Forest acquires US rights to Saphris from Merck Inc
Forest Laboratories Holdings Limited, a wholly owned subsidiary of Forest Laboratories, Inc. 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 & 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 all closing conditions.
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.
The FDA recently issued a Complete Response Letter to Forest in relation to its new antipsychotic cariprazine delaying its progress to registration.
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