RBC Capital Markets continues to believe that Teva Pharmaceutical Industries Ltd.'s (NASDAQ: TEVA) generic Copaxone is unlikely in the near term. The brokerage also said FDA denied Copaxone Citizen Petition (CP) as it is premature to make a decision on generic approvability.
Given the complicated structure of Copaxone, combined with the fact that its mechanism of action is not well understood and that there are no clear surrogate markers of efficacy, we believe it is likely that clinical studies will be required for generic approval, said Shibani Malhotra, an analyst at RBC Capital.
Moreover, Malhotra is encouraged by the fact that in this petition the Agency recognizes the unique challenges related to a generic for Copaxone (for example, the complexity of the active ingredient) and despite considering this for a while now, has not yet been able to come to a view on what data would be required to approve a generic.
On Tuesday afternoon, we learned that the FDA denied Peptimmune’s CP regarding generics for Copaxone. Importantly, the FDA had denied this petition because it is still considering what evidence would be sufficient to show that the active ingredient in a proposed product is the same as Copaxone and it would be 'premature and inappropriate to definitively opine on this matter at this time', said Malhotra.
Malhotra said the agency had to take final action on the CP within 180 days of submission and thus was forced to respond even though it has not made a final determination on whether or not (and on what basis) to approve a generic Copaxone.
Peptimmune had filed a CP last year requesting that the FDA not approve a generic Copaxone without preclinical and clinical studies demonstrating equivalence using a variety of assays and studies including ones that specifically show equivalence in exposure and systemic effect on immunity.
Malhotra said this is based on Peptimmune’s view that without using the same manufacturing process it is unlikely a generic will be identical to Copaxone and that the safety and efficacy of this complex drug cannot be guaranteed by physiochemical characterization alone.
Teva's American Depository Receipt (ADR) is trading up 0.30 percent at $50.15 on the NASDAQ Stock Market at 9:36 am EDT.