Biotech and pharmaceutical companies opened the week with clinical, legal, financial and structural updates, and stocks moved accordingly in both directions, luring indices to dabble a bit in the red.
gave the most
on Monday saying it intends to make 31 submissions for new drugs by the end of 2010, and that it has 48 drugs in late-stage development.
The pharmaceutical and human vaccine company also said its xaliproden treatment for Alzheimer's disease didn't demonstrate a statistically significant effect in late-stage studies and thus will be discontinued. But Sanofi expects to file its antidepressant saredutant, which was effective in two late-stage trials, for marketing approval in the U.S. and Europe in 2008. Also, another antidepressant, amibergon, met its target in one of four studies and the company expects to assess its complete efficacy data in the next year.
Sanofi also plans to refile its marketing application for obesity drug Acomplia (Zimulti) in the U.S. pending long-term late-stage trial data expected in 2010. The drug, which is already available in Europe, was rejected by the Food and Drug Administration earlier this year when regulators questioned its psychological side effects. Sanofi shares fell 98 cents, or 2.3%, to $41.70.
In a smaller update,
said Monday that it initiated two large phase III clinical studies with vicriviroc, for adults with HIV who have only the R5-type virus and who have already tried another treatment.
The two phase III studies, VICTOR-E3 and VICTOR-E4 (Vicriviroc in Combination Treatment with an Optimized Antiretroviral Therapy Regimen in HIV- Infected Treatment-Experienced Subjects), will evaluate the benefit of adding vicriviroc in a 30 mg dose once daily to an optimized background therapy compared to a control group receiving new optimized background therapy alone. The studies, which will enroll about 375 patients each, will also evaluate the safety and tolerability of vicriviroc compared to placebo.
Schering-Plough shares edged down 17 cents, or 0.6%, to $30.19. Schering-Plough and Sanofi-Aventis are both components of the Amex pharmaceutical index, which was down 3.91, or 1.2%, to 337.40.
Other health stocks delivered financial and legal announcements. One of those,
, said it completed a $20 million secured loan agreement with a syndicate of lenders led by GE Healthcare Financial Services and including Merrill Lynch Capital and Oxford Finance.
The company said the financing will strengthen its cash position and should fund clinical development expenses into 2009. Specifically, it will be used for ongoing clinical studies with the company's Panzem, MCK-1 and ENMD-1198 and to fund IND-directed activities for Panzem in rheumatoid arthritis and the company's Aurora-angiogenesis inhibitor in oncology.
The collateral for the loan includes EntreMed's interest in royalty revenue on sales of
Thalomid. EntreMed shares were gaining 3 cents, or 2.6%, at $1.19. Celgene was pulling back 80 cents, or 1.2%, to $68.21.
announced it reached a "favorable" agreement with Conor Medsystems, a subsidiary of
Johnson & Johnson
, over a patent dispute regarding Conor's CoStar paclitaxel stent.
At the time of the settlement, there was ongoing litigation in the U.K., the Netherlands and Australia. The company didn't release terms of the settlement, but Chief Executive William Hunter said in a press release, "With this agreement now in place, Angiotech expects that the resources required to defend and enforce our intellectual property should decrease."
After trading up early on, Angiotech shares gave up 4 cents, or 0.6%, at $6.37. J&J was trading down 28 cents, or 0.4%, at $62.92.
And finally, a structural update in light of a clinical short-fall: Specialty pharmaceutical company
announced that it was reducing its workforce by roughly one-fourth in addition to other cost-cutting initiatives to conserve cash and realign in light of the disappointing results from a phase III study on an extended-release version of Gabapentin for postherpetic neuralgia.
The regular version of the drug, which treats persistent pain that's caused by nerve damage after a shingles infection, is already approved by the FDA. Shares gave up 18 cents, or 8%, to $2.06 Monday.