Onyx Pharmaceuticals Inc. has secured a commitment for up to $150 million in common stock financing from Azimuth Opportunity Ltd., the company announced Friday.

Under the two-year agreement, Emeryville, California based Onyx (NASDAQ ONXX) may sell registered shares of common stock to Azimuth Opportunity at a small discount to market price. The timing and amount will be solely decided, subject to certain conditions, by Onyx.

Onyx plans to use the proceeds to fund further development and commercialization of its Nexavar tablets, and for other purposes.

Onyx is a biopharmaceutical company focused on therapies targeting molecular mechanisms that cause cancer.

Biotechnology company Amgen Inc. said Friday it will buy privately held Avidia for $290 million in cash and additional milestone payments.

Avidia, a biopharmaceutical company, is developing a class of therapeutics called Avimer proteins. Specifically, the deal gives Amgen a lead product candidate for the treatment of inflammation and autoimmune diseases, currently in early-stage clinical trials.

Both companies' boards have approved the deal, which includes up to an additional $90 million in milestone payments. Amgen Ventures, the company's investment division, already owns a 4 percent stake in Avidia.

"The Avimer technology is among the most attractive protein-based technologies currently under development," said Dr. Roger M. Perlmutter, Amgen's executive vice president for research and development, in a statement. "Avimers may have several advantages as therapeutic products in terms of biological activity, tissue distribution, reduced immunogenicity and improved manufacturing efficiencies."

The deal is expected to close during the fourth quarter, at which point Mountain View, Calif.-based Avidia will become a wholly owned subsidiary of Amgen.

News of the acquisition comes at the end of a busy week for Amgen. It moved into the week after receiving a non-exclusive licensing agreement for a key patent to rival ImClone Systems Inc.'s Erbitux cancer drug. That was followed by Food and Drug Administration approval of its colon cancer drug Vectibix, which competes with Erbitux.

Shares of Amgen fell 2 cents to $71.53 on the Nasdaq in Friday's trading.

Corcept Therapeutics Shares Hit All-Time Low After 2nd Corlux Clinical Trial Fails

Shares of Corcept Therapeutics Inc. took another hit Friday and sunk to an all-time low after the drug developer said the second of three clinical trials for its Corlux depression drug had failed.

Corcept shares dropped 54 cents, or 41.2 percent, to 77 cents in midday trading on the Nasdaq at more than double their average volume. The stock, which went public at $12 in April 2004, hit a new all-time low of 75 cents earlier in the session.

On Aug. 25, the stock shed 56 percent of its value in one day, trading at hundreds of times its average volume, to close at $1.54 on the Nasdaq after the company announced that the first of three Corlux trials had failed.

In the second study, researchers found no significant difference between Psychotic Major Depression patients who were given Corlux or a placebo and then assessed using a psychiatric rating scale.

As in the first study, the company noted there was an unusually high placebo response rate in the second study. After 56 days, about 95 percent of those taking Corlux or a placebo had responded by improving their scores on the rating scale by 50 percent, the study's primary endpoint.

The company said it has about $17.5 million in cash and securities, enough to complete the third clinical trial. Results of the third study are expected early next year.

Labopharm Inc.'s chief executive said on Friday he was "pretty confident" the company's once-daily version of the pain-killer tramadol would receive U.S. approval despite a letter from the U.S. Food and Drug Administration that said some issues still must be resolved.

"We're pretty confident. You're not done until you're done," James Howard-Tripp, Labopharm president and CEO, told Reuters.

"We have got it approved in other jurisdictions. We believe it's a good product. We believe in our data package, so we would be pretty optimistic."

Labopharm shares dropped almost 25 percent on Friday after the company said it had received an approvable letter from the U.S. Food and Drug Administration for its version of the tramadol pain killer, but that the FDA said there are some unresolved issues.

The shares were down C$1.69, or 20.8 percent, at C$6.42 on the Toronto Stock Exchange, after dropping as low as C$6.09 earlier in the day. On Nasdaq, the shares were off $1.56, or 21.3 percent, at $5.75 after earlier falling as low as $5.42.

Howard-Tripp said the company plans to discuss the letter with the FDA "fairly rapidly" and believes it can address the issues raised without the need for additional data.

Howard-Tripp refused to say what issues were flagged.

"We are not trying to be deliberately obscure. We need to fully understand quite what it is they want, and until we fully understand, we obviously can't tell the marketplace what it is," he said.

"If we can't understand it, it doesn't make sense to try to put information out."

Analysts said the news was a setback for the company and raised doubts that it would meet its earlier targeted approval date.

"I think this is more of a setback in timing, but the problem is, we don't know for how long," said Laurence Terrisse-Rulleau, a biotechnology analyst at Blackmont Capital in Montreal.

"I'm still confident in the product. I'm still confident that they will get approved, I just don't know when."

Terrisse-Rulleau said it is unlikely that the company will meet the approval target of first quarter 2007. She said it will now "most likely" be in the third quarter of 2007.

"The problem is it depends if the FDA is going to take 50 days or six months," she said. "And it is going to take weeks before we find out."

Labopharm's new drug application for tramadol was submitted to the FDA in November 2005.

Once-daily tramadol, Labopharm's key product, has received regulatory approval in 22 European countries and commercial launch of the product across Europe is under way.

Eli Lilly and Co. (NYSE LLY) said on Friday that U.S. regulators will require a new three-year clinical trial for its investigational diabetic eye treatment, leading the company to weigh the feasibility of continuing development.

The drug maker said such a study of the treatment, called ruboxistaurin mesylate, would take up to five years to compete. The drug treats a common effect of diabetes in which leaky blood vessels in the eye can lead to blindness.

"It is disappointing, because it was going to be a novel drug for a new indication," said Heather Brilliant, who covers the sector at ratings company Morningstar Inc., and had predicted sales could reach $1 billion by 2015.

Other analysts predicted a market for the drug, which had the proposed trade name Arxxant, as half that size.

Lilly's decision about whether to go forward with the drug, which it has been studying in humans for a decade, would be based on its own market projections, Brilliant said.

The U.S. Food and Drug Administration asked the company for additional effectiveness data before it will consider approving the molecule for the treatment of moderate to severe diabetic retinopathy, Lilly said.

The company only submitted one major trial in its application to the FDA, which is unusual and made its approval riskier than is typical, analysts said.

Last month, Lilly said it received a so-called "approvable letter" from the FDA, rather than approval of the drug outright.

"We still believe that ruboxistaurin has potential as a treatment for diabetic eye disease and are exploring the feasibility of further development of this molecule," Dr. John Lechleiter, Lilly president and chief operating officer, said in a statement.

Lilly said ongoing clinical trials for ruboxistaurin will continue while Lilly evaluates options for its further development.

Lilly shares fell 48 cents, or 0.8 percent to $56.84 on the New York Stock Exchange in midmorning trading.

Shares of biopharmaceutical company Imclone Systems Inc. edged higher Thursday, despite news from rival Amgen Inc. that its competing colon cancer treatment received approval.

Imclone's stock added 25 cents to $29 in midday trading on the Nasdaq, after being up as much as 3.8 percent earlier in the session. The stock is still near its 52-week low of $27.40 set Aug. 11 after the company decided to remain independent. It had considered selling the company. Shares have traded as high as $43.08 over the last 52 weeks.

Perform Background Checks On Corporate Executives


On Wednesday, Thousand Oaks, Calif.-based Amgen received Food and Drug Administration approval for its colon cancer drug Vectibix. The approval means the drug can be used to treat patients who failed other forms of treatment or who are also receiving chemotherapy treatment.

Vectibix goes up against Imclone's Erbitux and Amgen said it expects to price the drug at a 20 percent discount to Erbitux.

Shares of Amgen held mostly steady in midday trading, falling 48 cents to $71.66 on the Nasdaq.

A key patent for Erbitux, which is Imclone's only commercial drug, was recently given to Yeda Research & Development Co. after a long-standing dispute between Imclone and three scientists from the Israeli-based research arm of the Weizmann Institute of Science. Yeda immediately gave non-exclusive licensing rights for the patent, which deals with the process used to deliver Erbitux, to Amgen.

Imclone has said it plans to appeal the decision.

Analysts for both Amgen and Imclone are considering varying scenarios for the drug rivalry, with most saying pricing and other factors will put Vectibix ahead.

Baird U.S. Equity Research analyst Christopher J. Raymond reaffirmed his "Outperform" rating with a $90 price target for Amgen, saying Vectibix will beat Erbitux in the market because of lower pricing, its once every other week dosing schedule and fewer side effects.

"We view the pricing strategy of marketing Vectibix at a 20 percent discount to Erbitux as a good way to position Vectibix in both terms of undercutting Erbitux's position and in public relations," he wrote in a note to investors.

Raymond also cited the company's patient program to cap out of pocket expenses at 5 percent of gross income as another strong competitive factor.

HSBC Global Research analyst Gene Mack also cited the program in a note to investors, reaffirming a "Overweight" rating with a $92 price target.

"We expect this program to be an incentive for clinicians and patients who choose Vectibix over Erbitux," he wrote.

Erbitux could still give Vectibix a tough time in the market, as it already has an established position, said Rodman & Renshaw analyst Michael G. King Jr., in a note to investors.

"Since Verbitux is a late market entrant, has a comparable label (depending on which market parameter one looks at), it will likely not usurp Erbitux in colorectal cancer over the remainder of the year," King wrote.

Still several other analysts, in notes on Imclone, said Vectibix will likely become the treatment of choice in its area because of various factors, including pricing and dosing.

Drug developers Biogen Idec Inc. and Elan Corp. said Thursday data from a late-stage study of Tysabri showed it was effective in reducing cognitive degeneration in multiple sclerosis patients.

The drug was recalled three months after approval in November 2004 because of links to a fatal brain disease called progressive multifocal leukoencephalopathy. Patients died in two of three cases found.

Biogen,a biotech company headquartered in Cambridge, Mass. (Nasdaq: BIIB) and Dublin-based Elan (NYSE: ELN) worked with regulators on a program called Touch Prescribing. Patients are now prescribed the medication as part of that program and patients are monitored for the brain inflammation.

Conduct Reverse Lookups On Cell Phones, Emails, and IP #s


In the latest study, which was presented to a European commission and included 942 patients worldwide, treatment with Tysabri reduced the risk of sustained cognitive worsening by 43 percent when compared to a placebo.

The drug has previously shown a 68 percent reduction in the relapse rate of patients and a 42 percent reduction in the relative risk of disability progression.

Areas affected by cognitive dysfunction include memory, ability to process information and learning. The drug reduced the risk of cognitive dysfunction by 43 percent, the study showed.

Elan shares closed down .39% to 15.48 in trading on the Nasdaq.

Threshold Pharmaceuticals Shares Rise As Pancreatic Cancer Gets Orphan Drug Status From FDA

Biotech drugmaker Threshold Pharmaceuticals Inc. said Thursday the Food and Drug Administration granted orphan drug status to its treatment for pancreatic cancer.

In August, the company said it was focusing on a late-stage clinical trial of glufosfamide for the second-line treatment of pancreatic cancer and a mid-stage clinical trial, in combination with another drug, for an initial treatment.

Orphan drug status is given to drugs meant to treat conditions affecting fewer than 200,000 patients in the United States.

The announcement caused shares to jump. Shares of Threshold rose 35 cents, or 14 percent, to $2.85 in early morning trading on the Nasdaq.

The company's shares hit a 52-week high of $16.98 in April but plummeted in May when the FDA found a safety risk with the company's treatment for enlarged prostate. They dropped again in July when the company discontinued development of the drug.

The orphan status allows a company seven years of market exclusivity for the particular use if approved, along with tax breaks, development funding, and other incentives.

Discovery Labs Files Corrective Plan for Manufacturing Issues to Gain Looming FDA Approval

Biotech drugmaker Discovery Laboratories Inc. said Thursday that it formally filed a briefing with the Food and Drug Administration addressing concerns that are holding up the approval of the company's lung treatment.

The announcement caused shares to jump before the opening bell. Discovery shares climbed 69 cents, or 35.2 percent, to $2.65 in premarket activity on the INET electronic exchange, after closing at $1.96 Wednesday on the Nasdaq.

The company also requested a meeting with the FDA to determine the appropriate path to approval for Surfaxin, a synthetic substance that reduces surface tension that allows lung tissue to absorb oxygen. The agency has already indicated the drug is approvable for premature infants who are born with little or none of the natural substance that Surfaxin mimics in their lungs. The FDA should notify the company within 14 days of a date for the scheduled meeting, which should occur within the next 75 days.

In April, the FDA once again delayed a decision on Surfaxin, saying the company needed to address issues on how long the treatment can be stored before it degrades. Similar issues caused Discovery Labs to withdraw its marketing application for the treatment in Europe in June.

The filing with the FDA covers how Discovery plans to correct chemistry, manufacturing and control matters addressed in the April letter. The company also said it is on track to make new batches of Surfaxin showing that manufacturing is up to code by the fourth quarter.

Sinovac Biotech announces first sales of its seasonal influenza vaccine, Anflu Sinovac Biotech announced that the third product of the co, seasonal influenza vaccine, is successfully released for sale by National Institute for the Control of Pharmaceutical and Biological Products. On the same day, the first bunch of purchase orders is signed with several customers. These purchase orders represent a major step for the co as its third vaccine product begins sales in China. And it is expected to be another major source to generate sales revenue for the Company.

BioCryst Pharmaceuticals Shares Jump on Forecast for Positive Peramivir Study Results

Shares of drug developer BioCryst Pharmaceuticals Inc. jumped Wednesday after the company said it will present positive study data on its influenza treatment at a weekend conference.

The stock gained 90 cents, or 7.1 percent, to reach $12.16 in morning trading on the Nasdaq. Shares have traded between $8.20 and $23 over the last 52 weeks.

The treatment candidate, called peramivir, is in preclinical trials. The company said research at the University of Texas funded by the National Institute of Allergy and Infectious Diseases showed the drug's effectiveness on avian flu in mice and ferrets. The data will be presented Saturday at the 46th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy in San Francisco.

The announcement prompted to Caris & Co. analyst Douglas Chow to reaffirm his "Above Average" rating on the company. In a note to investors, he said he expects the data to be similar to a successful dose-response study in mice conducted in 2001.

The company said this is the first data to describe the activity of peramivir in an established animal model using the highly pathogenic H5N1 strain of avian flu.

Also, independent research by the Ordway Research Institute will be presented at the conference indicating that peramivir is more potent versus several other treatments in seasonal influenza, strain H3N2.

More than 200,000 people are hospitalized each year in the United States because of flu complications, according to the Centers for Disease Control and Prevention. About 36,000 people die each year from the flu. According to the World Health Organization, 247 people worldwide have contracted the H5N1 avian flu and 144 have died.

Germany's Altana said it sold its stake in biopharmaceutical firm GPC Biotech to Goldman Sachs, two days after success in tests of GPC's main drug hope sent the stock up 40 percent.

Altana said on Wednesday it had sold the 7.1 percent GPC stake to investment bank Goldman Sachs . Investment banks typically buy shares in companies and place them with institutional investors at a later date.

An Altana spokesman said the selling price "did not differ strongly" from the current market value of the 2.36 million shares, which Altana said was around 36.3 million euros ($46.06 million).

Altana decided last week to sell its drugs unit to Danish group Nycomed for 4.5 billion euros ($5.71 billion). Proceeds from the sale are expected to be distributed to Altana shareholders in the coming year.

In future it will focus on its chemicals business, which it has said it wants to grow through both organic means and acquisitions.

GPC Biotech, which is listed on the German technology index <.TECDAX>, said on Monday that it expected to submit satraplatin for U.S. approval as a treatment for prostate cancer after tests proved successful.

GPC has said satraplatin could provide the company with peak sales of more than $500 million.

Shares in Altana were 0.8 percent lower at 44.23 euros by 1425 GMT, while GPC shares were 1.3 percent down at 15.20 euros.

Peregrine Announces Issuance of Broad Patent Covering Vascular Targeting Agents in Combination Therapy Regimens

- Extends Proprietary Protection for Peregrine's VTA Approach That Has Demonstrated Encouraging Anti-Cancer Potential in Preclinical Studies -
- Expands Peregrine's Technology Base and Opportunities for Technology Out-Licensing -

Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a biopharmaceutical company with a portfolio of innovative, clinical stage products for the treatment of cancer and hepatitis C virus infection, today announced the issuance of a U.S. patent covering broad therapeutic uses of its Vascular Targeting Agent (VTA) technology platform in combination with standard treatments. Peregrine has in-licensed worldwide exclusive rights to the VTA technology, which includes the new patent, from UT Southwestern Medical Center. Peregrine is currently collaborating with UT Southwestern researchers to evaluate VTA constructs in preclinical studies for solid tumor therapy. In addition to its own research efforts, Peregrine can sub-license rights under the VTA technology platform on an exclusive or non-exclusive basis, and it has already licensed rights for use of VTA technology to a number of other companies.

"It is noteworthy that this key patent has issued soon after our collaborators reported additional encouraging animal data on the anti-cancer potential of our VTA approach," said Steven W. King, president and CEO of Peregrine. "This broad new patent further extends our U.S. intellectual property rights to cover VTA agents used in combination with standard cancer therapeutics -- both those VTA agents in preclinical development at Peregrine and similar approaches being developed by others. Extensive preclinical studies show that these agents are most effective in destroying tumors when used in combination regimens, so in effect these new claims mirror how we expect physicians to use these drugs in actual clinical practice. By covering these broad concepts of VTA therapy as well as the VTA agents themselves, this new patent provides additional impetus to our efforts to advance our VTA drug development and licensing programs."

Peregrine's VTA technology platform includes over 200 patents and patent applications covering broad concepts of tumor therapy using agents that target tumor blood vessels. The newly issued patent covers the therapeutic use of all regimens that combine agents specifically targeting tumor blood vessels with other anti-cancer agents, such as chemotherapy drugs.

"We believe that the breadth of this patent's allowed claims make it relevant to many of the researchers pursuing targeted combination therapy approaches based on destroying the essential blood supply of tumors," said F. David King, vice president of business development for Peregrine. "Sub-licenses to our VTA intellectual property will provide them with freedom to operate in this area, and this new patent should therefore be a valuable addition to our business development initiatives."

The patent, "Combined Methods and Compositions for Tumor Vasculature Targeting and Tumor Treatment," U.S. Patent No. 7,112,317, was invented by Philip E. Thorpe, professor of pharmacology at UT Southwestern Medical Center, and Francis J. Burrows, and issued today, September 26, 2006.

About Peregrine Pharmaceuticals

Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative product candidates in clinical trials for the treatment of cancer and hepatitis C virus (HCV) infection. The company is pursuing three separate clinical trials in cancer and HCV infection with its lead product candidates bavituximab and Cotara®. Peregrine also has in-house manufacturing capabilities through its wholly owned subsidiary Avid Bioservices, Inc.

Biopharmaceutical company CytRx Corp. said a mid-stage study of its Lou Gehrig's disease treatment candidate showed the drug was well tolerated, and it plans to continue development.

However, shares of the company tumbled because the drug had no statistical significance on disease progression.

The goal of the Phase IIa clinical trial was to study the safety of arimoclomol in treating the disease, also called amyotrophic lateral sclerosis. The 10-center, double-blind and placebo-controlled study dealt with three dose levels given three times daily for 12 weeks and involved 84 patients. But the study showed there was no statistical significance in treating the disease.

The company said it expected that result, based on the study design's scale and scope, which was focused on safety and tolerability, not efficacy.

Shares of CytRX fell 48 cents, or 26.2 percent, to close at $1.35 as trading volume surged to nearly seven times its three-month average. The stock has traded between 85 cents and $2.30 over the last 52 weeks.

No statistically significant increases in adverse events were reported as compared with placebo. CytRx said it will continue on with a Phase IIb clinical trial, which will focus on the drug's effectiveness in treating the disease. It hopes to start that study in the first half of 2007.

"The results of the Phase IIa trial are encouraging for the future development of arimoclomol in that even the highest dose was shown to be safe and well tolerated in a patient population that has virtually no treatment options," said Jack Barber, senior vice president of drug development, in a statement.

Secondary endpoints, or measurements, of the study, also showed the drug was well absorbed by the body, specifically, by passing the blood-brain barrier. Preliminary analyses shows the drug entered the cerebral spinal fluid effectively, marking the breaking of an important barrier for drugs intended to treat neurodegenerative diseases.

The Phase IIb clinical trial, which is still in a planning stage, will likely involve about 390 patients at between 30 and 35 clinical sites.

Shares of AnorMED Inc. surged Tuesday after the biotechnology firm said it will be bought by Millennium Pharmaceuticals Inc. for $515 million.

Shares of AnorMED added $2.70, or 27 percent, to close at $12.65 on the Nasdaq after hitting a new 52-week high of $12.98 earlier in the session. The stock traded between $3.35 to $10.50 previously and has more than doubled since the beginning of the year.

AnorMED said it agreed to be bought out by Millennium for $12 per share, which is 40 percent higher than a Sept. 1 takeover bid of $8.55 per share from Genzyme Corp., which AnorMED advised investors to reject.

AnorMED, a Canadian company, has the right to withdraw, modify or change its support of the offer if it receives a superior bid. But AnorMED could owe Cambridge, Mass.-based Millennium a termination fee of $19.5 million for calling off the deal under certain circumstances.

Shares of Millennium closed unchanged at $10.15 on the Nasdaq.

Millennium, which is also a biopharmaceutical company, said the tender offer will begin within 10 days and be open for at least 35 days.

If the deal is completed, Millennium said it will market AnorMED's Mozobil cancer drug, if approved by the Food and Drug Administration. The drug is in late-stage clinical development and is expected to be launched in 2008. Mozobil helps collect bone marrow stem cells for transplantation in patients with non-Hodgkin's lymphoma and multiple myeloma.

"This proposed acquisition is aligned with our goal to bring in products that accelerate revenue growth, leverage our oncology sales infrastructure and benefit from our development, regulatory and commercial expertise," said Millennium Chief Executive and President Deborah Dunsire.

Goldman Sachs & Co acted as financial adviser to AnorMED, while JP Morgan Securities Inc. and Morgan Stanley acted as Millennium's financial adviser.

Bank of America analyst David Witzke in a client note said he is skeptical of how big a market Mozobil could serve, given that there is already a successful treatment available, called Neupogen, made by biotechnology giant Amgen Inc.

"As a result, we see Mozobil as a niche product used in the salvage setting and are skeptical that it can become an important growth driver for MLNM," he wrote.

He also said Amgen Inc. considered AnorMED as a possible acquisition target, but passed. AnorMED officials could not be reached for comment.

EpiCept Corporation shares up 28%

EPCT says that Myriad Genetics Inc has reported positive clinical results for Azixa, a compound discovered by EpiCept and licensed to Myriad. Based on the results, Myriad intends to initiate Phase II clinical trials, triggering a milestone payment to EpiCept.

Alnylam Pharmaceuticals Inc. said Tuesday it licensed two genes to Quark Biotech Inc., which turned around and licensed one to drugmaker Pfizer Inc. to develop a treatment for wet age-related macular degeneration.

Alnylam licensed the genes p53 and RTP801 to Quark for an undisclosed amount. The agreement includes upfront, annual, and milestone payments, along with royalties on any product that makes it to market. The licenses cover RNAi, or RNA interference therapeutics, or drugs that use a naturally occurring mechanism in cells for selectively silencing and regulating specific genes.

Quark said it granted an exclusive worldwide license to Pfizer to develop the RTP-801 gene as a treatment for wet age-related macular degeneration. Financial details were not disclosed.

Wet AMD is a condition where abnormal blood vessels grow over the retina and leak, causing scar tissue and destroying a person's central field of vision. The Federal Trade Commission still needs to approve the deal.

Pfizer already has a partnership with OSI Pharmaceuticals Inc. for the FDA-approved wet AMD treatment Macugen. Pfizer spokesman Paul Fitzhenry said that the RTP801 gene is still in very early preclinical development and that the company could not comment on what a resulting drug's possible profile might be.

A competing drug to Macugen, Genentech Inc.'s Lucentis, received FDA-approval in June.

The p53 gene is likely to be developed for the treatment of kidney disease.

Alnylam shares added 45 cents, or 3.3 percent, to $14.09, while OSI shares rose 9 cents to $37.21 in morning trading on the Nasdaq. Shares of Pfizer were down 1 cent to $28.34 on the New York Stock Exchange.

The chairman of CV Therapeutics Inc., which develops drugs to treat chronic cardiovascular diseases, plans to sell 50,000 shares of the company under a new trading plan filed with the Securities and Exchange Commission.

Louis G. Lange, chairman and chief executive of the Palo Alto, Calif.-based company, has entered into a written trading plan with E-Trade Securities LLC that authorizes the sale of up to 50,000 shares, according to the SEC filing dated Sept. 18 but made public Monday.

Lange's new plan will begin as early as Nov. 1, and end on March 31, 2007.

"The shares subject to the trading plan do not represent all of Dr. Lange's holdings in CV Therapeutics' securities," according to the SEC filing. "During the term of the trading plan, Dr. Lange may from time-to-time buy or sell CV Therapeutics' securities outside of the plan."

According to a separate filing with the SEC, Lange held about 134,300 shares directly and about 1.8 million shares in his 401(k), along with another 10,000 held by family members or in a trust, as of Aug. 25.

Shares of CV Therapeutics gained 4 cents to $10.18 in afternoon trading on the Nasdaq.

Genentech Inc. has added warnings about a rare brain condition called reversible posterior leukoencephalopathy syndrome, or RPLS, in patients using its cancer drug Avastin, the U.S. Food and Drug Administration said on Monday.

The drug's label also now includes information about reports of patients who developed holes inside the nose called septum perforations, the FDA said on its Web site.

San Francisco, California-based Genentech said in March it was working to include the information on the prescribing label while it reviewed data about the frequency of the brain condition.

According to the March issue of the New England Journal of Medicine, two women developed RPLS while taking the blockbuster drug. Both later recovered from the condition, which can cause blindness and other complications.

In a letter sent to doctors this month, Genentech said it received reports of confirmed and possible RPLS in Avastin patients participating in clinical studies at a rate of less than 0.1 percent.


Representatives for the drugmaker could not be immediately reached for comment.

Genentech shares were off 4 cents at $78.43 in late afternoon trading on the New York Stock Exchange.

Swiss drug maker Roche Holding AG is the majority owner of Genentech and markets Avastin outside the United States.

Pharmion, GPC Biotech Shares Soar

Pharmion, GPC Biotech and Spectrum Shares Gain on Positive Late-Stage Satraplatin Study

Shares of several partnered biotechnology companies surged Monday after a prospective prostate cancer treatment lowered progression rates in a late-stage study.

Pharmion Corp. gained $3.92, or 21.8 percent, to reach $21.93 in afternoon trading on the Nasdaq, as trading volume rose more than sixfold from its average. Shares have traded between $14.76 and $23.34 over the last 52 weeks.

Meanwhile, American depositary shares of Germany-based GPC Biotech AG jumped $4.46, or 31.8 percent, to $18.46 on the Nasdaq, as trading volume surged to more than elevenfold. Early in the day, the stock climbed to a new 52-week high of $19.45, replacing the previous high of $18.59 set on Feb. 27.

The study showed that prostate cancer patients receiving satraplatin with prednisone had a 40 percent lower risk of disease progression, compared with those given placebo with prednisone. Boulder, Colo.-based Pharmion said it plans on filing a marketing application for the drug in Europe during the first half of 2007 while GPC Biotech plans to file with the Food and Drug Administration by the end of the year.

The news prompted Lazard Capital Markets analyst Matthew S. Osborne to upgrade Pharmion's stock to "Buy" from "Hold" with a $28 price target.

"We expect satraplatin to contribute meaningfully to Pharmion revenues," he said in a note to investors.

The assessment, which factors in competition, said the modest penetration of the European market could generate sales of $112 million by 2011 for the drug's current indication as a second-line treatment. Possible expansion to other uses leaves room for potential upside.

As part of the collaboration, Pharmion will pay GPC Biotech 26 percent to 30 percent royalties on sales of the drug below $500 million.

Osborne also reaffirmed his "Buy" position with a $10 price target on Spectrum Pharmaceuticals. The Irvine, Calif.-based company said it could see up to $20 million in milestone payments stemming from U.S. and European approval. It is partnered with GPC Biotech.

The stock rose $1.32, or 37.8 percent, to $4.81, as trading volume soared more than 32 times its average. Shares have traded between $3.36 and $5.69 over the last 52 weeks.

Acorda Shares Triple on MS Drug Data

Acorda Therapeutics Shares Triple As Multiple Sclerosis Drug Succeeds in FDA Recommended Study

Shares of Acorda Therapeutics Inc. more than tripled Monday, hitting a new 52-week high, after the biotech drug developer announced the success of a late-stage clinical trial to test its treatment to improve the walking ability of multiple sclerosis patients.

Acorda shares rose $5.25 to $7.47 in midday trading on the Nasdaq. Earlier in the session, shares went as high as $7.75. They hit an all-time low of $2.20 on Thursday after sliding from a previous high of $7.48 on their first day of trading on Feb. 10.

The company released results from its Phase III study of Fampridine-SR showing that nearly 35 percent of patients taking the drug improved their walking speed compared with just over 8 percent of patients taking a placebo. Of those patients who responded, those given Fampridine rated significantly better on a walking scale than those given a placebo. Improvements lasted over the 14-week treatment period.

The three criteria were those outlined by the Food and Drug Administration's Special Protocol Assessment, a study design that is most likely to yield the best results. The company said it plans to meet with the agency soon to discuss how to advance the drug closer to a possible approval.

The results represent one of the two positive trials the company will need for FDA approval. The drug has Orphan Drug status from the agency for improving walking in multiple sclerosis patients, meaning the company will have seven years of marketing exclusivity for that use should it be approved.

Multiple sclerosis is an incurable disease which causes the body's immune system to destroy the insulation of nerve fibers. The company said lab studies have shown that Fampridine can improve communication between damaged nerves.

In a research note, Rodman & Renshaw analyst Elemer Piros maintained his "Outperform" rating on the company with a target price of $14.

Germany's Schwarz Pharma is in talks to be taken over by Belgian drugmaker UCB , Schwarz Pharma said late on Sunday.

"Schwarz Pharma AG is in negotiations with UCB S.A., Brussels concerning a business combination of both companies by an offer to all shareholders of Schwarz Pharma AG," it said in a statement.

"A finalisation of these talks is expected in near-term."

A source familiar with the situation told Reuters late on Friday that the Schwarz-Schuette family that owns Schwarz Pharma had started a process to sell their approximate 60-percent stake in the company.

The source said that talks had been started some weeks ago. A second source said a decision on a possible sale was nearing.

The Schwarz-Schuette family expect a price of around 4 billion euros ($5.1 billion), the first source said.

Gilead Sciences Inc on Friday said it struck a deal with eight India-based generic drug companies, for them make cheaper copies of Gilead's AIDS drug Viread to be sold in low-income countries.

The Foster City, California-based company said it signed the non-exclusive license deals with Alkem Laboratories Ltd., Aurobindo Pharma Ltd, FDC Ltd., J.B. Chemicals & Pharmaceuticals Ltd., Matrix Laboratories Ltd., Medchem International, Ranbaxy Laboratories Ltd.and Shasun Chemicals & Drugs Ltd.

The deal lets the companies produce and distribute Viread to 95 developing countries, Gilead said.

The move follows a similar agreement with three companies announced in August.

The one year chart of the AMEX Biotech HOLDRs (BBH) shows period of consolidation starting in May. The index may be poised to breakout as it crosses the 50 day moving average.

Shares of Epix Pharmaceuticals (EPIX) were among health care stocks' losers Friday, plummeting 15.6% on disappointing study results of its experimental anxiety drug.

Epix Pharmaceuticals Inc. said on Thursday that early results from a pivotal-stage trial of its experimental treatment for general anxiety disorder show it does not work better than a placebo.

"Based on these top-line results, we plan to refocus our efforts away from anxiety to evaluate the benefit in depression more closely and assess opportunities for initiating a Phase 2 clinical trial in depression sooner than originally planned," Chief Executive Michael Kauffman said in a statement.

The company said the anxiety trial showed a trend in favor of patients treated with PRX-00023, but the outcome may have been affected by a higher than expected response in the placebo-treated patients.

Epix also said a preliminary review indicated that the treatment was well tolerated and that side effects, including impact on sexual function and sleep, in patients receiving PRX-00023 were similar to placebo.

Medical research and services company Charles River Laboratories International Inc. said Friday it received a $111.6 million grant from the National Cancer Institute.

The 10-year contract doubles the size of the company's current contract with NCI. Charles River will use a portion of the funds to build a shared-use research and services facility. The facility is expected to be completed by the third quarter of 2008.

The company will also assume management responsibilities for NCI's and the National Institutes of Health Tumor and Natural Products Repositories in support of the Development Therapeutics Program. The repositories store tumor samples used by researchers studying causes of cancer and searching for treatments.

Charles River, which focuses on developing research models for the drug discovery industry, saw revenue totaling $1.12 billion in 2005.

The portion of the facility used by NCI will be staffed by Charles River's consulting and staffing services group.

Shares of Charles River fell 42 cents to $41.22 on the New York Stock Exchange in morning trading.

Biotechnology company Medivation Inc. said Thursday a midstage study testing its Dimebon treatment for Alzheimer's showed the drug was significantly effective, sending shares soaring in morning trading.

Shares surged $2.25, or 37 percent, to $8.30 on the American Stock Exchange.

The Phase II clinical trial involved 183 patients with mild to moderate Alzheimer's disease at 11 sites in Russia. The drug met all five of its efficacy endpoints, which included different measurement scales for improvement in the disease, during the six-month, randomized and double-blind study.

Results also showed the drug was well tolerated with mild side effects.

"We believe that these results are important, in part because the primary and key secondary efficacy endpoints used in this trial are accepted by the Food and Drug Administration for registration of drugs to treat mild to moderate Alzheimer's disease," said Dr. David Hung, Medivation president and chief executive, in a statement.

The company has also started an extension study on the drug, which allows patients to continue treatment for up to a total of 12 months. Those results are expected in the second quarter of 2007.

Dimebon is also being studied for possible use in treating Huntington's disease.

Biotech company Incyte Corporation (INCY) announced the offering of about $132 million aggregate principal amount of 3-1/2 percent Convertible Senior Notes due 2011 in a private placement.

The drug maker will use net proceeds of the offering, estimated to be about $96 million, to redeem outstanding 5.5 percent Convertible Subordinated Notes due Feb. 1, 2007.

Remaining proceeds will be used for working capital and general corporate purposes.

The offering is expected to close on September 26.

INCY shares are down 55 cents (11.09%) to $4.41 in early afternoon trading on the Nasdaq.

Pfizer CEO sets goal to be No. 1 in biotech


Future growth for Pfizer Inc., the world's largest drugmaker, will come from its own laboratories and external deals as it aims to become the No. 1 biotech company, Chief Executive Jeffrey Kindler said on Wednesday.

In a wide-ranging keynote address at a Bank of America investment conference, Kindler also outlined an increasing trend toward working with insurance companies and governments to prove the value of drugs that are under development.

Kindler, previously Pfizer's top lawyer, was named CEO in July, replacing Hank McKinnell who had been criticized by investors for his irascible nature and large compensation package at a time when Pfizer struggled to grow and its stock price fell.

"We are in the process of creating a culture that embraces change," Kindler said.

At the sidelines of the conference, the Pfizer CEO told Reuters that the company's future growth will come from both its existing medicines and outside deals.

He declined to comment, however, on whether Pfizer is interested in acquiring Bristol-Myers Squibb , which earlier this month fired CEO Peter Dolan due, in part, to a botched deal to halt a generic form of Bristol's Plavix blood clot drug.

Kindler said Pfizer is already the No. 8 biotech company in the world, with new products like kidney cancer drug Sutent, and "aspires to become No. 1 in the not too distant future."

He said the combination of a longer-lived population increasingly focused on health will mean big opportunities for drugmakers as long as those who foot the bills are aware that the benefits of new drugs outweigh their cost.

To that end, Pfizer will work more with insurers and government payers before new drugs are developed to make sure they are on board with the treatments, Kindler said.

Biotechnology company Threshold Pharmaceuticals Inc. said Tuesday chief medical officer Dr. Alan Colowick will resign effective Oct. 13.

Colowick joined the company in January 2005. He will continue as a consultant for the company and as a member of Threshold's scientific advisory board.

Dr. Michael Brawer, who joined the company's management team earlier this year, will be interim chief medical officer.

"Alan has had a tremendous impact on the company, where he has overseen the recruitment of a world-class clinical team and the implementation of clinical trial practices capable of supporting multiple, simultaneous clinical trials worldwide," said Barry Selick, chief executive. "He has been a great colleague to all of us at Threshold and we wish him much success as he pursues new business interests."

Shares of Threshold fell 8 cents, or 3 percent, to close at $2.59 on the Nasdaq.

Vaccine developer Avant Immunotherapeutics Inc. said Wednesday that GlaxoSmithKline PLC has paid royalties on its sales of Rotarix rotavirus vaccine in Australia and certain European countries at the lower of two rates established under the companies' 1997 license agreement.

Avant said Glaxo decided to pay the lower royalty rate _ which is 70 percent of the full rate _ because it claims Rotarix is not covered by the patents it licensed from Avant in Australia and these certain European countries.

Avant said it is evaluating various options to counter Glaxo's claims.

"Although we have sold the bulk of Avant's royalties from sales of Rotarix to Paul Royalty Fund II, and only retain a residual interest, we are of course disappointed in this news. We are determined to take all available steps to enforce our rights under our license agreement with GSK, both regarding the recent sales in Australia and Europe and future sales in the other countries in which we hold patents," said Una S. Ryan, Avant president and CEO.

In May 2005, Avant sold a stake in the royalties to Paul Royalty Fund II for up to $61 million, and to date, has received $50 million. Avant said it doesn't believe the $50 million already paid and the potential $11 million in additional milestone payments are affected by Glaxo's action.

However, Avant said that if it's unable to reverse Glaxo's decision to pay the lower rate, the value of Avant's residual interest in Rotarix royalties will be impacted.

Avant shares fell 12 cents, or 8.5 percent, to $1.30 in morning trading on the Nasdaq. Over the past year, shares have traded between $1.23 and $2.82.

Biopharmaceutical research and development company CytRx Corporation (Nasdaq:CYTR) today announced that initial findings from data analysis of the Company's Phase IIa clinical trial with arimoclomol for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) will be presented by President and CEO Steven A. Kriegsman and Senior Vice President of Drug Development, Jack Barber, Ph.D., at the UBS Global Life Sciences Conference. The Company's presentation is scheduled for Tuesday, September 26, 2006 at 9:30 a.m. Eastern time (6:30 a.m. Pacific time) at the Grand Hyatt New York Hotel in New York City.

CYTR is up 13.97% to $1.55 in early afternoon trading on the Nasdaq.

Genta Inc says to sell 20 mln shares

Biotech company Genta Inc. on Tuesday said it has agreed with institutional investors to sell 20 million shares of common stock through a registered offering for proceeds totaling about $16 million. The sale is expected to close on or about Sept. 22, the drug maker said in a statement.

France's Exonhit Therapeutics and U.S. drugmaker Allergan (AGN) have renewed their partnership and extended it to developing treatments that target neurological diseases like Alzheimer's and Parkinson's.

The French biotechnology company did not disclose financial terms of the three-year agreement but said on Tuesday it would receive annual research and development payments as well as payments for milestones it reaches in its development.

Allergan, maker of Botox anti-wrinkle treatment, and Exonhit already worked together on developing drugs that combat pain and eye diseases and amyothropic lateral sclerosis, which affects nerve cells in the brain and spinal cord.

It is the second time the two companies have renewed their partnership in those areas, Exonhit said in a statement.

An influential lawmaker promised generic drug makers Tuesday that he'll make a top priority in 2007 their longstanding goal of marketing generic versions of biotech drugs, which are some of the most advanced and expensive medicines on the market.

At a conference of the Generic Pharmaceutical Association, Congressman Henry Waxman (D.-Calif.) said he would introduce a bill before year's end that would prod the Food and Drug Administration in its efforts to create guidelines for generic versions of biotech drugs. That could lower what consumers and government agencies that administer Medicaid pay for biotech drugs, such as insulin and human growth hormone.

The Food and Drug Administration approves generic versions of conventional drugs once the original products' patents have expired. The biotech industry, led by giants such as Amgen Inc. and Genentech Inc. produce drugs made from proteins taken from living cells.

Federal health officials say the scientific complexity of biotech products makes it difficult to design a process to ensure the safety of generic versions.

"There remain important scientific questions that need to be worked out, so it is premature to discuss a political framework," said Scott Gottlieb, FDA Deputy Commissioner. "It is not known, for example, how you show that two similar proteins can be safely substituted for one another and used interchangeably without incurring potentially dangerous immune reactions."

Generic drug companies point out that the European Union already has a regulatory process for generic biotechs. The FDA has been working on guidelines for approving generic biotech drugs since at least 2000 but has yet to release any details. A bill from Waxman, ranking member of the House Government Reform Committee, would likely push the FDA toward releasing the guidance.

Earlier on Tuesday, Barr Pharmaceuticals Inc. CEO Bruce Downey, chairman of the GPA, suggested drug makers should ask elected officials at the state level to join the effort to get generic biotechs.

Last month, four state governors petitioned the FDA to release guidelines on the production of generic insulin and human growth hormone, two of the most commonly prescribed biotech drugs.

Generic drug makers say $11.5 billion worth of biotech drug patents expire by the end of 2006. The potential for such a huge market comes as the global market for conventional pharmaceuticals is slowing.

According to UBS, which looked at a handful of generic drug companies representative of the industry, gross margins fell to 47 percent in the second year compared to 52.2 percent a year ago. At the same time, the market for pharmaceuticals in the United States and major European countries increased by only about 5 percent in the last year, according to separate statistics from IMS Health.

Shares of Barr Pharmaceuticals rose 2 cents to close at $53.74 Tuesday on the New York Stock Exchange. Shares of Amgen fell 31 cents to $69.45 on the Nasdaq while shares of Genentech rose 27 cents to end at $79.29 on the New York Stock Exchange.

Shares of Cell Therapeutics fell more than 15 percent on Tuesday in high volume trading following the biotechnology company's announcement of a secondary share offering at $1.73 per share.

On Monday, shares of Cell Therapeutics had risen almost 7 percent to close at $2.08, after hitting a high of $2.53 in intra-day trading, on news of a licensing deal worth up to $285 million with Swiss drug firm Novartis.

Tuesday's pricing of the 23.1 million share offering was at a 16.8 percent discount to Monday's closing stock price.

The licensing deal Cell Therapeutics announced on Monday was for the development and commercialisation of XYOTAX, an investigational medicine for the treatment of cell lung cancer and other cancers.

Shares of the company were trading down 32 cents at $1.76 in morning trade on the Nasdaq with more than 18 million shares changing hands.

Generex Biotechnology Corporation (NASDAQ GNBT) the leader in metabolic diseases drug delivery through the inner lining of the mouth, announced today that Cardinal Health will distribute its new Glucose RapidSpray™ product in the U.S.

Glucose RapidSpray is expected to be in stores by October, 2006.

Glucose RapidSpray is an innovative alternative for people who require or want additional glucose in their diet. Glucose RapidSpray delivers a fat-free, low-calorie glucose formulation that was developed using the Company's proprietary buccal drug delivery technologies. Glucose RapidSpray delivers glucose directly into the mouth where the proprietary formulation is rapidly absorbed into the blood stream. Glucose RapidSpray is simple to carry and use, with no large tablets to chew or messy gels to swallow.

"Using our patented technology -- RapidMist™ -- we've developed a product that will deliver glucose to anyone who needs a fast and efficient means for receiving glucose," said Anna Gluskin, President & Chief Executive Officer of Generex. "We expect that Glucose RapidSpray will appeal to people battling the symptoms of low blood sugar who now use other over-the-counter glucose products but want a faster-acting product. We expect to position Glucose RapidSpray as a companion product to Generex Oral-lyn™, our proprietary oral insulin spray product, in the diabetes management field."

About Generex

Generex is engaged in the research and development of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company's proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company's proprietary RapidMist™ device. The Company's flagship product, oral insulin (Generex Oral-lyn™), which is available for sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes, is in various stages of clinical trials around the world.

Hemispherx Biopharma to Present At Fall 2006 Micro Cap Conference

Sept. 18, 2006--Hemispherx Biopharma, Inc. (AMEX HEB) today announced that William A. Carter, MD, Chairman & CEO, will present at the Fall 2006 Micro Cap Conference in New York City on Tuesday, September 19, at 10:30 AM EST. The Conference, sponsored by Friedland Capital, Inc., will be held at the Doubletree Suites Times Square, 1568 Broadway (47th Street & 7th Avenue).

Dr. Carter's presentation will recount the year-to-date achievements of Hemispherx Biopharma and the strategy going forward. The Company will continue to focus its efforts on three areas that have the greatest potential for revenue growth and corporate expansion.

1) Submitting the first new drug application (NDA) for the experimental drug Ampligen® for Chronic Fatigue Syndrome (CFS), one of the last severe chronic diseases without a recognized treatment. The Company is currently formulating a marketing strategy for potential distribution of Ampligen® for CFS.

2) The Company is also formulating a broad-spectrum biodefense strategy around the experimental agents Ampligen® and Alferon LDO (Low Dose Oral). The initial phase of this strategy is focused on avian and seasonal influenza.

3) Clinical efforts are focused to validate suggestions that Alferon N Injection®, already approved for HPV-related genital warts, may have application in vulvar vestibulitis syndrome (VVS), an HPV-related disease. VVS is an ailment affecting approximately 14% of the female population in the U.S. and can also be severely debilitating.

About Hemispherx

Hemispherx Biopharma, based in Philadelphia, is a biopharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of viral and immune-based disorders. Hemispherx Biopharma's flagship products include Alferon® and the experimental drugs Ampligen®, Alferon LDO and Oragens(TM). Alferon® is approved for a category of STD infection, and Ampligen® and Oragens(TM) represent experimental nucleic acids being developed for globally important diseases. Hemispherx's platform technology includes large and small agent components for potential treatment of various viral infections. Hemispherx has in excess of 100 patents comprising its core intellectual property estate, a fully commercialized product (Alferon® N) and GMP certified manufacturing facilities for its novel pharma products.

China, which catapulted into the top ranks of global manufacturing, is now aiming to turn itself into a biotechnology power.

"There's no reason the things that make China so powerful in manufacturing cannot apply to knowledge-driven industries," said Kevin Chen, vice president of Bioduro Co. Ltd., a San Diego biotech contract research company with a growing operation in Beijing.

China's biotech strategy mirrors the one it used to become a dominant force in manufacturing. It is using the biotech contract research industry -- in which companies take on projects for foreign clients -- as a springboard to develop the expertise and technical prowess that will help Chinese companies compete internationally. The goal is to build a world-class biotechnology sector that develops a steady stream of proprietary products for the global market.

So far, Western pharmaceutical and biotech firms have not flocked to China. Global pharmaceutical firms will outsource about $3.5 billion in research this year, according to Kalorama Information. Less than 5 percent of that is earmarked for China.

China's main barriers to growth in biotech include concerns over its lax intellectual property rights, language barriers and quality issues.

But that's not inhibiting companies such as Bioduro from betting big on China's research potential. Officials of the company, which does only contract work, figure they can do high-quality biotech research for about 30 percent of what it would cost in the United States.

"There is a gap in Chinese capabilities, especially in laboratory experience, but we have so many good individuals with knowledge and skills," Chen said.

The potential saving is a powerful argument for an industry in which it generally costs about $1 billion to discover and market a new drug.

The Chinese government is moving aggressively to address quality and intellectual property worries. Officials understand that high-margin, high-wage industries such as biotech can help boost China's technical capabilities and take the nation's economy to a new level.

With rival India having a significant lead over China in pharmaceuticals and biotech, China's State Council, its cabinet, has formed a powerful leadership committee to develop the national biotech industry. That's a move usually reserved for crucial sectors.

The government has also increased funding for biology, restructured the science and technology ministries to focus on the creation of intellectual property rights, established a peer-review system in which scientists judge the work of fellow scientists, and deregulated venture capital.

Over the last few years, several biotech parks designed from scratch to meet the standards of the U.S. Food and Drug Administration have been created around Beijing, which is fast becoming China's leading biotech center.

Most of these parks, such as the China Biotech Research Center, touted as Asia's largest biotech incubator, have risen on the sites of emerald rice fields that once ringed this historic capital city. They're equipped to house the operations of startups, research centers and venture capital firms.

That's making it easier for foreign companies to work in China. Last month, Bridge Pharmaceutical Inc. of San Francisco opened a 100,000-square-foot, 200-person research center in Beijing.

T.J. Deng, Bioduro's director of analytical chemistry, who worked for several years with Wilmington, N.C., pharmaceutical company PPD Inc., said one of the factors supporting the growth is that Chinese scientists working in the United States are returning to China in large numbers.

"There are huge growth opportunities and a great lifestyle here, and people like me are seeing that," said Deng, who is from central Sichuan province. "The skills and experience they bring is a crucial element (because) without Western-trained people Chinese outsourcing firms would find it hard to get American clients."

Making sure research facilities meet international standards is a major preoccupation.

At Bioduro, Chen and Deng have instituted several security measures that control which employees have access to foreign clients' information, weekly videoconference calls with overseas managers, restrictions on which employees can enter different sections of the laboratory, and intensive training on technical and issues.

A handful of Chinese companies have already met world-class standards. For example, Shanghai's WuXi Pharmatech performs chemistry research and development for 18 of the world's 20 largest pharmaceutical companies.

The company, like other Chinese firms, is taking advantage of the virtual absence of animal rights groups in this authoritarian nation to specialize in animal testing, rapidly becoming a major niche market for China.

Bridge Pharmaceutical CEO Glenn Rice has said one of the reasons the company chose China as a base was the ease with which it could conduct experiments on primates and beagles.

By contrast, India bans some types of animal testing.

While China forges ahead in contract research, its proprietary pharmaceutical industry is also making strides.

Investment is beginning to flow into the sector. China's first biotech-focused venture capital fund, BioVeda China Fund, was set up last year by BioVeda Capital, a private investor group. And Temasek Holdings of Singapore will invest $40 million in China's life sciences sector.

Today, there are about 200 Chinese corporations using molecular biology to create new drugs. Xu Ming Bo, director of Beijing Shuang Lu, a pharmaceutical company preparing to go public, said his 300-person company is working to create a patented anti-cancer drug within the next decade.

Xu said that although China's biotech expertise is growing, "Right now it's very hard for Chinese pharmaceuticals to enter the U.S. market, not only for technical reasons but also because of invisible barriers," such as consumer concerns.

In 2003, SiBiono GeneTech Co. Ltd., based in Shenzhen, said it had developed the world's first gene-therapy drug, which could be used to shrink tumors. China's State Food and Drug Administration granted SiBiono permission to produce its potentially life-saving drug, named Gendicine, after five years of clinical trials. The company is manufacturing 150 million doses in collaboration with New Brunswick Scientific Co. Inc., a U.S. lab-equipment supplier. But the U.S. Food and Drug Administration has not yet approved the sale of Gendicine, mainly because the results of the clinical trials are unclear.

Xu said China recognizes the image and quality challenges it faces and is working to fix them.

"China will be a force in pharma," he said. "Just give us time."

King Pharmaceuticals Inc. on Friday said its blood pressure drug ramipril failed to meet the main goal in a diabetes reduction assessment.

The finding suggests that a longer trial would be necessary to detect significant benefits of ramipril on the incidence of new onset diabetes and cardiovascular morbidity, the pharmaceutical company said in a statement.

Ramipril is currently marketed as Altace by King Pharmaceuticals and Wyeth to treat patients with heart disease or high blood pressure.

King Pharma's shares fell 3% to $16.05 in trading on the NYSE.

Critical Therapeutics Drug Isn't Seen As Effective in Mid-Stage Trial

Shares of biotech drugmaker Critical Therapeutics Inc. set a fresh 52-week low Friday after the company said a mid-stage clinical trial for an anti-inflammatory compound that was stopped early showed no trends that the drug was effective.

The company said the Phase II trial looked to see if the compound CTI-01 was effective in reducing complications 14 to 28 days after heart surgery. However, the study was halted in March after a manufacturing issue arose surrounding the drug's container closure.

Only 102 patients had been enrolled, not enough to show statistical significance for efficacy. But even data from these patients did not show a trend toward effectiveness, the company said.

Critical Therapeutics plans to assess if there is an opportunity to continue development of CTI-01 with a collaborative partner, or to out-license it.

Shares of Critical Therapeutics fell 12 cents, or 4.3 percent, to $2.70 in morning trading on the Nasdaq. Earlier in the session, the stock set a new 52-week low of $2.56. The previous low of $2.73 was set Thursday.

Aastrom Biosciences Inc., a biotech company which focuses on regenerative medicine, said Wednesday its fiscal fourth-quarter loss widened as costs and expenses expanded by 39 percent.

The loss for the quarter ended June 30 was $4.3 million, or 4 cents per share, compared with $3.36 million, or 3 cents per share. Average diluted shares outstanding amounted to 117.1 million versus 102 million a year ago.

Revenue grew to $328,000 from $96,000 on higher grant revenue, while total costs and expenses rose to $5.13 million from $3.7 million, reflecting more spending on research and development as well as higher staffing and legal costs.

On average, three analysts surveyed by Thomson Financial forecast a loss of 4 cents per share and revenue of $160,000.

For the fiscal year, the loss widened to $16.5 million, or 15 cents per share, on revenue of $863,000.

At June 30, Aastrom Biosciences had $43 million in cash, cash equivalents and short-term investments, an improvement from $32.4 million last year.

Shares of biotech company Genentech Inc. jumped Thursday on strong analyst comment, several days after the company suffered from a setback on its cancer drug, Avastin.

The stock gained $1.18, or 1.5 percent, to reach $78.87 in morning trading on the New York Stock Exchange. Shares have traded between $75.58 and $100.20 over the last 52 weeks.

The upward shift contrasts with Monday, when the stock fell 4.6 percent on news the Food and Drug Administration asked for more data on clinical trials testing Avastin for use in breast cancer. The drug is already approved for colorectal cancer.

The request for more safety and efficacy data includes an independent radiologic assessment, but the company will not need to conduct a new clinical trials. Analysts held their positions on the stock, with several saying the news did not impact the ultimate approval for the expanded use.

On Thursday, Stifel Nicolaus & Co. analyst Edward H. Nash took a bullish view on the stock, upgrading it to "Buy" from "Hold," and setting a $90 price target.

"We believe that the FDA will ultimately grant approval based on the robustness of the Avastin clinical data seen to date in the breast cancer setting," he wrote in a note to investors.

The delay will likely not impact physician's use of Avastin, he said, and the stock price decline sparked by the news has provided an attractive entry point for investors. Momentum going into the fourth quarter will be sparked by product expansions and launches, such as Herceptin in breast cancer and the launches of Tarceva and Lucentis.

The FDA request is more indicative of increasingly stringent approval standards for cancer treatments and not a reflection any issues with Avastin. The drug, he notes, is already used off-label by physicians for breast cancer.

Merrill Lynch analyst Eric Ende added the company to his focus list in a note to investors, saying Avastin is expected to be a long-term growth driver for the company, based on its use for colorectal cancer and growth in treating lung and breast cancer.

"As a strong stable growth, high beta story, we believe Genentech should be bought in the current environment," he wrote.

Current and potential indications for the drug could allow it to achieve annual sales of more than $10 billion, he wrote. Second-quarter U.S. sales of Avastin rose 72 percent to $423 million.

InvivoSciences a startup biotechnology firm with laboratories in Milwaukee, is working to help drug developers bridge the gap between molecular and animal testing methods. For researchers studying heart diseases, skin disorders, and other maladies, Invivo's manufactured live tissue system could provide that bridge.

Using tissues derived from neonatal rats, the company has created a screening system that allows researchers to test drug candidates on live tissue en masse.

A single rat, culled from colony surpluses, can provide five to 10 live tissue samples. With two weeks of preparation, Invivo scientists can mature heart tissue, for example, so that it will continue contracting like a beating heart for a month or longer.

The result is a high throughput screening method that allows drug developers to screen between 2,000 and 3,000 samples per day.

Tetsuro Wakatsuki, chief scientist and co-founder of Invivo and assistant professor of physiology at the Medical College of Wisconsin, explained that the technology is advantageous because it eliminates cell-to-cell variability. It also minimizes unrelated and invalid leads and protein targets at very early stages of the biotech drug-discovery process.

The information gleaned from the testing method also allows researchers to study biological responses in a three-dimensional environment instead of gathering data from chemical reactions.

The heart tissue or blood vessel samples can be cultivated to suit large drug-screening projects on 96-well plates, and they can be assembled to provide models for specific disease conditions with either healthy, sick, or genetically modified tissue.

The technology has the ability to help scientists address a variety of diseases, including cardiac fibrosis, hypertension, and asthma with applications in scar contracture, wound healing, and aging skin therapies.

"The ultimate goal is to discover new drugs," Tetsuro said.

Cardiome Reports Positive Heart Drug Data With Lower Dose Better Than Higher Dose

Cardiome Pharma Corp. said Wednesday that a mid-stage clinical trial showed its experimental drug normalized heartbeats in patients with the lower dose performing better than the higher dose.

The Phase IIa trial treated patients with atrial fibrillation, a type of irregular heart beat where the upper chambers of the heart quiver and do not pump blood effectively to the lower chambers. Patients were given either 300 milligrams or 600 milligrams of RSD1235 or a placebo intraveneously.

In the 300 milligrams group, 61 percent of patients had a normal heartbeat by the end of the study, compared with 43 percent taking placebo. This difference was statistically significant, the type of difference the Food and Drug Administration looks for in a drug application.

However, in the 600 milligram group, the difference was not statistically significant even though the percentages were the same, because fewer people participated in the higher-dose group.

When both dose groups were combined, the difference was statistically significant.

Cardiome Pharma shares fell $1.63, or 12.25 percent, to $11.68 in lat afternoon trading on the Nasdaq.

Oscient Pharmaceuticals Unlikely to Get Factive Acute Bacterial Sinusitis Approval From FDA

Drug maker Oscient Pharmaceuticals Corp. said Wednesday that an advisory panel to the Food and Drug Administration recommended the agency not approve the company's anti-infective drug Factive for the treatment of acute bacterial sinusitis.

Shares of Oscient fell 20 cents, or 17.5 percent, to 94 cents on the INET electronic exchange, after closing at $1.14 on the Nasdaq. Shares have traded between 60 cents and $2.81 over the past 52 weeks.

The FDA advisory panel voted 10 to 4 that data from the company's clinical trial showed that the treatment was not effective as a five-day treatment for acute bacterial sinusitis, or inflammation of the sinuses caused by bacteria. The panel also voted 11 to 2 that the benefits of the drug did not outweigh the risks in treating ABS.

The agency is set to rule on the company's application for ABS by Dec. 15. While the FDA is not bound by panel recommendations, it usually follows them. An approval doesn't look likely as the FDA earlier accepted the application under protest.

The company also has a Factive application on file as a five-day treatment for community-acquired pneumonia. The FDA is set to decide on that application by Sept. 21.

Factive is currently FDA-approved as a five-day treatment for worsening acute chronic bronchitis caused by bacteria, and as a seven-day treatment of mild to moderate community-acquired pneumonia.

Stratagene Corp. (STGN)

Last Trade:	5.48
Trade Time:	3:47PM ET
Change:	1.17 (27.15%)

Stratagene Corporation, a developer, manufacturer and marketer of specialized life science research and diagnostic products, today highlighted the U.S. Food and Drug Administration's (FDA) publication of results from its MicroArray Quality Control (MAQC) project.

As part of the FDA's Critical Path Initiative, the MAQC project aimed to develop standards and quality measures for the microarray community, so that microarrays, as a core technology of pharmacogenomics and toxicogenomics, could successfully and reliably be used in clinical practice and regulatory decision-making. As a result, the MAQC project will help improve microarray technology and foster its proper applications in the discovery, development and review of FDA regulated products.

"We are proud to have been a part of this collaboration that brought together a broad range of academic, governmental, and commercial organizations, all with the future of microarray technology in mind," said Joseph A. Sorge, MD, President and CEO of Stratagene. "Stratagene's Universal Reference RNA was one of two high-quality reference standards selected as part of the MAQC project. These reference RNAs allow laboratories with many different microarray platforms to compare and share data in the global microarray community."

The project involved six FDA Centers, major providers of microarray platforms and RNA samples, the U.S Environmental Protection Agency, the National Institute of Standards and Technology, academic laboratories, and other stakeholders. By providing the public with large reference datasets along with readily accessible reference RNA samples, the MAQC project aimed to establish quality control metrics and thresholds for objectively assessing the performance achievable by various microarray platforms and evaluating the advantages and disadvantages of various data analysis methods.

-----------------------------------------------------------------------------------------------

Arena Pharmaceuticals (ARNA) announced on Tuesday that the company is enrolling patients in trials involving its proposed obesity drug Lorcaserin. The trial is one of three phase III studies evaluating the safety and efficacy of the drug.

Nasdaq Halts Oscient Shares; FDA Panel Meets to Review Factive Sinusitis Treatment

Oscient Pharmaceuticals Corp. said Tuesday the Nasdaq has halted trading of its shares ahead of a Food and Drug Administration meeting to review a new use for its drug Factive.

An FDA panel is scheduled to vote on whether the drug, which is currently used to treat certain types of pneumonia and bronchitis, should be used to treat acute sinus infections.

But the drug has raised some safety concerns. According to FDA documents released Monday, patients taking Factive were more likely to develop an allergic rash than those taking other approved products. JMP Securities analyst Adam Cutler on Monday said approval of the drug's new use is "probaby a long shot."

The company's shares closed at $1.14 on Monday.

Shares of Oscient Pharmaceuticals Corp. gained in heavy trading Monday, possibly on speculation that the company could receive positive review for a new use of its drug Factive, despite news that the Food and Drug Administration has safety concerns about the drug.

An FDA panel of experts is scheduled to vote Tuesday on whether the drug, which is currently used to treat certain types of pneumonia and bronchitis, should be used to treat acute sinus infection. More than 30 million adults and children get sinus infections each year, according to the National Institutes of Health. There are concerns the FDA panel might decide not to recommend the sinus infection use for this drug.

According to documents released Monday by the FDA before the panel meeting, patients taking Factive were more likely to develop an allergic rash than those taking other approved products.

JMP Securities analyst Adam Cutler noted that in the briefing documents FDA staff scientists recommended against approving the drug for the new use.

"It's probably a long shot that the committee will recommend approval," Cutler said.

Shares of Waltham, Mass.-based Oscient rose 8 cents, or 7.3 percent, to $1.17 on the Nasdaq in midday trading. In the year to date, the stock has lost nearly half of its value.

Competitor Replidyne Inc. of Louisville, Colo., is also seeking to have the same use approved for its drug Faropenem. Replidyne shares lost 15 cents to $9.90 on the Nasdaq.

Merrill Lynch analyst David Munno said in a note Friday that Faropenem does not carry the same safety concerns as Oscient's drug.

According to Munno, FDA could make a decision on Replidyne's drug by Oct. 20.

Genentech Receives FDA Letter for More Data on Proposed Expanded Use of Avastin

Biotech giant Genentech Inc. said Monday the Food and Drug Administration had sent it a complete response letter asking for more safety and efficacy information on a new application for its metastatic breast cancer treatment Avastin.

The company had asked the FDA to approve Avastin's use as a first-line therapy in conjunction with chemotherapy for metatastic breast cancer. The request means the company will have to recollect information from study sites.

The study was sponsored by the National Cancer Institute and conducted by a network of researchers led by the Eastern Cooperative Oncology Group. Genentech had submitted interim data from the trial in May.

Genentech anticipates resubmitting the data by the middle of 2007. The FDA will start a new six-month review once the data is submitted, the company said.

Avastin was approved in 2004 for the treatment of metastatic colectoral cancer. The company has been testing Avastin as a treatment for several other types of cancer. The company halted a trial testing its effectiveness on pancreatic cancer in June, after early data showed it was not significantly effective.

Shares of Genentech fell $3.16, or 3.9 percent, to $78.91 on the New York Stock Exchange in morning trading. The stock has traded between $75.58 and $100.20 over the last 52 weeks. The stock is often seen as a bellwether for the Biotechnology Sector.

Genentech Receives FDA Letter for More Data on Proposed Expanded Use of Avastin

Drug maker Genentech Inc. said Monday the Food and Drug Administration had sent it a complete response letter asking for more safety and efficacy information on a new application for its metastatic breast cancer treatment Avastin.

The company had asked the FDA to approve Avastin's use as a first-line therapy in conjunction with chemotherapy for metatastic breast cancer. The request means the company will have to recollect information from study sites.

The study was sponsored by the National Cancer Institute and conducted by a network of researchers led by the Eastern Cooperative Oncology Group. Genentech had submitted interim data from the trial in May.

Genentech anticipates resubmitting the data by the middle of 2007. The FDA will start a new six-month review once the data is submitted, the company said.

Avastin was approved in 2004 for the treatment of metastatic colectoral cancer. The company has been testing Avastin as a treatment for several other types of cancer. The company halted a trial testing its effectiveness on pancreatic cancer in June, after early data showed it was not significantly effective.

Shares of Genentech fell $3.16, or 3.9 percent, to $78.91 on the New York Stock Exchange in morning trading. The stock has traded between $75.58 and $100.20 over the last 52 weeks.

As part of its evolution into a pure-play vaccine development company, Hawaii Biotech Inc. has spun off its drug development business to Science & Technology International Inc., a Honolulu research and development firm.

Hawaii Biotech will maintain a 20 percent ownership stake in the new company, PanThera Biopharma Inc., said Dr. Len Firestone, Hawaii Biotech's chief executive. PanThera will focus on developing drugs to treat anthrax and botulism, said Will Alameida, PanThera's chief executive.

Exploiting STI's strength and experience in using federal money to develop technologies with applications for both the military and private sector, PanThera plans to apply for grant financing from the National Institutes of Health, the Department of Defense and the federal BioShield Program, which is spending $5.6 billion to develop and stockpile drugs to protect against acts of terrorism, Alameida said.

PanThera also is seeking to qualify for Hawaii's Act 215 program, which enables investors in technology companies to receive state income tax credits designed to encourage investment in startups, a spokeswoman said.

Firestone said the spinoff enables Hawaii Biotech to further refine its focus as a vaccine developer, while enabling Science & Technology International to use its expertise as a defense contractor to grow PanThera.

Hawaii Biotech's work focuses on using a fragment of a virus to provoke an immune response in the person who takes the vaccine.

The spinoff comes approximately six months after Hawaii Biotech merged its vaccine business with that of Avantogen Ltd., an Australian biotech firm headquartered in La Jolla, Calif. At that time, Hawaii Biotech spun off its anti-inflammatory drug-development business and named it Cardax Pharmaceuticals Inc.

Investment research firm Susquehanna Financial initiated coverage of the Durect (DRRX)with a positive rating.....DRRX moved up 5.7% to $3.70 .......

AstraZeneca (AZN) was downgraded to a hold from a buy by
Citigroup......AZN shares were 1.3% lower to $61.35.

Citigroup also downgraded generic drugmaker Endo Pharmaceuticals (ENDP) from a buy rating to a hold...... with a price target of $34. Shares fell 1.4% to $31.24.

Abraxis BioScience Names Leadership Team for Its Abraxis Pharmaceutical Products Division; Appointment of President and Chief Operating Officer of APP Solidifies Management Structure of Hospital-Based Division



New Corporate General Counsel Also Named for Abraxis BioScience

Abraxis BioScience, Inc. (NASDAQ:ABBI), an integrated, global biopharmaceutical company, today announced that Thomas H. Silberg, who had previously served as the company's executive vice president, commercial operations & operational excellence, has now been named as president of Abraxis Pharmaceutical Products (APP), and Frank Harmon, who has served as executive vice president, global operations, will now report to Silberg and assume the role of chief operating officer for the APP division. It was also announced that Richard E. Maroun, the company's chief administrative officer, will add to his current responsibilities and assume the role of general counsel and corporate secretary. Maroun, Silberg and Harmon will continue to serve on the Executive Committee for Abraxis BioScience.

Maroun replaces John F. Weidenbruch as general counsel and corporate secretary. Maroun, prior to the merger of American BioScience, Inc. (ABI) and American Pharmaceutical Partners, Inc., served as general counsel and vice president of corporate development of ABI. Weidenbruch has chosen to accept a position as executive vice president and general counsel at Idenix Pharmaceuticals, Inc. based in Cambridge, Massachusetts.

"I would like to welcome Rick, Tom and Frank to their new roles. Rick has been a valuable member of this team and his continued leadership in this broader role will only serve to strengthen the foundation of the company. Both Tom and Frank have been playing vital roles in the APP division over the last few months and already have demonstrated their capabilities in taking on their new responsibilities. I have every confidence they will continue to show the same dedication and devotion to growing the business moving forward," said Patrick Soon-Shiong, M.D., chairman and chief executive officer of Abraxis BioScience. "Finally, this last year has been an incredibly busy time for the company and I can't thank John enough for his dedication to the company. We wish him the best of luck as he begins this new chapter in his career."

Each of these appointments are subject to approval from the Board of Directors.

About Abraxis BioScience, Inc.

Abraxis BioScience, Inc. is an integrated global biopharmaceutical company dedicated to meeting the needs of critically ill patients. The company develops, manufactures and markets one of the broadest portfolios of injectable products and leverages revolutionary technology such as its nab(TM) platform to discover and deliver breakthrough therapeutics that transform the treatment of cancer and other life-threatening diseases. The first FDA approved product to use this nab platform, ABRAXANE(R), was launched in 2005 for the treatment of metastatic breast cancer. Abraxis trades on the Nasdaq National Market under the symbol ABBI

King Pharmaceuticals Buys Rights to Avinza Painkiller From Ligand Pharmaceuticals

- Drug maker King Pharmaceuticals Inc. said Thursday it agreed to buy rights to the painkiller Avinza owned by Ligand Pharmaceuticals Inc.

Under the agreement, King will pay $265 million for rights to Avinza in the U.S., its territories, and Canada. King also will assume a $48 million product liability to a third party, and all existing product royalty obligations.

Additionally, King will pay Ligand a 15 percent royalty during the first 20 months after closing, after which royalties will vary between 5 percent and 15 percent depending on total sales. Royalties will last until Avinza's patent expires in 2017.

The transaction, which is expected to close by the end of the year, is subject to antitrust review and Ligand shareholder approval.

Before closing, King will use its sales force to help sell the product. Upon closure, King will hire a large portion of Ligand's Avinza sales force, nearly doubling its current neuroscience sales force.

Avinza, which is an extended release form of morphine, generated sales of about $179 million in 2005.

King shares rose 36 cents, or 2.3 percent, to $16.29 in morning trading on the New York Stock Exchange.

Ligand shares fell 28 cents, or 2.8 percent, to $9.59 in morning trading on the Nasdaq. Shares have traded between $7.78 and $10.50 over the past 52 weeks.

Biotech company Amgen Inc. said Thursday it has launched the Aranesp prefilled SureClick autoinjector to treat anemia in patients with chronic kidney disease and patients undergoing chemotherapy.


Amgen said it included three safety features to its new product. One is a safety cover that limits needle exposure before and after the injection. The device also makes two audible clicks that signify the beginning and the end of the injection. There is also a large inspection window that shows the device has delivered the entire injection.

There are now three available ways to deliver Aranesp to patients: the SureClick autoinjector, SingleJect prefilled syringes and prefilled vials.

Amgen's new SureClick device will be available in clinics, hospitals and retail pharmacies and will be offered at the same price as the other administration methods.

Amgen shares closed down 16 cents to $68.33 in trading on the Nasdaq.

The Nasdaq Biotechnology Index closed down 0.74%

Dynavax Technologies Corp. the biotech company said it signed a deal with London-based pharmaceutical company AstraZeneca PLC to develop treatments for asthma and chronic lung disease.

Under the terms of the deal, Dynavax said it will receive an upfront fee of $10 million, plus research funding and preclinical milestones that could bring the total committed funding to $27 million. This could potentially place the deal's total value at about $136 million, the company said.

Berkeley, Calif.-based Dynavax's shares climbed 30 cents, or 7.1 percent, to $4.50 in trading on the Nasdaq.

EpiCept Corp. lost one-third of its market value Wednesday after announcing late-stage test results for its experimental pain killer patch did not meet expectations.


Shares of the pharmaceuticals company plunged 94 cents, or 33 percent, to $1.92 in Nasdaq trading.

The company's LidoPain analgesic patch, which primarily targets back pain, recently completed Phase III trials in Europe. The patch, which releases a dose of the painkiller lidocaine, is also designed for surgery patients recovering from suture wounds.


The tests were conducted on 440 patients who underwent surgery to repair hernias, according to a statement released by the company after markets closed Tuesday.


Test results showed LidoPain was not statistically more effective in relieving pain than the placebos given to some of the patients.


CEO Jack Talley said in a statement that the company was "disappointed" LidoPain did not meet its trial goals, particularly since the product had tested well in earlier European trials.


"A thorough analysis of the trial results has been initiated and our findings will serve as the basis for our decision on next steps for this product candidate," Talley said.


The product has yet to reach late-stage trials in the U.S., the company said.


EpiCept had been privately held until January, when it merged with publicly traded Maxim Pharmaceuticals Inc. of San Diego. Shares of the combined company hit a high of $12 on their first day of trading, but the stock has slipped steadily since then.


On Aug. 30, EpiCept announced it had received a $10 million loan to help move along its pipeline, which, in addition to LidoPain, includes the Leukemia drug Ceplene and EpiCept NP-1, its prescription painkiller cream.

The 5 year chart of the Nasdaq Biotechnology Index shows a long stretch of consolidation. A rally back to the 900 level could be in store later this year as institutional money rotates from sector to sector.

Shares of drug developer Genta Inc. dropped sharply Tuesday after the Food and Drug Administration questioned whether its leukemia treatment candidate would offer any substantial improvement over chemotherapy.


The comments were released a briefing from the FDA ahead of an Oncology Drug Advisory Committee review of Genasense, scheduled for Wednesday. Genta is seeking approval for the drug, to be injected in conjunction with chemotherapy to treat a form of the blood cancer called refractory chronic lymphocytic leukemia.

The company's stock sank fell 53 cents, or 38 percent, to close at 86 cents per share on the Nasdaq, as trading volume skyrocketed to more than 40 million shares. Average trading volume is approximately 2.2 million shares. Also, the stock touched off a new 52-week low of 75 cents a share, beating the previous low of $1.07 set a year ago. Shares traded as high as $3.48 Feb. 6.

"The study approached, but did not quite achieve statistical significance for its primary endpoint," the company said, in a summary it filed with the FDA.

The FDA in its summary said while trial results showed the difference in treatments is greater, it is "of questionable clinical significance."

The response rate, or complete response to the treatment, was 17 percent, compared with a 7 percent response rate for chemotherapy alone. That falls short of a 20 percent rate of remission goal. Also, the median survival rate for patients in the 223-person study on a combination of Genasense and chemotherapy was 33.8 months. The group solely on chemotherapy had a median survival rate of 32.9 months.

Genta requested a "Fast Track" approval in December, citing the drug candidate would address an unmet need.

GNTA shares are currently halted from trading on the Nasdaq.

Oscient Pharmaceuticals Corp. (OSCI) on Tuesday said it had agreed to stop co-promoting Auxilium Pharmaceuticals Inc.'s (AUXL) Testim testosterone gel, effective Aug 31.

With the termination of the partnership, the companies will share profits from the drug's primary care sales, Oscient said.

Oscient will also receive a $1.8 million payment from Auxilium as additional compensation for marketing efforts.

In a separate statement, Auxilium said the termination of the agreement was part of the company's strategic initiative to control the commercial development of Testim.

Auxilium said it plans to increase its sales force coverage for the drug, a topical gel used to treat hypogonadism, to about 150 territories from 94.

In April, the companies had entered into the agreement under which Oscient promoted Testim to primary care physicians and Auxilium marketed the drug to urologists, endocrinologists and select primary care physicians.

Oscient said the termination will allow it to focus on cardiovascular drug Antara, for which it bought U.S. rights from Reliant Pharmaceuticals.

Vasogen Inc. said on Tuesday that new data shows its heart treatment, which failed a key clinical trial earlier this year, can reduce the risk of death from some heart problems significantly, sending its shares up 20 percent.

Vasogen shares, which slipped 70 percent in one day in June following disappointing results from a trial of its Celacade treatment, were up 12 Canadian cents, or 20 percent, at 77 Canadian cents on the Toronto Stock Exchange after earlier rising as high as 85 Canadian cents

The results, presented at a major cardiology meeting in Spain over the weekend, showed there was a 31 percent reduction in risk of death or first cardiovascular hospitalization in a patient subgroup that had not progressed to more advanced stages of heart failure.

The biotech company said Celacade could go on sale in Europe in mid 2007. It said it also expects to discuss the results with U.S. and Canadian regulators.

Vasogen's Celacade treatment targets the chronic inflammation associated with cardiovascular disease.

"The news is obviously very intriguing and promising. Vasogen has had a lot past hiccups with regard to the headlines surrounding the studies," said Joseph Pantginis, an analyst at Canaccord Adams in New York.

"We do believe that our long-standing assessment that Celacade can provide significant clinical benefit to patients suffering from chronic heart failure does remain the same."

But Pantginis said the company must still overcome "a couple of hurdles" before it can persuade institutional investors that the treatment is viable.

This includes striking a European partnership agreement ahead of the 2007 target date for the treatment and receiving U.S. Food and Drug Administration feedback on the data.

"The company needs to address and overcome significant past and future hurdles as it claws its way back to the position that we perceive it should be in," Pantginis said.

The analyst maintains a "hold" rating on the shares.