A story in the Wall Street Journal today about an ethics complaint against a top official at the FDA has brought new attention to Cambridge, MA-based Momenta Pharmaceuticals’ effort to win approval of its generic version of a multibillion-dollar blood thinner.
The WSJ reports that Amphastar Pharmaceuticals, of Rancho Cucamonga, CA, is alleging that Momenta (NASDAQ:MNTA), a competitor, has had special access to Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, while both firms were seeking approval for copycat versions of enoxaparin, which French drug giant Sanofi-Aventis markets as Lovenox. The complaint cites, among other things, the fact that Woodcock was a co-author with Momenta scientists including technical founder Ram Sasisekharan, on two scientific papers published last year, the WSJ says. Sasisekharan, an MIT professor with expertise of the role of complex sugar structures in diseases, is also a founder of Cambridge biotechs Cerulean Pharmaceuticals and Parasol Therapeutics.
With both Amphastar’s and Momenta’s applications still pending (they were filed in 2003 and 2005, respectively), Amphastar wants Woodcock to recuse herself from any FDA proceedings related to the applications, according to the WSJ. So far, an FDA spokesman told a Journal reporter, Woodcock has chosen not to recuse herself.
Time will tell what the outcome of the ethics complaint will be, and whether the WSJ story will influence Woodcock’s decision about recusal, but in the meantime the article is worth a read. It explains the somewhat complicated history of the companies’ efforts to get their drugs approved, as well as Sasisekharan’s involvement with the FDA’s 2008 investigation of contaminated heparin from China. (The two co-authored papers in question resulted from that investigation.)
At least one observer thinks Amphastar’s complaint won’t amount to much. “We don’t believe that this last ditch effort by Amphastar will have any real effect on the outcome of the [applications],” wrote Simos Simeonidis, a biotech analyst for research and investment firm Rodman & Renshaw in New York, in a note to investors today. “However, we believe that in the end, the data will determine the outcome of both these applications, and we believe that the science is on Momenta’s side.”
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