| Dendreon: Yes, It Got FDA Approval, But Here's What It Did Wrong Michael Shulman submits: Dendreon (DNDN) investors – and traders long the stock – got what they wanted yesterday with the FDA approval of their treatment for advanced metastatic prostate cancer, Provenge. The FDA was under enormous pressure to approve the treatment and in trials, Provenge hit primary endpoints and showed it was more effective – not that effective, but more effective – than the existing standard of care. The company plans to come to market slowly due limited production capacity and will charge $93,000 for a three treatment cycle of therapy. This approach is a very big mistake and should give investors pause.The management team at Dendreon is looking at too small a picture -- a mistake free ramp of production, the difficulty of getting insurance company approvals, starting new trials for Provenge earlier in the treatment cycle and perhaps re-activating research and trials into the use of Provenge against other cancer types. They need to think big picture – how to dominate the immunotherapy market and become the next Genentech in the coming decade. This will probably not happen – I have followed DNDN for many years and the performance of senior executives, despite this approval fro Provenge, is somewhere just north of an "F." But here is why and how they should consider the big picture.Complete Story » seekingalpha.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 |
Alliance HealthCare Services, Inc. Announces Commencement of Exchange Offer of its 8.00% Senior Notes due 2016 for Registered Notes (Business Wire) NEWPORT BEACH, Calif.----Alliance HealthCare Services, Inc. , announced today that it has commenced a registered exchange offer to exchange up to $190 million aggregate principal amount of its 8.00% series B senior notes due 2016 which have been registered under the Securities Act of 1933, as amended , for any and all of its outstanding 8.00% senior notes due 2016 which were issued in a private placement . us.rd.yahoo.com |
Roche Boosts China Presence Roche is increasing its investments in China to accommodate the country's growing health-care needs, its chief executive said. online.wsj.com |
Justice Launches Probe of Amedisys Amedisys received a civil investigative demand from the Justice Department amid federal probes of Medicare-reimbursement practices. online.wsj.com |