ViibrydTreatment for Depression
Update: Viibryd (vilazodone) Now FDA Approved - January 21, 2011
Clinical Data, Inc. Announces Issuance of New U.S. Patent for Vilazodone
- Extends Exclusive Protection of Polymorphic Form Nearly Three Additional Years –
NEWTON, Mass.--(BUSINESS WIRE)--Nov 16, 2010 - Clinical Data, Inc.) 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," 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.
Vilazodone is a novel dual-acting modulator of serotonin neurotransmission in development for the treatment of Major Depressive Disorder, with the potential for follow-on indications including Generalized Anxiety Disorder and other related mood disorders. Vilazodone has a unique dual mechanism of action and is a Serotonin 1A Receptor Partial Agonist and Reuptake Inhibitor (SPARI). Vilazodone, a compound to which Clinical Data holds exclusive worldwide rights from Merck KGaA, Darmstadt, Germany, is currently under review by the FDA with a PDUFA data of January 22, 2011.
About Clinical Data, Inc.
Clinical Data develops first-in-class and best-in-category therapeutics. The Company is advancing its late-stage drug candidates for central nervous system disorders and cardiovascular diseases, to be followed by promising drug candidates in major therapeutic areas including oncology and inflammatory diseases. Clinical Data plans to differentiate its therapeutics by combining its drug development and biomarker expertise to develop products with enhanced efficacy and tolerability, improving patient health and reducing costs. To learn more, please visit the Company's website at www.clda.com.
SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
This press release contains certain forward-looking information and statements that are intended to be covered by the safe harbor for forward looking statements provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. Words such as "expect(s)", "feel(s)", "believe(s)", "will", "may", "anticipate(s)" and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements about our ability to obtain regulatory approval for, and successfully introduce, vilazodone and our other drug candidates; our ability to expand our long-term business opportunities; and all other statements regarding future performance. All such information and statements are subject to certain risks and uncertainties, the effects of which are difficult to predict and generally beyond the control of the Company, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements contained in this press release. These risks and uncertainties include, but are not limited to, whether vilazodone or any of our other therapeutic products will advance further in the clinical trials process and whether and when, if at all, vilazodone or any of our other therapeutic products will receive final approval from the U.S. Food and Drug Administration and equivalent foreign regulatory agencies and for which indications; whether vilazodone or any of our other therapeutic products will be successfully marketed if approved; the strength of our intellectual property rights, including, but not limited to, our patents for the various polymorphic versions of vilazodone; competition from pharmaceutical, biotechnology and diagnostics companies; general economic conditions; and those risks identified and discussed by Clinical Data in its filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward looking statements that speak only as of the date hereof. Clinical Data does not undertake any obligation to publish revised forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Readers are also urged to carefully review and consider the various disclosures in Clinical Data's SEC periodic and interim reports, including but not limited to its Annual Report on Form 10-K for the fiscal year ended March 31, 2010, Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2010, and Current Reports on Form 8-K filed from time to time by the Company.
Contact: Clinical Data, Inc.
Theresa McNeely, 617-467-6673
Vice President, Corporate Communications
Posted: November 2010
- FDA Approves Viibryd to Treat Major Depressive Disorder - January 24, 2011
- Clinical Data, Inc. Announces FDA Acceptance of New Drug Application for Vilazodone for the Treatment of Major Depressive Disorder - May 24, 2010
- Clinical Data Submits NDA for Depression Compound - March 23, 2010