FDA Denies Teva Pharmaceutical (TEVA) Citizen Petition

Goldman Sachs analysts Randall Stanicky, Stephan Stewart and Gregory Waterman commented on the FDA's denial of a Citizen Petition (CP) from Teva Pharmaceutical Industries TEVA that requested that the FDA not approve any ANDA applications for a generic Copaxone unless specific requirements are met. The analysts said that the denial of Teva Pharmaceutical Industries' Citizen Petition was expected. The analysts are currently Not Rated on Teva Pharmaceutical Industries. The Goldman Sachs analysts wrote, "we continue to see no imminent threat to Teva’s Copaxone franchise (about 20% of GP from 2010 US sales) and see the FDA’s response as a positive sign that the Agency recognizes the complications involved in approving a generic Copaxone. Guidance for peak sales of c. $3 billion midway through the planning period of 2010-2015 reflect novel competition in 2012 and generic competition in 2014. Background: Teva’s CP requested that the FDA not approve any generic Copaxone unless: (1) Copaxone had been fully characterized and the generic contains exactly the same polypeptide sequence with the same structure as Copaxone; and (2) all polypeptide sequences that contribute to the therapeutic effects of Copaxone have been identified and the ANDA has proven that its product contains exactly the same clinically relevant polypeptide sequences. Momenta and Mylan (via an India based partner we met with in March) are the only two P-IV filers to have ANDAs accepted by the FDA, to our knowledge. Momenta is first to file, with 30-month stay expiring in February 2011."