Clinical Data to pay $15.6 million milestone to Merck KGaA, as FDA accepts vilazodone filing

The US Food and Drug Administration has accepted for filing Massachusetts-based Clinical Data's New Drug Application for vilazodone for the treatment of major depressive disorder (MDD).

The news triggers a 12.5 million-euro ($15.6 million) milestone payment to German drug major Merck KGaA, payable in 920,901 shares of Clinical Data common stock to be issued within 30 days of the NDA acceptance date for vilazodone, a dual-acting potent and selective serotonin reuptake inhibitor and a 5-HT1A receptor partial agonist. The drug was licensed from the German firm's Swiss affiliate Merck Serono. The NDA will be subject to a standard review.

'The acceptance of the NDA for review by the FDA is another positive step toward our goal of bringing vilazodone to market, and if approved, vilazodone will offer a novel treatment to the millions of people suffering from depression,' said Carol Reed, executive vice president and chief medical officer of Clinical Data.