Par Pharmaceutical Companies, Inc. recently announced that its partner, Spectrum Pharmaceuticals, Inc., has entered into a settlement agreement with GSK that resolves U.S. patent litigation related to GSK’s Imitrex® Injection, thereby eliminating the inherent uncertainty and costs of litigation. The confidential terms of the settlement, which remain subject to government review, permit Par to sell generic versions of certain sumatriptan injection products with an expected launch date during GSK’s sumatriptan pediatric exclusivity period which begins on August 6, 2008, but with the launch occurring not later than November 2008. Imitrex Injection (sumatriptan succinate injection) is used for the acute treatment of migraine attacks with or without aura, and the acute treatment of cluster headache episodes. Annual U.S. sales of Imitrex Injection are approximately $220 million, according to IMS Health.”Par is very pleased that this agreement permits us to go to market with a generic version of Imitrex sooner than may otherwise have been possible,” said Paul Campanelli, senior vice president, Business Development and Licensing. “Importantly, this settlement also eliminates the expenses and uncertainties associated with patent litigation.”In February 2006, Par entered into an agreement with Spectrum Pharmaceuticals to develop and market generic drugs, including sumatriptan injection. In 2004, Spectrum Pharmaceuticals filed an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the FDA seeking marketing clearance for sumatriptan injection. Spectrum Pharmaceuticals and Par believe that Spectrum Pharmaceuticals was the first to file an ANDA for the product.
