ovarian, breast, and colon cancers. The company’s development stages products also comprise Quassinoids and Linked Cytotoxics, preclinical development stage products for Cancers. Tapestry Pharmaceuticals was founded in 1991 and is based in Boulder, Colorado.
Tapestry Pharmaceuticals, Inc. has developed a novel taxane analog, TPI 287. TPI 287 is synthetically manufactured from naturally occurring taxanes extracted from yew starting material. The synthesis involves modification to the taxane side chain to overcome multidrug resistance and to achieve mutant tubulin binding. This study will be a multi-center, dose escalation, sequential group, phase I study evaluating the intravenous administration of TPI 287, a novel third generation taxane.
Taxane inhibits microtubules thus stopping cell division. Microtubules pull the chromosomes apart during mitosis, and are a big drug target. Taxol is the first generation microtubule inhibitor.
Last Trade: 1.99
Trade Time: 12:31PM ET
Change: 0.52 (35.37%)
Not much in the way of data here, just looking for reasons this stock is shooting up today.
Tapestry Pharmaceuticals, Inc., together with its subsidiaries, develops therapies for the treatment of cancer. Its development stages therapeutic candidate products include TPI 287 IV, a Phase I product for prostate, nonsmall cell lung, and breast cancers; TPI 287 oral formulation, a preclinical development stage product for prostate, nonsmall cell lung, pancreatic, ovarian, breast, and colon cancers. The company’s development stages products also comprise Quassinoids and Linked Cytotoxics, preclinical development stage products for Cancers. Tapestry Pharmaceuticals was founded in 1991 and is based in Boulder, Colorado.
Tapestry Pharmaceuticals, Inc. has developed a novel taxane analog, TPI 287. TPI 287 is synthetically manufactured from naturally occurring taxanes extracted from yew starting material. The synthesis involves modification to the taxane side chain to overcome multidrug resistance and to achieve mutant tubulin binding. This study will be a multi-center, dose escalation, sequential group, phase I study evaluating the intravenous administration of TPI 287, a novel third generation taxane.
Taxane inhibits microtubules thus stopping cell division. Microtubules pull the chromosomes apart during mitosis, and are a big drug target. Taxol is the first generation microtubule inhibitor.
Wanted: Space for 'wet labs': Arizona's Biotech growth slowed by space limitations
Arizona will spend $1.4 billion to foster a thriving biotechnology economy, yet there is little space for small research companies to conduct business.
Entrepreneurs and scientists with dreams of inventing disease-curing drugs first must tinker with waterlines, sinks and ventilation systems to turn old office buildings or warehouses into labs that can handle their research needs.
Some small biotech companies bypass the Valley altogether because they can't find ready-to-move-in lab space outfitted with basics such as sinks and high-powered air systems.
"At one point, we had at least six companies that were serious about relocating to Greater Phoenix," said Troy Ignelzi, vice president of emerging technologies for the Greater Phoenix Economic Council, the Valley's principal economic development group. "Because of inadequate lab space, we've only been able to land two of those."
A lack of wet-lab space has cost the region high-wage research jobs and has undercut efforts to build the state's 21st-century economy. The critical space shortage is a hurdle that economic-development leaders, science leaders and cities are aware of and are taking steps to address. Among the problems cited by developers: high expense, lack of available land and the general risk of building for unproven companies.
Ignelzi and others say the problem stems in part from Arizona's buzz of biotech activity. More than a half-dozen new Arizona labs with state-of-the-art equipment have sprouted in the past few years to support the state's burgeoning biotech efforts, but the lab space is reserved for hospitals, universities and non-profit research groups such as the Translational Genomics Research Institute.
There is little private lab room, the type of space that can make Arizona home to the next Pfizer or Merck, multibillion-dollar drug companies that drive a region's economy and invent treatments to improve quality of life.
Out-of-state businesses or startups seeking privately owned lab space to mix chemicals or conduct experiments have few options amid the region's concrete menu of box-style warehouses and offices.
Michelle Hanna couldn't find a sliver of laboratory space when she arrived in the Valley six years ago.
So she pieced together a makeshift "wet lab" from a toilet at her brother's Scottsdale warehouse. She later moved her company, RiboMed Biotechnologies, to a doctor's office at 32nd Street and Indian School before buying and converting an old building in downtown Phoenix.
"It was a long path of survival that led me to this building," Hanna said of RiboMed's lab at Seventh and Van Buren streets downtown. Her company works in cancer research.
"I showed up here six years ago with five U-Haul trucks full of equipment, and I could find no place to put it."
InSys Therapeutics
Some companies are still searching.
Lake Forest, Ill.-based InSys Therapeutics Inc., a small company developing pain medication for cancer patients, is the type of company that Arizona hopes will power the state's future economy.
The company committed itself to relocating its 10-person corporate office to the Valley within the first six months of 2007. The company is targeting an initial public stock offering next year.
But despite the best effort of economic-development types, InSys has yet to find suitable lab space in the Valley.
"We want to move somewhere that already has new lab space," said Mike Babich, an InSys board member and analyst with InSys investor EJ Financial Enterprises.
Entrepreneurs and scientists with dreams of inventing disease-curing drugs first must tinker with waterlines, sinks and ventilation systems to turn old office buildings or warehouses into labs that can handle their research needs.
Some small biotech companies bypass the Valley altogether because they can't find ready-to-move-in lab space outfitted with basics such as sinks and high-powered air systems.
"At one point, we had at least six companies that were serious about relocating to Greater Phoenix," said Troy Ignelzi, vice president of emerging technologies for the Greater Phoenix Economic Council, the Valley's principal economic development group. "Because of inadequate lab space, we've only been able to land two of those."
A lack of wet-lab space has cost the region high-wage research jobs and has undercut efforts to build the state's 21st-century economy. The critical space shortage is a hurdle that economic-development leaders, science leaders and cities are aware of and are taking steps to address. Among the problems cited by developers: high expense, lack of available land and the general risk of building for unproven companies.
Ignelzi and others say the problem stems in part from Arizona's buzz of biotech activity. More than a half-dozen new Arizona labs with state-of-the-art equipment have sprouted in the past few years to support the state's burgeoning biotech efforts, but the lab space is reserved for hospitals, universities and non-profit research groups such as the Translational Genomics Research Institute.
There is little private lab room, the type of space that can make Arizona home to the next Pfizer or Merck, multibillion-dollar drug companies that drive a region's economy and invent treatments to improve quality of life.
Out-of-state businesses or startups seeking privately owned lab space to mix chemicals or conduct experiments have few options amid the region's concrete menu of box-style warehouses and offices.
Michelle Hanna couldn't find a sliver of laboratory space when she arrived in the Valley six years ago.
So she pieced together a makeshift "wet lab" from a toilet at her brother's Scottsdale warehouse. She later moved her company, RiboMed Biotechnologies, to a doctor's office at 32nd Street and Indian School before buying and converting an old building in downtown Phoenix.
"It was a long path of survival that led me to this building," Hanna said of RiboMed's lab at Seventh and Van Buren streets downtown. Her company works in cancer research.
"I showed up here six years ago with five U-Haul trucks full of equipment, and I could find no place to put it."
InSys Therapeutics
Some companies are still searching.
Lake Forest, Ill.-based InSys Therapeutics Inc., a small company developing pain medication for cancer patients, is the type of company that Arizona hopes will power the state's future economy.
The company committed itself to relocating its 10-person corporate office to the Valley within the first six months of 2007. The company is targeting an initial public stock offering next year.
But despite the best effort of economic-development types, InSys has yet to find suitable lab space in the Valley.
"We want to move somewhere that already has new lab space," said Mike Babich, an InSys board member and analyst with InSys investor EJ Financial Enterprises.
Sunday, October 22, 2006
STOCKS EXPECTED TO EXTEND RALLY THIS WEEK, BE READY
NEW YORK--U.S. stocks should extend their rally this week, taking the Dow to fresh records, as long as corporate earnings keep topping expectations and beat back concerns that equities have gotten a tad pricey recently.
ADVERTISEMENT
This week, which is smack in the middle of the third-quarter earnings reporting period, the Federal Reserve's monetary policy committee meets and is expected to leave interest rates unchanged again, making the two-day meeting a likely nonevent for stocks.
Investors will need to be cautious of huge, index-moving, swings like those of the shares of heavy equipment maker Caterpillar Inc. (NYSE:CAT - News), which sorely disappointed investors with a smaller-than-expected profit and a poor outlook, and easily held the Dow in negative territory in Friday trading.
A flood of earnings reports is expected. Companies due to report include American Express Co. (NYSE:AXP - News), AT&T Inc. (NYSE:T - News), Ford Motor Co. (NYSE:F - News), Halliburton Co. (NYSE:HAL - News), Kimberly-Clark Corp. (NYSE:KMB - News), Texas Instruments Inc. (NYSE:TXN - News), Kraft Foods Inc. (NYSE:KFT - News) and Exxon Mobil Corp. (NYSE:XOM - News).
"I think the fundamental earnings figures that are going to come out are going to be positive enough to keep us inching forward," said Brett Gallagher, deputy chief investment officer with Julius Baer in New York.
Third-quarter earnings for Standard & Poor's 500 companies are on pace to rise close to 15 percent from a year ago, according to Reuters Estimates. That would be the 17th straight quarter of double-digit profit growth for U.S. companies.
"As long as we have a combination of solid earnings, a market-friendly Fed and no geopolitical trepidation, gains in stocks may still continue," said Andre Bakhos, president of Princeton Financial Group in Princeton, New Jersey.
The Fed is expected to leave interest rates unchanged at its policy-setting committee meeting Oct 24-25.
THIS IS GOING TO BE A BIG WEEK! GET READY.
ADVERTISEMENT
This week, which is smack in the middle of the third-quarter earnings reporting period, the Federal Reserve's monetary policy committee meets and is expected to leave interest rates unchanged again, making the two-day meeting a likely nonevent for stocks.
Investors will need to be cautious of huge, index-moving, swings like those of the shares of heavy equipment maker Caterpillar Inc. (NYSE:CAT - News), which sorely disappointed investors with a smaller-than-expected profit and a poor outlook, and easily held the Dow in negative territory in Friday trading.
A flood of earnings reports is expected. Companies due to report include American Express Co. (NYSE:AXP - News), AT&T Inc. (NYSE:T - News), Ford Motor Co. (NYSE:F - News), Halliburton Co. (NYSE:HAL - News), Kimberly-Clark Corp. (NYSE:KMB - News), Texas Instruments Inc. (NYSE:TXN - News), Kraft Foods Inc. (NYSE:KFT - News) and Exxon Mobil Corp. (NYSE:XOM - News).
"I think the fundamental earnings figures that are going to come out are going to be positive enough to keep us inching forward," said Brett Gallagher, deputy chief investment officer with Julius Baer in New York.
Third-quarter earnings for Standard & Poor's 500 companies are on pace to rise close to 15 percent from a year ago, according to Reuters Estimates. That would be the 17th straight quarter of double-digit profit growth for U.S. companies.
"As long as we have a combination of solid earnings, a market-friendly Fed and no geopolitical trepidation, gains in stocks may still continue," said Andre Bakhos, president of Princeton Financial Group in Princeton, New Jersey.
The Fed is expected to leave interest rates unchanged at its policy-setting committee meeting Oct 24-25.
THIS IS GOING TO BE A BIG WEEK! GET READY.
U.S. stocks to take pause as focus turns to Fed
Interest rate decision due Wednesday as earnings flood continues
U.S. stocks are expected to move into choppy territory next week to take a breather from runs to fresh highs and as investors turn some energy away from corporate earnings to the Federal Reserve's decision and outlook on interest rates.
Along with wall-to-wall earnings reports, the first look at the Gross Domestic Product for the third quarter will be released and will headline a list of economic reports including figures for durable goods orders, home sales, and consumer sentiment in October.
"The good news is that the market has shown a lot of momentum being able to get up to this level and [the Dow Jones Industrial Average] rising 12% in the last two and a half months," said Al Goldman, chief market strategist at A.G. Edwards.
"The bad news is we're up 12% in the last two and a half months. I think the market over the next week is going to go into a very normal pause to refresh."
Earnings reports have injected bullish energy into stocks and pulled the Dow to its first ever close past the 12,000 level on Thursday. It held above 12,000, barely, on Friday.
The earnings season is heading into the second of its two busiest weeks.
U.S. stocks are expected to move into choppy territory next week to take a breather from runs to fresh highs and as investors turn some energy away from corporate earnings to the Federal Reserve's decision and outlook on interest rates.
Along with wall-to-wall earnings reports, the first look at the Gross Domestic Product for the third quarter will be released and will headline a list of economic reports including figures for durable goods orders, home sales, and consumer sentiment in October.
"The good news is that the market has shown a lot of momentum being able to get up to this level and [the Dow Jones Industrial Average] rising 12% in the last two and a half months," said Al Goldman, chief market strategist at A.G. Edwards.
"The bad news is we're up 12% in the last two and a half months. I think the market over the next week is going to go into a very normal pause to refresh."
Earnings reports have injected bullish energy into stocks and pulled the Dow to its first ever close past the 12,000 level on Thursday. It held above 12,000, barely, on Friday.
The earnings season is heading into the second of its two busiest weeks.
Saturday, October 21, 2006
Novartis stock up on FDA Gleevec approval
In another important milestone, Gleevec/Glivec® (imatinib mesylate)* tablets has received US regulatory approval to help patients with five distinct and potentially life-threatening disorders, representing the first time that a regulatory authority has ever simultaneously approved one targeted medicine for so many disorders.
With today's decision, and in only five years, Gleevec has now been approved in the US for seven diseases, including two solid tumors and five blood disorders with molecular targets known to be inhibited by the drug.
All of the diseases covered in the new approval by the US Food and Drug Administration (FDA) are rare and potentially life threatening. For many of the patients who suffer from them, few, if any approved treatments were available prior to Gleevec.
"The effectiveness of Gleevec in these five diseases further underscores how cancers and diseases of different origin and location can share common pathways that often respond to the same targeted treatment," said Diane Young, MD, Vice President and global head of Clinical Development at Novartis Oncology. "These approvals further build and demonstrate our historical commitment to developing therapies for patients with rare diseases such as acromegaly, carcinoid syndrome and gastrointestinal stromal tumors."
The FDA approvals are based on data from Novartis-sponsored clinical studies and clinical data from independent medical researchers showing the efficacy of Gleevec in the treatment of these diseases, in which there is a suggested connection between a Gleevec-sensitive pathway and a disease.
Gleevec targets the activity of proteins called tyrosine kinases that appear to play important roles within some cancer cells. Gleevec has been shown to inhibit the function of the tyrosine kinase Bcr-Abl in patients with certain forms of blood cancer -- Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) -- and the receptor tyrosine kinase Kit in Kit-positive GIST (gastrointestinal stromal tumor).
Researchers have found Gleevec also inhibits other tyrosine kinases, including platelet-derived growth factor receptor (PDGFR), which have been shown to be activated in disease pathways that underlie a number of rare hematologic diseases, as well as some solid tumors.
The new diseases for which Gleevec received approval include one solid tumor and various rare blood disorders. The solid tumor is dermatofibrosarcoma protuberans (DFSP), a type of tumor that begins as a hard lump found in the skin of the chest, abdomen or leg.
The four blood diseases include:
Relapsed/refractory Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), a rapidly progressive blood cancer characterized by the presence of the Philadelphia chromosome * Certain forms of myelodysplastic/myeloproliferative diseases (MDS/MPD), which involve certain blood cells made in the bone marrow * Hypereosinophilic syndrome/chronic eosinophilic leukemia (HES/CEL), which is characterized by the persistent overproduction of eosinophils, a certain type of white blood cell * Aggressive systemic mastocytosis (ASM), which is marked by the presence of too many mast cells, a certain type of white blood cell.
Novartis also said the Food and Drug Administration approved Zaditor for over-the-counter use to relieve itchy eyes due to allergies.
Novartis NVS trades on the NYSE and closed friday at $60.62 up 0.53 cents with a volume of 1,945,300.
With today's decision, and in only five years, Gleevec has now been approved in the US for seven diseases, including two solid tumors and five blood disorders with molecular targets known to be inhibited by the drug.
All of the diseases covered in the new approval by the US Food and Drug Administration (FDA) are rare and potentially life threatening. For many of the patients who suffer from them, few, if any approved treatments were available prior to Gleevec.
"The effectiveness of Gleevec in these five diseases further underscores how cancers and diseases of different origin and location can share common pathways that often respond to the same targeted treatment," said Diane Young, MD, Vice President and global head of Clinical Development at Novartis Oncology. "These approvals further build and demonstrate our historical commitment to developing therapies for patients with rare diseases such as acromegaly, carcinoid syndrome and gastrointestinal stromal tumors."
The FDA approvals are based on data from Novartis-sponsored clinical studies and clinical data from independent medical researchers showing the efficacy of Gleevec in the treatment of these diseases, in which there is a suggested connection between a Gleevec-sensitive pathway and a disease.
Gleevec targets the activity of proteins called tyrosine kinases that appear to play important roles within some cancer cells. Gleevec has been shown to inhibit the function of the tyrosine kinase Bcr-Abl in patients with certain forms of blood cancer -- Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) -- and the receptor tyrosine kinase Kit in Kit-positive GIST (gastrointestinal stromal tumor).
Researchers have found Gleevec also inhibits other tyrosine kinases, including platelet-derived growth factor receptor (PDGFR), which have been shown to be activated in disease pathways that underlie a number of rare hematologic diseases, as well as some solid tumors.
The new diseases for which Gleevec received approval include one solid tumor and various rare blood disorders. The solid tumor is dermatofibrosarcoma protuberans (DFSP), a type of tumor that begins as a hard lump found in the skin of the chest, abdomen or leg.
The four blood diseases include:
Relapsed/refractory Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), a rapidly progressive blood cancer characterized by the presence of the Philadelphia chromosome * Certain forms of myelodysplastic/myeloproliferative diseases (MDS/MPD), which involve certain blood cells made in the bone marrow * Hypereosinophilic syndrome/chronic eosinophilic leukemia (HES/CEL), which is characterized by the persistent overproduction of eosinophils, a certain type of white blood cell * Aggressive systemic mastocytosis (ASM), which is marked by the presence of too many mast cells, a certain type of white blood cell.
Novartis also said the Food and Drug Administration approved Zaditor for over-the-counter use to relieve itchy eyes due to allergies.
Novartis NVS trades on the NYSE and closed friday at $60.62 up 0.53 cents with a volume of 1,945,300.
Friday, October 20, 2006
The week's top news and analysis, Oct. 16-20
As the Dow industrials continued to notch record highs this week, including the benchmark's first-ever close atop 12,000, earnings season moved into full swing. But some on Wall Street were less focused on what the likes of Google and Apple earned than on what Richard Grasso, arguably, did not.
On the week, the Dow Jones Industrial Average for all its accomplishments, edged upward by just 0.4%, while the Nasdaq Composite Index dipped 0.6% and the S&P 500 tacked on 0.2%.
It seems fitting, according to Mark Hulbert, that the Dow Jones Industrial Average would close above 12,000 and at a new all-time high on the 19th anniversary of the 1987 crash, the worst in U.S. stock-market history. It turns out, Mark says, that we can learn important lessons about investing by reviewing how investment newsletters have performed since Oct. 19, 1987.
On the week, the Dow Jones Industrial Average for all its accomplishments, edged upward by just 0.4%, while the Nasdaq Composite Index dipped 0.6% and the S&P 500 tacked on 0.2%.
It seems fitting, according to Mark Hulbert, that the Dow Jones Industrial Average would close above 12,000 and at a new all-time high on the 19th anniversary of the 1987 crash, the worst in U.S. stock-market history. It turns out, Mark says, that we can learn important lessons about investing by reviewing how investment newsletters have performed since Oct. 19, 1987.
Google extends rise after results; Lumera active
Google extends rise after results; Lumera active
-- Google Inc. shares continued to gain ground in late trading Friday, building on a nearly 8% rise during the regular session following the search giant's surge in quarterly profit and sales.
The Nasdaq-100 After Hours Indicator, which tracks the evening trading of the index's leading technology stocks, was off 0.17 points to 1,709.41.
Google shares picked up 48 cents to end at $460.15 extending their 7.9% increase during the day. Late Thursday, the company said its quarterly profit almost doubled on stronger sales. A number of Wall Street analysts raised their price targets on Google's stock and three set price targets of $600 for the shares. See full story.
Shares of Lumera Corp. topped volume movers during the late session, and closed down 3.8% at $6.41. From Monday through the close of regular trading Friday, the stock has jumped 33% after the electronics manufacturer said that tests of its millimeter-wave wireless bridge were successful.
The system allows for the transmission of large amounts of data through a variety of high-speed telecommunications networks, the company said.
-- Google Inc. shares continued to gain ground in late trading Friday, building on a nearly 8% rise during the regular session following the search giant's surge in quarterly profit and sales.
The Nasdaq-100 After Hours Indicator, which tracks the evening trading of the index's leading technology stocks, was off 0.17 points to 1,709.41.
Google shares picked up 48 cents to end at $460.15 extending their 7.9% increase during the day. Late Thursday, the company said its quarterly profit almost doubled on stronger sales. A number of Wall Street analysts raised their price targets on Google's stock and three set price targets of $600 for the shares. See full story.
Shares of Lumera Corp. topped volume movers during the late session, and closed down 3.8% at $6.41. From Monday through the close of regular trading Friday, the stock has jumped 33% after the electronics manufacturer said that tests of its millimeter-wave wireless bridge were successful.
The system allows for the transmission of large amounts of data through a variety of high-speed telecommunications networks, the company said.
Tuesday, October 17, 2006
MEMY Trial Halted...FDA wants more information
FDA Requests Further Information
Memory Pharma provides update on Phase 2a trial of MEM 3454 in alzheimer's disease; FDA requires further explanations of revisions Co announces an update on the investigational new drug application filed in Sept 2006 with the FDA for MEM 3454.
The FDA has advised the co that in order to fully review the toxicology reports that were submitted with the I.N.D, the agency requires further explanations of revisions that were made to those reports since they were submitted with the co's first I.N.D for this trial in May, and as a result the proposed Phase 2a clinical trial for MEM 3454 in Alzheimer's disease has been placed on clinical hold. The FDA has also deferred assessment of the adequacy of the Investigator's Brochure for the trial pending submission of the additional information.
MEMY also reported that the FDA confirmed that the clinical hold was not related to any manufacturing issues with MEM 3454 and that the potential impurities issue, previously raised by the FDA in connection with the co's first IND for the proposed Phase 2a clinical trial of MEM 3454, had been adequately resolved. The co believes that no additional studies or data will be required to address the FDA's questions and that, as a result, it should be able to provide to the FDA, by early November, the information necessary to facilitate the FDA's review
The nicotinic alpha-7 receptor target represents a novel approach to thetreatment of CNS disorders, and we are pleased by the rapid progress of MEM3454," said Peter Hug, Roche's Global Head of Pharma Partnering. "Ourrelationship with Memory Pharmaceuticals has been a productive one and allowsus to leverage their strengths in CNS drug discovery and development.
Memory Pharma provides update on Phase 2a trial of MEM 3454 in alzheimer's disease; FDA requires further explanations of revisions Co announces an update on the investigational new drug application filed in Sept 2006 with the FDA for MEM 3454.
The FDA has advised the co that in order to fully review the toxicology reports that were submitted with the I.N.D, the agency requires further explanations of revisions that were made to those reports since they were submitted with the co's first I.N.D for this trial in May, and as a result the proposed Phase 2a clinical trial for MEM 3454 in Alzheimer's disease has been placed on clinical hold. The FDA has also deferred assessment of the adequacy of the Investigator's Brochure for the trial pending submission of the additional information.
MEMY also reported that the FDA confirmed that the clinical hold was not related to any manufacturing issues with MEM 3454 and that the potential impurities issue, previously raised by the FDA in connection with the co's first IND for the proposed Phase 2a clinical trial of MEM 3454, had been adequately resolved. The co believes that no additional studies or data will be required to address the FDA's questions and that, as a result, it should be able to provide to the FDA, by early November, the information necessary to facilitate the FDA's review
The nicotinic alpha-7 receptor target represents a novel approach to thetreatment of CNS disorders, and we are pleased by the rapid progress of MEM3454," said Peter Hug, Roche's Global Head of Pharma Partnering. "Ourrelationship with Memory Pharmaceuticals has been a productive one and allowsus to leverage their strengths in CNS drug discovery and development.
Quick Market Update:
U.S. stocks trimmed losses Tuesday after a better-than-expected report on the housing sector eased concerns about a slowdown in the nation's economy, with Johnson & Johnson a notable outperformer following strong quarterly results.
The Dow industrials fell 40 points to 11,940, off a session low of 11,887.
Cytomedix Stock tumbles on FDA Ruling
Shares of Cytomedix Inc. lost more than half of their value on Tuesday after it said U.S. regulators denied the company's claim on a gel for healing diabetic foot ulcers.
A unit of the Food and Drug Administration denied the claim that Cytomedix's AutoloGel is substantially equivalent to a legally marketed device, the company said in a statement. [also there is a chance for host rejection, as bovine thrombin is antigenic.]
The primary grounds for the rejection appeared to be the use of bovine thrombin, a clotting agent derived from cows, in the gel, the company said.
Bovine thrombin is used on humans in surgery and other instances to stop bleeding, but the FDA body cited studies that said it could also lead to a bleeding tendency, the company added.
Cytomedix said it will appeal the agency's decision and expects the process to be completed in 60 to 90 days.
The company's shares were down $1.46 at $1.29 in morning trade on the American Stock Exchange
A unit of the Food and Drug Administration denied the claim that Cytomedix's AutoloGel is substantially equivalent to a legally marketed device, the company said in a statement. [also there is a chance for host rejection, as bovine thrombin is antigenic.]
The primary grounds for the rejection appeared to be the use of bovine thrombin, a clotting agent derived from cows, in the gel, the company said.
Bovine thrombin is used on humans in surgery and other instances to stop bleeding, but the FDA body cited studies that said it could also lead to a bleeding tendency, the company added.
Cytomedix said it will appeal the agency's decision and expects the process to be completed in 60 to 90 days.
The company's shares were down $1.46 at $1.29 in morning trade on the American Stock Exchange
Another Hepatitis Protease Inhibitor: Vertex drug could trump everyone else
Vertex pipeline drug for hepatitis could top $5 billion: analyst
-- Vertex Pharmaceuticals, a small biotech, and its marketing partner Johnson & Johnson stand to gain billions of dollars in annual sales if their experimental hepatitis drug is successful, analysts say.
Vertex (down $1.06 to $35.71, Charts), a biotech based in Cambridge, Mass., is experimenting with a potential blockbuster hepatitis C treatment called VX-950. If tests are successful, the drug could enter the American market by 2009, reaching peak U.S. annual sales of $3 billion by 2013, said Ding Ding, analyst for Maxim Group. Most of the U.S. sales would go to Vertex.
In addition, overseas annual sales would peak at $2.4 billion by 2015, said Ding. Most of the non-U.S. sales would go to Johnson & Johnson (up $1.16 to $66.09, Charts), which would market the drug overseas.
Hepatitis C is a blood-borne viral infection that damages the liver and can result in chronic infection and disease, according to the National Institutes of Health. It has infected three million Americans and 170 million people worldwide.
"This is probably the most efficacious anti-Hepatitis C oral compound that will come to market," said Ding. "VX-950 is the one with the most promise so far."
Geoff Porges, analyst for Sanford C. Bernstein, also projects blockbuster sales for VX-950, peaking at about $2.7 billion in annual revenue by 2011. That includes $1.8 billion in U.S. sales, with most of that going to Vertex, and $840 million in non-U.S., with the lion's share going to Johnson & Johnson.
Les Funtleyder, analyst for Miller Tabak, said that VX-950 and other hepatitis drugs could be well-received in the emerging markets of Asia, where hepatitis is a more pervasive health problem. In the coming years, individuals in Asia will have more personal income to spend on healthcare, and drugs like VX-950 could get a sales boost, said Funtleyder.
As in previous HCV drugs, its a viral protease inhibitor that stops viral replication. HUGE drug targets.
-- Vertex Pharmaceuticals, a small biotech, and its marketing partner Johnson & Johnson stand to gain billions of dollars in annual sales if their experimental hepatitis drug is successful, analysts say.
Vertex (down $1.06 to $35.71, Charts), a biotech based in Cambridge, Mass., is experimenting with a potential blockbuster hepatitis C treatment called VX-950. If tests are successful, the drug could enter the American market by 2009, reaching peak U.S. annual sales of $3 billion by 2013, said Ding Ding, analyst for Maxim Group. Most of the U.S. sales would go to Vertex.
In addition, overseas annual sales would peak at $2.4 billion by 2015, said Ding. Most of the non-U.S. sales would go to Johnson & Johnson (up $1.16 to $66.09, Charts), which would market the drug overseas.
Hepatitis C is a blood-borne viral infection that damages the liver and can result in chronic infection and disease, according to the National Institutes of Health. It has infected three million Americans and 170 million people worldwide.
"This is probably the most efficacious anti-Hepatitis C oral compound that will come to market," said Ding. "VX-950 is the one with the most promise so far."
Geoff Porges, analyst for Sanford C. Bernstein, also projects blockbuster sales for VX-950, peaking at about $2.7 billion in annual revenue by 2011. That includes $1.8 billion in U.S. sales, with most of that going to Vertex, and $840 million in non-U.S., with the lion's share going to Johnson & Johnson.
Les Funtleyder, analyst for Miller Tabak, said that VX-950 and other hepatitis drugs could be well-received in the emerging markets of Asia, where hepatitis is a more pervasive health problem. In the coming years, individuals in Asia will have more personal income to spend on healthcare, and drugs like VX-950 could get a sales boost, said Funtleyder.
As in previous HCV drugs, its a viral protease inhibitor that stops viral replication. HUGE drug targets.
Monday, October 16, 2006
Expected Active Trading Tuesday
Companies whose shares are expected to see active trade in Tuesday's earnings reports are Intel Corp., Johnson & Johnson and CA Inc.
Intel is expected to report third-quarter earnings of 18 cents a share, according to analysts polled by Thomson First Call.
International Business Machines Corp. is expected to post earnings of $1.35 a share for the third quarter.
Johnson & Johnson is expected to report third-quarter earnings of 93 cents a share for the third quarter.
Merrill Lynch & Co. is expected to post earnings of $1.47 a share for the third quarter.
Motorola Inc. is expected to report third-quarter earnings of 34 cents a share.
Novellus Systems Inc. is expected to post earnings of 51 cents a share for the third quarter.
Office Depot is expected to report third-quarter earnings of 44 cents a share.
U.S. Bancorp is expected to post earnings of 66 cents a share for the third quarter.
United Technologies Corp.is expected to report third-quarter earnings of 96 cents a share.
Yahoo is expected to post earnings of 11 cents a share for the third quarter.
E.R. from major Biotech will be posted.
Intel is expected to report third-quarter earnings of 18 cents a share, according to analysts polled by Thomson First Call.
International Business Machines Corp. is expected to post earnings of $1.35 a share for the third quarter.
Johnson & Johnson is expected to report third-quarter earnings of 93 cents a share for the third quarter.
Merrill Lynch & Co. is expected to post earnings of $1.47 a share for the third quarter.
Motorola Inc. is expected to report third-quarter earnings of 34 cents a share.
Novellus Systems Inc. is expected to post earnings of 51 cents a share for the third quarter.
Office Depot is expected to report third-quarter earnings of 44 cents a share.
U.S. Bancorp is expected to post earnings of 66 cents a share for the third quarter.
United Technologies Corp.is expected to report third-quarter earnings of 96 cents a share.
Yahoo is expected to post earnings of 11 cents a share for the third quarter.
E.R. from major Biotech will be posted.
Roche, InterMune Combine to develop hepatitis C treatments
Oct 16. Roche (ROG.VX: Quote, Profile, Research) and InterMune Inc. (ITMN.O: Quote, Profile, Research) said on Monday they have agreed to develop and commercialize products from InterMune's hepatitis C protease inhibitor program.
The agreement includes InterMune's ITMN-191, which is expected to enter clinical trials before year end. The companies will also collaborate on a research program to identify, develop and commercialize novel second-generation protease inhibitors for treatment of hepatitis C.
Upon closing, Roche will pay InterMune an upfront payment of $60 million. Assuming the successful development and commercialization of ITMN-191 in the U.S. and other countries, InterMune could potentially receive up to $470 million in milestones, including $35 million within the next 12 months, the companies said.
WHAT IS THIS DRUG AND WHAT DOES IT TARGET?Current treatment options for chronic HCV infections provide sustained virologic response rates of ~50%, indicating novel therapeutic approaches are needed. We therefore embarked on a rational drug design campaign to produce inhibitors of the HCV NS3/4A protease. ITMN 191 emerged from this discovery effort and was nominated as a preclinical candidate.
The HCV genome encodes for glycoproteins E1 and E2 that form the structural proteins
of the virion. Non-structural (NS) proteins NS2, NS3,NS4A, NS4B, NS5A and NS5B have important roles in the polyprotein processing and HCV replication (they are termed polymerases). These are the drug targets.
The agreement includes InterMune's ITMN-191, which is expected to enter clinical trials before year end. The companies will also collaborate on a research program to identify, develop and commercialize novel second-generation protease inhibitors for treatment of hepatitis C.
Upon closing, Roche will pay InterMune an upfront payment of $60 million. Assuming the successful development and commercialization of ITMN-191 in the U.S. and other countries, InterMune could potentially receive up to $470 million in milestones, including $35 million within the next 12 months, the companies said.
WHAT IS THIS DRUG AND WHAT DOES IT TARGET?Current treatment options for chronic HCV infections provide sustained virologic response rates of ~50%, indicating novel therapeutic approaches are needed. We therefore embarked on a rational drug design campaign to produce inhibitors of the HCV NS3/4A protease. ITMN 191 emerged from this discovery effort and was nominated as a preclinical candidate.
The HCV genome encodes for glycoproteins E1 and E2 that form the structural proteins
of the virion. Non-structural (NS) proteins NS2, NS3,NS4A, NS4B, NS5A and NS5B have important roles in the polyprotein processing and HCV replication (they are termed polymerases). These are the drug targets.
Vical to Sell 2.5 Million Shares in Direct Offering, Raise $12.5 Million
Biopharmaceutical company Vical Inc. said Monday it plans to sell $12.5 million in stock as part of a direct offering to raise financing for existing drug programs and general corporate purposes.
Vical said it received firm commitments from undisclosed investors to buy 2.5 million shares at $5.02 each.
That is a discount of 1.6 percent from the stock's closing price of $5.10 on Friday, but equal to the closing bid price on the Nasdaq, according to Vical.
The company expects the sale to close Monday.
Vical is focused on DNA vaccines through new age delivery mechanisms.
The stock is trading up 9 cents just before closing.
Vical said it received firm commitments from undisclosed investors to buy 2.5 million shares at $5.02 each.
That is a discount of 1.6 percent from the stock's closing price of $5.10 on Friday, but equal to the closing bid price on the Nasdaq, according to Vical.
The company expects the sale to close Monday.
Vical is focused on DNA vaccines through new age delivery mechanisms.
The stock is trading up 9 cents just before closing.
DOW closing in on 12,000
U.S. stocks rose Monday, buoyed by technology-sector strength, but the Dow Jones Industrial Average saw choppy trade as a broker upgrade for Alcoa Inc. was tempered by downgrades for General Electric Co. and Home Depot Inc.
The Dow Jones Industrial Average rose 6 points to 11,966.
A lot of people missed out on the recent rally, which is leading to a sort of emotional stampede which has nothing to do with fundamentals," according to Michael Metz, chief investment strategist at Oppenheimer & Co.
Metz said the Dow Industrials are set to break through the 12,000 mark, barring any major bad news.
On the broader market for equities, advancers outpaced decliners by 19 to 10 on the New York Stock Exchange and by 8 to 5 on the Nasdaq.
The Dow Jones Industrial Average rose 6 points to 11,966.
A lot of people missed out on the recent rally, which is leading to a sort of emotional stampede which has nothing to do with fundamentals," according to Michael Metz, chief investment strategist at Oppenheimer & Co.
Metz said the Dow Industrials are set to break through the 12,000 mark, barring any major bad news.
On the broader market for equities, advancers outpaced decliners by 19 to 10 on the New York Stock Exchange and by 8 to 5 on the Nasdaq.
OMRIX Biopharmaceuticals Announces Positive Phase 3 Clinical Trial Results for Human Thrombin--Shares Drop
OMRIX Biopharmaceuticals, Inc. a commercial-stage biopharmaceutical company that develops and markets biosurgical and antibody-based products, announced today positive results from its Phase 3 pivotal clinical trial of human thrombin in achieving hemostasis in general surgery procedures. The non-inferiority clinical trial evaluated the equivalence of topical human thrombin to bovine thrombin in terms of safety and efficacy. All primary endpoints were met.
"We are pleased with the results of our pivotal Phase 3 Thrombin trial and intend to file our BLA by November 15, 2006," said Robert Taub, President and Chief Executive Officer. "OMRIX is committed to advancing its biosurgery pipeline and commercializing a product portfolio of safe, effective and easy to use solutions for surgeons worldwide."
THROMBIN is an enzyme in the blood coagulation cascade. Blood coagulates by the transformation of soluble fibrinogen into insoluble fibrin. There are steps in the cascade to arrest bleeding from a damaged blood vessel and thrombin one of these enzymes. Many of these clotting factors are targets for drug therapy. This drug will replace bovine thrombin, since there have been problems with immune reactions (rejection).
The stock is down 14% to 17.51 at this hour. The stock is down even though all endpoints of the trial were met, yet the net effect of the drug was not as effective as planned.(NASDAQ:OMRI)
"We are pleased with the results of our pivotal Phase 3 Thrombin trial and intend to file our BLA by November 15, 2006," said Robert Taub, President and Chief Executive Officer. "OMRIX is committed to advancing its biosurgery pipeline and commercializing a product portfolio of safe, effective and easy to use solutions for surgeons worldwide."
THROMBIN is an enzyme in the blood coagulation cascade. Blood coagulates by the transformation of soluble fibrinogen into insoluble fibrin. There are steps in the cascade to arrest bleeding from a damaged blood vessel and thrombin one of these enzymes. Many of these clotting factors are targets for drug therapy. This drug will replace bovine thrombin, since there have been problems with immune reactions (rejection).
The stock is down 14% to 17.51 at this hour. The stock is down even though all endpoints of the trial were met, yet the net effect of the drug was not as effective as planned.(NASDAQ:OMRI)
Sunday, October 15, 2006
Pfizer Gets Into Vaccines
Pfizer Inc. made a strategic advance into vaccines, acquiring DNA vaccines specialist PowderMed Ltd. The value of the deal, which includes a needle-free delivery system and a portfolio of products, was not disclosed.
PowderMed's lead product against seasonal flu has just entered a Phase I/IIa challenge trial in London and a U.S. Phase I trial, and is in line to become the first DNA vaccine to reach the market.
PowderMed's particle-mediated epidermal delivery technology uses pressurized helium to deliver microscopic gold particles coated in DNA directly to antigen-presenting cells in the epidermis. Once inside the APCs, the DNA become transcriptionally active, producing the encoded proteins, which then are presented by the APCs to lymphocytes, initiating a T-cell mediated immune response.
Apart from the immunological advantages of that route of delivery, the gold particle formulations are stable at room temperature, making them easy to store, and the needle-free device opens up the possibility of self-administration. The delivery device can be used to deliver conventional vaccines and other drugs in a powdered format, also.
PFE closed at 27.59 friday on NYSE.
PowderMed's lead product against seasonal flu has just entered a Phase I/IIa challenge trial in London and a U.S. Phase I trial, and is in line to become the first DNA vaccine to reach the market.
PowderMed's particle-mediated epidermal delivery technology uses pressurized helium to deliver microscopic gold particles coated in DNA directly to antigen-presenting cells in the epidermis. Once inside the APCs, the DNA become transcriptionally active, producing the encoded proteins, which then are presented by the APCs to lymphocytes, initiating a T-cell mediated immune response.
Apart from the immunological advantages of that route of delivery, the gold particle formulations are stable at room temperature, making them easy to store, and the needle-free device opens up the possibility of self-administration. The delivery device can be used to deliver conventional vaccines and other drugs in a powdered format, also.
PFE closed at 27.59 friday on NYSE.
Exelixis submits IND for XL281 RAF inhibitor
Exelixis, Inc. has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration for XL281, a novel anticancer compound designed to potently inhibit the RAS/RAF/MEK/ERK signaling pathway. Mutational activation of RAS occurs in about 30 percent of all human tumors, including non-small cell lung, pancreatic, and colon cancer. XL281 is a specific inhibitor of RAF kinases, including the mutant form of B-RAF, which is activated in 60 percent of melanomas, 24-44 percent of thyroid cancers, and 9 percent of colon cancers.
"XL281 emerged from our strategy to advance novel compounds that potently and selectively inhibit mutationally activated downstream kinases implicated in promoting the growth of specific tumor types," said George A. Scangos, Ph.D., president and chief executive officer of Exelixis. "We have identified five additional next-generation compounds that selectively inhibit key targets in the PI3 kinase, RAS/RAF and JAK/STAT pathways and expect to file IND applications throughout the next nine months."
SO, what's RAF? What's a kinase? First of all there are specific paths from which the cell uses to obtain certain goals. For example, when a cell gets a growth factor binding to the cell surface, it activates proteins downstream all the way to the nucleus. RAF is one such protein in the cascade from the EGFR growth pathway. Stopping it's function thus, my limit how the cell grows, an important step in cancer drugs.
Kinases are enzymes that use ATP as energy to transfer a phospate group and attach it to another protein, at specific amino acids, being tyrosine, serine and threonine.
Exelixis trades on the Nasdaq: EXEL and was trading up 16 cents on friday to 9.82. I would keep an eye on this stock, I think it should spike up with it's encouraging pipeline of next generation protein inhibitors.
"XL281 emerged from our strategy to advance novel compounds that potently and selectively inhibit mutationally activated downstream kinases implicated in promoting the growth of specific tumor types," said George A. Scangos, Ph.D., president and chief executive officer of Exelixis. "We have identified five additional next-generation compounds that selectively inhibit key targets in the PI3 kinase, RAS/RAF and JAK/STAT pathways and expect to file IND applications throughout the next nine months."
SO, what's RAF? What's a kinase? First of all there are specific paths from which the cell uses to obtain certain goals. For example, when a cell gets a growth factor binding to the cell surface, it activates proteins downstream all the way to the nucleus. RAF is one such protein in the cascade from the EGFR growth pathway. Stopping it's function thus, my limit how the cell grows, an important step in cancer drugs.
Kinases are enzymes that use ATP as energy to transfer a phospate group and attach it to another protein, at specific amino acids, being tyrosine, serine and threonine.
Exelixis trades on the Nasdaq: EXEL and was trading up 16 cents on friday to 9.82. I would keep an eye on this stock, I think it should spike up with it's encouraging pipeline of next generation protein inhibitors.
Watch list for non Biotech stocks for Monday
Mattel Inc. is expected to report earnings per share for the third quarter of 61 cents, according to analysts polled by Thomson First Call.
Robbins & Myers Inc. is expected to post fourth-quarter per-share income of 40 cents.
Sonic Corp. is expected to post income of 28 cents per share for the fourth quarter.
Stanley Furniture is expected to report third-quarter per-share income of 28 cents.
Universal Forest Products Inc. is expected to post third-quarter per-share income of $1.13.
Wachovia is expected to report earnings of $1.19 per share for the third quarter.
After Friday's closing bell, Research In Motion , maker of the BlackBerry handheld devices, said it is delaying filing its second-quarter results, due Oct. 17, pending the completion of a stock-option grant review.
Robbins & Myers Inc. is expected to post fourth-quarter per-share income of 40 cents.
Sonic Corp. is expected to post income of 28 cents per share for the fourth quarter.
Stanley Furniture is expected to report third-quarter per-share income of 28 cents.
Universal Forest Products Inc. is expected to post third-quarter per-share income of $1.13.
Wachovia is expected to report earnings of $1.19 per share for the third quarter.
After Friday's closing bell, Research In Motion , maker of the BlackBerry handheld devices, said it is delaying filing its second-quarter results, due Oct. 17, pending the completion of a stock-option grant review.
New River Pharmaceuticals Inc. Conducts End-Of-Phase II Meeting With FDA For NRP290
New River Pharmaceuticals Inc. announced that company officials conducted an end- of-phase II meeting on Thursday with staff members of the Center for Drug Evaluation and Research of the U.S. Food and Drug Administration to discuss NRP290, under development as a potential treatment for acute pain. A derivative of hydrocodone, NRP290 has undergone two pharmacokinetic clinical studies.
RJ Kirk, New River's chairman and CEO, commented, "This is certainly an exciting time for New River. This week's discussions with the FDA will help us finalize our efficacy and safety studies and define our regulatory strategy as we advance NRP290 into late-stage testing."
We believe our proprietary Carrierwave™ technology can be applied in various ways to improve existing drugs. We refer to our Carrierwave™ compounds as Conditionally Bioreversible Derivatives (CBDs). We create a new molecule—a derivative—made of the active pharmaceutical ingredient of a drug such as an amphetamine or opioid, covalently attached to an adjuvant. We design the new molecules to be pharmacologically inactive and only activated ("bioreversed") when taken as directed.
Their lead compounds in amphetamines and opioids are designed to confer overdose protection by restricting the release of the active pharmaceutical ingredient from the CBD at greater than therapeutically prescribed amounts. The CBDs are also designed to be less prone to abuse and addiction by limiting the "rush" or "high" available from the active pharmaceutical ingredient released by the CBD and limiting the ability of abusers to obtain greater doses of the active ingredient through alternative routes of administration or extraction techniques. As a result of these characteristics, we believe that some of our CBDs may be subject to fewer restrictions by the DEA on their manufacture, distribution, prescribing and dispensing.
Extended release opioids will be a great help to people with chronic pain.
NRPH closed down friday at 45.82 or 29 cents per share.
RJ Kirk, New River's chairman and CEO, commented, "This is certainly an exciting time for New River. This week's discussions with the FDA will help us finalize our efficacy and safety studies and define our regulatory strategy as we advance NRP290 into late-stage testing."
We believe our proprietary Carrierwave™ technology can be applied in various ways to improve existing drugs. We refer to our Carrierwave™ compounds as Conditionally Bioreversible Derivatives (CBDs). We create a new molecule—a derivative—made of the active pharmaceutical ingredient of a drug such as an amphetamine or opioid, covalently attached to an adjuvant. We design the new molecules to be pharmacologically inactive and only activated ("bioreversed") when taken as directed.
Their lead compounds in amphetamines and opioids are designed to confer overdose protection by restricting the release of the active pharmaceutical ingredient from the CBD at greater than therapeutically prescribed amounts. The CBDs are also designed to be less prone to abuse and addiction by limiting the "rush" or "high" available from the active pharmaceutical ingredient released by the CBD and limiting the ability of abusers to obtain greater doses of the active ingredient through alternative routes of administration or extraction techniques. As a result of these characteristics, we believe that some of our CBDs may be subject to fewer restrictions by the DEA on their manufacture, distribution, prescribing and dispensing.
Extended release opioids will be a great help to people with chronic pain.
NRPH closed down friday at 45.82 or 29 cents per share.
Saturday, October 14, 2006
Friday, October 13, 2006
I have to remember that .......
The markets are closed tomorrow, but there's a ton of data to relay. I think there are a lot of short positions opening up based on today's numbers. Trial data is coming out too. I will post that data between games tomorrow.
BioTech down a bit: Nasdaq Composite Index gains 2.5% during period
The Nasdaq Composite Index rose 11.11 points to 2,357.29 and the S&P 500 Index added 2.79 points to 1,365.62.
For the week, the Dow gained 0.9%, the Nasdaq rose 2.5% while the S&P 500 advanced 1.2%.NICE!
"It's been a good week for the market with a new high for the Dow," said Charles Rotblut, senior market analyst at Zacks.com, an independent research firm. "We had some good news from the Fed with the Beige Book and the minutes of the last [Federal Open Market Committee] meeting seemed to indicate solid economic growth going through into 2008. But clearly there are still some concerns about inflation."
On Thursday, the Fed said the U.S. economy appeared fragmented into pockets of strength and weakness, but, in general, economic activity continues to expand, according to its 'Beige Book' survey of current economic conditions.
HOWEVER; our interest in biotech was down to 1,098.08 or .38%. Not bad.
For the week, the Dow gained 0.9%, the Nasdaq rose 2.5% while the S&P 500 advanced 1.2%.NICE!
"It's been a good week for the market with a new high for the Dow," said Charles Rotblut, senior market analyst at Zacks.com, an independent research firm. "We had some good news from the Fed with the Beige Book and the minutes of the last [Federal Open Market Committee] meeting seemed to indicate solid economic growth going through into 2008. But clearly there are still some concerns about inflation."
On Thursday, the Fed said the U.S. economy appeared fragmented into pockets of strength and weakness, but, in general, economic activity continues to expand, according to its 'Beige Book' survey of current economic conditions.
HOWEVER; our interest in biotech was down to 1,098.08 or .38%. Not bad.
FDA Approves AstraZeneca's NEXIUM For The Treatment Of Zollinger-Ellison Syndrome
AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved a new indication for the prescription proton pump inhibitor NEXIUM® (esomeprazole magnesium) for the treatment of Zollinger-Ellison Syndrome (ZES). NEXIUM already is indicated for the treatment of gastroesophageal reflux disease (GERD) in adults and children ages 12 to 17, and to reduce the risk of NSAID-associated gastric ulcers in at-risk patients.
ZES is a rare but serious chronic condition characterized by the development of tumors that secrete excessive levels of gastrin, a hormone that stimulates acid production by the stomach.
"Zollinger-Ellison Syndrome is the prototypical gastric acid hypersecretory condition. Patients with this condition require long-term antisecretory therapy to reduce their acid output to levels that are not injurious," said David C. Metz, MD, Professor of Medicine, and Director of the Acid-Peptic Program, Division of Gastroenterology, University of Pennsylvania Health System. "NEXIUM provides early, effective, and sustained acid suppression to help in the management of this disease."
WHAT IS A PROTON PUMP? Well...A proton pump is the site within the stomach cell where hydrochloric acid is actually made and pumped out into the stomach. These inhibitors block the formation of acid in the stomach from 80% to over 90% if enough of the drug is taken.
Since their introduction in the late 1980s, proton pump inhibitors have demonstrated gastric acid suppression superior to that of histamine H2-receptor blockers. Proton pump inhibitors have enabled improved treatment of various acid-peptic disorders, including gastroesophageal reflux disease, peptic ulcer disease, and nonsteroidal anti-inflammatory druginduced gastropathy. Proton pump inhibitors have minimal side effects and few significant drug interactions, and they are generally considered safe for long-term treatment.
AstraZeneca finished down in lower volume today at 61.99 (34 cents)
ZES is a rare but serious chronic condition characterized by the development of tumors that secrete excessive levels of gastrin, a hormone that stimulates acid production by the stomach.
"Zollinger-Ellison Syndrome is the prototypical gastric acid hypersecretory condition. Patients with this condition require long-term antisecretory therapy to reduce their acid output to levels that are not injurious," said David C. Metz, MD, Professor of Medicine, and Director of the Acid-Peptic Program, Division of Gastroenterology, University of Pennsylvania Health System. "NEXIUM provides early, effective, and sustained acid suppression to help in the management of this disease."
WHAT IS A PROTON PUMP? Well...A proton pump is the site within the stomach cell where hydrochloric acid is actually made and pumped out into the stomach. These inhibitors block the formation of acid in the stomach from 80% to over 90% if enough of the drug is taken.
Since their introduction in the late 1980s, proton pump inhibitors have demonstrated gastric acid suppression superior to that of histamine H2-receptor blockers. Proton pump inhibitors have enabled improved treatment of various acid-peptic disorders, including gastroesophageal reflux disease, peptic ulcer disease, and nonsteroidal anti-inflammatory druginduced gastropathy. Proton pump inhibitors have minimal side effects and few significant drug interactions, and they are generally considered safe for long-term treatment.
AstraZeneca finished down in lower volume today at 61.99 (34 cents)
Advancis Cuts Year Forecast on Keflex
Advancis Pharmaceutical Corp. shares fell sharply Friday, after the drugmaker cut its full-year forecast on lower-than-expected stocking of antibiotic Keflex at pharmacies.
The company now expects about $7 million to $10 million in Keflex sales, down from a previous forecast of $16 million to $17 million.
As a result, Advancis forecasts a loss of $37 million to $40 million, or about $1.21 to $1.31 per share, for the year, compared with a narrower loss estimate of $32 million to $37 million, or about $1.05 to $1.25 per share.
Analysts surveyed by Thomson Financial expect a loss per share of $1.12 on revenue of $14.9 million.
The company also said it launched a new 750 milligram dose of Keflex capsules.
"While our Keflex 750 launch has taken longer to develop than our original expectations, we are optimistic that the expanded distribution of Keflex 750 to more than 20,000 pharmacies, especially in the major chains, will enable us to meet our 2007 and long-term goals for the product," said Edward Rudnic, Advancis president and chief executive, in a statement.
Shares of Advancis dropped $1.15, or 22.4 percent, to $4.07 in morning trading on the Nasdaq. Shares have traded between $1.20 and $6.70 over the past 52 weeks.
Keflex is a cephalosporin drug similar to the penicillins, but are more stable against bacterial enzymes, making them a broad range antibiotic. It is classified as a first generation drug. Although this class of drug is relatively non-toxic, they are rarely the drug of choice for any infection. Oral cephalosporins are never relied upon for serious systemic infections.
The company now expects about $7 million to $10 million in Keflex sales, down from a previous forecast of $16 million to $17 million.
As a result, Advancis forecasts a loss of $37 million to $40 million, or about $1.21 to $1.31 per share, for the year, compared with a narrower loss estimate of $32 million to $37 million, or about $1.05 to $1.25 per share.
Analysts surveyed by Thomson Financial expect a loss per share of $1.12 on revenue of $14.9 million.
The company also said it launched a new 750 milligram dose of Keflex capsules.
"While our Keflex 750 launch has taken longer to develop than our original expectations, we are optimistic that the expanded distribution of Keflex 750 to more than 20,000 pharmacies, especially in the major chains, will enable us to meet our 2007 and long-term goals for the product," said Edward Rudnic, Advancis president and chief executive, in a statement.
Shares of Advancis dropped $1.15, or 22.4 percent, to $4.07 in morning trading on the Nasdaq. Shares have traded between $1.20 and $6.70 over the past 52 weeks.
Keflex is a cephalosporin drug similar to the penicillins, but are more stable against bacterial enzymes, making them a broad range antibiotic. It is classified as a first generation drug. Although this class of drug is relatively non-toxic, they are rarely the drug of choice for any infection. Oral cephalosporins are never relied upon for serious systemic infections.
Volume Spikes CYTR AGAIN! Watching this one....
--Late afternoon trading showed unusually heavy volume Friday on the Nasdaq around 2 p.m. Higher-than-normal volume can indicate increased activity by institutions such as mutual funds and insurance companies. Upward stock movement on such volume can show increased confidence among investors, while selling can signal further downward pressure on a stock.
Biopharmaceutical research company CytRx Corp. traded heavily despite a lack of any notable news. The company didn't issue any press releases and no analysts released research on the company.
But trading volume exceeded 10.5 million at 2 p.m., far higher than typical trading volume of 864,067 shares.
I think i'll go looking for some short share if any are still out there.
CYTR closed up 32 cents or 26% at close today.
Biopharmaceutical research company CytRx Corp. traded heavily despite a lack of any notable news. The company didn't issue any press releases and no analysts released research on the company.
But trading volume exceeded 10.5 million at 2 p.m., far higher than typical trading volume of 864,067 shares.
I think i'll go looking for some short share if any are still out there.
CYTR closed up 32 cents or 26% at close today.
Aspreva Sees 3Q Revenue Missing Street
Aspreva Pharmaceuticals Sees 3rd-Quarter and Full-Year Revenue Missing Wall Street Targets
NEW YORK-- Canadian drug developer Aspreva Pharmaceuticals Corp. said Friday it expects third-quarter revenue of $48 million, up sharply from the year-ago level, but below Wall Street's target.
Shares of the Victoria, British Columbia-based company sank on the news, shedding $2.02, or 8.1 percent, to $22.87 on the Nasdaq. Over the past 52 weeks, the stock has traded between $11.18 and $34.89.
The preliminary figure marks a 54.8 percent increase over revenue of $31 million during the same period a year ago. The figure also includes the negative impact of preliminary reconciliation payments to Roche, under the terms of a collaboration agreement.
Two analysts polled by Thomson Financial are looking for higher revenue of $54.3 million.
Aspreva also reaffirmed full-year guidance for revenue in excess of $200 million, while expecting CellCept prescriptions to increase by 20 percent to 25 percent.
Analysts expect the company to book $225.9 million in revenue.
The company uses drugs that are already on the market and innovates new ways to use them, such as new indications. Autoimmune disease is a major target.
NEW YORK-- Canadian drug developer Aspreva Pharmaceuticals Corp. said Friday it expects third-quarter revenue of $48 million, up sharply from the year-ago level, but below Wall Street's target.
Shares of the Victoria, British Columbia-based company sank on the news, shedding $2.02, or 8.1 percent, to $22.87 on the Nasdaq. Over the past 52 weeks, the stock has traded between $11.18 and $34.89.
The preliminary figure marks a 54.8 percent increase over revenue of $31 million during the same period a year ago. The figure also includes the negative impact of preliminary reconciliation payments to Roche, under the terms of a collaboration agreement.
Two analysts polled by Thomson Financial are looking for higher revenue of $54.3 million.
Aspreva also reaffirmed full-year guidance for revenue in excess of $200 million, while expecting CellCept prescriptions to increase by 20 percent to 25 percent.
Analysts expect the company to book $225.9 million in revenue.
The company uses drugs that are already on the market and innovates new ways to use them, such as new indications. Autoimmune disease is a major target.
Discovery Laboratories Shares Up After Drug's Positive Mid-Stage Trials
Discovery Laboratories, Inc. (NASDAQ:DSCO - News) today announced encouraging results from its recently completed Phase 2 clinical trial of Surfaxin(r) (lucinactant) for the prevention and treatment of Bronchopulmonary Dysplasia (BPD), a debilitating and chronic lung disease typically affecting premature infants who have suffered Respiratory Distress Syndrome (RDS). The results suggest that Surfaxin, administered up to five times, may represent a novel therapeutic option for infants at risk for BPD. Presently there are no approved therapies for this disease. Surfaxin has received an Approvable Letter from the United States FDA for the prevention of RDS and has Orphan Drug Status and Fast Track designation from the FDA for the prevention and treatment of BPD.
DSCO makes a fully synthetic surfactant for use in infants with respiratory distress. Basically surfactants are a types of proteins and lipids that help oxygen diffuse into the blood stream within the lung. The cool thing about DSCO's Surfaxin is that it is non immunogenic meaning the body wont see it as foreign an mount an immune response against it.
DSCO 's shares were up almost 60 cents in yesterday's rally. Midday trading today is holding at $2.59 down 5 cents in large volume trading.
DSCO makes a fully synthetic surfactant for use in infants with respiratory distress. Basically surfactants are a types of proteins and lipids that help oxygen diffuse into the blood stream within the lung. The cool thing about DSCO's Surfaxin is that it is non immunogenic meaning the body wont see it as foreign an mount an immune response against it.
DSCO 's shares were up almost 60 cents in yesterday's rally. Midday trading today is holding at $2.59 down 5 cents in large volume trading.
Asia Follows the Bull...Right to the MONEY! Asian stocks follow US Markets:
Asian stocks were sharply higher Friday, with indexes in Japan and South Korea leading the advance as investors chased blue-chips such as Sony Corp., Toshiba Corp., and Posco after upbeat earnings reports from large U.S. companies raised expectations of a strong showing by their Asian counterparts.
Investors also apparently shelved concerns over North Korea to focus instead on Wall Street, where the Dow Jones Industrial Average set a fresh record closing high.
The Nikkei 225 Index ended the morning session up 1% to 16,537.9. The Tokyo Stock Price Index, or Topix, was up 0.9% to 1,628.9.
South Korea's Kospi was up 1.2% to 1,348.0. Shares in Australia were also on the move, as the benchmark S&P/ASX 200 gained 0.9%, touching a fresh five-month high.
Shares listed in Singapore and Taiwan gained more than 1.2%. Indexes in Malaysia and New Zealand were also higher.
Hong Kong's Hang Seng Index was up 1% to 18,043.9. The China Enterprises Index, a gauge of 37 leading mainland-incorporated shares listed in Hong Kong, was up 1.2% to 7,378.1.
"Around the region we have seen funds continue flowing into the equity market," said Ben Kwong, an analyst at KGI Securities in Hong Kong. "We are basically in a similar kind of situation to the U.S. where funds still favor the equity market ahead of the midterm elections."
He added China banking shares would continue to be in focus as investors sought exposure to the sector ahead of the upcoming initial public offering for the Industrial & Commercial Bank of China. He added large capitalization stocks are also expected to mark gains as cash that had been sidelined over regional security concerns moves into the equity market
"I expect the uptrend will continue for a few weeks, followed by a moderate downtrend in November," Kwong said.
Crude-oil futures rose as much as 36 cents to $58.22 a barrel in electronic trading. The November contract gained 27 cents at $57.86 a barrel on the New York Mercantile Exchange after the U.S. Energy Department said domestic distillate supplies, which include winter heating oil, fell for the first time in nine weeks.
Shares of electronic and entertainment conglomerate Sony were up 3.3% while diversified industrial conglomerate Toshiba gained 3%.
Investors also apparently shelved concerns over North Korea to focus instead on Wall Street, where the Dow Jones Industrial Average set a fresh record closing high.
The Nikkei 225 Index ended the morning session up 1% to 16,537.9. The Tokyo Stock Price Index, or Topix, was up 0.9% to 1,628.9.
South Korea's Kospi was up 1.2% to 1,348.0. Shares in Australia were also on the move, as the benchmark S&P/ASX 200 gained 0.9%, touching a fresh five-month high.
Shares listed in Singapore and Taiwan gained more than 1.2%. Indexes in Malaysia and New Zealand were also higher.
Hong Kong's Hang Seng Index was up 1% to 18,043.9. The China Enterprises Index, a gauge of 37 leading mainland-incorporated shares listed in Hong Kong, was up 1.2% to 7,378.1.
"Around the region we have seen funds continue flowing into the equity market," said Ben Kwong, an analyst at KGI Securities in Hong Kong. "We are basically in a similar kind of situation to the U.S. where funds still favor the equity market ahead of the midterm elections."
He added China banking shares would continue to be in focus as investors sought exposure to the sector ahead of the upcoming initial public offering for the Industrial & Commercial Bank of China. He added large capitalization stocks are also expected to mark gains as cash that had been sidelined over regional security concerns moves into the equity market
"I expect the uptrend will continue for a few weeks, followed by a moderate downtrend in November," Kwong said.
Crude-oil futures rose as much as 36 cents to $58.22 a barrel in electronic trading. The November contract gained 27 cents at $57.86 a barrel on the New York Mercantile Exchange after the U.S. Energy Department said domestic distillate supplies, which include winter heating oil, fell for the first time in nine weeks.
Shares of electronic and entertainment conglomerate Sony were up 3.3% while diversified industrial conglomerate Toshiba gained 3%.
Thursday, October 12, 2006
Lung cancer treatment gets FDA approval
Genentech Inc. has received federal approval to sell the drug Avastin for treatment of the most common kind of lung cancer.
The U.S. Food and Drug Administration approved the use of the drug in combination with chemotherapy for non-small cell lung cancer, the South San Francisco company said Wednesday. Genentech has a manufacturing plant in Vacaville.
In a clinical trial of 878 people, 51 percent of patients treated with Avastin and chemotherapy were still alive after one year compared to 44 percent of those who only received chemotherapy. The median survival rate was two months longer for patients who took Avastin than those who got chemotherapy alone.
Lung cancer kills 162,000 people per year in the United States, more than any other type of cancer.
Genentech said it would cap the price of the drug at $55,000 per year. Treatment of colorectal cancer with Avastin costs less than $4,400 per month, but lung cancer treatment requires higher doses at a typical cost of $8,800 per month.
The FDA approved use of the drug for colorectal cancer in February 2004.
There are quite a few types of cells (duh) in the lung and non small cell reflects the cancer of the bronchi. It is the number one cause of cancer related deaths in developed countries. NSCC are more treated by surgery, respond poorly to chemotherapy and are most often treated by surgery. [Since most patients present with solid tumors that have not metastisized] The most incriminating evidence for the origin of NSCC is cigarette smoke.
Remember Avastin is a humanized monoclonal antibody that inhibits vascular endothelial growth factor. [see earlier post from sept 11]
The U.S. Food and Drug Administration approved the use of the drug in combination with chemotherapy for non-small cell lung cancer, the South San Francisco company said Wednesday. Genentech has a manufacturing plant in Vacaville.
In a clinical trial of 878 people, 51 percent of patients treated with Avastin and chemotherapy were still alive after one year compared to 44 percent of those who only received chemotherapy. The median survival rate was two months longer for patients who took Avastin than those who got chemotherapy alone.
Lung cancer kills 162,000 people per year in the United States, more than any other type of cancer.
Genentech said it would cap the price of the drug at $55,000 per year. Treatment of colorectal cancer with Avastin costs less than $4,400 per month, but lung cancer treatment requires higher doses at a typical cost of $8,800 per month.
The FDA approved use of the drug for colorectal cancer in February 2004.
There are quite a few types of cells (duh) in the lung and non small cell reflects the cancer of the bronchi. It is the number one cause of cancer related deaths in developed countries. NSCC are more treated by surgery, respond poorly to chemotherapy and are most often treated by surgery. [Since most patients present with solid tumors that have not metastisized] The most incriminating evidence for the origin of NSCC is cigarette smoke.
Remember Avastin is a humanized monoclonal antibody that inhibits vascular endothelial growth factor. [see earlier post from sept 11]
Genentech Recruiting for Eale's Disease Clinical Trial
They will be using a VEGF Inhibitor [vascular endothelial growth factor] (Lucentis) in Refractory Macular Edema [aquous humor leakage] due to Eales’ Disease.
Eales Disease is a rare disorder of sight that appears as an inflammation and white haze around the outercoat of the veins in the retina. The disorder is most prevalent among young males and normally affects both eyes. Usually, vision is suddenly blurred because the clear jelly that fills the eyeball behind the lens of the eye seeps out (vitreous hemorrhaging).
Genentech (DNA) finished down in today's action 74 cents to 83.41 in active trading.
Records Set yet Again! : Earnings help push Dow to fresh record
NEW YORK (MarketWatch) -- U.S. stocks rallied Thursday as a string of stronger-than-expected earnings reports led by McDonald's Corp., Costco Wholesale Corp. and Yum Brands Inc. propelled the Dow Jones Industrial Average to a fresh all-time high.
The Dow industrials rose 80 points to 11,932, just off an all-time high of 11,934.73 reached earlier in the session. Gains for McDonald's Boeing Co. Intel Corp. and Microsoft Corp. spurred the blue-chip advance.
Of the 30 Dow stocks, 24 contributed to gains.
The Nasdaq Composite Index gained 20 points to 2,328, while the S&P 500 Index climbed 9 points to 1,358.
"The catalyst is basically a slew of better-than-expected earnings in a market where there is already a lot of positive momentum" said Jim Paulsen, chief investment officer at Wells Capital Management.
The Biotech sector is up at this hour 0.1% (that's 1.10) to 1097.28.
The Dow industrials rose 80 points to 11,932, just off an all-time high of 11,934.73 reached earlier in the session. Gains for McDonald's Boeing Co. Intel Corp. and Microsoft Corp. spurred the blue-chip advance.
Of the 30 Dow stocks, 24 contributed to gains.
The Nasdaq Composite Index gained 20 points to 2,328, while the S&P 500 Index climbed 9 points to 1,358.
"The catalyst is basically a slew of better-than-expected earnings in a market where there is already a lot of positive momentum" said Jim Paulsen, chief investment officer at Wells Capital Management.
The Biotech sector is up at this hour 0.1% (that's 1.10) to 1097.28.
Wednesday, October 11, 2006
Wyeth initiates phase I trial of Rifampin on multiple dose pharmacokinetics
The study is entitled "Study to Determine the Impact of Multiple Doses of Rifampin on Single-Dose Pharmacokinetics of HCV-796".
Primary Outcomes: To evaluate the effects of multiple oral doses of rifampin on the pharmacokinetic (PK) profile of a single oral dose of HCV-796 in healthy subjects.
Secondary Outcomes: To assess the safety and tolerability of HCV-796 and rifampin when coadministered to healthy subjects.
HCV-796 is an anti-hepatitis C drug that works by inhibiting viral polymerases. An example of this is NS5B, which is a RNA polymerase. This drug stops it's action leading to inhibition of viral replication.
Wyeth NYSE: WYE, closed after hours up .4% at 51.71. Other companies actively working on anti hep C drugs are Anadys (NASDAQ: ANDS), 3M and Coley. Both Anadys and 3M are developing toll like receptor agonists to stimulate innate immunity.
Primary Outcomes: To evaluate the effects of multiple oral doses of rifampin on the pharmacokinetic (PK) profile of a single oral dose of HCV-796 in healthy subjects.
Secondary Outcomes: To assess the safety and tolerability of HCV-796 and rifampin when coadministered to healthy subjects.
HCV-796 is an anti-hepatitis C drug that works by inhibiting viral polymerases. An example of this is NS5B, which is a RNA polymerase. This drug stops it's action leading to inhibition of viral replication.
Wyeth NYSE: WYE, closed after hours up .4% at 51.71. Other companies actively working on anti hep C drugs are Anadys (NASDAQ: ANDS), 3M and Coley. Both Anadys and 3M are developing toll like receptor agonists to stimulate innate immunity.
Markets Higher in Asia up early Thursday
HONG KONG-- Asian stocks were mostly higher Thursday, with South Korea fronting the advance as investors chased LG.Philips LCD, Hanjin Shipping and other blue-chips, while in Japan, Sony Corp. rose for the third straight session.
South Korea's Composite Stock Price Index, or Kospi, was up 0.6%, as bargain hunting apparently outweighed investors' concerns over North Korea's nuclear ambitions.
The Nikkei 225 Average ended the morning session up 0.4% to 16,459.4. The broader Topix index ended up 0.2% to 1,625.1.
Elsewhere across the region, shares listed in Australia were down 0.1%. Stocks in Malaysia, Singapore and New Zealand were higher. Taiwan's leading index fell 0.2% while Indonesia's Jakarta Composite was down 0.1%. Shares listed in Shanghai were down 0.3%.
In Hong Kong the blue-chip Hang Seng Index traded nearly flat to 17,848.3. The China Enterprises Index, which tracks 37 mainland-incorporated companies listed in Hong Kong, rose 0.7% to 7,269.7.
"I don't believe the [nuclear] test materially change anything," said Spencer White, Merrill Lynch's chief equity strategist, Asia Pacific. "There has been some short-term volatility with currencies and equity markets in both South Korea and Japan, but the reaction of overseas investors was to buy in very considerable size."
South Korea's Composite Stock Price Index, or Kospi, was up 0.6%, as bargain hunting apparently outweighed investors' concerns over North Korea's nuclear ambitions.
The Nikkei 225 Average ended the morning session up 0.4% to 16,459.4. The broader Topix index ended up 0.2% to 1,625.1.
Elsewhere across the region, shares listed in Australia were down 0.1%. Stocks in Malaysia, Singapore and New Zealand were higher. Taiwan's leading index fell 0.2% while Indonesia's Jakarta Composite was down 0.1%. Shares listed in Shanghai were down 0.3%.
In Hong Kong the blue-chip Hang Seng Index traded nearly flat to 17,848.3. The China Enterprises Index, which tracks 37 mainland-incorporated companies listed in Hong Kong, rose 0.7% to 7,269.7.
"I don't believe the [nuclear] test materially change anything," said Spencer White, Merrill Lynch's chief equity strategist, Asia Pacific. "There has been some short-term volatility with currencies and equity markets in both South Korea and Japan, but the reaction of overseas investors was to buy in very considerable size."
Immucor tops analyst forcast: with blood machine:
Immucor Inc. late Wednesday posted quarterly results that beat analysts' forecasts due to strong sales of its blood diagnostics systems, but the shares lost ground as the company said it now expects to launch the latest version of its Galileo automated blood bank system in its fiscal fourth quarter instead of the third.
The Norcross, Ga.-based company (BLUD : NASDAQ) reported net income for its fiscal first quarter ended Aug. 31 of $12.7 million, or 18 cents a share, vs. $8 million, or 11 cents a share, in the same quarter a year earlier. Revenue rose to $51 million from $42.4 million. The number of outstanding shares stood at 70.2 million at the end of the latest quarter vs. 71.6 million the year before. The effect of currency added $600,000 to the sales results.
Analysts had been looking for a per-share profit of 17 cents on revenue of $49 million, according to Thomson First Call.
Sales of reagent products using the company's Capture technology were up 16% at $9.2 million; those not using the Capture technology rose 20% to $31.1 million year-over-year.
Instrument sales jumped 57% to $3.3 million.
Immucor said that as of as of Aug. 31, it had received 386 purchase orders for its automated blood test instrument know as Galileo.
A new version of the diagnostic machine, called Galileo Echo, is now expected to be launched in the United States and Europe in fourth quarter, the company said. Immucor had previously forecast it would be launched in its fiscal third quarter.
"This [fourth-quarter] expected launch date is dependent on Food and Drug Administration clearance in the United States and assumes our submission to the FDA is made by the third quarter of fiscal 2007," Chief Executive Gioacchino De Chirico said in a statement. The new forecast launch date also assumes clearance is granted within 90 days of the FDA submission, he said.
Robert Baird & Co. analyst Quintin Lai said the difference is important because once the Echo is launched it's expected to have "very robust adoption."
"So the sooner it gets launched, the sooner it can help boost cost sales," Lai said.
Shares of Immucor , which had closed the regular session with a more than 6% gain at $23.34, fell to $22.85 in late dealings.
The Norcross, Ga.-based company (BLUD : NASDAQ) reported net income for its fiscal first quarter ended Aug. 31 of $12.7 million, or 18 cents a share, vs. $8 million, or 11 cents a share, in the same quarter a year earlier. Revenue rose to $51 million from $42.4 million. The number of outstanding shares stood at 70.2 million at the end of the latest quarter vs. 71.6 million the year before. The effect of currency added $600,000 to the sales results.
Analysts had been looking for a per-share profit of 17 cents on revenue of $49 million, according to Thomson First Call.
Sales of reagent products using the company's Capture technology were up 16% at $9.2 million; those not using the Capture technology rose 20% to $31.1 million year-over-year.
Instrument sales jumped 57% to $3.3 million.
Immucor said that as of as of Aug. 31, it had received 386 purchase orders for its automated blood test instrument know as Galileo.
A new version of the diagnostic machine, called Galileo Echo, is now expected to be launched in the United States and Europe in fourth quarter, the company said. Immucor had previously forecast it would be launched in its fiscal third quarter.
"This [fourth-quarter] expected launch date is dependent on Food and Drug Administration clearance in the United States and assumes our submission to the FDA is made by the third quarter of fiscal 2007," Chief Executive Gioacchino De Chirico said in a statement. The new forecast launch date also assumes clearance is granted within 90 days of the FDA submission, he said.
Robert Baird & Co. analyst Quintin Lai said the difference is important because once the Echo is launched it's expected to have "very robust adoption."
"So the sooner it gets launched, the sooner it can help boost cost sales," Lai said.
Shares of Immucor , which had closed the regular session with a more than 6% gain at $23.34, fell to $22.85 in late dealings.
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