Momenta Pharmaceuticals, Inc. (MNTA)

[floblu14]

Momenta Presents Key Glatopa(TM) (glatiramer acetate injection) Data at American Academy of Neurology Annual Meeting
Date : 04/20/2015 @ 8:00AM

Momenta Presentation Highlights:

Poster #P1.144 – Comparative Gene Expression Profiling between a Generic (Glatopa) and Brand COPAXONE (glatiramer acetate injection)

Microarray analysis across the entire genome was performed in murine glatiramer acetate-responsive Th2-polarized T cells, a test system highly relevant to the biology of glatiramer acetate. Multiple statistical methods consistently demonstrated assay sensitivity as well as equivalent gene expression profiles between Glatopa and Copaxone.

Poster #P1.145 – Demonstration of Equivalence between a Generic (Glatopa) and Brand COPAXONE (glatiramer acetate injection)

This poster summarized Momenta's overall approach of comparison, as well as multiple examples of equivalence of starting materials and basic chemistry; equivalence of structural manufacturing process signatures; equivalence of physicochemical (structural) properties; and equivalence of biological/immunological (functional) properties.

The selected assays and data presented at AAN are examples of the extensive physicochemical methods and biological/immunological assays that were submitted to the FDA as part of the recently approved data package for Glatopa.

"These posters not only provide examples of the comprehensive program we conducted to evaluate the equivalence of Glatopa and daily COPAXONE 20 mg, these data also further validate Momenta's ability to deeply characterize complex drugs and disease biologies and develop high-quality drugs," said Ganesh V. Kaundinya, Chief Scientific Officer of Momenta Pharmaceuticals.

http://ir.momentapharma.com/releasedetail.cfm?ReleaseID=907307