Supernus Provides Update on the Launch of Its Two Epilepsy Products Trokendi XR and SPN-804

Supernus Pharmaceuticals, Inc. SUPN announced on June 26 that it received a tentative approval letter from the Food & Drug Administration (the "FDA") for Trokendi XR™, a once-daily extended release formulation of topiramate (formerly known as SPN-538). The letter states that the FDA completed its review of the Trokendi XR NDA and that no additional clinical trials are required. The letter also states that final approval may not be made effective by the FDA until the period of exclusivity protection associated with safety information regarding a specific pediatric population expires. Since then, the Company has been in discussion with the FDA to clarify which of the three marketing exclusivities (December 2012, June 2013 or July 2014) that are listed in the Orange Book the FDA is referring to and how such exclusivity applies to its NDA. The Company is pleased to provide the following update. The marketing exclusivity that the FDA is referring to relates to pediatric patients, age 1-24 months. This exclusivity expires on June 22, 2013. Although such age bracket is not part of the patient population for which Trokendi XR will be indicated, the FDA is requesting that such safety information be included in the Trokendi XR label. Therefore, final approval may not be made effective by the FDA until such exclusivity expires.