Forest Laboratories Holdings Limited, a wholly owned subsidiary of Forest Laboratories, Inc. (NYSE:FRX) 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. (NYSE:MRK). 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 CY2014 pending regulatory review and satisfaction of all closing conditions. Saphris is an atypical antipsychotic approved by the US Food and Drug Administration (FDA) and launched in 2009. Merck recorded net sales of $150 million in the 12month period ending September 2013. “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."
Schizophrenia and acute bipolar mania are significant areas of unmet medical need and it is important to have treatment options available for physicians and patients.About Saphris ® Saphris is approved by the U.S. Food and Drug Administration 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. Important Safety Information
|WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS|
|Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that seen in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5 percent, compared to a rate of about 2.6 percent in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. SAPHRIS® (asenapine) is not approved for the treatment of patients with dementia-related psychosis.|
In short-term bipolar mania (monotherapy) trials with SAPHRIS 5 or 10 mg BID vs. placebo: somnolence (24% vs. 6%), dizziness (11% vs. 3%), extrapyramidal symptoms other than akathisia (7% vs. 2%) and weight increase (5% vs. less than 1%).In the short term bipolar mania (adjunctive) therapy trial with SAPHRIS 5 or 10 mg BID vs. placebo: somnolence (22% vs. 10%) and oral hypoesthesia (5% vs. 0%). Postmarketing Experience: Application site reactions, primarily in the sublingual area, have been reported. These application site reactions included oral ulcers, blisters, peeling/sloughing, and inflammation. In many cases, the occurrence of these application site reactions led to discontinuation of therapy. About Forest Laboratories and Its Products Forest Laboratories (NYSE: FRX) is a leading, 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. Our strategy of acquiring product rights for development and commercialization through licensing, collaborative partnerships and targeted mergers and acquisitions allows us to take advantage of attractive late-stage development and commercial opportunities, thereby managing the risks inherent in drug development. The Company is headquartered in New York, NY. To learn more, visit www.FRX.com. This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in Forest Laboratories’ Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and any subsequent SEC filings. Forest assumes no obligation to update forward-looking statements contained in this release to reflect new information or future events or developments.