Healthcare Industry News: migraine
News Release - February 23, 2006
Par Pharmaceutical Announces Product Collaboration with Spectrum Pharmaceuticals, Inc.Par Gains Access to Several Generic Injectable and Ophthalmic Products Currently Awaiting FDA Approval, Including Potential First-to-File Sumatriptan Injection
SPRING VALLEY, N.Y., Feb. 23 (HSMN NewsFeed) -- Par Pharmaceutical Companies, Inc. (NYSE: PRX ) today announced that it has entered into a collaborative agreement with Spectrum Pharmaceuticals, Inc. to develop and market generic drugs, including generic versions of injectable and ophthalmic pharmaceuticals. Spectrum, located in Irvine, California, is a specialty pharmaceutical company that develops both proprietary and generic drugs.
"Our collaboration with Spectrum will expand the therapeutic scope, as well as the size of Par's generic product pipeline," said Scott Tarriff, president and chief executive officer. "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."
While Abbreviated New Drug Applications (ANDAs) have been filed on several of the products subject to the agreement, 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 6 mg/0.5 mL, the generic version of GlaxoSmithKline's (GSK) Imitrex® Injection. Imitrex® 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.
In 2004, Spectrum filed an ANDA containing a paragraph IV certification with the U.S. Food and Drug Administration seeking marketing clearance for its generic version of the drug. Spectrum and Par believe that Spectrum was the first to file and is entitled up to 180 days of marketing exclusivity for the product. Spectrum is currently in litigation with GSK, who has alleged that Spectrum's product infringes U.S. Patent No. 5,037,845. Spectrum has alleged that its product does not infringe this patent and that the patent is invalid and unenforceable.
Terms of the Agreement
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.
Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI ) is a specialty pharmaceutical company engaged in the business of acquiring, developing and commercializing prescription drug products for the treatment of cancer and other unmet medical needs. By leveraging its operational flexibility and regulatory proficiency, and using the extensive research and development capabilities of its strategic alliance partners, Spectrum has built a diversified portfolio of proprietary and generic drug products in various stages of development and regulatory approval. More information about Spectrum can be found at http://www.spectrumpharm.com.
Par Pharmaceutical Companies, Inc. develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets. In 2005, Par received approval for and introduced Megace® ES, its first branded pharmaceutical product, and expects to launch its second in 2006. Par's Generic Products Division is committed to providing high-quality pharmaceuticals that are affordable and accessible to patients. Par manufactures, markets or licenses more than 100 generic drugs. For press release and other company information, visit http://www.parpharm.com.
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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