NEW YORK—Forest Laboratories Holdings Limited, a wholly owned subsidiary of Forest Laboratories, Inc. today announced that the company is acquiring exclusive rights in the United States for Saphris (asenapine) sublingual tablets, a treatment for adult patients with schizophrenia or acute bipolar mania, from Merck Sharp & Dohme B.V., a wholly owned subsidiary of Merck & Co., Inc.
Under the terms of 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 details of the financial terms of the agreement were not disclosed. The agreement is expected to close in early 2014 pending regulatory review and satisfaction of customary closing conditions.
Saphris is an atypical antipsychotic approved by the U.S. Food and Drug Administration and launched in 2009. Merck recorded net sales of $150 million in the 12-month period ending September 2013. Saphris is prescribed for the treatment of schizophrenia in adults, and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, as monotherapy or as adjunctive therapy with either lithium or valproate. Schizophrenia and acute bipolar mania are considered areas of significant unmet medical need and Saphris is an important treatment option for physicians and patients.
“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," said 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."
"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," said 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 Saphris divestiture came concurrently with the announcement by MSD (formerly Merck Sharp & Dohme) that it intended to close its women’s healthcare product business in Sword, Ireland, by the end of 2017. Up to 570 staff at the facility were reported to face “redundancy” in the second major jobs blow at the company this year, with layoffs commencing in the second half of next year. Earlier this year, MSD announced it was closing its active ingredient plant at Rathdrum, Co Wicklow, with the loss of 280 jobs.
The decision to close the MSD plant was taken following a review of the company’s worldwide manufacturing capabilities. Of the 570 people working at the Swords facility, MSD said it expected about 130 people to leave in the second half of 2014 with the remaining positions being phased out over the following three years. MSD employs more than 2,000 people in the Irish Republic.
Forest Laboratories is a fully integrated, specialty pharmaceutical company largely focused on the United States market. The company markets a portfolio of branded drug products and develops new medicines to treat patients suffering from diseases principally in five therapeutic areas: central nervous system, cardiovascular, gastrointestinal, respiratory, and anti-infective. Its strategy of acquiring product rights for development and commercialization through licensing, collaborative partnerships and targeted mergers and acquisitions is intended to take advantage of attractive late-stage development and commercial opportunities, thereby managing the risks inherent in drug development.
Source: Forest Laboratories, Inc.