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NEW YORK — Forest Laboratories Holdings Ltd., a subsidiary of Forest Laboratories Inc., plans to buy the exclusive U.S. rights for Saphris sublingual tablets, a medication for schizophrenia or acute bipolar mania, from Merck Sharp & Dohme B.V., a unit of Merck & Co.
The pharmaceutical companies said Monday that under the agreement, 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.
Other financial terms of the deal weren’t disclosed. The companies said the agreement is slated to close in early 2014, pending regulatory review and satisfaction of all closing conditions.
Saphris is an atypical antipsychotic approved by the Food and Drug Administration and launched in 2009. Merck posted net sales of $150 million in the 12-month period ended in September.
“We are pleased to gain access to another commercial product in the CNS category. 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," stated Brent Saunders, chief executive officer and president of Forest Laboratories. "This deal is immediately accretive to Forest’s earnings and makes us more relevant to our customers, as well as our current and future business partners in the CNS category."
According to the companies, schizophrenia and acute bipolar mania are "significant areas of unmet medical need."
"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," commented Jay Galeota, president of 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."
