Merck & Co Inc and DOV Pharmaceutical Inc signs an agreement for the development and commercialization of DOV's novel triple uptake inhibitors being developed for depression and related psychiatric disorders.
Merck has licensed exclusive worldwide rights to DOV 21,947, which is in phase I, for all therapeutic indications. Merck has also licensed exclusive worldwide rights to DOV 216,303 for the treatment of depression, anxiety and addiction. DOV retains rights to DOV 216,303 for other indications.
Subject to approval under the Hart-Scott-Rodino Act, DOV will receive a $35 million up-front licensing payment. In addition, DOV could receive as much as $300 million for achieving certain clinical development and regulatory milestones for multiple territories and approval of two indications, and up to $120 million upon achievement of certain sales thresholds. Merck will assume responsibility for the full development, manufacturing and commercialization of DOV 21,947 and pay DOV royalties which increase based upon certain sales thresholds. DOV has an option to co-promote in the United States to psychiatrists and other specialists who treat depression, a release from Merck said.
"Merck's premier research and development capabilities, coupled with its extensive sales and marketing resources, make it the ideal partner for our novel depression programme," said Dr. Arnold Lippa, president and CEO of DOV. "Our co-promotion right provides DOV with the enhanced ability to build a first-rate, central nervous system-focused sales force in the United States. In addition, the $35 million initial payment and reduced clinical development expenditures will enable us to aggressively pursue our other clinical development programmes," added Dr Arnold.
Dr. Peter S Kim, president of Merck Research Laboratories said, "We believe that a triple uptake inhibitor that affects the neurotransmitters norepinephrine, serotonin and dopamine has the potential to offer physicians a real advance in the treatment of depression and related conditions."
Serotonin, norepinephrine and dopamine are neurotransmitters often linked to depression and other psychiatric disorders. In preclinical studies to date, DOV's compounds have shown to be potent and highly efficacious compared to commonly used antidepressants and have been generally safe and well-tolerated in early-stage clinical studies, the release added.
Clinical depression is one of the most common mental illnesses, affecting more than 50 million people worldwide each year. Depression is associated with significant loss of functioning and high morbidity.