FDA Warning Letter Creates Doubt of Momenta’s Generic Copaxone Launch in 2017
Despite fourth-quarter revenue coming in ahead of our expectations, Momenta's results have become overshadowed by an FDA warning letter issued on a key generic Copaxone 40mg manufacturing facility owned by Pfizer. While the warning will not restrict the production or shipment of the firm’s older generic Copaxone 20mg product (called Glatopa) at the Pfizer-owned facility, the issues raised by the FDA will likely delay approval of the pending 40mg drug application. As a result, management does not...Momenta Pharmaceuticals is a biotechnology company focused on the discovery and development of biologic therapies for the treatment of rare immune-mediated diseases. The company's programs include: M281, which is a fully-human anti-neonatal Fc receptor (FcRn), aglycosylated immunoglobulin G (IgG1), monoclonal antibody, designed to reduce circulating human immunoglobulin G (IgG) antibodies by completely blocking endogenous IgG recycling via FcRn; M230, which is a recombinant trivalent human IgG1 Fc multimer; and M254, which is a hyper-sialylated immunoglobulin designed as a high potency alternative to IVIg, a therapeutic drug product that contains pooled, IgG antibodies purified from blood plasma.
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