Copaxone glatiramer acetate regulatory update

Peptimmune Inc. (Cambridge, Mass.) submitted a Citizen's Petition to FDA that seeks to block approval of a generic version of Teva's multiple sclerosis (MS) drug Copaxone glatiramer. The petition, filed Oct. 1, requests that the agency not approve ANDAs for a generic Copaxone, as well as applications for a follow-on using section 505(b)(2) of the Food Drug and Cosmetics Act, which allows sponsors to reference data on safety and efficacy from scientific literature or from previously approved products. The petition asks the agency to require companies submitting the applications to include biological and biochemical assays and in vivo pharmacokinetic and pharmacodynamic profiles that demonstrate equivalence to the selective major histocompatibility complex (MHC) class II modulator. In the petition, Peptimmune provided data characterizing Copaxone based on its own methods of characterization.

Peptimmune said it is developing PI-2301, which is from a similar class as Copaxone, to treat MS. The company plans to start Phase II testing of the 4 amino acid random sequence peptide copolymer later this year. ...