Forest Laboratories Holdings is acquiring exclusive rights in the U.S. for Saphris® (asenapine) from Merck Sharp & Dohme. The sublingual tablets are used in the treatment of adult patients with schizophrenia or acute bipolar mania.
Forest will make an upfront payment of $240 million and additional payments to Merck based on defined sales milestones. Merck will remain responsible for product supply. Forest will assume responsibility for continued commercialization including completing certain post-marketing studies of Saphris following a transition period, and will be the marketing authorization holder.
Saphris is an atypical antipsychotic approved by the FDA and launched in 2009. Merck recorded net sales of $150 million in the 12-month period ending September 2013.
“With Viibryd and our soon-to-be-launched product, Fetzima, Saphris complements our current position in psychiatry and gives us access to the important schizophrenia segment as we continue to work toward registering and commercializing cariprazine with our partner Gedeon Richter,” said Brent Saunders, president and CEO of Forest.
“The decision to divest Saphris in the U.S. is part of our ongoing strategy to sharpen our commercial and R&D focus and improve our operational effectiveness,” added Jay Galeota, president, hospital and specialty care at Merck. “This agreement will allow Merck to focus both R&D and commercial resources on other opportunities, while complementing Forest’s product portfolio and allowing for continued access to Saphris for physicians and patients.”
The National Institute of Mental Health estimates that approximately 2.4 million American adults, or about 1.1% of the population age 18 and older in a given year, have schizophrenia. The institute also estimates that bipolar disorder affects approximately 5.7 million American adults, or about 2.6% of the U.S. population age 18 and older in a given year.