Momenta seeks FDA approval for generic Lovenox

Momenta is developing its version, M-Enoxaparin, in collaboration with Sandoz, the generics division of Novartis AG. The companies will hope to take a slice of the worldwide sales for Lovenox, reported by Sanofi-Aventis to be $2.4 billion in 2004.

“The ANDA for M-Enoxaparin is a major accomplishment for Momenta, representing the first application for marketing approval filed with the FDA based upon our technology,” said Alan Crane, CEO of the Company. “We believe that our proprietary approach to characterizing and sequencing complex sugars can be applied to both the development of generic versions of complex drugs as well as to the discovery and development of novel products based on sugars.”

Under the FDA’s ANDA requirements, a generic drug must be shown to have, among other things, the same active ingredients as the innovator product upon which the generic application is based. Like other low molecular weight heparins, Lovenox consists of a heterogeneous mixture of complex sugar chains.