Over the past few days there's been a remarkable confluence of newsflow, most of it positive, out of biopharma.
First the bad news.
New York Attorney General Andrew Cuomo is leading a multi-state lawsuit against biotech giant Amgen over alleged kickbacks. The company says the case is without merit. Then, just a few hours later, on Halloween Eve, the results of the so-called TREAT trial came out. There were nearly twice as many strokes among diabetic, pre-dialysis kidney disease patients who got AMGN's anemia drug Aranesp. Most analysts say the results, while obviously not good, may have already been baked into the stock price. It's also worth noting that Amgen paid for this study. So, it'll be interesting to see how far it might go to help dispel perceptions that drug companies buy only favorable research and try to sweep everything else under the rug. In the press release, Amgen'shead of R & D even acknowledges "the risk...will exceed the benefit...."
And now the good stuff.
Where do I start? Dendreon files a little bit earlier than expected for FDA approval of its prostate cancer treatment Provenge. Human Genome Sciences says the second of two late-stage studies on the Lupus drug it shares with GlaxoSmithKline met its main goal. Vertex Pharmaceuticals says a mid-stage study shows a twice-a-day version of its experimental hepatitis C drug works as well as the further along three-time-a-day version. It's partners with Johnson & Johnson on that one. Vertex and HGSI both hit new intra-day highs. And finally, Amylin Pharmaceuticals hit a trifecta over the weekend. The FDA okayed use of the diabetes drug Byetta as a stand-alone treatment. The agency did put a new warning on the Byetta label for pancreatitis, but it isn't the more severe "boxed" warning. And the company did a potential $1-billion-plus partnership deal on its developmental obesity drugs. Amylin and Lilly are partners on the twice-a-day injectable Byetta. And the pair, along with Alkermes , are waiting for the FDA okay of a once-a-week version of the drug.
Today, I interviewed the CEOs of AMLN, HGSI and VRTX. If you missed them, you can check them out here on this blog page as they appear and get posted. Sure, things get hectic when there's so much to keep track of, but it's days like this when I'm glad to be on this beat.
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