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Spectrum: Sumatriptan Injection
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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 U.S. Food and Drug Administration seeking marketing clearance for sumatriptan injection, which was tentatively approved by the FDA in October 2006.
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Spectrum will not issue any shares of its common stock to PAR Pharmaceutical in relation to this milestone payment or any other transaction. In addition, Par will focus solely on the marketing and distribution of sumatriptan injection pursuant to the amended agreement.
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In November, Spectrum and GSK reached an agreement to settle patent litigation relating to sumatriptan injection. The terms of the confidential agreement 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 pediatric 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 Pharmaceutical Companies, Inc.
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Sumatriptan Injection