Par, Spectrum Enter Generic Pact

Par Pharmaceutical Companies, Inc. has entered into a collaborative agreement with Spectrum Pharmaceuticals, Inc. to develop and market generic drugs, including generic versions of injectable and ophthalmic pharmaceuticals.

ANDAs have been filed on several of the products subject to the agreement and other product candidates are currently in development or will be subject to future development. Among the products included in the agreement is sumatriptan succinate injection, the generic version of GlaxoSmithKline’s Imitrex Injection. In 2004 Spectrum filed an ANDA containing a paragraph IV certification with the FDA seeking marketing clearance for its generic version of the drug. Spectrum is currently in litigation with GSK, which has alleged that Spectrum’s product infringes U.S. Patent No. 5,037,845.

Under the terms of the agreement, Spectrum will be responsible for the development of all products. Par will have exclusive rights to market, promote, sell and distribute the products in the U.S. Par will be responsible for all future sumatriptan litigation expenses. Spectrum will receive milestone payments in connection with each successfully developed product. Par and Spectrum will share the net profits generated by all marketed products. At Spectrum’s request, Par will make an equity investment in the company during the next 24 months.