Clinical Data, Inc. Announces Approval Of Generic Name Vilazodone, First In A New Class Of Experimental Treatments For Depression

Main Category: Depression
Also Included In: Regulatory Affairs / Drug Approvals;  Psychology / Psychiatry;  Mental Health
Article Date: 22 Jun 2009 - 3:00 PDT

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Clinical Data, Inc. (NASDAQ: CLDA) announced today that the United States Adopted Name Council (USAN) has approved the generic name vilazodone hydrochloride. Vilazodone, if approved, would represent a first-in-class drug for the treatment of depression, due to its novel dual mechanism of action as both a potent and selective serotonin reuptake inhibitor (SSRI) and a partial agonist of the 5-hydroxytryptamine 1a (5-HT1A) receptor. Thus, vilazodone combines first-line therapy for depression with 5-HT1A partial agonism, an accepted adjunctive treatment for depression and a first-line therapy for anxiety disorders. Clinical Data has recently completed the second of two positive Phase III registration studies. Results of these studies will form the basis of a new drug application (NDA) that the Company intends to submit with the U.S. Food and Drug Administration (FDA) by the end of 2009.

The purpose of the USAN Council is to select simple, informative and unique nonproprietary names for drugs based on pharmacological and/or chemical relationship. The American Medical Association, the United States Pharmacopeial Convention and the American Pharmacists Association sponsor the Council. The Council works closely with the World Health Organization's International nonproprietary Name Program.

On June 2, 2009, Clinical Data announced top-line results from its second Phase III studies for vilazodone, with results confirming its prior positive Phase III trial. Vilazodone was generally well-tolerated and met both the primary and secondary endpoints of the study with high statistical significance. In addition, study findings corroborate that effects of vilazodone on sexual function were comparable to placebo when measured by an objective validated scale, an important finding since many antidepressants have been associated with causing or exacerbating sexual dysfunction. In this second study, the most frequent side effects associated with vilazodone were diarrhea, nausea, and headache.

The Company has projected that its current cash will be sufficient to fund operations through the submission of the NDA for vilazodone this year, as well as the commencement of its Phase III clinical program for Stedivaze, a vasodilator used for cardiac stress testing, anticipated in the next month. Management continues to evaluate additional sources of financing including partnering opportunities with pharmaceutical or biotechnology companies for development and marketing of late-stage or pre-clinical compounds, sale of non-core assets and the sale of equity or debt securities.

At March 31, 2009, the Company reported cash and marketable securities totaling $56.4 million. Based on its cash position, Clinical Data received a going concern explanatory paragraph in the unqualified audit opinion included in its Annual Report on Form 10-K which was filed with the Securities and Exchange Commission on Monday, June 15, 2009. This announcement is required by NASDAQ Marketplace Rule 4350(b)(1)(B), which requires separate disclosure of receipt of an audit opinion containing a going concern qualification. This announcement does not represent any change to the Company's Annual Report on Form 10-K or the financial statements included therein.

About Depression and the Anti-Depressant Market

According to the National Institute of Mental Health (NIMH), 18.1 million Americans suffered from depression in 2007. In addition, major depressive disorder is the leading cause of disability in individuals ages 1544. IMS Health's National Prescription Audit reported more than 200 million prescriptions for antidepressants in 2008. The Surgeon General's Office also estimates that 5.3% of American adults, approximately 17 million people, suffer from depressive illness.

Source
Clinical Data, Inc.