SOMERVILLE, Mass., Oct. 4 /PRNewswire/ — Peptimmune, Inc.
announced today that it has filed a technically focused Citizen
Petition requesting that the FDA not approve any application for a
generic version of Copaxone® [glatiramer acetate injection] (Teva Pharmaceuticals).
“We feel that it is important for the FDA to have access to
Peptimmune’s data resulting from our characterization of Copaxone
using proprietary methods when considering ANDA applications for
generic forms of glatiramer acetate. We believe that
manufacturers of any purported generic version of Copaxone need to
demonstrate biological equivalence using state of the art methods.
Most importantly, this extensive biological characterization
that we have developed can serve to further guarantee the safety in
multiple sclerosis patients of any purported generic version of
Copaxone,” stated Thomas P. Mathers, President and Chief Executive
Officer of Peptimmune.
The Citizen Petition provides data that highlights several key
points for the FDA’s consideration:
- Comparative pharmacokinetic (PK) studies with a state of
the art method should be required to demonstrate bioequivalence of
a purported generic Copaxone
- The demonstrated bioavailability of Copaxone is linearly
correlated to its direct effect on the innate immune
- Pharmacodynamic (PD) studies with state of the art
methods are just as important as PK studies due to Copaxone’s
potent effect on the innate immune system
- Copaxone is a pro-drug which makes the demonstration of
bioequivalence very difficult for a purported generic
Eric H. Zanelli, PhD, Vice President of Research and Development
remarked that, “The safety and efficacy of any proposed generic
copy of such a complex drug cannot be guaranteed by physicochemical
characterization only. Demonstration of bioequivalen