According to a SEC 8-K filing today, an amendment has been submitted to the FDA for Momenta Pharma's (MNTA) Enoxaparin Sodium Injection Abbreviated New Drug Application [ANDA] by its partner, Sandoz, which is the generic drug operating division of Novartis (NVS). Momenta believes the amendment represents a complete response to the agency's concerns over the potential for immune-mediated reactions to the product, which is intended to be a generic equivalent of the injectable blood thinner Lovenox.
Momenta Pharma represents a pure-play on the future of complex bio-generic drugs with a major near-term opportunity to steal market share from Lovenox, which posted blockbuster sales of $3.8 billion worldwide in 2007. The Company's stock price tanked to below $5 per share last November as the FDA rejected the ANDA for Enoxaparin. The generic division of the FDA does not issue decision date deadlines, but the fact that no new clinical trials were required and the complete response has now been filed by Sandoz removes a degree of uncertainty and makes it a waiting game for Momenta investors.
$55.07 (09/26/08)
