Momenta Pharmaceuticals, Inc. (MNTA)

[DewDiligence]

The FDA can approve NVS/MNTA’s Copaxone ANDA irrespective of the patent litigation. Pursuant to Hatch-Waxman, there’s a 30-month stay on FDA approval following a Paragraph-IV challenge, but this 30-month stay for NVS/MNTA’s Copaxone ANDA expired on 1/11/11. (The clock on the 30-month stay started when the FDA accepted NVS/MNTA’s Copaxone ANDA for review on 7/11/08 [#msg-30621490] and NVS/MNTA notified Teva of their Paragraph-IV challenge, triggering the patent lawsuit by Teva.)

NVS/MNTA have clearly decided not to launch Copaxone “at risk” unless the Appellate Court reverses the District Court’s ruling. Hence, even following FDA approval of NVS/MNTA’s ANDA, there will no actual launch of generic Copaxone prior to the conclusion of the appeal unless there is a settlement between the parties.

Nevertheless, from the standpoint of MNTA’s shareholders, FDA approval of the Copaxone ANDA is consequential insofar as it can be expected to boost the share price substantially by re-validating MNTA’s technical prowess in replicating complex drugs and by guaranteeing that a generic-Copaxone launch is possible following the expiration (or settlement) of Teva’s patents.