Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that the Food and Drug Administration (FDA), following a thorough administrative review of governing statutory and regulatory standards and public comments, has affirmed its prior decision to grant five-year New Chemical Entity (NCE) exclusivity to lisdexamfetamine dimesylate-currently marketed by Shire U.S. Inc. for the treatment of attention-deficit hyperactivity disorder under the name VYVANSE(R). The five-year exclusivity period for VYVANSE expires on February 23, 2012. VYVANSE is covered by United States patents which remain in effect until June 29, 2023.
On February 23, 2007, after reviewing the requisite clinical studies submitted on behalf of VYVANSE, the FDA determined that VYVANSE qualified as a NCE and was entitled to five-year market exclusivity. The FDA therefore appropriately refused to file the Abbreviated New Drug Application submitted by Actavis Elizabeth, LLC (Actavis) for generic lisdexamfetamine dimesylate in January 2009. On February 24, 2009, Actavis sued the FDA in the District Court of the District of Columbia challenging the NCE decision. On April 13, 2009, the FDA opened a public docket to consider Actavis's challenge to the FDA's regulations governing NCE exclusivity and the corresponding award of exclusivity to VYVANSE. The court case was stayed pending the outcome of this FDA review.
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