Spectrum Pharmaceuticals, Inc. has settled a patent litigation with GlaxoSmithKline relating to sumatriptan injection, the generic version of GlaxoSmithKline's Imitrex Injection.
The confidential terms of the settlement, which remain subject to government review, provide that Spectrum may exclusively distribute authorized generic versions of certain sumatriptan injection products in the United States with an expected launch during GSK's sumatriptan paediatric exclusivity period which begins on August 6, 2008, but with the launch occurring not later than November 6, 2008. Spectrum will launch sumatriptan injection through its partner for the sale and distribution of the drug, Par Pharmaceuticals Companies, Inc., a Spectrum press release stated.
GlaxoSmithKline's Imitrex Injection (sumatriptan succinate injection) for the acute treatment of migraine attacks and the acute treatment of cluster headache episodes has annual US sales of approximately $220 million, according to IMS Health.
"This settlement with GlaxoSmithKline for sumatriptan injection represents another milestone achieved by Spectrum this year, as we now have clarity regarding our exclusive launch of the important products covered under this agreement," stated Rajesh C. Shrotriya, M.D., chairman, chief executive officer and president of Spectrum Pharmaceuticals, Inc. "Spectrum will receive the majority of the profits from the sale of sumatriptan injection, and we expect to use those profits to fund the further development of our proprietary drug pipeline."
In February 2006, Spectrum entered into an agreement with Par Pharmaceutical to develop and market generic drugs for the company, including sumatriptan injection. In 2004, Spectrum filed an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the US Food and Drug Administration seeking marketing clearance for sumatriptan injection, which was approved by the FDA in October 2006.
In accordance with the settlement agreement, pending litigation between Spectrum and GSK in the United States District Court for the District of Delaware is expected to be dismissed pending review by the Federal Trade Commission. GSK will grant Spectrum an exclusive license to market, sell and distribute certain generic versions of sumatriptan injection in the United States during GSK's sumatriptan pediatric exclusivity period, which begins on August 6, 2008, but with the launch occurring not later than November 6, 2008.