Clinical Data Inc. has completed the transfer of the manufacturing technology necessary to produce a commercial supply of vilazodone, its dual serotonergic antidepressant currently in pivotal phase III clinical trials in the United States.
The company's wholly owned subsidiary, Genaissance Pharmaceuticals, Inc., acquired the rights to develop and commercialise vilazodone from Merck KGaA of Darmstadt, Germany in September 2004. Under the terms of the license agreement, the company was required to make a milestone payment to Merck for the transfer of the vilazodone manufacturing technology in Clinical Data Common Stock equivalent in value to EUR 1.25 million Euro.
The milestone payment has been made through the issuance of an aggregate of 102,588 shares of Clinical Data Common Stock, 24,947 of which shares were issued at the time of the exercise of the company's right to transfer the manufacturing technology in August of this year, and 77,641 of which shares were issued on December 20, 2006, when the transfer was completed. All of the shares issued to Merck are unregistered but carry certain demand and incidental registration rights as provided under the license agreement.
The company intends to conduct aspects of the manufacturing of the clinical development and commercial supply of vilazodone through a third party.
Vilazodone is a dual serotonergic antidepressant in pivotal phase III clinical trials that Clinical Data is developing with a companion biomarker, which will act as a genetic-based, predictive screening tool to guide the use of this novel antidepressant. It is both a Selective Serotonin Reuptake Inhibitor and a 5HT1A partial agonist that has been found to have an acceptable safety profile for this stage of development.