Spectrum, Par form alliance to develop, market generic drugs

By Elaine Rigoli

Tampa, Fla., Feb. 23 - Spectrum Pharmaceuticals, Inc. and Par Pharmaceutical Cos. Inc. announced Thursday that they have entered into a strategic alliance to sell and distribute Spectrum's generic drugs.

"We are very pleased to have Par as our partner as they have the expertise in the field of generics, financial strength and drug distribution skills. I believe our complementary skills and experience will enhance and expedite the development of our generics program, including what we hope will be a successful paragraph IV challenge for sumatriptan injection," said Rajesh C. Shrotriya, MD, Spectrum chairman, chief executive officer and president, in a company statement.

Under 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 United States.

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, according to a news release.

As of the date of signing the agreement, Spectrum had three abbreviated New Drug Applications approved and nine under review by the Food and Drug Administration. The agreement also covers additional aNDAs that Spectrum is developing, according to the release.

Among the products included in the agreement is sumatriptan succinate injection 6 mg/0.5 mL, the generic version of GlaxoSmithKline's Imitrex Injection 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 about $220 million, according to IMS Health.

"This agreement provides Par access to generic injectable and ophthalmic drugs, and adds a highly valued, first-to-file opportunity to our portfolio of potential new products. We look forward to working closely with our colleagues at Spectrum to make this a very successful alliance," said Scott Tarriff, Par president and chief executive officer, in a company statement.

Spectrum is based in Irvine, Calif., and is a pharmaceutical company that develops prescription drug products for the treatment of cancer and other unmet medical needs.

Par is based in Woodcliff Lake, N.J., and develops generic drugs and branded pharmaceuticals for specialty markets.

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