. in June 2015. INVEGA TRINZA uses the company’s proprietary technology and is manufactured by Janssen. RISPERDAL CONSTA is approved in the U.S. for the treatment of schizophrenia and as both monotherapy and adjunctive therapy to lithium or valproate in the maintenance treatment of bipolar I disorder. RISPERDAL CONSTA is approved in various countries outside of the U.S. for the treatment of schizophrenia and the maintenance treatment of bipolar I disorder. RISPERDAL CONSTA uses the company’s polymer-based microsphere injectable extended-release technology to deliver and maintain therapeutic medication levels in the body through just one injection every two weeks. RISPERDAL CONSTA microspheres are manufactured by the company. Revenues from Janssen accounted for approximately 40% of the company’s consolidated revenues for the year ended December 31, 2015. AMPYRA/FAMPYRA AMPYRA (dalfampridine)/FAMPYRA (fampridine) is the first treatment approved in the U.S. and in approximately 50 countries across Europe, Asia, and the Americas to improve walking in adults with multiple sclerosis who have walking disability, as demonstrated by an increase in walking speed. Extended-release dalfampridine tablets are marketed and sold by Acorda Therapeutics, Inc. (Acorda) in the U.S. under the trade name AMPYRA and by Biogen outside the U.S. under the trade name FAMPYRA. In 2011, the European Medicines Agency conditionally approved FAMPYRA in the European Union for the improvement of walking in adults with multiple sclerosis. This authorization was renewed as of August 2015. AMPYRA and FAMPYRA incorporate the company’s oral controlled-release technology. AMPYRA and FAMPYRA are manufactured by the company. BYDUREON BYDUREON (exenatide extended-release for injectable suspension) is approved in the U.S. and the European Union for the treatment of type 2 diabetes. In 2014, AstraZeneca plc (AstraZeneca) assumed sole responsibility for the development and commercialization of BYDUREON. BYDUREON, a once-weekly formulation of exenatide, the active ingredient in BYETTA, uses the company’s polymer-based microsphere injectable extended-release technology. BYDUREON is manufactured by AstraZeneca. BYDUREON Pen 2 mg, a pre-filled, single-use pen injector that contains the same formulation and dose as the original BYDUREON single-dose tray, is available in the U.S., certain countries in the European Union and Japan. Key Development Programs ALKS 5461 ALKS 5461 is a proprietary, oral investigational medicine in development for the treatment of major depressive disorder in patients who have an inadequate response to standard antidepressant therapies. ALKS 5461 includes samidorphan in combination with buprenorphine. Samidorphan is a proprietary oral opioid modulator characterized by limited hepatic metabolism and durable pharmacologic activity in modulating brain opioid receptors. ALKS 5461 acts as a balanced neuromodulator in the brain and represents a new approach with a novel mechanism of action for treating major depressive disorder. In 2013, the U.S. Food and Drug Administration granted Fast Track status for ALKS 5461 for the adjunctive treatment of major depressive disorder in patients with inadequate response to standard antidepressant therapies. In January 2015, the company announced topline results from FORWARD-1, one of a series of supportive clinical studies in the FORWARD phase 3 pivotal program designed to evaluate the safety and tolerability of two titration schedules of ALKS 5461. In December 2015, the company also announced positive topline results from a human abuse potential study of ALKS 5461. In January 2016, the company announced the topline results of FORWARD-3 and FORWARD-4, two phase 3 clinical studies of ALKS 5461 in major depressive disorder. In the case of a clear positive outcome for FORWARD-5, the company would consult with the U.S. Food and Drug Administration to determine whether the evidence provided by it and the previously completed successful, randomized, placebo-controlled phase 2 study, together with supportive evidence from FORWARD-4, collectively could provide substantial evidence
alkermes plc (ALKS:NASDAQ GS)
1 Burlington Road
Dublin, D04 C5Y6
Phone: 353 1 772 8000
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