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Peptimmune Files Citizen Petition Regarding Generic Copaxone and Demonstrates Significant Enabling Technology for Biological Characterization of Copaxone
Date:10/4/2010

ce for a generic copy of Copaxone should include the comparative PK and PD studies proposed in the Citizen Petition.  Our studies demonstrate a direct correlation between Copaxone serum exposure and activation of the innate immune system.  Controlling this relationship in particular is critical to ensure safety and therapeutic effect of any generic copy of Copaxone.  The effect of Copaxone cannot just be simply explained by induction of regulatory T cells; its effect on antigen presenting cells is just as important.  Systemic exposure of Copaxone facilitates the direct effect on monocyte activity, perhaps even in the brain.  If a generic manufacturer primarily limits its characterization of a generic copy to comparative antibody responses or T cell responses they could be significantly underestimating the copy's biological effects."

The Citizen Petition is available for download at www.peptimmune.com/news.

About Multiple Sclerosis

Over 400,000 Americans have multiple sclerosis (MS), and MS may affect over 2.5 million individuals worldwide.  MS is an autoimmune disease in which the individual's immune system responds against multiple components of nerve-insulating myelin.  The effects of these immune-mediated attacks can range from relatively benign to somewhat disabling to devastating, as communication between the brain and other parts of the body is disrupted.

About Peptimmune

Peptimmune, Inc. is a privately held clinical stage biotechnology company focused on the development of PI-2301, a second-generation peptide copolymer from a similar compound class as Copaxone. PI-2301 has shown to be more potent and effective than Copaxone in treating disease models for multiple sclerosis. The Company plans to continue developing this promising compound by initiating a Phase II study in relapsing remitting multiple sclerosis patients later this y
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SOURCE Peptimmune, Inc.
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