Shire plc, the global specialtybiopharmaceutical company, announces that the Food and DrugAdministration (FDA), following a thorough administrative review ofgoverning statutory and regulatory standards and public comments, hasaffirmed its prior decision to grant five-year New Chemical Entity(NCE) exclusivity to lisdexamfetamine dimesylate — currently marketed byShire US Inc for the treatment of attention-deficit hyperactivitydisorder under the name VYVANSE.
OnFebruary 23, 2007, after reviewing the requisite clinical studiessubmitted on behalf of VYVANSE, the FDA determined that VYVANSEqualified as a NCE and was entitled to five-year market exclusivity.The FDA therefore appropriately refused to file the Abbreviated NewDrug Application submitted by Actavis Elizabeth, LLC (Actavis) forgeneric lisdexamfetamine dimesylate in January 2009. On February 24,2009, Actavis sued the FDA in the District Court of the District ofColumbia 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. The court case was stayed pending the outcomeof this FDA review.