Healthcare Industry News: sumatriptan
News Release - November 13, 2006
Par Pharmaceutical Announces Agreement With GlaxoSmithKline to Settle Imitrex(R) Injection Patent LitigationSettlement Agreement with GSK Resolves Imitrex(R) Injection Patent Litigation and Permits Par to Launch Generic Version in 2008
WOODCLIFF LAKE, N.J., Nov. 13 (HSMN NewsFeed) -- Par Pharmaceutical Companies, Inc. (NYSE: PRX ) today announced that its partner, Spectrum Pharmaceuticals, Inc., has entered into a settlement agreement with GlaxoSmithKline (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 U.S. Food and Drug Administration seeking marketing clearance for sumatriptan injection. Spectrum Pharmaceuticals and Par believe that Spectrum Pharmaceuticals was the first to file an ANDA for the product.
Settlement and License Agreements
In accordance with the settlement and license agreement, pending litigation between Spectrum Pharmaceuticals 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.
Par Pharmaceutical Companies, Inc. develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets. For press release and other company information, visit http://www.parpharm.com.
Safe Harbor Statement
Certain statements in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this news release contain information that is not historical, these statements are essentially forward- looking and are subject to risks and uncertainties, including the difficulty of predicting FDA filings and approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, uncertainty of patent litigation filed against us, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission, such as the Company's Form 10-K, Form 10-Q, and Form 8-K reports.
Source: Par Pharmaceutical
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