| Covance slides on 1Q results and cuts to forecast (AP) Shares of Covance Inc. sank Thursday after the drug development company said demand for late-stage services was weak in the first quarter, and cut its expectations for the year. us.rd.yahoo.com |
Pfizer Dumps Arthritis Drug After Trial Results Fail to Excite The Burrill Report submits: By Michael FitzhughPfizer (PFE) cut one rheumatoid arthritis drug from its pipeline while reiterating its commitment to develop a second drug for the inflammatory disease from the same company, Trubion Pharmaceuticals (TRBN). The decision to pare the dumped drug, TRU-015, comes as Trubion released trial results showing a higher than usual placebo response in a mid-stage trial. While the company said its TRU-015 did show significant biological and clinical activity without significant safety concerns, Trubion CMO Scott Stromatt said that “market dynamics” dictated a focus on moving the company’s other rehumatoid drug, SBI-087, toward late-stage trials. Pfizer picked up rights to both drugs as part of its 2009 acquisition of Wyeth. The goal, says Evan Loh, senior vice president of biotherapeutics research and development at Pfizer, is to help develop a winning CD20-targeted therapy—a type of treatment that targets the markers on certain white blood cells involved in the inflammatory process of the disease. Trubion's TRU-015 likely faced formidable internal competition from CP-690550 (tasocitinib), a second-generation rheumatoid arthritis treatment candidate that Pfizer has already advanced into a late-stage trial. Losing Pfizer's support TRU-015 probably came as a disappointment for Trubion. At least it seemed to be a disappointment for investors, who docked the company's shares when the news emerged. But Trubion still has a lot to be happy about. On June 3, the Board of Appeal for the European Patent Office upheld a decision revoking Genentech (DNA) and Biogen Idec's (BIIB) European Patent 1176981, directed to the use of an anti-CD20 antibody for the treatment of rheumatoid arthritis. Also, its partnership with Facet Biotech (FACT) still stands. Facet has already fronted Trubion $20 million to support a potential treatment for lymphocytic leukemia (TRU-016). It could pay an additional $176.5 million in milestone payments. Complete Story » seekingalpha.com |
Designer Drugs Baffle Europe Europe is grappling with a flood of powerful and sometimes lethal new narcotics that are often legal when they first appear because authorities have never seen or banned them before. online.wsj.com |
Arena's Lorcaserin: Weighed Down by Qnexa and Meridia Joseph Krueger submits: Before the FDA review panel’s of Vivus’s (VVUS) drug Qnexa, I expressed significant doubt that the panel review would be positive based primarily on the safety issues surrounding one of its ingredients topiramate here. The safety issues had to do with contraindications between topiramate itself as well as contraindications with the other ingredient phenteramine. I made the following statements:With so many contraindications and side effects of phentermine and topiramate, who can safely use Qnexa? Given the FDA’s historic stance on the safety of weight loss drugs, and the long list of potential safety issues with phentermine and topiramate, is it likely that the FDA will allow its marketing?I concluded (accurately) that Qnexa efficacy was never in question, and that these safety concerns would be the outstanding issues that would prevent Qnexa approval (PDUFA date is Oct 28, 2010). After the review panel vote, it appears that the only hope for Qnexa approval in October is that the FDA feels the safety risks are worth the clear weight loss benefit.Finally, I finished up this discussion with this statement: Investors should also consider the effects of any VVUS events could have on other companies developing obesity drugs. The outcome of the Qnexa panel review will have an impact on the trading of Orexigen (OREX) and Arena Pharmaceuticals (ARNA) obesity drugs up for review before the end of the year. In this brief analysis, I compared Orexigen's (OREX) Contrave to Arena’s (ARNA) Lorcaserin and hypothesized how the Qnexa panel could affect the share prices of OREX and ARNA. I stated: Between these three drugs, Qnexa is perhaps the most effective but also by far the one facing the most potential safety concerns. A favorable review for Qnexa is logically likely to rally VVUS but also OREX and especially ARNA stocks as it would demonstrate the review panel’s willingness to endorse an effective weight loss drug even in the face of potential side effects. An unfavorable Qnexa review is logically likely to cause a short term gut-response sell off in both of these stocks. However, a little further out I would expect ARNA not to recover (due to the safety concerns) but a rally in OREX could occur (due to its strong efficacy and very safe profile) as it demonstrates a continued concern over safety, and the elimination of its competitors.Complete Story » seekingalpha.com |
Court Lets Stem-Cell Funds Flow for Now A federal appeals court said the Obama administration can continue to fund embryonic stem-cell research, reversing for the time being a trial judge's injunction barring the funding. online.wsj.com |