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John P. Gavin, CFA, is the founder and CEO of Disclosure Insight®, an independent publisher of investment research. Mr. Gavin has spent his entire career of over 25 years in the financial services industry. Prior to starting “DI” in 2000, he worked as an equity analyst and portfolio manager... More
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  • MDCO Reaches Settlement With APP Pharmaceuticals, But Legal Issues Not Over Yet 0 comments
    Jan 23, 2012 1:50 PM | about stocks: MDCO

    The Medicines Company (NASDAQ: MDCO announced this morning that it had settled its litigation with APP Pharmaceuticals regarding that company's attempt to manufacture a generic version of Angiomax. While the settlement appears to be an amicable end to the matter, MDCO still faces challenges from several other generic manufacturers.

    In addition to the APP matter, MDCO was involved in litigation with Mylan and Dr. Reddy's Laboratories as of the 10-Q filed 9-Nov-11. The company also disclosed that Sun Pharmaceutical Industries had submitted an ANDA in Oct-11. Each of those companies seeks permission to manufacture a generic version of Angiomax prior to the expiration of two patents covering the drug.

    As part of the settlement, MDCO entered into a license agreement whereby APP will have the right to launch a generic product effective 1-May-19. The two parties also entered into a manufacturing agreement under which APP agreed to manufacture and supply Angiomax to MDCO, providing the company additional supply capacity for its biggest product.

    Also of note is the Sep-11 resolution of a similar legal battle with Teva. As part of that settlement, Teva will be able to manufacture and market a generic version of Angiomax effective 30-Jun-19. The fact that the two license dates are relatively close suggests that the outstanding matters with Mylan, Dr. Reddy's, and Sun could be resolved with a similar outcome.

    As of the 10-Q filed 9-Nov-11, MDCO had 3 approved products. Sales of Angiomax accounted for approximately 99.8% of the company's $352.5 million in 9M11 net revenue.

    Stocks: MDCO
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