Shares of Momenta Pharmaceuticals Inc. continue to rise on news of its generic version of Lovenox, to be submitted for FDA approval next month.
The company's stock (NASDAQ:MNTA) increased $5.74 Friday, or 24.6 percent, to close at $29.09.
Valued at less than $10 per share only two months ago, Momenta's stock has steadily climbed throughout the summer, with a 62 percent jump June 16 following a judge's ruling invalidating Paris-based Sanofi-Aventis Group's Lovenox patent. The decision cleared the way for Momenta to file an abbreviated new drug application for M-Enoxaparin. Shares closed at $16.50 that day, up $6.36.
Other companies already have filed their abbreviated new drug applications, such as Jerusalem-based Teva Pharmaceuticals Industries Ltd. and Rancho Cucamonga, Calif.-based Amphastar Pharmaceuticals. But analyst Andrew McDonald, of ThinkEquity Partners LLC in San Francisco, said early indications suggest Momenta's generic could have "the best shot" at getting FDA approval
"We've been trying to gauge FDA sentiment," he told BioWorld Today, and consultants to the agency seem to believe that "the ANDAs in front of the FDA right now are not going to get approved."
Lovenox, a widely prescribed low-molecular-weight heparin, has proved to be a difficult drug to produce as a generic and maintain a pharmaceutical equivalency, McDonald said. He added that, if consultants are reading the FDA correctly, "the risk has been mitigated for Momenta."
Still, that might not fully explain the increased traffic Friday, when nearly 5.4 million shares changed hands, more than 11 times its average trading volume. But McDonald expects the climb to continue.
Once Momenta files its ANDA, the FDA's decision could come in 18 to 24 months. "I think there will continue to be incremental positives between now and then," he said.
M-Enoxaparin is partnered with Sandoz Inc., of Princeton, N.J.