Genaissance Pharmaceuticals Inc has acquired an exclusive worldwide license from Merck KGaA to develop and commercialize vilazodone, a selective serotonin reuptake inhibitor (SSRI) and a 5HT1A partial agonist. In phase II clinical trials for depression, the compound has shown signals of efficacy and a favourable side effects profile in the more than 1,000 patients exposed to the compound.
Under the terms of the agreement, Merck KGaA is entitled to receive up to EUR 36 million worth of common shares of Genaissance for the initial license fee and milestone payments up to the first commercial sale, based on a trailing average of the closing price of the stock prior to the relevant payment dates. The license fee consisted of 369,280 shares, 84,000 of which were issued upon the execution of the letter of intent in April 2004. Merck KGaA will also receive royalties on all product sales and a share of all sub-licensing income from any third party, a company release says.
"As compared to the traditional drug development process, we see this agreement as representing a compelling value-creation template for Genaissance," said Kevin Rakin, president and CEO of Genaissance. "In this instance, as opposed to traditional drug development, a relatively modest investment should determine within two years whether a phase II compound can proceed to late stage pivotal clinical testing. Moreover, the compound has a novel mechanism of action with potentially superior claims for what is currently a $13 billion market in the US. We are also pleased to have a partner like Merck KGaA and that they have elected to become a stockholder in Genaissance."
"This is an innovative approach for the further development of one of our compounds that allows Merck to be in the forefront of pharmacogenomic developments with a leading company in this dynamic new field," said Merck chairman Bernhard Scheuble. "At the same time, Merck can continue to focus its R&D resources on its main therapeutic areas of Oncology and CardioMetabolic Care," he concluded.
According to the release, during the first half of 2005, Genaissance intends to commence enrolment for a phase II clinical trial that will include pharmacogenomic characterization of patients. Genaissance will apply its HAP Technology and clinical genetics experience and leverage the existing knowledge of the genetics of depression and response to antidepressants, especially to SSRIs. The primary goal of the clinical trial will be to find genetic markers that can be used to identify a population of patients who will respond to the drug.
"There is great potential to differentiate vilazodone from other drugs targeted for depression and anxiety," said Carol R. Reed, vice president, Medical Affairs of Genaissance. "Not only is its mechanism of action unique, but a pharmacogenomic-based drug should specifically target the problem of poor overall efficacy of current first-line treatments for depression. Since approximately 50 per cent of patients do not achieve initial relief of their depression, switching and discontinuation rates are very high and patient and physician satisfaction are low. By using genetics to target vilazodone, we believe that patients will achieve a satisfactory response and stay with the drug," he added.
Depressive illnesses interfere with normal functioning and cause pain and suffering not only for those affected, but also for those who care about them. Sales of products for the treatment of depression represent one of the largest therapeutic categories in the world.