Amgen Inc. disclosed negative findings in studies of its Aranesp anemia drug and Vectibix colon cancer treatment, including a higher risk of death among cancer patients not undergoing chemotherapy who were treated with Aranesp.
"There was a statistically significant increased risk of death in the Aranesp-treated group," Amgen said in a release, although no specific unexplained safety concerns could be identified in the late-stage trial. It involved patients with anemia and active cancer who were not receiving chemotherapy or radiation.
"These were patients with an especially dire prognosis," said Roger Perlmutter, Amgen's executive vice president of research and development.
The company said that at the end of 16 weeks, the trial showed no statistically significant difference in the frequency of blood transfusions in the population receiving placebo injections as opposed to those receiving Aranesp.
Perlmutter said the data provides "a lot of hypotheses to test," and Amgen is conducting further studies.
AMGN is down over 4% in todays late afternoon trading to $71.62 per share.
What is Aranesp and how does it work?
Patients with anemia often need blood transfusions to restore their levels of hemoglobin, the red component of blood that carries oxygen to the rest of the body. Aranesp is a recombinant human protein made in the laboratory that is very similar to the protein erythropoietin that your body makes. It is a type of growth factor that stimulates red blood cells to be made. It's mechanism of action is the same as natural RBC production: release from the kidney in response to hypoxia and cell release from the bone marrow.
What about Vectibix?
Vectibix is another humanized monoclonal antibody treatment directed towards certain cancers. Panitumumab is the antibody name and is made in the laboratory. It binds specifically to the human Epidermal Growth Factor Receptor (EGFR). Overexpression of EGFR is detected in many human cancers, including those of the colon and rectum. When Vectibix binds to EGFR it competitively inhibits the binding of ligands for EGFR. This results in inhibition of cell growth, induction of apoptosis [cell death], decreased pro-inflammatory cytokine and vascular growth factor production.
Friday, January 26, 2007
Thursday, January 25, 2007
Neurocrine to submit NDA for Indiplon AGAIN in 2Q07
The market woke to investor pleasing news from Neurocrine biosciences, Inc. which plans to resubmit the new drug application for the immediate release (IR) insomnia drug indiplon during the second quarter, with review likely taking about 6 months.
After trading ended monday, Neurocrine disclosed that another safety and efficacy trial will not be done for the compound, a non-benzodiazepine agent that acts on a specific site of the GABA-A receptor that is designed for use as needed by patients, whether to fall asleep quickly or go back to sleep after waking in the night.
After talks with the agency [FDA] the odds of indiplon's approval "are so high that to spend $20 million on an 'insurance' study they didnt ask for would not be prudent." Instead, neurocrine will spend the money on pre-commercial work and phase IIIb/IV activities.
The companies shares NBIX closed tuesday at $13.88, up 93 cents. TODAY- NBIX closed at $14.02.
After trading ended monday, Neurocrine disclosed that another safety and efficacy trial will not be done for the compound, a non-benzodiazepine agent that acts on a specific site of the GABA-A receptor that is designed for use as needed by patients, whether to fall asleep quickly or go back to sleep after waking in the night.
After talks with the agency [FDA] the odds of indiplon's approval "are so high that to spend $20 million on an 'insurance' study they didnt ask for would not be prudent." Instead, neurocrine will spend the money on pre-commercial work and phase IIIb/IV activities.
The companies shares NBIX closed tuesday at $13.88, up 93 cents. TODAY- NBIX closed at $14.02.
Tuesday, January 23, 2007
Coley Pharmaceutical Group To Suspend Hepatitis C Program As It Cuts Staff
WELLESLEY, Mass.-- Coley Pharmaceutical Group, Inc. today announced that the company has made the strategic decision to suspend the independent development of ACTILON, its product candidate for the treatment of Hepatitis C virus (HCV) infection. Coley will focus its resources towards discovering and developing new TLR Therapeutics(TM), including its preclinical pipeline of synthetic RNA-based drugs designed to stimulate Toll-like receptors (TLRs) 7 and 8, as well as other synthetic agonists and antagonists targeting TLRs 7, 8 and 9. "The decision to suspend a drug development program is a difficult one," commented Robert L. Bratzler, Ph.D., President and Chief Executive Officer for Coley Pharmaceutical Group. "However, we are confident that the changes being made today are the right ones for our shareholders. As a result of these modifications to our drug development program, Coley plans to redirect the necessary resources in our efforts to expand and diversify our portfolio of product candidates and maintain our leadership position in the TLR Therapeutics space."
Nasdaq: COLY is trading down today 1.25 per share or down to $8.64.
As you remember TLR receptors are intracellular innate immunity receptors that recognize among other things viral RNA, DNA and bacterial cell wall components. COLY had a rather big stake in TLR agonists and clinical development programs, so this is surprising to me.
Clincial trail data from ACTILON shows that 5 of 7 patients regressed back to serologically positive for viral infections. These 7 patients completed 48 weeks of therapy by year-end 2006 and were followed to determine if a sustained virologic response (SVR), defined as continued viral clearance for six months after cessation of treatment, was achieved. Today, the company reported that 2 of 7 patients remained HCV viral negative at one- and four-months, respectively, following the cessation of treatment.
Nasdaq: COLY is trading down today 1.25 per share or down to $8.64.
As you remember TLR receptors are intracellular innate immunity receptors that recognize among other things viral RNA, DNA and bacterial cell wall components. COLY had a rather big stake in TLR agonists and clinical development programs, so this is surprising to me.
Clincial trail data from ACTILON shows that 5 of 7 patients regressed back to serologically positive for viral infections. These 7 patients completed 48 weeks of therapy by year-end 2006 and were followed to determine if a sustained virologic response (SVR), defined as continued viral clearance for six months after cessation of treatment, was achieved. Today, the company reported that 2 of 7 patients remained HCV viral negative at one- and four-months, respectively, following the cessation of treatment.
Monday, January 22, 2007
Discovery Labs Gets Surfaxin Guidance
Discovery Labs Gets FDA Guidance on How to Improve Surfaxin Approval Chances; Shares Surge
WARRINGTON, Pa.-- Discovery Laboratories Inc. said Monday that the Food and Drug Administration provided the company with guidance on how to improve chances on getting its Surfaxin lung treatment approved.
Shares of the company jumped on the news, adding 65 cents, or 25.2 percent, to $3.20 in premarket trading, after closing Friday at $2.55 on the Nasdaq.
In April, the biotech drug developer received an "approvable" letter from the FDA, meaning the agency considered the company's drug application in order but needed additional information for approval. Discovery expects to have a formal response to the letter by October, and anticipates a six-month FDA review period to follow.
The guidance resulted from meetings with the FDA in September and December 2006.
The company is trying to get Surfaxin approved to treat Respiratory Distress Syndrome in premature infants.
Surfaxin is a synthetic substance that reduces surface tension that allows lung tissue to absorb oxygen. The FDA said Surfaxin is already approvable for premature infants who are born with little or none of the natural substance that the drug mimics. However, the company has been plagued with manufacturing problems.
The FDA approvable letter focused on the company's chemistry, manufacturing and controls.
Here's a briefing of a previous post I wrote on Discovery Labs:
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 closed today's trading at 2.66 per share.
WARRINGTON, Pa.-- Discovery Laboratories Inc. said Monday that the Food and Drug Administration provided the company with guidance on how to improve chances on getting its Surfaxin lung treatment approved.
Shares of the company jumped on the news, adding 65 cents, or 25.2 percent, to $3.20 in premarket trading, after closing Friday at $2.55 on the Nasdaq.
In April, the biotech drug developer received an "approvable" letter from the FDA, meaning the agency considered the company's drug application in order but needed additional information for approval. Discovery expects to have a formal response to the letter by October, and anticipates a six-month FDA review period to follow.
The guidance resulted from meetings with the FDA in September and December 2006.
The company is trying to get Surfaxin approved to treat Respiratory Distress Syndrome in premature infants.
Surfaxin is a synthetic substance that reduces surface tension that allows lung tissue to absorb oxygen. The FDA said Surfaxin is already approvable for premature infants who are born with little or none of the natural substance that the drug mimics. However, the company has been plagued with manufacturing problems.
The FDA approvable letter focused on the company's chemistry, manufacturing and controls.
Here's a briefing of a previous post I wrote on Discovery Labs:
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 closed today's trading at 2.66 per share.
Friday, January 19, 2007
Quiet Altus Pharma Has Big Things in Store
Altus Pharmaceuticals (ALTU) has a novel drug-enhancement technology, two products entering phase III clinical trials, and most recently, a collaboration with one of biotech's biggest players.
But one year after going public, this young biotech firm still keeps a fairly low profile.
If you haven't gotten to know Altus yet, now is a good time, before the phase III trials begin in the second quarter and the news flow gears back up. Altus' lead product, known as ALTU-135, is a pancreatic enzyme-replacement therapy for cystic fibrosis and other diseases.
Highly pure, with more stability and improved convenience and dosing compared with existing products, ALTU-135 should be able to grab a significant chunk of a $600 million to $700 million worldwide commercial opportunity.
The second late-stage product in Altus' bag is ALTU-238, an extended-release human growth hormone that appears to be potent enough to allow for once-weekly injections. Existing human growth hormones -- a large, $2 billion market -- require daily injections. In December, Genentech (DNA) signed on as Altus' development and marketing partner for ALTU-238.
It's Altus' core technology platform that ties together these two drug programs -- and the rest of the company's early-stage pipeline. Altus has figured out a way to produce crystallized formulations of protein drugs at commercial scale.
Crystals are pure and highly stable (think table salt), which is one reason why Big Pharma has focused historically on developing small-molecule drugs in crystalline form. Proteins, on the other hand, are larger molecules, more complex and therefore harder to crystallize.
Confused? A couple of examples borne of Altus' technology platform will help clarify. ALTU-135, its pancreatic enzyme-replacement therapy, is a single capsule taken by patients before every meal. Existing pancreatic enzymes, by comparison, are less potent, which forces patients to swallow three to five larger capsules per meal.
Likewise, the slow release of human growth hormone from the protein crystals that make up ALTU-238 are what should allow the therapy to be dosed weekly.
Biotech companies -- and stocks -- are typically associated with a very high level of risk due to the uncertain nature of drug development, not to mention the guessing game that can be the Food and Drug Administration. But in Altus' case, clinical and regulatory risk is reduced because the therapies and diseases the company is attacking are very well understood, with plenty of scientific and commercial precedent.
Altus was spun out of Vertex Pharmaceuticals (VRTX) in 1999 and went public in January 2006, selling 7 million shares at $15 that raised $95 million. On Thursday, Altus' stock closed at $18.53, which gives the company a $425 million market cap and $344 million enterprise value.
What is ALTU-135?
ALTU-135 is an orally-administered enzyme replacement therapy for the treatment of malabsorption due to exocrine [outflow] pancreatic insufficiency. Exocrine pancreatic insufficiency is a deficiency of digestive enzymes normally produced by the pancreas which leads to malnutrition, impaired growth and shortened life expectancy. Exocrine pancreatic insufficiency
can result from a number of diseases and conditions, including cystic fibrosis, chronic pancreatitis and pancreatic cancer.
According to IMS Health, global prescription sales of existing pancreatic enzyme replacement products were
$658 million in 2004.
But one year after going public, this young biotech firm still keeps a fairly low profile.
If you haven't gotten to know Altus yet, now is a good time, before the phase III trials begin in the second quarter and the news flow gears back up. Altus' lead product, known as ALTU-135, is a pancreatic enzyme-replacement therapy for cystic fibrosis and other diseases.
Highly pure, with more stability and improved convenience and dosing compared with existing products, ALTU-135 should be able to grab a significant chunk of a $600 million to $700 million worldwide commercial opportunity.
The second late-stage product in Altus' bag is ALTU-238, an extended-release human growth hormone that appears to be potent enough to allow for once-weekly injections. Existing human growth hormones -- a large, $2 billion market -- require daily injections. In December, Genentech (DNA) signed on as Altus' development and marketing partner for ALTU-238.
It's Altus' core technology platform that ties together these two drug programs -- and the rest of the company's early-stage pipeline. Altus has figured out a way to produce crystallized formulations of protein drugs at commercial scale.
Crystals are pure and highly stable (think table salt), which is one reason why Big Pharma has focused historically on developing small-molecule drugs in crystalline form. Proteins, on the other hand, are larger molecules, more complex and therefore harder to crystallize.
Confused? A couple of examples borne of Altus' technology platform will help clarify. ALTU-135, its pancreatic enzyme-replacement therapy, is a single capsule taken by patients before every meal. Existing pancreatic enzymes, by comparison, are less potent, which forces patients to swallow three to five larger capsules per meal.
Likewise, the slow release of human growth hormone from the protein crystals that make up ALTU-238 are what should allow the therapy to be dosed weekly.
Biotech companies -- and stocks -- are typically associated with a very high level of risk due to the uncertain nature of drug development, not to mention the guessing game that can be the Food and Drug Administration. But in Altus' case, clinical and regulatory risk is reduced because the therapies and diseases the company is attacking are very well understood, with plenty of scientific and commercial precedent.
Altus was spun out of Vertex Pharmaceuticals (VRTX) in 1999 and went public in January 2006, selling 7 million shares at $15 that raised $95 million. On Thursday, Altus' stock closed at $18.53, which gives the company a $425 million market cap and $344 million enterprise value.
What is ALTU-135?
ALTU-135 is an orally-administered enzyme replacement therapy for the treatment of malabsorption due to exocrine [outflow] pancreatic insufficiency. Exocrine pancreatic insufficiency is a deficiency of digestive enzymes normally produced by the pancreas which leads to malnutrition, impaired growth and shortened life expectancy. Exocrine pancreatic insufficiency
can result from a number of diseases and conditions, including cystic fibrosis, chronic pancreatitis and pancreatic cancer.
According to IMS Health, global prescription sales of existing pancreatic enzyme replacement products were
$658 million in 2004.
Thursday, January 18, 2007
Anesiva Cancels Anesthetic Development: OUCH!
Anesiva Closes Development of 1207 Anesthetic Based on Disappointing Study Results
SOUTH SAN FRANCISCO, Calif.-- Biopharmaceutical company Anesiva Inc. said an early stage study of its topical anesthetic showed the drug was safe and tolerable, but failed to show any anesthetic effect.
The company said it will cease development of the drug, called 1207, based on the results of the Phase I clinical trial, which involved 24 healthy adult males. The drug was aimed at treating neuropathic pain.
Anesiva said it will continue to focus on its other developing pain treatments Zingo and 4975.
Shares of Anesiva fell 15 cents to $7.62 in morning trading on the Nasdaq. The stock has traded between $6.31 and $10.36 over the last 52 weeks.
HOW did 1207 NOT work?
1207 is a novel anesthetic with properties that provide pain relief by binding to the fast sodium channel [ion channels] on neurons responsible for transmitting pain signals from nerve endings to the brain. Specifically, 1207 binds to the fast sodium channel on both A nerve fibers responsible for transmitting immediate "adaptive pain" signals and C nerve fibers responsible for transmitting longer-term, dull, aching throbbing pain signals. By interrupting the communication channel of both A fibers and C fibers, 1207 is designed to provide effective topical pain relief with a faster onset and longer duration of action than currently marketed pain products. Potential applications for 1207 include pre-procedural use in dermatological surgery and post-surgical incision pain.
SOUTH SAN FRANCISCO, Calif.-- Biopharmaceutical company Anesiva Inc. said an early stage study of its topical anesthetic showed the drug was safe and tolerable, but failed to show any anesthetic effect.
The company said it will cease development of the drug, called 1207, based on the results of the Phase I clinical trial, which involved 24 healthy adult males. The drug was aimed at treating neuropathic pain.
Anesiva said it will continue to focus on its other developing pain treatments Zingo and 4975.
Shares of Anesiva fell 15 cents to $7.62 in morning trading on the Nasdaq. The stock has traded between $6.31 and $10.36 over the last 52 weeks.
HOW did 1207 NOT work?
1207 is a novel anesthetic with properties that provide pain relief by binding to the fast sodium channel [ion channels] on neurons responsible for transmitting pain signals from nerve endings to the brain. Specifically, 1207 binds to the fast sodium channel on both A nerve fibers responsible for transmitting immediate "adaptive pain" signals and C nerve fibers responsible for transmitting longer-term, dull, aching throbbing pain signals. By interrupting the communication channel of both A fibers and C fibers, 1207 is designed to provide effective topical pain relief with a faster onset and longer duration of action than currently marketed pain products. Potential applications for 1207 include pre-procedural use in dermatological surgery and post-surgical incision pain.
Wednesday, January 17, 2007
Volume Spikes: IOMI STSI
The following companies showed unusually heavy volume in Wednesday afternoon trading on the Nasdaq Stock Market. 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 higher investor confidence, while selling can signal pressure on a stock.
Shares of Iomai Corp. went into accelerated trading after the biopharmaceuticals company said it expects to receive a contract from the federal Department of Health and Human Services for development of a dose-sparing patch for use with a pandemic influenza vaccine. The agreement could pay up to $128 million.
The patch is designed to stimulate immune system responses to small doses of flu vaccine, which could help stretch vaccine supplies in the event of a pandemic.
Trading volume increased to 1.4 million shares, compared with average daily volume of 50,000. Shares rose $1.16, or 22.8 percent, to $6.26.
Star Scientific Inc. traded heavily, after the company said it expects a judge to render decisions soon related to a patent infringement lawsuit against R.J. Reynolds Tobacco Co., a unit of Reynolds American Inc. Star Scientific is the developer of a process to lower cancer-causing agents found in tobacco products.
In a Securities and Exchange Commission filing, Star Scientific said Judge Marvin J. Garbis plans to post decisions on three pending summary judgment motions related to the suit, which was filed by Star, on a United States District Court Web site on Friday.
Volume increased to 6.9 million shares, from a usual level of 460,000, while shares added $1.23, or 36.3 percent, to $4.62.
IOMI Iomai Corporation, a biopharmaceutical company, focuses on the discovery, development, and commercialization of vaccines and immune system stimulants delivered to the skin. Its vaccines and immune system stimulants are delivered through a needle-free technology, known as transcutaneous immunization. The technology targets Langerhans cells, a specialized component of the immune system located in the outer layers of the skin for the delivery of adjuvants or antigens. The company has four product candidates in development: three targeting influenza and pandemic flu, and one to prevent E. coli-related travelers' diarrhea.
STSI engages in the development, implementation, and licensing of scientific technology for the curing of tobacco so as to prevent the formation of carcinogenic toxins present in tobacco and tobacco smoke.
Shares of Iomai Corp. went into accelerated trading after the biopharmaceuticals company said it expects to receive a contract from the federal Department of Health and Human Services for development of a dose-sparing patch for use with a pandemic influenza vaccine. The agreement could pay up to $128 million.
The patch is designed to stimulate immune system responses to small doses of flu vaccine, which could help stretch vaccine supplies in the event of a pandemic.
Trading volume increased to 1.4 million shares, compared with average daily volume of 50,000. Shares rose $1.16, or 22.8 percent, to $6.26.
Star Scientific Inc. traded heavily, after the company said it expects a judge to render decisions soon related to a patent infringement lawsuit against R.J. Reynolds Tobacco Co., a unit of Reynolds American Inc. Star Scientific is the developer of a process to lower cancer-causing agents found in tobacco products.
In a Securities and Exchange Commission filing, Star Scientific said Judge Marvin J. Garbis plans to post decisions on three pending summary judgment motions related to the suit, which was filed by Star, on a United States District Court Web site on Friday.
Volume increased to 6.9 million shares, from a usual level of 460,000, while shares added $1.23, or 36.3 percent, to $4.62.
IOMI Iomai Corporation, a biopharmaceutical company, focuses on the discovery, development, and commercialization of vaccines and immune system stimulants delivered to the skin. Its vaccines and immune system stimulants are delivered through a needle-free technology, known as transcutaneous immunization. The technology targets Langerhans cells, a specialized component of the immune system located in the outer layers of the skin for the delivery of adjuvants or antigens. The company has four product candidates in development: three targeting influenza and pandemic flu, and one to prevent E. coli-related travelers' diarrhea.
STSI engages in the development, implementation, and licensing of scientific technology for the curing of tobacco so as to prevent the formation of carcinogenic toxins present in tobacco and tobacco smoke.
Tuesday, January 16, 2007
Study show Genzyme's Cerezyme may be effective
Will GENZ stock move today on this trial data?
Genzyme Corp. is promoting results from a new clinical study that apparently validate long-term use of its enzyme replacement drug Cerezyme.
The Cambridge, Mass., company said on Monday that Cerezyme has been shown to significantly improve bone density in patients with a form of Gaucher disease.
According to the study, which was published in the January issue of the Journal of Bone and Mineral Research, 342 patients with Type 1 Gaucher disease who received treatment with Cerezyme were compared to 160 who did not receive treatment. Those who did receive treatment enjoyed a significant increase in bone mineral density.
Gaucher disease patients are at an increased risk of developing complications with their bones including fractures and osteoporosis.
What is cerezyme and Gaucher's Disease?
Cerezyme is an analog of the human enzyme ß-glucocerebrosidase, produced by recombinant DNA technology [cloned]. ß-Glucocerebrosidase is a lysosomal glycoprotein enzyme which catalyzes the hydrolysis of the glycolipid glucocerebroside to glucose and ceramide. This keeps the lysosomal proteins from aggregating on macrophages [and other cells] which then infiltrate other tissues, thus resulting in Gaucher disease.
Gaucher disease is an inherited metabolic disorder in which harmful quantities of a fatty substance called glucocerebroside accumulate in the spleen, liver, lungs, bone marrow, and sometimes in the brain. There are three types of Gaucher disease. The first category, called type 1, is by far the most common. Patients in this group usually bruise easily and experience fatigue due to anemia and low blood platelets. They also have an enlarged liver and spleen, skeletal disorders, and, in some instances, lung and kidney impairment. There are no signs of brain involvement. Symptoms can appear at any age. In type 2 Gaucher disease, liver and spleen enlargement are apparent by 3 months of age. Patients have extensive and progressive brain damage and usually die by 2 years of age. In the third category, called type 3, liver and spleen enlargement is variable, and signs of brain involvement such as seizures gradually become apparent. All Gaucher patients exhibit a deficiency of an enzyme called glucocerebrosidase that is involved in the breakdown and recycling of glucocerebroside. The buildup of this fatty material within cells prevents the cells and organs from functioning properly. Gaucher disease is one of several lipid storage diseases.
Nasdaq: GENZ on friday closed trading at down 55 cents.
Genzyme Corp. is promoting results from a new clinical study that apparently validate long-term use of its enzyme replacement drug Cerezyme.
The Cambridge, Mass., company said on Monday that Cerezyme has been shown to significantly improve bone density in patients with a form of Gaucher disease.
According to the study, which was published in the January issue of the Journal of Bone and Mineral Research, 342 patients with Type 1 Gaucher disease who received treatment with Cerezyme were compared to 160 who did not receive treatment. Those who did receive treatment enjoyed a significant increase in bone mineral density.
Gaucher disease patients are at an increased risk of developing complications with their bones including fractures and osteoporosis.
What is cerezyme and Gaucher's Disease?
Cerezyme is an analog of the human enzyme ß-glucocerebrosidase, produced by recombinant DNA technology [cloned]. ß-Glucocerebrosidase is a lysosomal glycoprotein enzyme which catalyzes the hydrolysis of the glycolipid glucocerebroside to glucose and ceramide. This keeps the lysosomal proteins from aggregating on macrophages [and other cells] which then infiltrate other tissues, thus resulting in Gaucher disease.
Gaucher disease is an inherited metabolic disorder in which harmful quantities of a fatty substance called glucocerebroside accumulate in the spleen, liver, lungs, bone marrow, and sometimes in the brain. There are three types of Gaucher disease. The first category, called type 1, is by far the most common. Patients in this group usually bruise easily and experience fatigue due to anemia and low blood platelets. They also have an enlarged liver and spleen, skeletal disorders, and, in some instances, lung and kidney impairment. There are no signs of brain involvement. Symptoms can appear at any age. In type 2 Gaucher disease, liver and spleen enlargement are apparent by 3 months of age. Patients have extensive and progressive brain damage and usually die by 2 years of age. In the third category, called type 3, liver and spleen enlargement is variable, and signs of brain involvement such as seizures gradually become apparent. All Gaucher patients exhibit a deficiency of an enzyme called glucocerebrosidase that is involved in the breakdown and recycling of glucocerebroside. The buildup of this fatty material within cells prevents the cells and organs from functioning properly. Gaucher disease is one of several lipid storage diseases.
Nasdaq: GENZ on friday closed trading at down 55 cents.
Monday, January 15, 2007
Markets closed today: I will find some upcoming trial data and post later today
I hate it when the markets close and I forget. Then I keep checking the markets and finding no change! Tomorrow is a new day!
Thursday, January 11, 2007
Genentech vaults on earnings from cancer drugs
U.S. stocks rose on Thursday as higher profits from biotech company Genentech Inc. (NYSE:DNA - news)brightened the outlook for corporate earnings at the start of the reporting period.
Oil futures fell further, but some energy stocks rebounded as technical indicators suggested the shares were cheap after days of heavy selling. Meanwhile, the drop in oil prices eased pressure on consumers and fuel-dependent industries, such as manufacturing and transportation.
Genentech (DNA.N) is one of the biggest companies to report earnings, following aluminum maker Alcoa Inc. (NYSE:AA - news), which gave better-than-forecast results on Tuesday.
"The question is, will fourth-quarter earnings hold up to even lowered expectations, and so far it looks pretty good when you consider Genentech and Alcoa," said Peter Dunay, investment strategist at Leeb Capital Management in New York.
The Dow Jones industrial average (^DJI - news) was up 37.89 points, or 0.30 percent, at 12,480.05. The Standard & Poor's 500 Index (^SPX - news) was up 5.35 points, or 0.38 percent, at 1,420.20. The Nasdaq Composite Index (^IXIC - news) was up 13.70 points, or 0.56 percent, at 2,473.03.
Genentech stock rose to 3.5 percent to $86.66 on the NYSE.
Oil futures fell further, but some energy stocks rebounded as technical indicators suggested the shares were cheap after days of heavy selling. Meanwhile, the drop in oil prices eased pressure on consumers and fuel-dependent industries, such as manufacturing and transportation.
Genentech (DNA.N) is one of the biggest companies to report earnings, following aluminum maker Alcoa Inc. (NYSE:AA - news), which gave better-than-forecast results on Tuesday.
"The question is, will fourth-quarter earnings hold up to even lowered expectations, and so far it looks pretty good when you consider Genentech and Alcoa," said Peter Dunay, investment strategist at Leeb Capital Management in New York.
The Dow Jones industrial average (^DJI - news) was up 37.89 points, or 0.30 percent, at 12,480.05. The Standard & Poor's 500 Index (^SPX - news) was up 5.35 points, or 0.38 percent, at 1,420.20. The Nasdaq Composite Index (^IXIC - news) was up 13.70 points, or 0.56 percent, at 2,473.03.
Genentech stock rose to 3.5 percent to $86.66 on the NYSE.
Wednesday, January 10, 2007
Illumina Unveils Industry's Most Comprehensive Whole-Genome DNA Analysis Solution
Human 1M and Human 450S BeadChips Provide Unmatched Access to Common Genetic Variations
SAN DIEGO--Illumina, Inc. today announced that the next BeadChip in its Infinium® product family will profile over one million diverse genetic variants. The new Human 1M BeadChip combines an unprecedented level of content for both whole-genome (WG) and copy number variation (CNV) analysis, along with additional unique, high-value genomic regions of interest - all on a single microarray chip. Illumina also announced that it plans to introduce the Human 450S BeadChip, which will enable customers using Illumina's HumanHap550 BeadChip, to further extend their genetic studies to include the one million content level. The Human 1M and Human 450S BeadChips will be powered by Illumina's revolutionary Infinium Assay, providing industry-leading data quality, genomic coverage, and intelligent probe selection. Both products are expected to enter the market by the close of the second quarter, 2007.
"The Human 1M BeadChip represents the dawn of a new era for the genetic research community. It combines even higher tagSNP coverage than our HumanHap650Y BeadChip, adds several hundred thousand, individually-selected SNPs in genes and functional areas, and provides novel content for copy number variant analysis not currently available in public databases," said Sarah Shaw Murray, Ph.D., staff geneticist at Illumina. "As a complete DNA analysis solution that addresses applications beyond just traditional whole-genome association studies, this BeadChip will set the new standard as being the most comprehensive and most powerful tool available for genetic analysis."
"With Illumina's unique ability to target any specific regions in the genome, we continue to be impressed by the level of coverage, performance, and speed the Infinium technology offers the industry. We are pleased to have collaborated with Illumina's research and development team on content selection for the Human 1M and Human 450S BeadChips. This capability enables us to speed the discovery of the underlying causes of disease," said Jeffrey Gulcher, Chief Scientific Officer of deCode Genetics.
The Human 1M and Human 450S BeadChips will provide high density coverage in greater than 99 percent of known genes. The BeadChips will utilize SNP and non-SNP content to provide uniform spacing for the analysis of both known and novel copy number variants. The new BeadChips will also include additional tagSNPs selected from all populations studied by the International HapMap Project. In addition to an unprecedented level of content for both WG and CNV analyses, the Human 1M and Human 450S BeadChips will offer the same level of performance customers have experienced with all of Illumina's DNA analysis products, including the industry's highest call rates and overall data quality.
"During 2006 Illumina launched eight new products in the Infinium family. The upcoming commercialization of the Human 1M, a single-chip solution, will be a major milestone for the Company. It will more importantly provide the genetic research community with yet another advance in their ability to perform whole-genome DNA analysis," said Jay Flatley, President and Chief Executive Officer of Illumina.
Infinium Genotyping utilizes a novel assay together with Illumina's BeadArray(TM) technology to deliver industry-leading performance, genome-wide access and scalable solutions for SNP genotyping and the analysis of CNV. The revolutionary Infinium Assays and corresponding BeadChips allow large-scale interrogation of variation in the human genome, accelerating the ability of researchers to cost-effectively unlock the genetic basis of disease.
This is big time action here from a strictly research point of view. In my opinion from doing this very type of research, this will revolutionize the field. I am very excited to see how this develops.
NASDAQ:ILMN closed todays trading down 17 cents a share at 39.32.
SAN DIEGO--Illumina, Inc. today announced that the next BeadChip in its Infinium® product family will profile over one million diverse genetic variants. The new Human 1M BeadChip combines an unprecedented level of content for both whole-genome (WG) and copy number variation (CNV) analysis, along with additional unique, high-value genomic regions of interest - all on a single microarray chip. Illumina also announced that it plans to introduce the Human 450S BeadChip, which will enable customers using Illumina's HumanHap550 BeadChip, to further extend their genetic studies to include the one million content level. The Human 1M and Human 450S BeadChips will be powered by Illumina's revolutionary Infinium Assay, providing industry-leading data quality, genomic coverage, and intelligent probe selection. Both products are expected to enter the market by the close of the second quarter, 2007.
"The Human 1M BeadChip represents the dawn of a new era for the genetic research community. It combines even higher tagSNP coverage than our HumanHap650Y BeadChip, adds several hundred thousand, individually-selected SNPs in genes and functional areas, and provides novel content for copy number variant analysis not currently available in public databases," said Sarah Shaw Murray, Ph.D., staff geneticist at Illumina. "As a complete DNA analysis solution that addresses applications beyond just traditional whole-genome association studies, this BeadChip will set the new standard as being the most comprehensive and most powerful tool available for genetic analysis."
"With Illumina's unique ability to target any specific regions in the genome, we continue to be impressed by the level of coverage, performance, and speed the Infinium technology offers the industry. We are pleased to have collaborated with Illumina's research and development team on content selection for the Human 1M and Human 450S BeadChips. This capability enables us to speed the discovery of the underlying causes of disease," said Jeffrey Gulcher, Chief Scientific Officer of deCode Genetics.
The Human 1M and Human 450S BeadChips will provide high density coverage in greater than 99 percent of known genes. The BeadChips will utilize SNP and non-SNP content to provide uniform spacing for the analysis of both known and novel copy number variants. The new BeadChips will also include additional tagSNPs selected from all populations studied by the International HapMap Project. In addition to an unprecedented level of content for both WG and CNV analyses, the Human 1M and Human 450S BeadChips will offer the same level of performance customers have experienced with all of Illumina's DNA analysis products, including the industry's highest call rates and overall data quality.
"During 2006 Illumina launched eight new products in the Infinium family. The upcoming commercialization of the Human 1M, a single-chip solution, will be a major milestone for the Company. It will more importantly provide the genetic research community with yet another advance in their ability to perform whole-genome DNA analysis," said Jay Flatley, President and Chief Executive Officer of Illumina.
Infinium Genotyping utilizes a novel assay together with Illumina's BeadArray(TM) technology to deliver industry-leading performance, genome-wide access and scalable solutions for SNP genotyping and the analysis of CNV. The revolutionary Infinium Assays and corresponding BeadChips allow large-scale interrogation of variation in the human genome, accelerating the ability of researchers to cost-effectively unlock the genetic basis of disease.
This is big time action here from a strictly research point of view. In my opinion from doing this very type of research, this will revolutionize the field. I am very excited to see how this develops.
NASDAQ:ILMN closed todays trading down 17 cents a share at 39.32.
Tuesday, January 09, 2007
Array Seen as Top Biotech Pick for 2007
In his weekly round-up of picks and pans for the biotech sector, Banc of America analyst David Witzke on Tuesday told clients to push money into one attractive drug-maker and to ditch shares of another that he said will not outperform in the year ahead.
Boulder, Colo.-based Array BioPharma remains Witzke’s top pick for 2007 because of the company’s strong partnership potential. Array is a biopharmaceutical company concentrating on the treatment of cancer and inflammatory disease.
Witzke wrote in a client note that he recently met with management and he continues to think that the company’s drug, ARRY-543, represents a promising compound for a potential partnership or acquisition.
“We believe ARRY-543…could be an attractive target for large pharma or major biotech to partner in 2007 based on its potential to become a best-in-class compound,” Witzke wrote.
The analyst said that preclinical data recently suggested that the drug appears superior to GlaxoSmithKline’s Tykerb, allowing greater drug absorption and potentially greater potency, while decreasing the negative gastrointestinal side-effects.
.....The huge market of breast cancer drugs continues to make headway with ARRY-543. It specifically targets the family of epidermal growth factor receptors Her2/ErbB2 and EGFR. Unlike monoclonal antibody therapy, like herceptin, ARRY is a small molecule kinase inhibitor:
ErbB-2 is a receptor kinase target that has been found to be over-expressed in human breast and other cancers. Herceptin is an IV-dosed protein therapeutic currently on the market that modulates ErbB-2. EGFR is also a receptor kinase target that has been found to be over-expressed in numerous human cancers. ARRY's mechanism of action is as a reversible ATP-competitive inhibitor with nanomolar potency both in vitro and in cell-based proliferation assays. In preclinical models, ARRY-543 demonstrated significant dose related tumor growth inhibition when administered orally. ARRY-543 has demonstrated enhanced efficacy in certain preclinical models when compared to Herceptin, Tarceva or Iressa.
NASDAQ: ARRY closed today's trading down 5 cents per share at 12.89.
Boulder, Colo.-based Array BioPharma remains Witzke’s top pick for 2007 because of the company’s strong partnership potential. Array is a biopharmaceutical company concentrating on the treatment of cancer and inflammatory disease.
Witzke wrote in a client note that he recently met with management and he continues to think that the company’s drug, ARRY-543, represents a promising compound for a potential partnership or acquisition.
“We believe ARRY-543…could be an attractive target for large pharma or major biotech to partner in 2007 based on its potential to become a best-in-class compound,” Witzke wrote.
The analyst said that preclinical data recently suggested that the drug appears superior to GlaxoSmithKline’s Tykerb, allowing greater drug absorption and potentially greater potency, while decreasing the negative gastrointestinal side-effects.
.....The huge market of breast cancer drugs continues to make headway with ARRY-543. It specifically targets the family of epidermal growth factor receptors Her2/ErbB2 and EGFR. Unlike monoclonal antibody therapy, like herceptin, ARRY is a small molecule kinase inhibitor:
ErbB-2 is a receptor kinase target that has been found to be over-expressed in human breast and other cancers. Herceptin is an IV-dosed protein therapeutic currently on the market that modulates ErbB-2. EGFR is also a receptor kinase target that has been found to be over-expressed in numerous human cancers. ARRY's mechanism of action is as a reversible ATP-competitive inhibitor with nanomolar potency both in vitro and in cell-based proliferation assays. In preclinical models, ARRY-543 demonstrated significant dose related tumor growth inhibition when administered orally. ARRY-543 has demonstrated enhanced efficacy in certain preclinical models when compared to Herceptin, Tarceva or Iressa.
NASDAQ: ARRY closed today's trading down 5 cents per share at 12.89.
Monday, January 08, 2007
Incyte Shares Jump on Trials, Upgrade
Incyte Surges to New 52-Week High on Positive Trial Results of HIV, Diabetes Drugs
NEW YORK- Shares of Incyte Corp. surged in Monday trading after the biotechnology drug developer reported promising results from clinical trials of its HIV and diabetes candidates, and an analyst upgraded the stock predicting its pipeline would see breakthroughs in 2007.
Piper Jaffray & Co. analyst Thomas Wei lifted Incyte to "Outperform" from "Market Perform," expecting positive news about INCB9471, a once-a-day HIV drug, and INCB13739, a type 2 diabetes treatment.
Wei also raised his price target for Incyte by $4 to $8 per share, which implies growth of 32.5 percent over its Friday closing price of $6.04 on the Nasdaq.
"We remain impressed with Incyte's proliferative medicinal chemistry effort and the speed with which it has developed deep biology expertise around its targets," the analyst said, adding that he believes "that 2007 could be a breakthrough year for that 2007 could be a breakthrough year for Incyte's pipeline."
At the JPMorgan HealthCare Conference, Incyte revealed the results of clinical trials for both drugs. Seven HIV patients improved after taking INCB9471 for 14 days. The improvement continued in the 20 days after the trial. Separately, the company revealed a study of six obese type II diabetes patients also showed positive results.
Wilmington, Del.-based Incyte also announced that it will begin trials for another HIV drug, and an oral compound that could treat multiple sclerosis, lupus and other autoimmune diseases.
Incyte stock climbed 29 cents, or 4.8 percent, to $6.66 in midday Nasdaq trading. Earlier in the session, the stock rose to a fresh 52-week high of $6.49, breezing past its prior peak of $6.25.
INCB9471 is a novel class of drug that is a receptor antagonist. Receptor antagonists bind to a distinct specific cellular receptor and inhibit it's activity. The ligand, here INCB9471, binds to the receptor and downregulates it (shuts it off). The significant thing here is that it binds to CCR5 receptor, which is the main entry way into the cell by HIV. Thus they have conceptually blocked entry into the cell. The virus uses several other routes of entry ( CD3, B7 etc) but blocking the main entry route in combination with protease therapy could mean a significant contribution to the market.
NEW YORK- Shares of Incyte Corp. surged in Monday trading after the biotechnology drug developer reported promising results from clinical trials of its HIV and diabetes candidates, and an analyst upgraded the stock predicting its pipeline would see breakthroughs in 2007.
Piper Jaffray & Co. analyst Thomas Wei lifted Incyte to "Outperform" from "Market Perform," expecting positive news about INCB9471, a once-a-day HIV drug, and INCB13739, a type 2 diabetes treatment.
Wei also raised his price target for Incyte by $4 to $8 per share, which implies growth of 32.5 percent over its Friday closing price of $6.04 on the Nasdaq.
"We remain impressed with Incyte's proliferative medicinal chemistry effort and the speed with which it has developed deep biology expertise around its targets," the analyst said, adding that he believes "that 2007 could be a breakthrough year for that 2007 could be a breakthrough year for Incyte's pipeline."
At the JPMorgan HealthCare Conference, Incyte revealed the results of clinical trials for both drugs. Seven HIV patients improved after taking INCB9471 for 14 days. The improvement continued in the 20 days after the trial. Separately, the company revealed a study of six obese type II diabetes patients also showed positive results.
Wilmington, Del.-based Incyte also announced that it will begin trials for another HIV drug, and an oral compound that could treat multiple sclerosis, lupus and other autoimmune diseases.
Incyte stock climbed 29 cents, or 4.8 percent, to $6.66 in midday Nasdaq trading. Earlier in the session, the stock rose to a fresh 52-week high of $6.49, breezing past its prior peak of $6.25.
INCB9471 is a novel class of drug that is a receptor antagonist. Receptor antagonists bind to a distinct specific cellular receptor and inhibit it's activity. The ligand, here INCB9471, binds to the receptor and downregulates it (shuts it off). The significant thing here is that it binds to CCR5 receptor, which is the main entry way into the cell by HIV. Thus they have conceptually blocked entry into the cell. The virus uses several other routes of entry ( CD3, B7 etc) but blocking the main entry route in combination with protease therapy could mean a significant contribution to the market.
Friday, January 05, 2007
Genentech says cancer drug trial "encouraging"
- An ovarian cancer drug under development by Genentech Inc. that many investors had written off showed promise in a midstage trial, even though the trial may not have met its main goal.
Genentech said late on Thursday that results from a midstage, or Phase II trial of pertuzumab formerly known as Omnitarg, in combination with Eli Lilly and Co.'s cancer drug Gemzar, were "encouraging," though it did not provide data.
Jason Kantor, an analyst at RBC Capital Markets Corp., said the company told him in an interview that data showed pertuzumab did not stave off the disease by a statistically significant amount.
"I asked the company if the word "encouraging" implied that they did not meet the primary endpoint and they confirmed it with me," Kantor said.
However, he said the data may be strong enough to prompt the company to test the drug in late-stage trials.
Dimerization, or pairing with other receptor proteins, is essential for HER receptor activity and may have a major role in driving growth and survival in many tumor types. Pertuzumab (recombinant humanized monoclonal antibody 2C4; Omnitarg;) represents the first in a new class of agents known as HER dimerization inhibitors. Pertuzumab binds to HER-2, the most common HER pairing partner, at the dimerization domain, sterically inhibiting its ability to form dimers with other HER receptors and thus inhibiting tumor progression.
NYSE:DNA is trading down today 24 cents per share at 83.79.
Genentech said late on Thursday that results from a midstage, or Phase II trial of pertuzumab formerly known as Omnitarg, in combination with Eli Lilly and Co.'s cancer drug Gemzar, were "encouraging," though it did not provide data.
Jason Kantor, an analyst at RBC Capital Markets Corp., said the company told him in an interview that data showed pertuzumab did not stave off the disease by a statistically significant amount.
"I asked the company if the word "encouraging" implied that they did not meet the primary endpoint and they confirmed it with me," Kantor said.
However, he said the data may be strong enough to prompt the company to test the drug in late-stage trials.
Dimerization, or pairing with other receptor proteins, is essential for HER receptor activity and may have a major role in driving growth and survival in many tumor types. Pertuzumab (recombinant humanized monoclonal antibody 2C4; Omnitarg;) represents the first in a new class of agents known as HER dimerization inhibitors. Pertuzumab binds to HER-2, the most common HER pairing partner, at the dimerization domain, sterically inhibiting its ability to form dimers with other HER receptors and thus inhibiting tumor progression.
NYSE:DNA is trading down today 24 cents per share at 83.79.
Wednesday, January 03, 2007
Cytokinetics, Amgen Enter Collaboration to Develop, Sell Treatment for Heart Failure
Biotech drug makers Cytokinetics Inc. and Amgen Inc. said Wednesday they will partner to work on a class of drugs meant to treat heart failure by causing cardiac muscle to contract.
Shares of Cytokinetics climbed $1.36, or 18.3 percent, to $8.85 in morning trading on the Nasdaq at five times their average volume. The stock has traded between $5.20 and $8 over the past 52 weeks, and reached a new high of $9.50 earlier in the session.
Cytokinetics will get an upfront $42 million from Amgen, which will also purchase about 3.5 million shares of Cytokinetics for $9.47 per share, or for a total of about $33 million.
South San Francisco, Calif.-based Cytokinetics stands to earn up to $600 million in milestone payments not counting royalties for development of the drug candidate CK-1827452 and other products from the collaboration. CK-1827452 is meant to activate cardiac myosin, a protein in that converts chemical energy into mechanical force in heart tissue.
Under the agreement, Cytokinetics will research the compound for two years, and Amgen will have the option to conduct clinical trials for a $50 million payment if certain goals are met in mid-stage clinical trials, which are set to begin early in the year. The compound has already undergone two early stage clinical trials.
Cytokinetics will also have the option of selling the products along with Amgen.
Separately, Amgen reiterated its 2006 outlook of $3.85 to $3.95 in adjusted earnings per share. Analysts surveyed by Thomson Financial expect earnings per share of $3.93.
Shares of Amgen rose 90 cents to $69.22 on the Nasdaq.
Shares of Cytokinetics climbed $1.36, or 18.3 percent, to $8.85 in morning trading on the Nasdaq at five times their average volume. The stock has traded between $5.20 and $8 over the past 52 weeks, and reached a new high of $9.50 earlier in the session.
Cytokinetics will get an upfront $42 million from Amgen, which will also purchase about 3.5 million shares of Cytokinetics for $9.47 per share, or for a total of about $33 million.
South San Francisco, Calif.-based Cytokinetics stands to earn up to $600 million in milestone payments not counting royalties for development of the drug candidate CK-1827452 and other products from the collaboration. CK-1827452 is meant to activate cardiac myosin, a protein in that converts chemical energy into mechanical force in heart tissue.
Under the agreement, Cytokinetics will research the compound for two years, and Amgen will have the option to conduct clinical trials for a $50 million payment if certain goals are met in mid-stage clinical trials, which are set to begin early in the year. The compound has already undergone two early stage clinical trials.
Cytokinetics will also have the option of selling the products along with Amgen.
Separately, Amgen reiterated its 2006 outlook of $3.85 to $3.95 in adjusted earnings per share. Analysts surveyed by Thomson Financial expect earnings per share of $3.93.
Shares of Amgen rose 90 cents to $69.22 on the Nasdaq.
Tuesday, January 02, 2007
Best Performing Biotechs over the last 3 months:
Best Performing Stocks
Symbol Company Name Percent Change
IMRP Immune Response Corp Del 9,782.35%
BSTC BioSpecifics Technologies... 230.43%
HTI Halozyme Therapeutics Inc 203.77%
TGEN Targeted Genetics Corp 196.85%
SIGA Siga Technologies Inc 158.62%
OSIR Osiris Therapeutics Inc 152.95%
PRCS Praecis Pharmaceuticals In... 139.51%
RNAI Sirna Therapeutics Inc 133.57%
PGLA Progen Inds Ltd 121.95%
SQNM Sequenom Inc 118.69%
Symbol Company Name Percent Change
IMRP Immune Response Corp Del 9,782.35%
BSTC BioSpecifics Technologies... 230.43%
HTI Halozyme Therapeutics Inc 203.77%
TGEN Targeted Genetics Corp 196.85%
SIGA Siga Technologies Inc 158.62%
OSIR Osiris Therapeutics Inc 152.95%
PRCS Praecis Pharmaceuticals In... 139.51%
RNAI Sirna Therapeutics Inc 133.57%
PGLA Progen Inds Ltd 121.95%
SQNM Sequenom Inc 118.69%
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