FDA Accepts for Review OVATION's Two NDA Submissions for Sabril

Feb 27, 2008 - OVATION Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted the company's new drug applications (NDA) for Sabril(R) (vigabatrin) in two types of epilepsies. The FDA assigned a priority NDA review for Sabril for the treatment of Infantile Spasms (IS), and will review the submission for refractory complex partial seizures (CPS) in the same time frame. Sabril is currently under review by the FDA for use as a monotherapy for patients with IS and as an adjunctive treatment for adults with refractory CPS. A priority review designation is given to drugs that provide treatment where no adequate therapy exists, or that offer major advances in treatment.

"The FDA's acceptance of our Sabril NDA filings is a significant milestone for the company and for this development program as we continue to advance our late-stage central nervous system pipeline," said Jeffrey S. Aronin, OVATION President and Chief Executive Officer. "The Sabril program, along with other epilepsy compounds we have in development, reflect our commitment to exploring new treatment options for patients suffering from severe and catastrophic epilepsies, particularly where current treatment needs are not fully addressed."

To date, there are no medications approved by the FDA for the treatment of Infantile Spasms, a devastating form of epilepsy which usually strikes infants in the first year of life. In the United States, Infantile Spasms constitute about two percent of childhood epilepsies, and 25 percent of epilepsies with onset in the first year of life. Infants with IS suffer spasms that typically last for one to five seconds and occur in clusters of up to 100 spasms at a time.

Complex Partial Seizures are epileptic attacks that cause impaired consciousness and originate from a single region of the brain. About one-third of patients with CPS are unresponsive, or refractory, to treatment with many first- or second-line anti-epileptic drugs (AEDs). In patients with refractory CPS, these treatments may only reduce the frequency and severity of the seizures, rather than providing complete seizure control.