25 May 2011
Shire Receives VYVANSE® Paragraph IV Notice Letters
Dublin, Ireland – May 25, 2011 – Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that its subsidiary Shire LLC has received Paragraph IV Notice Letters from Amneal Pharmaceuticals, LLC. (“Amneal”) and Watson Laboratories, Inc. (“Watson”), advising of the filing of Abbreviated New Drug Applications (“ANDA”) by each company for generic version of all strengths of lisdexamfetamine dimesylate capsules, VYVANSE. These are the second and third Paragraph IV Notice Letters directed to VYVANSE received by Shire. The first Paragraph IV Notice Letter for Vyvanse was received by Shire on May 18, 2011 from Sandoz.
VYVANSE is protected by sixteen FDA Orange Book listed patents, all of which expire in 2023.
Shire is currently reviewing the details of Amneal’s and Watson’s Paragraph IV Notice Letters, which were directed to the patents listed in the Orange Book.
Under the Hatch-Waxman Act, Shire has 45 days from the receipt of each of the Notice Letters to determine if it will file patent infringement suits against Amneal and Watson. If Shire brings suit pursuant to the Hatch-Waxman regulations, a 30-month stay of approval will be imposed by the FDA on Amneal’s and Watson’s ANDA.
The Hatch-Waxman exclusivity period for VYVANSE runs until February 23, 2012.
Shire expects to receive additional Paragraph IV certifications filed against Vyvanse on terms similar to those already received. Shire will provide details of any further Paragraph IV certifications received, and any litigation that is subsequently initiated, in its periodic filings on Forms 10-Q and 10-K.
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Notes to editors
Shire’s strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit hyperactivity disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI) diseases as well as opportunities in other therapeutic areas to the extent they arise through acquisitions. Shire’s in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights. Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.
For further information on Shire, please visit the Company’s website: http://www.shire.com.
"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, the Company’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of the Company’s Specialty Pharmaceutical and Human Genetic Therapies products, as well as the ability to secure and integrate new products for commercialization and/or development; government regulation of the Company’s products; the Company’s ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company’s products; the Company’s ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Company’s ability to obtain and maintain government and other third-party reimbursement for its products; and other risks and uncertainties detailed from time to time in the Company’s filings with the Securities and Exchange Commission.