Shire plc Files Suit against Cadila Healthcare Limited, Doing Business As Zydus Cadila and Zydus Pharmaceuticals (USA) Inc.
The lawsuit was filed as a result of an Abbreviated New Drug Application (ANDA) filed by Zydus seeking FDA approval to market and sell generic versions of Lialda® (mesalamine) prior to the expiration of the „720 patent.
Lialda® was developed by Cosmo 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 patent expires in 2020.
Under the Hatch-Waxman Act, because Shire filed its patent infringement lawsuit within 45 days of receiving the Paragraph IV notification letter from Zydus, the FDA must refrain from approving Zydus‟ ANDA for 30 months, or until a district court decision finding that the patent is invalid or not infringed, whichever occurs earlier. The stay on the generic approval will expire November 2012 unless terminated earlier. Chris Tanner, CFO of Cosmo Pharmaceuticals, commented: "Cosmo's royalties from Lialda® are capped at US$ 95 million and the Company expects this cap to be reached in 2014 or 2015. Manufacturing revenues are likely to continue under most scenarios. Thus, whatever the outcome is of this event, it is unlikely to have a significant 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 2/2 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
Contact Dr. Chris Tanner, CFO and Head of Investor Relations Cosmo Pharmaceuticals S.p.A. Tel: +39 02 9333 7614
Some of the information contained in this press release contains forward-looking statements. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those in the forward-looking statements as a result of various factors. Cosmo undertakes no obligation to publicly update or revise any forward-looking statements.
Juliet Edwards Assistant Financial Communications
Holborn Gate, 26 Southampton Buildings London, WC2A 1PB T +44 (0)20 7269 7125 F +44 (0)20 7242 8695
www.fd.com