Clinical Data receives U.S. patent for vilazodone

Nov 16 2010

Clinical Data, Inc. (NASDAQ: CLDA) today announced the issuance of U.S. Patent No. 7,834,020 claiming the polymorphic form of vilazodone (vilazodone HCl, Form IV), a compound currently in development for the treatment of Major Depressive Disorder. The issued patent extends exclusive protection in the U.S. of the most commercially viable polymorphic form of vilazodone nearly three additional years beyond the projected allowable patent term extension of the composition of matter patent for the chemical structure of vilazodone. A New Drug Application for vilazodone was accepted for review by the U.S. Food and Drug Administration (FDA) on May 21, 2010 with January 22, 2011 currently assigned for decision-making by the FDA under the Prescription Drug User Fee Act (PDUFA).

“This patent is an important addition to our intellectual property estate for vilazodone, providing even greater protection for the product as we continue to advance our preparations for a commercial launch, upon approval, next year”

"This patent is an important addition to our intellectual property estate for vilazodone, providing even greater protection for the product as we continue to advance our preparations for a commercial launch, upon approval, next year," said Drew Fromkin, President and CEO of Clinical Data. "Adding three additional years of exclusivity for the key polymorphic form of a drug that has blockbuster potential and for which the Company holds exclusive worldwide rights should have a very positive impact on the value of Clinical Data going forward. Our strategies for securing further market exclusivity for vilazodone are also progressing, and we anticipate that related, additional claims are likely to be issued in the future."

The issued patent, which will expire in June 2022, covers vilazodone HC1 in Form IV, its process of preparation and method of treatment therewith. The patent is also listable in the FDA's Orange Book. A European counterpart, EP1397357, has also been granted, which will provide protection until May 2022. To date, related applications have also been granted in Australia, China, Hong Kong, Mexico, New Zealand, Pakistan, Russian Federation, Singapore, Ukraine, and South Africa. Applications are also pending in many other countries, including Japan.