Losing momentum

Momenta Pharmaceuticals Inc. placed a high stakes wager in September 2005 when it decided to submit its application for FDA approval of M-Enoxaparin as a generic drug, rather than use the regulatory pathway that other manufacturers have used to gain approvals of follow-on versions of biologics that are marketed under NDAs.

MNTA and partner Sandoz, the generics unit of Novartis AG (NVS; SWX:NOVN, Basel, Switzerland) are dangerously close to losing that bet, as FDA's Office of Generic Drugs last week issued a not approvable letter for M-Enoxaparin citing immunogenicity concerns. ...