LONDON -(Dow Jones)- Shire PLC (SHP.LN), the global specialty biopharmaceutical company, said Monday that the Food and Drug Administration, or FDA, has affirmed its prior decision to grant five-year New Chemical Entity, or NCE, exclusivity to lisdexamfetamine dimesylate-currently marketed by Shire U.S. Inc. for the treatment of attention-deficit hyperactivity disorder under the name VYVANSE.
MAIN FACTS:
-The five-year exclusivity period for VYVANSE expires on Feb. 23, 2012.
-VYVANSE is covered by United States patents which remain in effect until June 29, 2023.
-On Feb. 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.
-On Feb. 24, Actavis sued the FDA in the District Court of the District of Columbia challenging the NCE decision.
-On April 13, 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.
-By London Bureau, Dow Jones Newswires; Contact Ian Walker; +44 (0)20 7842 9296; ian.walker@dowjones.com