Pharma Blog Watch

New Study Bad News for Amgen (GoozNews)
Merrill Goozner calls The Cancer Letter's report that researchers stopped a trial of Amgen's Aranesp due to safety concerns "the second major blow for the biotech giant in recent months," noting that, "Late last year, researchers found that raising of red blood cell counts to near normal levels using Amgen's flagship product, Epogen, resulted in higher mortality rates among dialysis patients."

"Amgen isn't the only company that may get hurt by this study. [Johnson & Johnson's] Otho-Biotech division is the dominant player in the oncology market with Procrit, which is essentially the same thing as Aranesp," he continues. "According to the story, Michael Henke, a German oncologist who has been raising similar concerns about Roche's version of EPO (which is about to hit the U.S. market), believes that there are EPO receptors on all cancer tumors, and that may account for the higher mortality."

Analyzing LymphoStat-B Study Design (Pharma's Cutting Edge)
In his blog, Fred Cohen discusses a recent announcement by Human Genome Sciences (HGS) and GlaxoSmithKline (GSK) that they have initiated a Phase III trial of LymphoStat-B (belimumab) in systemic lupus erythematosus. "The only somewhat surprising design element here is that the companies elected to take two active doses into Phase III. It's obviously cheaper to study only one active dose, but perhaps regulators weren't convinced that the lowest effective dose had been demonstrated in Phase II."

"For whatever reason multiple doses are being studied here, I'm a bigger fan of dose-titration studies than parallel-arm studies when multiple doses are taken into Phase III," he writes. "Such studies are logistically more difficult, but they provide caregivers with efficacy information that is simply more relevant to practice than a parallel assignment study can offer. It looks like HGS/GSK are planning for two parallel-arm Phase III studies. Too bad."