District Court Upholds FDA's Grant of 5-Year Market Exclusivity to VYVANSE(R)
On February 23, 2007, after reviewing the requisite clinical studiessubmitted on behalf of VYVANSE, the FDA determined that VYVANSE qualified asan NCE within the meaning of the governing statutes and regulations. As anNCE, VYVANSE is entitled to 5-year market exclusivity. The FDA thereforeappropriately refused to file the Abbreviated New Drug Application ("ANDA")submitted by Actavis Elizabeth, LLC for generic lisdexamfetamine dimesylate.On February 24, 2009, Actavis sued the FDA in the District Court of theDistrict of Columbia challenging the NCE decision. On April 13, 2009, the FDAopened a public docket to consider Actavis's challenge to the FDA'sregulations governing NCE exclusivity and the corresponding award ofexclusivity to VYVANSE. On October 23, 2009, following a thoroughadministrative review, the agency affirmed lisdexamfetamine, the activeingredient in VYVANSE, is a new active moiety and that its prior designationof VYVANSE as an NCE was proper.
Shire is pleased that on March 4, 2010, following the extensive briefingof the parties and an oral hearing, the Court upheld the FDA's decision (andreaffirmation) that VYVANSE is entitled to 5-year market exclusivity. TheCourt correctly determined that FDA's actions complied with federaladministrative law standards as a reasonable exercise of the agency'sscientific expertise. The five-year exclusivity period for VYVANSE expires onFebruary 23, 2012, and precludes generic manufacturers from submitting anANDA to FDA until that time, or until February 23, 2011 should a genericapplicant challenge the United States patents covering Vyvanse, which remainin effect until June 29, 2023.
Notes to editors
Shire's strategic goal is to become the leading specialtybiopharmaceutical company that focuses on meeting the needs of the specialistphysician. Shire focuses its business on attention deficit hyperactivitydisorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI)diseases as well as opportunities in other therapeutic areas to the extentthey arise through acquisitions. Shire's in-licensing, merger and acquisitionefforts are focused on products in specialist markets with strongintellectual property protection and global rights. Shire believes that acarefully selected and balanced portfolio of products with strategicallyaligned 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 REFORMACT OF 1995
Statements included herein that are not historical facts areforward-looking statements. Such forward-looking statements involve a numberof risks and uncertainties and are subject to change at any time. In theevent such risks or uncertainties materialize, the Company's results could bematerially adversely affected. The risks and uncertainties include, but arenot limited to, risks associated with: the inherent uncertainty of research,development, approval, reimbursement, manufacturing and commercialization ofthe Company's Specialty Pharmaceutical and Human Genetic Therapies products,as well as the ability to secure and integrate new products forcommercialization and/or development; government regulation of the Company'sproducts; the Company's ability to manufacture its products in sufficientquantities to meet demand; the impact of competitive therapies on theCompany's products; the Company's ability to register, maintain and enforcepatents and other intellectual property rights relating to its products; theCompany's ability to obtain and maintain government and other third-partyreimbursement for its products; and other risks and uncertainties detailedfrom time to time in the Company's filings with the Securities and ExchangeCommission.
SOURCE Shire plc
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