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Complex Generics

Momenta develops generic versions of complex drugs that were approved by the United States Food and Drug Administration (FDA), under New Drug Applications (NDAs). Most drugs approved as NDAs are simple small molecules that are easy to duplicate. However, products such as LOVENOX® (enoxaparin sodium injection) and COPAXONE® (glatiramer acetate injection), are complex molecular mixtures that are difficult to analyze and therefore difficult to reproduce as generics. The limited availability of complex generics has presented a broad set of challenges in healthcare based on the rising cost of these of types of drugs.

Momenta set out to meet this challenge by employing its complex systems analysis platform to define the detailed structures present in these complex drugs. Once the precise structures were identified, or characterized, this structural characterization of the brand product was used to guide the development of a precise manufacturing process to produce a generic version. Finally, to demonstrate that the biological function of our generic replicated that of the brand, we utilized our complex systems analysis platform to evaluate and compare multiple orthogonal sets of biologic data from in-vitro, in-vivo and ex-vivo models.

We have validated our approach to the development of highly complex generic molecules by becoming the first company to achieve FDA regulatory approval of fully substitutable generic versions of LOVENOX (enoxaparin sodium injection) and daily COPAXONE 20 mg (glatiramer acetate injection). Our generic version of glatiramer acetate injection was given the trade name Glatopa®. Both products were developed in collaboration with and are marketed by Sandoz.

We are also collaborating with Sandoz for the development and commercialization of M356, a generic version of three times weekly COPAXONE 40mg/mL (glatiramer acetate injection). Sandoz's Abbreviated New Drug Application (ANDA) for this product is currently under FDA review.

 

LOVENOX® is a registered trademark of Sanofi-Aventis. COPAXONE® is a registered trademark of Teva Pharmaceutical Industries Ltd. Glatopa® is a trademark of Novartis AG.

Last Updated 1/4/2016