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Shire receives LIALDAź Paragraph IV Notice Letter from Zydus Pharmaceuticals
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
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.
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