Momenta Pharmaceuticals
The FDA said M-enoxaparin, a drug designed to have the same anti-clotting effect as Sanofi-Aventis'
"We are extremely pleased," said Craig Wheeler, Momenta's CEO, in a statement.
Of course, this being the generics business, Momenta isn't the only company eyeing this market. Last August, the Wall Street Journal reported that a competitor made an ethics complaint about the FDA handling of Momenta's application for M-enoxaparin. Amphastar Pharmaceuticals, of Rancho Cucamonga, CA, alleged that Momenta had special access to Janet Woodcock, a top FDA official, while both firms were seeking approval for generic versions of enoxaparin. The complaint said Woodcock was a co-author with Momenta scientists on two scientific papers published in 2008.
Momenta made a brief nod toward Amphastar, and another rival, Teva Pharmaceuticals, in today's statement. "The company is aware that other ANDAs for enoxaparin sodium injection have been filed. These other applicants may receive approval at a later date," Momenta said.
Shares of Momenta climbed 77 percent to $21.10 at noon Eastern Time today. Momenta is hosting a conference call at 1 pm ET to discuss the news in greater detail.
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Luke Timmerman is the National Biotech Editor of Xconomy, and the Editor of Xconomy Seattle. You can e-mail him at [email protected], or follow him at twitter.com/ldtimmerman.