Slow Posting on my part

I had a death in the family and have not thought about posting. I realize some of you come here to read daily, and I'm trying to get back to posting daily, but instead of quantity i'll give you quality. Thank you for stopping by and updates [I'm planning] will resume on Monday, Nov. 5.

Wyeth gets hit with multi million dollar verdict

A Nevada jury awarded $134.5 million to three women who claimed Wyeth's hormone-therapy drugs caused their breast cancer.

Jurors awarded compensatory damages to plaintiffs Arlene Rowatt, Jeraldine Scofield and Pamela Forrester after finding Wyeth was negligent, that its drugs were defective and that the company concealed a material fact about the products' safety. All these issues were a cause of injury or damage to the women, the jury said.

The jury, which also found that Wyeth acted with malice or fraud, awarded damages of $43.5 million to Ms. Scofield, $47.5 million to Ms. Forrester and $43.5 million to Ms. Rowatt.
A Wyeth spokesman declined to comment because the case "is not yet complete," citing a hearing on punitive damages scheduled for today. The plaintiffs' law firm also declined comment, citing today's hearing.

The suit, filed in Washoe County District Court in Reno, is one of some 5,300 hormone-replacement cases filed against Wyeth on behalf of 7,900 plaintiffs, according to the pharmaceutical maker. The complaints allege personal injury as a result of the plaintiffs' use of one or more of Wyeth's hormone- or estrogen-therapy products, including Prempro and Premarin, used to treat menopausal symptoms.

The Reno case is the seventh to reach a verdict since trials began last year. Three of the other six trials resulted in verdicts in favor of Wyeth. Of those favoring plaintiffs, one was overturned and judgment entered in favor of Wyeth, and verdicts in the two others were thrown out and new trials ordered by judges. None of the victorious plaintiffs in those cases had been awarded damages greater than $3 million.Three other cases also have been dismissed by courts on summary judgment, and a dozen other cases that had been set for trial were voluntarily withdrawn by plaintiffs before trial.

Wall Street didn't appear rattled by the verdict. Wyeth's shares, which have been in a slump lately for reasons related to the company's pipeline and generic drugs, were down 38 cents to $45.78 in 4 p.m. composite trading on the New York Stock Exchange.
Deutsche Bank drug analyst Barbara Ryan said that it is too early in the string of litigation to presume this case would be the start of a trend, and that in general the hormone-replacement cases appear tougher for plaintiffs to win than past "fen-phen" diet-drug litigation against the company. Wyeth is an investment-banking client of Deutsche Bank.

Lawyers for the Madison, N.J., drug maker have argued that the company clearly warned users that there was a slightly increased risk of breast cancer from taking Prempro, which was first marketed in 1995. In a recent filing with the Securities and Exchange Commission, the company said it hasn't established any litigation-reserve fund for its hormone-therapy litigation.
Howard Erichson, a professor at Seton Hall law school in New Jersey, said it is common for surprisingly large damage awards to be lowered. But, he added, "With thousands of cases remaining to be tried, it's a scary thing to know that juries don't like your argument."

Another, "I don't want to take responsibility for my actions" lawsuit(s) there has been research since the 1980's that suggested estrogen therapy has an incidence of breast cancers. This settlement is ridiculous.

FDA approves label expansion for medimmune's flumist

MedImmune, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the expanded use of FluMist(R) (Influenza Virus Vaccine Live, Intranasal) in children two to five years of age. FluMist is now approved for active immunization for the prevention of disease caused by influenza A and B viruses in individuals two to 49 years of age. Only one manufacturer had previously been licensed in the United States to produce influenza vaccine for children under four years of age.

FluMist is a live attenuated influenza virus vaccine indicated for active immunization of individuals two to 49 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.

MedImmune is wholly owned by AstraZeneca. AZN ended today's trading all square at 48.21 a share.

Stocks soar on fed news....Will BioTech take advantage?

A jubilant Wall Street barreled higher Tuesday after the Federal Reserve cut its benchmark interest rate by a larger-than-expected half percentage point. The Dow Jones industrial average reacted by surging 335 points -- its biggest one-day point jump in nearly five years.

Although some investors hoped for a rate cut of that magnitude, most were betting on a smaller, quarter-point cut in the federal funds rate. The Fed responded to the spilling of credit market problems into the rest of the economy by saying, "the tightening of credit conditions has the potential to intensify the housing (market) correction and to restrain economic growth more generally."

The Fed lowered the benchmark fed funds rate to 4.75 percent after keeping it unchanged for more than a year and not lowering the rate since 2003. It also reduced the discount rate -- what it charges banks borrowing from its discount window -- by a half percentage point to 5.25 percent. On Aug. 17, the central bank lowered the discount rate by a half-point to help keep cash moving in the U.S. banking system.

The central bank's decision and the wording of its accompanying economic assessment gratified a market that plunged during August amid fears that credit market tightness, spawned by a continuum of mortgage defaults and delinquencies, would send the economy toward recession.
There was no direct signal in the Fed's statement that it would make further rate cuts. It said "some inflation risks remain" and that it will keep monitoring inflation developments. Still, it did not call inflation its "predominant policy concern" as it did after holding rates steady in early August.

"What it says to me is you had a major shift in the last couple of months from a Fed that was very concerned about inflation to one that is concerned about the health of the financial months from a markets, the availability of liquidity," said Jerry Webman, chief economist at Oppenheimer Funds Inc.

Big Pharma has a lot of cash, will they spend it? ANDS sure could use a bolster of milestone payments for it's pipeline.

I love the quote "last couple of months from a Fed that was very concerned about inflation to one that is concerned about the health of the financial months from a markets, the availability of liquidity,"
I've been trying to get to full liquidity for a long, long, time.

Imclone clinical trial endpoint met, Stock gains momentum

NEW YORK - Positive results from a study involving Imclone Systems Inc.'s cancer drug Erbitux is raising the company's market value by nearly a quarter Tuesday, but some think it will take a lot longer before any effect is seen on the company's bottomline.

A study released this morning from Imclone's overseas marketing partner for Erbitux, Merck KGaA (MRK.XE), met its primary endpoint of increased survival rates in treating advanced non-small cell lung cancer when used in combination with chemotherapy. That type of lung cancer currently has limited treatment options and would add another market for the drug.

Remember that Erbitux was one of the first targeted drug therapies using monoclonal antibodies. Erbitux is targeted to the epidermal growth factor receptor family of proteins that are located on the cell surface. Once bound, the antibody neutralizes the signaling pathways that the receptors use to tell the cell to grow.

IMCL stock closed trading today +6.97 or 18% in afternoon trading and another 23 cents upward in after hours trading.

Anadys Drops Hep C Program

Anadys Pharmaceuticals Inc. said it was cutting its workforce by a third and discontinuing further development of ANA380, its drug to treat hepatitis B virus infection.

Anadys said it was halting all work on early discovery projects and will incur a charge of about $0.8 million related to the workforce reduction.

In a filing with U.S. regulators, the company said it was terminating its employment agreement with Chief Scientific Officer Devron Averett, effective Aug. 17. Averett will assume a consultancy role, it added.

Anadys expects the 33 percent workforce reduction to result in annual savings of between $4 million and $5 million.

The company said it would return all rights of the ANA380 compound to Korean pharmaceutical company LG Life Sciences Ltd.

Anadys and LG Life Sciences had entered into a joint development program in April 2004, under which Anadys had marketing rights to the compound in North America, Europe, Japan and some other countries.

Last week, the company said it was discontinuing development of ANA975, its drug to treat hepatitis C virus infection, on safety concerns. It was developing the drug with Swiss drug-maker Novartis.

Anadys said it will focus its resources on two drug candidates, ANA598 for hepatitis C and ANA773 for cancer. With a cash balance of about $69 million, it believes it can carry development of the two drugs forward.

The company posted a second-quarter loss of $7 million, or 24 cents a share, on revenue of $1.3 million. Analysts on average were expecting a loss of 29 cents a share, on revenue of $1.34 million, according to Reuters Estimates.

Computer Problems are Fixed!!!

My real day time job has been crazy the last 2 months and my computer death at home have prevented me from posting on a regular basis. Work has eased a bit and I have corrected my problem with my computer at home. Regular posting will begin!

Stick around and lets ride the market through the summer.

Multikine gets orphan drug status

CEL-SCI Corporation announced today that its cancer drug Multikine® has been granted orphan-drug designation as neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck (head and neck cancer) by the United States Food and Drug Administration (FDA).

An orphan drug is any drug developed under the Orphan Drug Act of January 1983 ("ODA"), a federal law concerning rare diseases (orphan diseases"), defined as diseases affecting fewer than 200,000 people in the United States. In 2003, the leading orphan drug by worldwide sales revenue was Amgen's Erythropeietin (Epogen®), with sales of $2.4bn.

Geert Kersten, CEO of CEL-SCI said, "Receiving orphan-drug designation for Multikine is yet another major achievement for CEL-SCI, following the go-ahead from the FDA earlier this year for the Company's Phase III study in advanced primary head and neck cancer patients and the subsequent raising of substantial funds in April, 2007. We are putting in place all of the pieces required to make this company very successful."

(Amex: CVM) closed friday's trading at 81 cents per share.

Further Reading: A letter to shareholders:

Dear Fellow Shareholders:

So far 2007 has been an excellent year for CEL-SCI and its cancer product Multikine®. In January we received the US FDA go-ahead for the Phase III clinical trial with Multikine, a huge achievement for any drug, yet an even bigger achievement for a completely new type of drug such as our Multikine. We followed this up with a $15 million commitment to finance the Multikine manufacturing facility in Baltimore, Maryland and another $15 million in equity financing in April. In June we announced that we received orphan drug status from the FDA for Multikine. This designation brings many substantial benefits to the Company. I believe that the opportunity ahead for CEL-SCI is so compelling that I have continued to purchase CEL-SCI stock in the open market.

In talking to investors it has become clear to me that few investors understand the enormous impact that our Multikine will have on the treatment of cancer if we can confirm in our Phase III study the impressive survival results we have seen in our Phase II trial. I believe that a background summary on Multikine is helpful for that reason.

    Background Summary on Multikine:
   -- The science:  The science behind Multikine is based on the premise that
      a healthy immune system can cure cancer.  When the immune system is
      imbalanced or weakened, diseases like cancer occur.  Balancing and
      strengthening the immune system is thought to be an effective strategy
      in fighting cancer.

   -- What is Multikine?  Multikine is a mixture of naturally occurring
      cytokines, substances that regulate the immune system.  The patented
      Multikine mixture is representative of the mixture of cytokines
      produced by a healthy immune system.  CEL-SCI scientists have published
      in the highly regarded "Journal of Clinical Oncology" that many
      different cytokines working together are needed to put in motion the
      comprehensive immune response needed to fight cancer.  Most other
      immunotherapies being developed are based upon the use of only one
      cytokine.

   -- How is it used?  Multikine is the first cancer immunotherapy being
      developed as a first line treatment.  This means it is administered
      prior to any other cancer therapy (e.g. surgery, radiation and/or
      chemotherapy) because that is the time when the immune system can still
      be fully activated.  Once the patient has had surgery or has received
      radiation and/or chemotherapy, the immune system is severely weakened
      and less able to mount an effective immune response.  We believe that
      most of the failures of immunotherapy drugs up to now have been the
      result of giving immunotherapy after the patient's immune system was
      damaged by other cancer therapies.

   -- How does it work?   Multikine works in two ways:
      1. It signals the immune system to mount an effective immune response.
         Multikine changes the type of immune cell that attacks the tumor
         from a CD-8 cell to a CD-4 cell.  This is important because tumors
         are able to defend themselves against the normal CD-8 cell attack,
         but appear to be unable to defend themselves against the CD-4 cell
         attack.  The CD-4 cell breaks what is known as "tumor tolerance,"
         thereby allowing the immune system to see and attack the tumor.

      2. Multikine has been shown to render cancer cells much more
         susceptible to radiation and chemotherapy treatments, thereby making
         these treatments much more effective.

         The combination of both of these is very important because Multikine
         will fight the tumor on two fronts, without toxicity.

   -- Results:  In a Phase II clinical trial, Multikine was shown to increase
      overall survival by 33% 3.5 years after the first treatment.

   -- Its effect on recurrence of cancer:  Chemotherapy, surgery and
      radiation do not always succeed in killing all the cancer cells.  The
      persistence of cancer cells is responsible for cancer recurrence.
      Multikine is injected around the tumor and into the local lymph nodes
      because those areas are the most likely places for the cancer to recur
      if any of the cancer cells survive.  Multikine uses the immune system
      to kill those cancer cells before they cause tumor recurrence.

   -- Safety:  Multikine has been shown to be safe and non-toxic in multiple
      studies.  This was not surprising because Multikine consists of
      naturally derived substances given in very small dosages, just as the
      body does itself every day.

   -- Potentially useful for multiple tumors:  Despite the fact that the
      Multikine treatment given to each patient is the same (i.e., not
      patient specific), the immune response induced by Multikine is
      completely targeted to the patient's own tumor.  This means that
      Multikine may be useful against many different tumors.  Multikine has
      already shown activity in small studies in cervical dysplasia/neoplasia
      and prostate cancer.  One of its mechanisms of action suggests that it
      should also be developed as an enhancement of radiation and
      chemotherapy.

   -- Clinical Status:  Multikine is currently cleared for a Phase III
      clinical trial in the US and Canada in advanced primary head and neck
      cancer patients.  These are recently diagnosed, not yet treated
      patients. Head and neck cancer is an aggressive cancer that accounts
      for about 500,000 - 600,000 new annual cases of cancer world-wide.

      Advanced primary head and neck cancer patients typically have a 50%
      chance of survival three years following the first treatment.
      Treatments for newly diagnosed head and neck cancer have not
      significantly improved over the last 50 years and therefore constitute
      a clear unmet medical need.

      The Phase III study, which is designed to prove that Multikine works,
      is expected to enroll about 800 advanced primary head and neck cancer
      patients worldwide.  In its last Phase II clinical trial Multikine
      increased overall survival by 33%.  The Phase III study will need to
      show a 10% increase in overall survival to be successful.

   -- Market size:  The current Phase III clinical trial pits Multikine plus
      the standard of care treatments against the standard of care treatments
      alone.  A win for the Multikine treatment group would mean that every
      patient with advanced primary head and neck cancer is supposed to get
      Multikine.  This would translate into a market potential of $15
      billion.

We believe that Multikine will ultimately be added to the cancer treatments of many solid tumors. This it will have a huge impact on the treatment of cancer because curing more patients with the first cancer treatment will significantly decrease the number of cancer deaths. We thank you for being part of this dream.

As shareholders we truly value your participation in and support of our company. In an effort to improve our image, which has not yet caught up to where the company is today, we are currently redeveloping our corporate identity and redesigning our website. You are our most important advocates and we want your voice to be heard. We would like to collect some personal letters from you that describe why you support CEL-SCI and Multikine, and what your hopes are for Multikine. Our hope is to publish these letters on our website. Please mail these letters to Gavin de Windt, Investor Relations Manager, CEL-SCI Corporation, 8229 Boone Boulevard, Suite 802, Vienna, VA 22182, USA or send it by e-mail to gdewindt@cel-sci.com .

Panel Rejects New Weight-Loss Drug

Federal Panel Rejects Sanofi-Aventis Weight-Loss Drug Rimonabant

WASHINGTON-- Federal health advisers unanimously rejected a weight-loss drug Wednesday after hearing testimony that it increases the risk of suicidal thoughts, even in patients without a history of depression.

The manufacturer, Sanofi-Aventis SA, further failed to show the drug rimonabant is safe, the panel said.

The back-to-back, 14-0 votes by the expert panel made it unlikely the Food and Drug Administration will approve the drug. The agency usually follows its panel's advice, but it isn't required to do so.

"There is a reasonable suspicion we better learn some more and watch this affair more closely before we launch into massive use of this drug," said panelist Dr. Jules Hirsch, a senior physician at New York's Rockefeller University.


SNY fell $1.31 in afternoon trading to close at 43.07 per share. In afterhours trading, the trend continued losing another 59 cents a share.

This is a cannaboid receptor binding drug---yes that one. I will post the mechanism of action soon. It's very interesting how this drug supposedly suppresses appetite.

I have internet connection problems this week, soon to be remedied, so that mechanism will be posted ASAP. thanks.

Good Article: Time to get some Genentech?

Genentech shares have nose-dived 16% over the last 6 months--from $89.05 on January 19 to $74.78 on June 7--due, at least in part, to a dearth of positive, stock-moving news. But that decline could now give stock-pickers just the right opportunity to buy.

Proving that point Jennifer Chao, an analyst at Deutsche Bank, says Genentech (nyse: DNA - news - people ) is a smart pickup because of a 52-week low in share price and a compelling valuation.

Also, Chao said there are new developments afoot that could act as catalysts for the stock. "The next 12 months represent major upside to fundamentals with multiple shots on goal," Chao wrote.

She wrote that her analysis shows positive results for the Phase III C-08 adjuvant colon cancer study, assigning a 60% positive outlook on first interim look in the second half of 2007, 75% on second interim look in the first-half of 2008, and 85% on third interim look in the second half of 2008.

A significant positive interim analysis in the second-half of 2007, Chao wrote, would translate into near immediate off-label usage and rapid penetration into adjuvant colon cancer with implications in other off-label indications. Regulatory filing would be anticipated in the first-half of 2008, with approval by late 2008 or early 2009.

Chao upgraded Genentech to "buy" from "hold." In Monday morning trading, shares of the company rose 1%, or 76 cents, to $77.73.

Source: Forbes online

La Jolla Shares Surge on Riquest Data

La Jolla Pharmaceutical Shares Surge on Presentation of Riquent Data

Shares of La Jolla Pharmaceutical Co. surged as the company highlighted positive data from several prior studies of its lupus drug candidate Riquent.

The stock surged $1.02, or 18.7 percent, to $6.49 in midday trading on more than 5 times average daily volume. Shares have traded between $2.77 and $8.68 over the last 52 weeks.
900-milligram doses were increasingly effective in reducing antibodies. The goal of the Phase III clinical study, results of which were first reported in March, was to prevent or delay renal flare in lupus patients with a history of the condition and antibodies to the disease. It involved 101 patients.

Renal (kidney) problems are very common in patients with lupus. Remember that lupus erythematosus is a disease caused by immune complexes. What this means is that the body produces immune complexes whenever there is an antibody response to a soluble antigen (infection that elicits and immune response). Lupus is a immune complex disease that is characterized by the formation of antibodies to DNA. As a normal process of cell turnover, nuclei [DNA] is exposed as newly made cells leave the bone marrow and mature into red blood cells.

These immune complexes are small and tend to be trapped/formed inside tissues and, primarily in the kidney. Renal disease is therefore the most frequently encountered symptom of LE.

Riquent's mechanism of action is to inhibit the production of autoantibodies from immune cells [B plasma cells]. Riquent is an immunomodulating agent that induces tolerance in B cells directed against double-stranded DNA. It does this by cross-linking surface antibodies. Tolerance basically is the cells not reacting to an antigen any further and sometimes the cells actually die. The fewer positive cells that produce autoantibodies then helps slow the progression of the disease.

DUSA Revisited: Shares Jump today:

A Continuation from post 4/29/07: Today;

DUSA Pharmaceuticals, Inc., announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for Levulan® (aminolevulinic acid HCl) Photodynamic Therapy (PDT) for the treatment of esophageal dysplasia. This disease occurs in some patients with Barrett's esophagus, a leading cause of esophageal cancer. The incidence of esophageal cancer is one of the most rapidly growing in the U.S., with more than 11,000 new diagnoses each year. Patients diagnosed with high grade dysplasia are at high risk for developing esophageal cancer and currently have limited treatment options.

Note that this is not a current indication from the FDA warning letter described on 29 April. Not even a skin lesion. Barrett's is a direct link to smoking, so this is big time news. More on how the mechanism of photoactivity treatment of dysplasia soon.

The Roller Coaster Ride Continues: DNDN

DNDN is up today (or this hour) ~40 cents a share in early afternoon trading. What's driving the volatility?
They are still trying to figure out exactly what the FDA really wants. More basic data is one thing, but additional clinical trial data and larger cohorts of patients is another.

One also has to realize that the patients in those clinical trials are at the last stages of the disease and are looking for something experimental to prolong life if not for a few days, or weeks.
The real benefit of the drug, in my opinion, would be to determine if the therapy is efficacious in newly diagnosed patients or people that have yet to present the later stages of disease. Using the treatments in combination with standard therapies is also being addressed.

DNDN is trading at $6.06 a share (up 6.5%) with roughly average volume.

DOW in uncharted waters today:

The Dow Jones industrial average rose 53.80, or 0.40 percent, to 13,362.87, after reaching a new trading high of 13,369.29. It was the blue chip index's 21st record close since the beginning of the year.

The Standard & Poor's 500 index advanced 4.86, or 0.32 percent, to 1,512.58 -- a new six-and-a-half-year high. The index is near its closing record of 1,527.46, reached March 24, 2000.

The Nasdaq composite index rose 4.59, or 0.18 percent, to 2,576.34.

The stock market has reacted well to the Fed's rate stance; the Dow has hit 43 record closes since the start of October, soon after the Fed stopped raising rates.


I believe that the most significant number here is the S & P being up, which is a more balanced index and IMO a better judge of overall economic strength. Let's ride the bull!!!

(Except DNDN--I will elaborate more on that disaster later....)

Stocks await Fed's move:

Wall street is anxious about todays Federal Reserve potential action that will outline it's decision on interest rates.

As soon as the news is out, it will be here.

In other biotech news, DNDN fell like a stone in today's trading, down 61% after the FDA requested additional data. I will update that news as well after market close.

Nasdaq is currently down 4.5 while the DOW is up 19.75.
The biotechnology index is down 0.5%.



UPDATE 11:30am PST---The Federal Reserve decided not to raise a key interest rate today. The funds rate will remain unchanged (the rate which banks charge each other) at 5.25%. Stocks intially retreated after the news, but have rallieda bit in afternoon trading.

Sunday Summary: What will the Fed do on Monday?

biotech follows the big boys:

After another record-setting week on Wall Street, investors are wondering whether stocks are due for a fall or are headed even higher. This week's words from the Federal Reserve and retail sales could provide some clues.

Recently, it has seemed as if nothing can derail the stock market's climb. Economic reports last week were mixed, but institutional investors remained enthusiastic thanks to soaring takeover activity. News Corp.'s bid for Dow Jones & Co. reinvigorated the stock market Tuesday after a morning of mixed economic news, and on Friday, reports that Microsoft Corp. might be mulling a buy of Yahoo Inc. nudged stocks higher despite lackluster jobs data.

Overall, economic data has shown slow and steady growth, alleviating investors' fears about recession. Still, worries linger about stagflation -- slowing growth amid soaring prices -- and what the Federal Reserve would do about it.

ApotheCure pulls injectable colchicine drug:

ApothéCure and FDA notified all healthcare professionals of recent deaths associated with the use of compounded injectable Colchicine 0.5mg/ml, 4ml vials, lot number 20070122@26. The company issued an immediate drug recall for all strengths, sizes and lots of compounded Injectable Colchicine sold within the last year. Customers are asked to examine their stock for ApothéCure compounded Colchicine on hand and to discontinue use immediately and prepare the product for return to the company.

I will elaborate on this later today. Briefly, colchicine is a anti cancer drug that stabilizes microtubules to keep cells from dividing.

DUSA Pharmaceuticals Receives FDA Warning letter

DUSA received a warning letter from the FDA concerning NDA #20-965 (Levulan Kerastick---aminolevulinic acid HCl ) topical solution.

It reads as follows:
"The Division of Drug Marketing, Advertising, and Communications (DDMAC) of the U.S. Food and Drug Administration (FDA) has reviewed an advertisement (MKT-1330 Rev C) for Levulan
Kerastick (aminolevulinic acid HCl) for Topical Solution, 20% (Levulan Kerastick) submitted by
DUSA Pharmaceuticals, Inc. (DUSA) under cover of Form FDA 2253. The advertisement is false or misleading because it presents efficacy claims for Levulan Kerastick, but omits and minimizes the risks associated with the use of the drug, broadens the indication, and overstates the efficacy of the drug. Therefore, the advertisement misbrands Levulan Kerastick in violation of the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. §§ 352(n) and 321(n), and FDA’s implementing regulations. See 21 CFR 202.1(e)(5); (e)(6)(i). This advertisement raises significant public health and safety concerns because it suggests that Levulan Kerastick is safer and more effective than has been demonstrated by substantial evidence or substantial clinical experience."

Bascially they are saying the company is misrepresenting the product by making claims of treating keratoses without data to support these claims.

SO WHAT IS THIS Levulan Kerastick?

Levulan Kerastick is a topical treatment for actinic keratoses (AK). Actinic keratoses are a direct result of prolonged exposure to sunlight. It is a small crusty, scaly or crumbly bump or horn that arises on the skin surface. They most likely appear on the face, lips, ears, scalp, neck, backs of the hands and forearms, shoulders and back — the parts of the body most often exposed to sunshine. AK's are considered the earliest stage in the development of skin cancer and they have the ability to progress into malignant skin cancer (squamous cell carcinoma).

The mechanism of action of levulan is not completely known and what is know in complicated. In brief, the drug consists of aminolevulinic acid (ALA) which is involved in heme synthesis (circular molecular structures much like the heme group in hemoglobin that carries molecular oxygen in red blood cells). The aminolevulinic acid is activated by sunlight and another product the patient applies that centers a very specific wavelength of light onto the affected area. When activated by light, the ALA is converted to another compound which then releases molecular oxygen (free radicals) and hydroxide ions. These molecular entities act as cytotoxic agents to kill kertosis developing cells.
That's a very basic mechanism of action of how this drug works, and has very complicated chemistry involved that I'm not exactly clear on either. Hope this helps.

DUSA closed friday's trading up 23 cents per share at $3.43. Investors do not seem to be worried.

Earnings update: 4-26-07

MMM up over 3 dollars per share (>4%) to $80.15.

BMY is down 60 cents a share to 29.11 as they are reporting lower 1Q profit as reflected by generic introduction of Plavix. BMY also lost patent protection of it's cholesterol drug Pravachol.

CYTK earnings due at 1:30pm Pacific. CYTK is trading down 5 cents/share in morning trading at $6.62.

IDIX earnings due at 1:30p pacific. Trading a bit down in light morning trading as investors await results.

MLNM is down 40 cents a share by narrowed 1Q losses, helped by higher sales of its cancer drug Velcade, royalties and a decrease in stock-based compensation expense. MLNM is trading at $11.55 a share at this hour.

Biotech Earnings Reports for Thursday, 4-26-07

Of the major pharmaceutical companies reporting tomorrow are:

3M (MMM)- time not specified. 3M has a hefty pipeline of drugs. Of note is the line of TLR agonists of their HCV and cancer interest. They are actively seeking a drug to complement imiquimod that treats HCV in addition to genital warts. MMM is expected to earn over 1 dollar per share.

Bristol-Myers Squibb (BMY) will announce earnings at an unspecified time. BMY has interests in cancer, ERBITUX and TAXOL. Viral products include Baraclude, which is a HBV drug. BMY is anticipating a 23 cent per share earning.

Cytokinetics (CYTK) will announce again at an unspecified time. CYTK is actively pursuing cardiovascular small molecule drugs. Cytokinetics is expected to report a net loss of40 cents per share.

Idenix Pharmaceuticals (IDIX) will announce a proposed loss of 30 cents per share. IDIX concentrates on viral diseases such as HCV, HBV and HIV. They have several drugs in phase IIb and II for treatment of HBV and HCV. IDIX is proposed to report a net 30 cent loss per share.

Millennium Pharmaceuticals (MLNM) will report no change before the market opens. MLNM has leukemia drugs in it's pipeline.

Will keep you posted on Friday's reports.

AVNR--riding a wave of good fortune

Avanir is still riding gains made since wednesday's announcement of positive results of Zenvia in diabetic neuropathy.
Minutes before the market closes today AVNR is up 11.5%, (that's another 46 cents a share ) to $4.37.

This stock might hit 10 dollars before this is all over!

AVANIR Pharmaceuticals Says Drug Shows Positive Results; Shares Soar

ALISO VIEJO, Calif.--(BUSINESS WIRE)--Avanir Pharmaceuticals today announced positive top-line results from the company's Phase III clinical trial evaluating the investigational drug Zenvia (dextromethorphan hydrobromide/quinidine sulfate ("DMQ")), an NMDA antagonist and sigma-1 agonist, in diabetic neuropathic pain.


HOW DOES ZENVIA WORK TO TREAT NEUROPATHIC PAIN? What is diabetic neuropathic pain?
Neuropathic pain is a condition basically defined by "as pain initiated or caused by a primary
lesion or dysfunction in the nervous system". That means researchers and doctors really don't know what actually causes neuropathy, but are working on how to treat the symptoms. The pain is described as shooting, electric or radiant. The pain was once described by elderly patients was that of their feet literally feeling like they were on fire and the patients had to be heavily sedated to combat it. I read somewhere in graduate school once that one person literally tried to cut their own foot off because of the pain.

So what about Zenvia? NMDA receptors are found in the brain (called glutamate receptors) that are mainly responsible for regulation of calcium flow in neurons. You may have heard of dextromethorphan as a cough suppressant. Inhibition of NMDA receptors stops calcium signaling, which is thought to alleviate pain.

Quinidine sulfate was originally used as a cardiac rhythmic drug. It's use in this case is stop the action of enzymes that degrade the dextromethorphan, thus raising it's therapeutic window.


Because of the encouraging data, AVNR ended today's trading up over 300% or $3.92 per share to close at $5.40 after hours.

Memory Pharmaceuticqls Continues Gains

Memory Pharma extended it's gains from Monday today on news that it's leading Alzheimer's drug candidate MEM1003. MEMY is trading up in late afternoon action 47 cents a share (thats up almost 20%) at $2.83. Monday MEMY traded up over 44%. The company has fully enrolled it's phase IIa clinical trial for MEM1003 which means a, they found enough people to run the study with mild to moderate disease; b, it tells investors that the company has confidence in the drug and will rather quickly know whether or not there is efficacy.

MEM1003 is a drug that targets L-type calcium channels in patients with Alzheimer's. Ongoing research strongly suggests that aging alters brain Ca2+ regulation, resulting in impaired neuronal function and, eventually, neurodegeneration.

Voltage-dependent Ca2+ currents and potentials are enhanced in neurons of aged experimental animals, and apparently are mediated by an increase in the membrane density of L-type voltage-sensitive Ca2+ channels. In addition, selective L-VSCC antagonists and other Ca2+ blockers can counteract the effects of aging on several aspects of neuronal and/or behavioral function, implying that channel activity may be necessary for the aging changes.
MEM1003 selectively blocks these channels and could help regulate calcium flow.

A new look is coming!

I intend to drop publishing the press releases from specific biotech companies and start looking at clinical trial data and moving stocks and expand from there, so there will be all original material from here on. I hope this makes the site more interesting and helpful at the same time. Any feedback on what I might be missing or what can make the site better, drop me an email.

ImClone Rallies on Erbitux News

A brief review of thursday's action; Markets closed today for Good Friday:

ImClone Systems and Bristol-Myers Squibb said Apr. 4 that their cancer drug Erbitux can improve the odds of survival in patients on chemotherapy whose head and neck cancers have spread. Investors bid up ImClone's stock nearly 5% to $42.49 on the Nasdaq, while Bristol-Myers Squibb, which is responsible for most of Erbitux's development and marketing costs, rose 0.9% to $27.78. What does this mean?

What is Erbitux and how does it work?
Erbitux is a humanized monoclonal antibody to the epidermal growth factor receptor (EGFR). The family of EGFRs include EGFR, HER2, HER3 and HER4. These receptors mediate and modulate the growth and differentiation of many cell types within the body. Specifically, [and in other cancers] it has been shown that in breast cancers, HER2 and EGFR are over-expressed and are a prognostic indicator of disease. Erbitux competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor alpha. Binding of ERBITUX to the EGFR blocks phosphorylation and activation of receptor-associated kinases, resulting in inhibition of cell growth, induction of apoptosis, and decreased matrix metalloproteinase and vascular endothelial growth factor production.

IMCL closed thursdays trading up 45 cents per share to 42.94.

News--Celgene Shares Jump on Revlimid Outlook

I will post more on how the drug works in a bit.........

Celgene Shares Gain on Positive Study and Market Outlook for Revlimid


NEW YORK (AP) -- Shares of biopharmaceutical company Celgene Corp. jumped Thursday on positive news that its cancer treatment Revlimid could be beneficial for multiple myeloma patients.

Shares of Celgene gained $1.83, or 3.3 percent, to $57.31 in afternoon trading on the Nasdaq Stock Market. The stock has traded between $36.02 and $60.12 over the last 52 weeks, and is off nearly 4 percent since the start of the year.
The drug was first approved to treat anemia and then to treat multiple myeloma, or blood cancer, in combination with the steroid dexamethasone. But that second approval is for patients who have already at least one prior treatment. A study released Wednesday by The Eastern

Cooperative Oncology Group said the drug improved survival rates, in combination with lower-than-normal doses of steroids for recently diagnosed patients.
In March the European Medicines Agency gave the drug a positive recommendation for approval.

Full results of the recent study will be presented at American Society of Clinical Oncology's June conference.

Merrill Lynch analyst Thomas McGahren reaffirmed a "Buy" rating with a $73 price target, suggesting upside of 31.5 percent over the stock's closing price Wednesday of $55.60, citing the research.

"We look for final results of the ECOG trial at ASCO in June, but it appears that a standard of care front-line treatment of Revlimid plus low-dose dex (dexamethasone) is taking shape," he wrote in a note to investors.

Piper Jaffray analyst Rachel L. McMinn reaffirmed a "Outperform" rating and boosted her price target to $68 from $63, also citing the study and drug's potential future market position.
"We expect the results will have a profound impact on the market acceptance for Revlimid -in combination with L-Dex- as a cornerstone of myeloma therapy," she wrote.

Other analysts reaffirmed positive outlooks including Lazard Capital Markets with a "Buy" rating and $70 price target.

IDI Pharma Inc.Rockets up on FDA meeting

IDI Pharma Inc. ( IDMI8.25, +3.00, +57.1%) shares soared after the company said during Tuesday's session that the Food and Drug Administration has scheduled an Oncologic Drugs Advisory Committee meeting on May 9 to discuss Junovan. IDM Pharma has filed a new drug application for Junovan to treat patients with newly diagnosed resectable high grade osteosarcoma following surgical resection in combination with multiple agent chemotherapy.


Resectable high grade osteosarcoma is bone cancer that can be operated on or partially removed. Junovan stimulates the immune system by activating immune cells called macrophages. The drug is actually a derivative of bacterial cell walls and this is how it activates the immune system. How it works is [very simply] is to activate the macrophage which in turn releases cytokines that further manifest the immune response.
Junovan has orphan drug status in the U.S. and Europe.

IDMI is trading in mid-afternoon up 55% to $8.18, that's 2.93 a share.

Prostate drugs keep rolling: Cell Genesys gets positive data

Cell Genesys Stock Surges on Positive Follow Up Data for Prostate Cancer Drug Candidate

Shares of biotechnology company Cell Genesys Inc. jumped Tuesday on positive follow-up data from the company's prostate cancer drug candidate.

The stock gained $1.39, or 32.3 percent, to close at $5.70 on the Nasdaq Stock Market. Shares have traded between $2.77 and $8.10 over the last 52 weeks. Volume Tuesday neared 60.3 million shares, more than 58 times its normal trade.

The company said follow-up data from a mid stage clinical trial of GVAX showed patients survived longer. Cell Genesys is using the same dosage in its ongoing late-stage study of the drug.

JP Morgan analyst Richard Smith reaffirmed a "Neutral" rating on the stock citing the data and said the company is a longer term play, with Phase III clinical trial data expected in late 2008.

"In the meantime, we see close management of expenses as necessary to reach the goal line," he wrote in a note to investors.

Cell Genesys was also given a boost by the recent Food and Drug Administration panel endorsement of Dendreon Corp.'s prostate cancer vaccine Provenge, he said. The FDA is expected to make a decision on whether to approve that drug May 15.

Meanwhile, Canaccord Adams analyst Joseph Pantginis reaffirmed a "Buy" rating with a $7 price target, also citing Dendreon's good news.

The data update from Cell Genesys can also help the company in its partnering discussions, he wrote in a note to investors.

"We view this GVAX prostate survival update as a strong incremental positive for Cell Genesys that further solidifies our projection that GVAX Prostate will play an integral role in the treatment of prostate cancer," he wrote.

Some on Wall Street urged caution, however. Lehman Brothers analyst Jim Birchenough noted that the study showed promising results compared to the current standard of treatment, but added that the small number of patients involved and other issues may have biased the results. He pointed to a number of Phase II studies that showed positive results that didn't pan out under further testing. "Indeed with only 22 patients as a basis for GVAX analysis and no way to control for patient selection bias, we believe that GVAX survival data is more likely driven by better patient baseline status than specific drug effect," he wrote.

Birchenough reiterated an "Equal Weight" rating and $3 price target on the shares.

CEGE What is the product?
GVAX is akin to DNDN's product in that it serves as a vaccine for tumor formation. It primes the immune system to help fight against cancerous cells by using whole-cells designed to stimulate an immune response. The vaccines are comprised of tumor cells that have been genetically in the laboratory that are modified to secrete GM-CSF, [see DNDN from yesterday] an immune stimulatory hormone that plays a key role in stimulating the body's immune response to vaccines. I don't buy the skeptic saying the study numbers are too small. Always another angle.

CEGE closed today's trading up 32% per share to $5.70.

Dendreon Continues to Gain on FDA Recommendation for Prostate Cancer Drug Provenge

Dendreon Continues to Gain on FDA Recommendation for Prostate Cancer Drug Provenge

Shares of Dendreon Corp., which doubled Friday after the company's prostate cancer vaccine was endorsed by a Food and Drug Administration advisory panel, continued to climb in early trading Monday.

The panel said Dendreon's Provenge could be useful in treating advanced prostate cancer. A final FDA ruling is expected May 15, and the agency usually follows recommendations from its committees. Results from a larger trial of Provenge are expected in May 2008.

Dendreon focuses on cancer drugs. Its has several prostate cancer drugs in late-stage clinical trials, and treatments for ovarian, colorectal and breast cancers in earlier testing. Treatments for those cancers, as well as kidney and cervical cancer, are in preclinical testing.
Analysts for JMP Securities and Banc of America Securities raised their prices targets for Dendreon Friday, but Wall Street overall has mixed views about the Seattle-based company's future. Four analysts reporting to Thomson Financial rate Dendreon stock at "Neutral" or the equivalent, three rate shares at "Sell" or its equal, and two at "Buy" or the equivalent.

Dendreon shares rose as high as $13.87 in early trading on the Nasdaq Stock Market before edging back to a gain of 52 cents, or 4 percent, at $13.45.

The stock closed at $12.93 Friday, up from $5.22 the previous day. Shares set an all-time high of $18.05 during the Friday session.

How does Provenge work?-----This is really cool. They take special immune cells from your body and put them in the laboratory. They then take very precise proteins from cancer cells and growth factors to make the cells grow [dendritic cells--which are the cells the body use to fight cancers and infections. They incubate cancer proteins with the cells basically to piss the cells off! Then they put the pissed off cells back into the patient and let them go to work! Bam.

DNDN is still trading up $1.52 (thats 11.7%) per share at 14.50.

Very Cool! Vical gets conditional approval for Canine Cancer Vaccine

SAN DIEGO-- Vical Incorporated (Nasdaq: VICL - News) today announced that its licensee Merial Limited, a joint venture of Merck & Co., Inc. and sanofi-aventis, received notification of conditional approval from the U.S. Department of Agriculture (USDA) to market a therapeutic DNA vaccine designed to treat melanoma, a serious form of cancer, in dogs. The approval triggers a $0.2 million milestone payment to Vical. "Conditional approval" means the product has been shown to be safe and have a reasonable expectation of efficacy in treating melanoma. The designation allows Merial to market the therapeutic vaccine while collecting additional efficacy data to support full marketing approval.

"This canine melanoma therapeutic DNA vaccine is the first companion animal product to receive conditional approval for our licensee Merial," said Vijay B. Samant, Vical's President and Chief Executive Officer, "which represents a significant advancement for our DNA delivery platform technology, building on the previous approval of a vaccine for farm-raised salmon for another of our licensees. Through our independent and partnered programs, we continue advancing toward initial approvals of DNA-based human health products for infectious diseases, cancer, and angiogenesis. We believe the progress of this DNA-based therapeutic vaccine for canine melanoma bodes well for DNA- based approaches for human melanoma. We are particularly encouraged by the prospects for our Allovectin-7® DNA-based immunotherapeutic for patients with metastatic melanoma."

About Canine Melanoma

Melanoma is an aggressive form of cancer that commonly occurs in the dog's mouth, toes or footpads, and is virtually always malignant at these sites. Normal treatment for canine melanoma includes surgery, radiation, and combination chemotherapy, but even after successful treatment, the melanoma often recurs. Merial's melanoma therapeutic DNA vaccine is designed as an adjunct to treat melanoma in dogs.


What is a DNA vaccine?
Vical uses DNA vaccines to express various proteins to stimulate the animals immune system or specific proteins to induce cancer cell apoptosis. The same technology exists for humans as well. The vaccine uses a bacterial DNA plasmid [a circular DNA that can replicate outside the nucleus and express proteins] that encodes for proteins of choice that are cloned into the plasmid. I used this technology in my graduate school days when expressing tyrosine kinases in cells.

VICL is up 18 cents per share in late afternoon trading to $4.98 in above average trading volume.

Charles River Forms China Joint Venture

Charles River Laboratories Expands Into China Through a Research and Development Venture

Medical research and services company Charles River Laboratories International Inc. said Friday it has established a drug research and development center in China through a joint venture.

The company said it will be majority owner of the joint venture, formed with Shanghai BioExplorer Co., a Chinese provider of early-stage drug development services.

The venture, which is expected to close at the end of the second quarter, is subject to certain closing conditions, including regulatory approval from the government.

As part of the agreement, Charles River will build a 50,000-square-foot facility in Shanghai. It is expected to open in mid-2008 and provide a wide range of research and development services, including toxicology studies.

"We expect demand for both research models and preclinical services in Asia to significantly increase over the next several years as pharmaceutical and biotechnology companies expand their research efforts in this market, and we intend to play a leading role in this emerging opportunity," James C. Foster, the company's chairman, president and chief executive officer, said in a statement.

Shares of Charles River rose 10 cents to $45.76 in morning trading on the New York Stock Exchange.

Gilead Jumps up 2 dollars a share on Outlook

Gilead Sciences Shares Rise Following Analysts' Positive Outlook for HIV Products, Pipeline

NEW YORK -- Shares of biotechnology company Gilead Sciences Inc. jumped Tuesday following positive sentiment from several analysts citing the company's development pipeline and HIV treatments.
The stock gained $2.63, or 3.7 percent, to reach $73.40 on the Nasdaq Stock Market in afternoon trading. Shares have traded between $52.55 and $74.97 over the last 52 weeks.

The company is attending Lehman Brothers 10th annual global health care conference in Miami this week. Earlier this month, Gilead said its developing HIV treatment GS-9137 met its goal in a mid-stage study.

Merrill Lynch analyst Eric Ende upgraded the company to "Buy" from "Neutral" and set a price target of $91 Tuesday, citing the company's products and upcoming launches.

"We view Gilead's HIV franchise as solid with a relatively low risk of disappointments because the drugs are standard of care and unlikely to experience any serious competitive threats for the foreseeable future," he wrote in a note to investors.

Ende also expects the company to launch Ambrisentan, aimed at treating pulmonary arterial hypertension, in the middle of 2007. That drug could see sales of $1 billion, he said. Also, the company could launch Aztreonam for cystic fibrosis in the middle of 2008 and it could see peak sales between $400 million and $500 million.

RBC Capital Markets analyst Jason Kantor reaffirmed his "Outperform" rating and price target of $78, citing the company's outlook.

"Gilead has steadily gained share in U.S. HIV market with the launch of Atripla and the sustained market presence of Truvada," he wrote in a note to investors. "Not only do we expect continued steady growth in market share, but we are not aware of any potential competitive threats to Gilead in development." [That's huge!]

Kantor also increased his 2007 earnings per share estimates, citing higher-than-expected revenue from the company's HIV drugs. He is also including some anticipated sales of Ambrisentan, as he too expects a launch in the middle of 2007.

Atripla is a fixed-dose combination of three widely used antiretroviral drugs, to be taken in a single tablet once a day, alone or in combination with other antiretroviral products for the treatment of HIV-1 infection in adults. Atripla is the first fixed dose combination available in the United States to combine two different classes of antiviral drugs in a single pill. This “one-pill-once-a-day” product to treat HIV/AIDS combines the active ingredients of Sustiva (efavirenz) a Nonnucleoside Reverse Transcriptase Inhibitor (NRTI), with Emtriva (emtricitabine) and Viread (tenofovir disoproxil fumarate), two Nucleoside Reverse Transcriptase Inhibitors (NRTIs). Emtriva and Viread are also available in a fixed dose combination known as Truvada.

Acadia Schizophrenia Drug Meets Endpoint

Acadia Schizophrenia Drug Meets Study Goal in Phase II Trial

SAN DIEGO-- Acadia Pharmaceuticals Inc. said Monday its schizophrenia drug met its goal in a Phase II trial, and shares nearly doubled in value.

The company's ACP-103 trial drug to treat schizophrenia showed a statistically significant level of effectiveness in the trial, which tested the drug used in conjunction with both a generic typical antispsychotic drug, haloperidol, and risperidone, an atypical antipsychotic drug.
Schizophrenia is a chronic, debilitating mental illness characterized by disturbances in thinking, emotional reaction and behavior.

"The use of ACP-103 in co-therapy with risperidone or other modern atypical antipsychotics may result in enhanced efficacy and an improved side effect profile," the company said in a statement.



Nearly all antipsychotics are 5-HT2A receptor inverse agonists, in that they can attenuate the basal constitutive signaling activity of this receptor, in contrast to neutral antagonists that can only block agonist-induced responses. 5HT receptors bind serotonin in the brain.

Acadia shares soared $5.86, or 87.6 percent, to $12.60 in morning trading on the Nasdaq Stock Market.

Hollis-Eden stock roars up 29%

Shares of Hollis-Eden Pharmaceuticals Inc. rose as much as 52 percent after the company said it is stopping further development of radiation drug Neumune and instead focus on its diabetes and prostrate cancer drugs.

The share spike, which made the stock the biggest percentage gainer on the Nasdaq Friday, reversed some of its prior-week losses that followed the contract rejection of Neumune by the U.S. Department of Health and Human Services.

Neumune was being developed to treat acute radiation syndrome under the U.S. government's Project BioShield program.

Analyst Joseph Pantginis of Canaccord Adams said as a public company, Hollis-Eden needed to go after drugs with real markets where it could potentially get return on investment.

The San Diego-based company had spent between $80 million to $90 million over four years developing Neumune with no current potential for reimbursements from the government.

It plans to file an investigational new drug application to treat type 2 diabetes by the end of the month. The company is also considering the same compound as a treatment of rheumatoid arthritis.

What is Neumune and how does it work?
Neumune was being developed as an acute radiation syndrome drug. Neumune or 5-androstenediol (AED), is a naturally occurring adrenal steroid hormone which stimulates multilineage recovery of bone marrow cells [Immune system cells like macrophages and T cells]. In other words, it stimulates the immune system to recover from radiation and grow new cells derived from the bone marrow. This relates directly to survival, in that any opportunistic infections can be stopped by the body's ability to defend itself unlike an irradiated animal which cannot defend itself without a functioning immune system.

AED is often misused by athletes as a performance enhancing anabolic steroid as well.

HEPH.O closed friday's trading up 74 cents per share to $3.25.

Biotech News Friday: Trimeris stock plunges on CEO's departure

The stock price of Trimeris collapsed Friday following the company's announcement that both its chief executive officer and chief financial officer have tendered their resignations.
The company said late Thursday afternoon that co-founder and CEO Dani Bolognesi, who also acts as chief scientific officer, would resign today. He will stay on as a "scientific consultant" to Trimeris through October 2008. Robert Bonczek, CFO and general counsel, plans to step down on April 30.

Trimeris officials did not cite a reason for the departure of either Bolognesi or Bonczek.
The company has named E. Lawrence Hill Jr. acting president and chief operating officer. Hill currently is president of Hickey & Hill Inc., a management services firm, and formerly served as CEO of Deltagen Inc. from 2003 through 2005.

Shares of Trimeris were down almost 22 percent to $7.86 in early trading Friday.
Thursday's announcement came on the heels of a difficult year for Trimeris, whose HIV drug Fuzeon has failed to reach expectations. The company announced in December plans to slash 25 percent of its work force.

Also Thursday, the company released 2006 fourth quarter and full-year financial results above Wall Street expectations.

FDA Approves GlaxoSmithKline's TYKERB(R) in combination for treating advanced/metastatic breast cancer

A competitor for herceptin?

-- GlaxoSmithKline plc announced today that the United States Food and Drug Administration (FDA) approved TYKERB(R) (lapatinib), in combination with Xeloda(R) (capecitabine), for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab. It is the first targeted, once-daily oral treatment option for this patient population. TYKERB was granted Priority Review by the FDA in November 2006.

"Tykerb is a significant breakthrough for women with advanced HER2 (ErbB2) positive breast cancer. The data clearly show that this small molecule, oral, targeted agent, in combination with capecitabine, is effective for women whose disease has progressed on previous therapies, including anthracyclines, taxanes and trastuzumab," said Paolo Paoletti, MD, Senior Vice President of the Oncology Medicine Development Center at GSK. "The approval of TYKERB demonstrates our R&D organization's strong commitment to the discovery and development of novel cancer treatments. We are dedicated to the further study and development of Tykerb in a variety of settings including adjuvant breast cancer as well as in other solid tumor types."

This approval reflects more than 16 years of research, including more than 60 clinical trials and investigator-initiated collaborative research studies. TYKERB inhibits two validated targets in oncology, the kinase components of the EGFR (ErbB1) and HER2 (ErbB2) receptors, commonly associated with cancer cell proliferation and tumor growth. As a targeted therapy, TYKERB is designed to interfere with discrete cellular processes or disease mechanisms prevalent in cancer. TYKERB will be available in the United States within two weeks and, as an oral therapy, offers added convenience for patients.

GSK finished today's trading down 42 cents at 54.83 per share. Monoclonal antibody treatments are gaining in popularity due to their target specificity. It remains to be seen if TYKERB has the same cardiac side effects as herecptin.

See post from January 9th for more info on herceptin and breast cancer.

Affymetrix Rises on Illumina Verdict

Affymetrix Shares Jump on $16.7 Million Patent Verdict Against Rival Illumina

NEW YORK-- Shares of Affymetrix Inc. climbed Wednesday after the company, which makes products used in analyzing genetic information, won a series of patent infringement claims against Illumina Inc.

Affymetrix said Tuesday a Delaware jury awarded it $16.7 million, finding that Illumina's scanners, software, arrays and other products infringed on five Affymetrix patents.
Robert W. Baird & Co. analyst Quintin Lai upgraded the stock to "Outperform" from "Neutral." He said the jury awarded Affymetrix a royalty rate of 15 percent on $111 million in revenue from 2002 to 2005 -- a higher rate than Affymetrix had sought. Illumina says it will appeal the ruling.
"If we assume 15 percent as the forward royalty rate, then Affymetrix stands to benefit from Illumina's current high-growth potential," said Lai. He raised his price target for the stock to $35 per share from $26, and reduced his target for shares of San Diego-based Illumina to $34 from $52.
Shares of Santa Clara, Calif.-based Affymetrix rose $1.99, or 7.5 percent, to $28.61. Illumina stock was up 80 cents, or 2.7 percent, to $29.63. Both stocks trade on the Nasdaq Stock Market.

REMEMBER that gene chips are a powerful tool that researchers use to identify genes are are activated or inhibited in disease states. Basically, DNA sequences are stuck to a slide and disease DNA is passed over it, where alike base pairs bind to each other or not. It's then put in a machine to look for differences. I posted about how this method works; on 9-8-06 you can search for that date and find more indepth info.

AFFX is up in afternoon trading 6.3% (or $1.71 per share ) to 28.36/share. The stock was upgraded as well.

Update: La Jolla Pharma still cruising

La Jolla pharma still rocking on today in late afternoon trading up up 41% [over $1.71 per share] to $5.84 on news of positive clinical data from it's Lupus drug Riquent.
Rock on!

In my backyard: La Jolla Pharma Shares Surge on data

La Jolla Pharmaceutical Co. shares continued to surge Thursday afternoon trading after the company announced positive interim antibody results from its Phase II trial of Riquent, its drug candidate for systemic lupus erythematosus. The results showed a significant dose response when comparing all Riquent-treated patients to placebo-treated patients, the company said. "We are very excited by these results," said Deirdre Gillespie, president and chief executive, in a statement. "The higher the dose, the greater the reduction in antibodies to dsDNA, and the relative magnitude of these reductions is greater than we have seen in previous studies, which used lower doses of Riquent."

LJPC continues to surge thursday, trading up over 34% (over $1.07 per share) at $4.23.

Whats
Riquent is a new treatment for Lupus. Lupus, which affects about one million people in the U.S. and Europe, is a chronic, potentially life-threatening autoimmune disorder in which patients' diseased B cells produce antibodies to double-stranded DNA (dsDNA). These antibodies are believed to cause lupus kidney disease that can lead to kidney failure, dialysis, kidney transplantation, and death.
It's mechanism of action is not fully understood, LJPC is using a technology that helps induce self tolerance from diseased B cells. What most likely is happening is Riquent is a peptide [small protein] that binds to the antibody producing cells that mimics another self protein. The antibody producing cell sees this protein as self and says "hey man, Im mounting an immune response to myself and that's not good. I should slow down". Thus less antibodies to self DNA and slows the progression of the disease.

Tercica Shares Surge on Settlement

Shares of Tercica Surge As Rival Agrees to Stop Marketing Competing Drug

NEW YORK-- Shares of drug maker Tercica Inc. surged Wednesday, a day after a rival agreed to stop marketing a competing drug.
Tercica and partner Genentech Inc. had sued a Glen Allen, Va.-based drug maker called Insmed Inc. Insmed makes Iplex, which treats growth disorders. Under a settlement announced late Wednesday, Insmed agreed to stop selling Iplex as a drug treating growth disorders.

Analysts called the settlement a big win for Tercica. BMO Capital Markets analyst Thomas Shrader said Tercica no longer has to share the spotlight with Insmed. Plus, the Brisbane, Calif.-based company can now focus its attention on doctors instead of lawyers.

Shares of Tercica rose 87 cents, or 16.3 percent, to $5.77 on the Nasdaq Stock Market. In late afternoon trading today, TRCA is continuing to climb---up 22% to $5.95 per share.

What's the drug?
A complex term helps explain why some children are much smaller than others their age. Insulin-like growth factor deficiency, or IGFD, is a term that describes lower than expected levels in the body of Insulin-like Growth Factor 1 (IGF-1), a naturally occurring hormone that plays a central role in growth. The drug is a human recombinant [man-made] insulin growth factor that is injected into children with severe primary IGF-1 deficiency. When injected, the insulin receptor binds it and leads to intracellular signaling to growth.

CV Therapeutics Drug Fails Study

Biopharmaceutical company CV Therapeutics Inc. said Tuesday its angina drug ranolazine, or Ranexa, showed no adverse trend in deaths or arrhythmias, but failed to meet its goal in a late stage study.
The drug is already approved as a second-line treatment for chronic angina.

The company said a Phase III clinical trial studying the drug for other uses as a treatment of coronary syndromes did not meet its primary study goal for effectiveness. But the safety results gathered from the study could support expansion of the drug into a first-line treatment.

Full results will be released March 27 at the American College of Cardiology Scientific Session in New Orleans, the company said.

Shares of CV Therapeutics rose 10 cents to close at $12.30 on the Nasdaq Stock Market.

CVTX in after hours trading, plunged down over 27% or $3.34 to a price of 8.96 a share.

Electrical excitation in cardiac cells causes sodium ions to enter the cell through membrane sodium channels.
Ranolazine used for angina works by reducing sodium entry into cardiac cells through those sodium channels. As a result, it improves sodium and calcium homeostasis and contractile function and balancing out ions that are the end result of ischemia.

BioCryst stock jumps on news of bird flu

BioCryst signs license agreement with Japanese biotech for experimental bird flu drug; could rival Tamiflu, Relenza.

BioCryst signed a licensing agreement with the Japanese biotech Shionogi for the development of peramivir, one of the most advanced experimental treatments for bird flu.

The licensing deal gives BioCryst Pharmaceuticals a $14 million up-front payment, with potentially more than $100 million in other payments and up to 20 percent royalties on Shionogi & Co's. anti-viral drug sales in Japan.


BioCryst's stock price jumped more than 6 percent on the news.

If peramivir gets approved by the Food and Drug Administration, it could some day rival the bird flu anti-viral Tamiflu produced by the Swiss drug giant Roche and the biotech Gilead Biosciences (down $0.21 to $69.78, Charts). GlaxoSmithKline (up $0.61 to $54.58, Charts) also produces a bird flu anti-viral: Relenza.

BioCryst, based in Birmingham, Ala., is one of the most active companies in developing potential treatments for the notorious H5N1 strain of bird flu, which has decimated bird flocks in Asia and Europe and led to at least 160 human deaths. Some bird flu experts fear that the H5N1 virus could mutate into a form that is contagious among humans, possibly leading to an outbreak like the 1918 pandemic that killed as many as 50 million people.

Feds award bird flu contracts to Novartis, Glaxo
Health and Human Services awarded BioCryst on Jan. 4 with a $102.6 million grant for the development of peramivir for the treatment of bird flu and seasonal flu. But many experts believe that a vaccine -- not an anti-viral - is the best way to deal with the threat of a pandemic.

An FDA advisory panel on Feb. 27 recommended the approval of an experimental vaccine from the French drugmaker Sanofi-Aventis (up $0.61 to $42.25, Charts). If the agency takes the advice of its experts and approves the product, it would be the first FDA-approved bird flu vaccine. The government has already begun to stockpile it.

What is Peramivir?
Peramivir is an anti-viral drug in the category of neuraminidase inhibitors. Anti viral drugs Tamiflu and Relenza are also neuraminidase inhibitors. These drugs shut down neuraminidase so the virus is not allowed to be released from host cells, therefore stopping the virus from infecting healthy cells.
Peramivir seems to be effective on influenza viruses that have become resistant to Tamiflu. Studies have been done on mice and ferrets so far.

Preclinical studies show effectiveness of peramivir in a broad range of influenza viruses including the H5N1 avian influenza virus.

BioCryst stock is trading (ticker symbol BCRX nasdaq) up 5.7% or 51 cents a share. Late afternoon trading price was $9.55/share.

Aftermarket News: InterMune Discontinues Phase 3 INSPIRE Trial of Actimmune in Idiopathic Pulmonary Fibrosis

InterMune, Inc. today announced that it has discontinued the Phase 3 INSPIRE clinical trial evaluating Actimmune(R) (interferon gamma-1b) in patients with idiopathic pulmonary fibrosis (IPF) based upon the recommendation of the study's independent data monitoring committee (DMC). In a planned interim analysis that included a total of 115 deaths, the DMC found the overall survival result crossed a predefined stopping boundary for lack of benefit of Actimmune(R) relative to placebo. Among the 826 randomized patients, there was not a statistically significant difference between treatment groups in overall mortality (14.5% in the Actimmune group as compared to 12.7% in the placebo group). Based on a preliminary review of the interim safety data, the adverse events associated with Actimmune(R) therapy appear generally consistent with prior clinical experience, including constitutional symptoms, neutropenia and possibly pneumonia.

INSPIRE was a randomized, double-blind, placebo-controlled Phase 3 study designed to evaluate the safety and efficacy of Actimmune(R) in IPF patients with mild to moderate impairment in lung function. The primary endpoint was survival time. The lack of benefit stopping boundary was developed to allow for early study termination in the event interim data were statistically inconsistent with a clinically meaningful treatment effect of Actimmune(R). InterMune plans to submit the data from the Phase 3 INSPIRE trial for presentation at an appropriate medical meeting and for publication in a peer-reviewed journal.

"The interim results of the INSPIRE trial and our decision to discontinue the trial are disappointing," said Steve Porter, M.D., Ph.D., Chief Medical Officer at InterMune. "We are extremely grateful for the strong support we received from physicians, healthcare providers and especially the patients who participated in the clinical evaluation of Actimmune(R). The overall conduct of the study by investigators and the participation by patients were exemplary."

Nasdaq: ITMN in after hours trading is down 18.7% down 5.25 dollars per share at $22.80. OUCH!

Actimmune is a human cytokine termed Interferon gamma-1b being used to treat idiopathic pulmonary fibrosis (that is an inflammatory lung disorder of unknown origin characterized by abnormal formation of fibrous tissue between the tiny air sacs of the lungs. ) IFN-1b acts as a potent stimulator of the immune system.

Memory Pharma Drops on Failed Study

Memory Pharmaceuticals Shares Drop on Failed Mania Treatment Study; Analyst Downgrades Stock


NEW YORK-- Shares of Memory Pharmaceuticals Corp. fell Monday after the biotech drug maker said results of a clinical study for one of its drugs to treat bipolar mania failed to show significant effectiveness.

Memory Pharmaceuticals shares fell 97 cents, or 31 percent, to $2.16 in afternoon trading on the Nasdaq at more than double their average volume. Shares have fallen from a 52-week high of $4.94 set in February.

Results of the midstage study showed a significant number of bipolar patients given the experimental drug MEM 1003 did not reach at least a 50 percent improvement on a mania scale, or other measured targets, compared to patients given a placebo. Bipolar disorder is major mood disorder where sufferers swing between episodes of mania and depression.

As a result, Lazard Capital analyst Terence C. Flynn cut the rating on the company to "Hold" from "Buy."

Flynn had expected the drug to be effective against acute mania, but given the results, does not think the company will advance study for this condition.

Despite the company's reassurance that the drug is still being studied as a treatment for Alzheimer's disease, Flynn said that he is no longer optimistic, and removed MEM 1003 from his model.

The analyst estimated a cash per share technology value of 50 cents for MEM 1003, with $2 for the company's MEM 3454 Alzheimer's drug candidate.

MEMY is trading down over 32% (thats over 1 dollar per share) in today's late afternoon session at $2.12/share.

MEM 1003 is a neuronal L-type calcium channel modulator. L-type channels are not only essential for cardiovascular function [they are targets for high blood pressure drugs as well] but are also widely expressed in neurons, (neuro-)endocrine and sensory cells. We know that these channels contribute to memory and control of mood and drug-related behavior, as well as vision, hearing, the release of a variety of hormones and skeletal muscle contraction. By blocking L-type calcium channels, MEM 1003 may regulate the flow of calcium. Calcium inhibition may enhance cognition by re-establishing normal levels of calcium, which is essential for normal functioning of neuronal pathways.

OncoGenex Delays IPO AGAIN

OncoGenex Delays IPO

NEW YORK — Biotechnology company OncoGenex Technologies Inc. has pushed its initial public offering (IPO) into next week. AGAIN.

The Vancouver, British Columbia-based company originally planned to begin trading on the Nasdaq Stock Market Wednesday, but postponed the offering after a volatile day of trading on global markets Tuesday.

The initial public offering is now expected to trade Tuesday, according to underwriters RBC Capital Markets.

"Once again, clearly we have a situation where an already tough biotech market has been made tougher by the tone of the market and dedicated biotech buyers are taking a wait and see attitude," said Scott Sweet, managing director of IPOboutique.com, an IPO research service near Tampa, Fla.

The delay comes after the company lowered its estimated IPO price range to $7.50 to $8.50 a share, from $10 to $12 in an amended filing with the Securities and Exchange Commission Thursday.

The underwriters also increased the size of the offering to 5 million shares from 4.5 million shares.

OncoGenex is attempting to commercialize new cancer therapies that address treatment resistance in patients.

The stock will trade under the ticker symbol "OGXI." By the time the initial IPO for the stock sells, and after what the market did today [down nearly 1%] this IPO might be at 5 dollars!!!

Biotechnology Mid-Day trading Report

Biotech and pharmaceutical issues slid into the red Thursday as the broader market turned bearish once again on concerns about the health of the Asian markets and U.S. lenders.
The DJ Wilshire Pharmaceutical Index was down nominally at 2,336.25 and the DJ Wilshire Biotechnology Index fell 1.6% to 3,052.20.

Amgen was the notable decliner among the large caps, with shares dropping 3% to $62.35.

The biotech giant said late Wednesday that the Securities and Exchange Commission had launched an informal investigation into a halted study run by the company for its anemia drug Aranesp as a possible treatment for head and neck cancers.
Amgen also said it will participate in a Food and Drug Administration meeting that will discuss using such drugs as Aranesp to treat certain types of cancer patients. The meeting is scheduled for May 10.

Bristol-Myers Squibb was one bright spot, with shares trading up 1% at $26.68. Analysts at UBS upgraded the stock from neutral to buy, citing valuation and its attractiveness as a takeover target.

Wyeth shares also rose, up 1% at $49.30. The drugmaker said late Wednesday that it sees first-quarter 2007 earnings beating the current Thomson Financial polled analysts' average estimate of 85 cents a share.
Wyeth also said that the number of cases filed against it over its hormone treatment Prempro has not substantially increased since its last update. About 8,400 women have filed suit, claiming they were injured by the product.

Shares of Hana Biosciences jumped 5% to $4.00. The stock's rating was upped to buy by Cantor Fitzgerald. End of Story

After this mornings meltdown, some good news: Alpharma's Pain Reliever Gets FDA Nod

Alpharma Inc. said the U.S. Food and Drug Administration approved a 200 mg dosage of Kadian, a chronic pain reliever capsule.

Alpharma expects to launch the capsule in the second quarter, the specialty pharmaceutical company said in a statement.

ALO is up 47 cents per share in late afternoon trading at $26.81/share in light trading (volume just under 482K0).

What is Kadian and how does it work?:

Kadian is sustained release morphine designed for 12-24 hour dosing. Cancer patients with chronic pain were randomized in clinical trials. Remember that morphine is an opiate which elicits its mechanism of action via specific receptors in the brain and GI tract. The major classes of opioid receptors are mu [for morphine], delta and kappa. These receptors are G protein coupled and each subtype can elicit varying effects. They effect intracellular signaling pathways such as calcium release, protein phosphorylation and ion gating.

Samaritan to Distribute Shire Drug

Monday February 26.

Samaritan Pharma Will Distribute Shire's Hunter's Disease Drug Elaprase in Greece and Cyprus

LAS VEGAS (AP) -- Samaritan Pharmaceuticals Inc. said Monday it signed a marketing agreement with Shire plc to sell Shire's Elaprase to treat Hunter's disease in Greece and Cyprus.
Samaritan will sell the drug on a "named patient" basis until Greece and Cyprus establish pricing and reimbursement for the drug. The drug is expected to launch in the two countries during the second quarter.

Hunter's disease is a hereditary disorder characterized by dwarfism, mental retardation and deafness. It first appears early in life in children and primarily affects males. Most patients die before age 20, Samaritan said.

Shares of Samaritan added 2 cents, or 8.3 percent, to 26 cents on the American Stock Exchange in morning trading. The stock has ranged from 17 cents to 90.5 cents over the past year.

American depository shares of U.K.-based Shire rose 79 cents to $67.40 on the Nasdaq Stock Market in morning trading. Earlier, shares traded as high as $67.73, eclipsing a previous 52-week high of $67.24.

ABOUT Elaprase:
Hunter syndrome, also known as Mucopolysaccharidosis II (MPS II), is a rare, life threatening, genetic disorder with no available treatment. Individuals with Hunter syndrome lack the enzyme iduronate-2-sulfatase, which is essential in the continuous process of replacing and breaking down glycosaminoglycans (GAG). As a result, GAG remains stored in cells in the body causing progressive damage. The symptoms of Hunter syndrome are usually not visible at birth, but usually start to become noticeable after the first or second year of life. Often the first symptoms may include hernias, frequent ear infections, runny noses, reduced growth rate and abnormal facial appearance.

As the disease progresses, a variety of symptoms appear including enlarged liver and spleen, heart failure, decreased endurance, obstructive and restrictive airway disease, sleep apnea, joint stiffness, and, in some cases, central nervous system involvement. If central nervous system involvement exists, the life expectancy for patients with Hunter syndrome is typically 10-15 years of age, however, some patients can survive into the fifth or sixth decade of life. There is currently no effective therapy for Hunter syndrome.

Elaprase is a human iduronate-2-sulfatase produced by genetic engineering technology, developed to replace the missing enzyme in Hunter syndrome patients. Elaprase has been designated an orphan drug in both the United States and in the European Union.

Gilead HIV Drug Passes Midstage Study

Gilead Sciences Developing HIV Treatment Meets Its Goal in Phase II Clinical Trial

FOSTER CITY, Calif.-- Biopharmaceutical company Gilead Sciences Inc. said its developing HIV treatment GS-9137 met its goal in a midstage study.
The drug candidate is an integrase inhibitor that aims to interfere with HIV replication by blocking the virus from integrating into cells. The Phase II clinical trial involved the drug candidate in combination with ritonavir and a background antiretroviral program. The study's goal was to at least be as effective as the comparison treatment.

The study involved 50-milligram and 125-milligram doses. The 20-milligram dose was discontinued early on in the study because of a high rate of virologic failure.

Shares of Gilead closed down 43 cents to $73.63 on the Nasdaq Stock Market.

Acorda Therapeutics, Cerus Shares Advance; PDL slips again

Acorda Therapeutics shares rose Friday after hedge fund Third Point LLC said late Thursday it has filed a Schedule 13D with the Securities and Exchange Commission, urging the board of Acorda to initiate a process to sell the company. Entities advised Third Point hold 9.9% of Acorda's shares. In a letter to Acorda Chief Executive Ron Cohen, Third Point said "should the board of directors not be responsive to our request, we will explore alternatives for exerting greater control of the company."

PDL BioPharma is still moving lower more than a day after the company missed fourth-quarter earnings targets. The stock was losing 26 cents, or 1.3%, to $19.45.

On the other hand, Cerus was one of the best performers of Friday's session. After the previous close, the biotech company swung to a fourth-quarter profit that easily beat Wall Street's estimates. Cerus was recently up 33 cents, or 5.8%, to $6.07.

Just some stocks I'm watching today. Cerus just had an approval in Germany, so I may jump in soon.

GTX releases positive data for prostate cancer therapy

Biotech group GTX Inc. said early Friday that data from a late-stage clinical trial for its proposed treatment Acapodene show the drug can mitigate two serious side effects associated with the prostate cancer therapy ADT.

GTX said the results were from interim analyses of an ongoing Phase III clinical study of 1,400 men with advanced prostate cancer who were on androgen deprivation therapy, or ADT, a drug combination used to keep prostate cancer tumors in remission. Patients on ADT generally stay on the therapy, which blocks the production of testosterone, for life.

However, one common side effect of ADT therapy is a decrease in bone density, which can lead to bone fractures. Another side effect can be an increase of certain fats in the blood, such as cholesterol and triglycerides, which can lead to cardiovascular disease and even diabetes.
The Phase III data unveiled Friday showed that Acapodene, also known as toremifene, was effective in both increasing bone density and improving levels of cholesterol and triglycerides.

"In previous studies, other agents -- including bisphosphonates -- have also been associated with significant improvements in bone mineral density in men receiving androgen deprivation therapy for prostate cancer," said Dr. Matthew Smith, an oncologist at the Massachusetts General Hospital Cancer Center who authored Friday's presentation, in a statement. See more health-care coverage.

"However, these results suggest that toremifene has the potential not only to reduce the risk of fractures in men with advanced prostate cancer, but also to improve lipid levels, addressing another significant side effect of the standard treatment for this disease," Smith added.
Examples of bisphosphonate drugs include Merck's Fosamax, Novartis' Zometa, Roche's Boniva, and Procter & Gamble and Sanofi-Aventis' Actonel, according to WedMD.
Smith presented the results at the American Society for Clinical Oncology's annual prostate cancer symposium, currently being held in Orlando, Fla.

In an interview with MarketWatch, Smith said the results indicate Acapodene could improve the long-term health and quality of life of ADT patients by making them less prone to bone fractures and cardiovascular disease as they age. He noted that because ADT blocks the production of testosterone, which feeds prostate cancer tumors, men often quickly become obese, a condition that predisposes them to diabetes.
Currently, there are about 1 million men on ADT therapy, with an additional 100,000 put on it every year, according to analysts.

Hopes grow for swing to profitability

GTX Chief Executive Officer Dr. Mitchell Steiner told MarketWatch the company hopes to have final results from the study during the fourth quarter of 2007 or early 2008. It was "shooting for" filing for U.S. regulatory approval during the first half of 2008, he said.

GTX is pursuing having Acapodene approved for the prevention of osteoporosis and other side effects in ADT patients.
The company is also conducting Phase III trials for the drug in the prevention of prostate cancer in men who already have precancerous lesions. Final results from the trials are expected during the first quarter of 2008. Steiner said if the results are positive, the company would file for U.S. approval for that indication in the latter half of 2008.
In a recent note, Cowen & Co. analysts said that each indication represents a potential sales opportunity in excess of $500 million.

Founded in 1997, GTX has yet to turn a profit. However, Steiner said that approval for Acapodene for either indication "would put us on solid footing to profitability."
GTX already markets toremifene under the brand name Fareston for the treatment of advanced breast cancer. According to a note by analysts at Leerink Swan & Co., the patent on toremifene for use in breast cancer is slated to run out in 2009. However, the patents for use in the prevention of prostate cancer and with ADT do not expire until 2019 and 2023, respectively.

he company is also developing a drug called Ostarine to treat the muscle wasting associated with kidney disease and cancer. The drug is currently in Phase II clinical trials.

GTX is up 3 cents per share at $20.80 in light trading this afternoon.

Biotech, pharma benchmarks move lower

The biotech and pharmaceutical benchmarks moved lower Thursday as shares of Genentech dipped on news that a study has found its oncology drug Avastin can be just as effective in treating lung cancer when used in lower doses.
The DJ Wilshire Pharmaceutical Index closed down 0.3% at 2386.32 and the DJ Wilshire Biotechnology Index eased 0.6% to close at 3219.42.

Shares of Genentech finished down 3% at $85.51.
Early Tuesday, Genentech's parent company, Swiss conglomerate Roche, said a company-sponsored study showed Avastin was effective in treating lung cancer when given in doses at about half of those currently prescribed.

According to DJ Newswires, the study could mean that doctors would be able to prescribe less of the drug, thereby dropping the monthly cost for treatment from $8,800 to $4,400.
Shares of Merck & Co. slipped almost 2% to $43.20 following reports that the company made a $5,000 campaign contribution to Texas Gov. Rick Perry, who later signed a controversial executive order mandating that Merck's HPV vaccine to prevent cervical cancer be given to all Texas girls entering the sixth grade.
A bill to override the executive order is currently making its way through the Texas state House. Earlier this week, Merck announced it was ceasing state lobbying efforts for the vaccine.

Shares of Hollis-Eden Pharmaceuticals rose 1% to $5.56 after hitting a session high of $5.79. The biotech group said it presented positive pre-clinical data for its compound HE3235 for the treatment of prostate and breast cancer. The data was presented in conjunction with the American Society for Clinical Oncology's Prostate Cancer Symposium.
Dyax Corp.shares plunged for the second day, tumbling 14% to close at $3.65. Earlier this week, Dyax said that it had agreed to terminate its collaboration with Genzyme Corp. for its lead drug candidate DX-88, a treatment for the rare disorder hereditary angioedema.

Genzyme shares slipped 1% to $63.99.

GTX Inc to release phase III clinical data Friday Morning

GTx, Inc. (Nasdaq: GTXI), today announced that Phase III data from a bone mineral density interim analysis and from a lipid interim analysis will be presented in separate podium sessions on February 23rd at the American Society of Clinical Oncology Prostate Cancer Symposium. Both analyses were conducted in the first 197 men to complete one year of treatment in the Phase III clinical trial evaluating ACAPODENE® (toremifene citrate) 80 mg for the treatment of multiple serious side effects of androgen deprivation therapy (ADT) for advanced prostate cancer.

Dr. S. Bruce Malkowicz, Professor of Urology at the University of Pennsylvania School of Medicine, will present the bone mineral density interim data, and Dr. Matthew Smith, Associate Professor at Massachusetts General Hospital Cancer Center, will present the lipid interim data. The presentations will be delivered in an Oral Abstract Session beginning at 1 p.m. on February 23rd in the Osceola Ballroom at the Gaylord Palms Resort & Conference Center in Orlando, Florida.

GTx has been notified that these presentations have been selected to be part of an ASCO press briefing the morning of February 23rd.

GTx is conducting the Phase III ADT clinical trial in approximately 1,400 patients at nearly 150 clinical sites in the United States and Mexico. The primary endpoint of the pivotal Phase III ADT clinical trial is a reduction in vertebral morphometric fractures. Secondary endpoints include improvements in BMD, hot flashes, gynecomastia, and lipid profiles. The last patient will complete the trial at the end of November, 2007. GTx will then evaluate the data and prepare it for public release. If the data demonstrate a significant fracture benefit, GTx will file a new drug application in 2008.

I'm keeping an eye out on this stock, and will post what data I can find that could allude to positive or negative results.

GTXI is unchanged in today's trading at $20.55 per share.

Genentech shares tumble on cancer drug news

Biotech company reveals that a lower dose of its drug Avastin worked just as well as a more expensive higher dose, raising revenue concerns.


-- Biotechnology company Genentech said on Thursday that a low dose of its cancer drug Avastin worked just as well as a more expensive high dose in a clinical trial of patients with lung cancer.

Genentech's shares fell nearly 3 percent amid concern the company, as well as its majority owner, Roche Holding (Charts), will receive less revenue from the drug if doctors choose the low-dose version.

"The risk and concern that investors have is that the similar findings from the two dose arms, and the still undisclosed adverse event rates from the two arms, may result in dose and effectively price reductions for Avastin," Geoffrey Porges, an analyst at Sanford Bernstein, said in a research report.

Participation certificates in Roche, its most widely traded form of equity, fell 1.7 percent to 224.20 Swiss francs.

Results from a late-stage clinical trial showed that both 7.5 mg/kg and 15 mg/kg doses of Avastin significantly lengthened the time patients with advanced non-small cell lung cancer (NSCLC) lived without the disease progressing significantly when compared with chemotherapy alone.

"This means that future prescribing is likely to be done with the low dose of Avastin instead of the high dose," said bank Vontobel analyst Karl-Heinz Koch. "The impact is that the monthly price for Avastin in non-small cell lung cancer drops to $4,400 from $8,800."

Analysts expect full data to be presented in May.

Avastin is one of a new family of drugs that work by starving tumors of their blood supply.

Roche and Genentech are banking on increased sales of Avastin to fuel future growth and are testing the drug in multiple different types of cancer.

U.S. sales of Avastin, which is approved for colon cancer and NSCLC and is being studied for a range of solid tumors, were $1.13 billion last year.

Shares of Genentech (down $2.64 to $85.10, Charts) fell 3 percent in midday trading on the New York Stock Exchange.