FDA's 5-year NCE exclusivity grant to VYVANSE: Court upholds decision

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that the United States District Court for the District of Columbia ("Court"), following extensive briefing by the parties and an oral hearing, has upheld the decision of the U.S. Food and Drug Administration ("FDA") to grant 5-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).

On February 23, 2007, after reviewing the requisite clinical studies submitted on behalf of VYVANSE, the FDA determined that VYVANSE qualified as an NCE within the meaning of the governing statutes and regulations. As an NCE, VYVANSE is entitled to 5-year market exclusivity. The FDA therefore appropriately 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 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. On October 23, 2009, following a thorough administrative review, the agency affirmed lisdexamfetamine, the active ingredient in VYVANSE, is a new active moiety and that its prior designation of VYVANSE as an NCE was proper.

Shire is pleased that on March 4, 2010, following the extensive briefing of the parties and an oral hearing, the Court upheld the FDA's decision (and reaffirmation) that VYVANSE is entitled to 5-year market exclusivity. The Court correctly determined that FDA's actions complied with federal administrative law standards as a reasonable exercise of the agency's scientific expertise. The five-year exclusivity period for VYVANSE expires on February 23, 2012, and precludes generic manufacturers from submitting an ANDA to FDA until that time, or until February 23, 2011 should a generic applicant challenge the United States patents covering Vyvanse, which remain in effect until June 29, 2023.

SOURCE Shire plc