Synthon, Pfizer autoimmune, generics news
Synthon granted Pfizer exclusive, U.S. commercialization rights to a generic version of glatiramer acetate for relapsing/remitting multiple sclerosis. Teva Pharmaceutical Industries Ltd. (NYSE:TEVA, Petah Tikva, Israel) markets the drug as Copaxone.
The deal includes Synthon’s once-daily and thrice-weekly formulations of glatiramer. Both are under FDA review. Synthon said it believes the thrice-weekly version may be eligible for 180 days of shared marketing exclusivity under the Hatch-Waxman Act, but Pfizer declined to clarify who would share the rights and did not say whether Pfizer or Synthon is planning to challenge Teva’s U.S. patent on the thrice-weekly formulation. Synthon said financial terms are not disclosed, and Pfizer did not provide additional details. ...