6/1/2010 12:34:22 PM
Lainate, Italy – 31 May 2010 – Cosmo Pharmaceuticals S.p.A. (SIX: COPN) today reports that Shire plc (LSE: SHP, NASDAQ: SHPGY) announced on 28 May 2010 that it has received a Paragraph IV Notice Letter from Zydus Pharmaceuticals USA, Inc. (“Zydus”) advising of the filing of an Abbreviated New Drug Application (“ANDA”) for a generic version of 1.2g mesalamine delayed release tablets LIALDA®.
LIALDA® was developed by Cosmo Technologies Ltd, Ireland and licensed to Giuliani S.p.A. who licensed it to Shire.
LIALDA® is protected by the following FDA Orange Book listed patent: U.S. Patent No. 6,773,720, Mesalazine Controlled Release Pharmaceutical Compositions (the “’720 patent”). The patent expires in 2020.
Shire is currently reviewing the details of Zydus’ Paragraph IV Notice Letter. Under the Hatch-Waxman Act, Shire has 45 days from the receipt of the notice letter to determine if it will file a patent infringement suit. If Shire brings suit pursuant to the Hatch-Waxman regulations, a stay of approval of up to 30-months will be imposed by the FDA on Zydus’ ANDA.
Chris Tanner, CFO of Cosmo Pharmaceuticals, commented: "Cosmo's royalties are capped at $ 95 million and Cosmo expects that this cap will be reached in 2014 or 2015. Manufacturing revenues are likely to continue under most scenarios. Thus, any outcome of this event will most likely have a very limited impact on Cosmo's total share of revenues from LIALDA®."
About Cosmo Pharmaceuticals
Cosmo is a speciality pharmaceutical company that aims to become a global leader in the field of optimized therapies for selected Gastrointestinal and topically treated Skin Disorders. The company’s proprietary clinical development pipeline specifically addresses innovative treatments for IBD, such as Ulcerative Colitis and Crohn’s Disease, and Colon Infections. In addition, the Company is developing a new chemical entity for the topical treatment of Acne, Alopecia and Hirsutism. Cosmo’s first MMX® product that has reached the market is Lialda®/Mezavant®/Mesavancol®, a treatment for IBD that is licensed globally to Giuliani and Shire Limited. Cosmo’s proprietary MMX® technology is at the core of the Company’s product pipeline and was developed from its expertise in formulating and manufacturing gastrointestinal drugs for international clients at its GMP (Good Manufacturing Practice) facilities in Lainate, Italy. The technology is designed to deliver active ingredients in a targeted manner in the intestines. For further information on Cosmo, please visit the Company’s website: www.cosmopharmaceuticals.com
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