DUBLIN--(BUSINESS WIRE)--Alkermes plc (NASDAQ: ALKS) today announced that data from studies of the company’s pipeline of central nervous system (CNS) drug candidates in schizophrenia and depression, including ALKS 3831, aripiprazole lauroxil and ALKS 5461, will be presented at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting in Miami, Fla., June 22-25, 2015.
Alkermes data presentations at ASCP include:
- Oral presentation, “ALKS 3831: A Novel Drug Candidate for the Treatment of Schizophrenia,” will be presented during the Pharmaceutical Pipeline symposium on Monday, June 22, 2015, 2:00 p.m. – 4:00 p.m. EDT.
- Poster #T6, “ALKS 3831: A Novel Drug Candidate for the Treatment of Schizophrenia,” will be available during Poster Session I, Tuesday, June 23, 2015, 11:15 a.m. – 1:00 p.m. EDT.
- Oral presentation, “A Phase 2, Randomized, Olanzapine-Controlled Study of the Safety, Tolerability and Efficacy of ALKS 3831 in Adults with Schizophrenia,” will be presented on Tuesday, June 23, 2015, 3:30 p.m. – 4:30 p.m. EDT.
- Poster #T88, “Effect of Aripiprazole Lauroxil on Metabolic and Endocrine Profiles, and Related Safety Considerations in Acute Schizophrenia,” will be available during Poster Session I, Tuesday, June 23, 2015, 11:15 a.m. – 1:00 p.m. EDT.
- Oral presentation, “Efficacy and Safety of Aripiprazole Lauroxil in Acute Exacerbation of Schizophrenia: Results from a Double-Blind Placebo-Controlled Study,” will be presented on Tuesday, June 23, 2015, 3:30 p.m. – 4:30 p.m. EDT.
- Poster #W88, “Effect of Aripiprazole Lauroxil on Personal and Social Functioning and Health-Related Quality of Life Among Patients with Schizophrenia,” will be available during Poster Session II, Wednesday, June 24, 2015, 12:00 p.m. – 2:00 p.m. EDT.
- Oral presentation “ALKS 5461 as Adjunctive Treatment of Major Depressive Disorder: Phase 3, Randomized, Double-Blind Study (FORWARD-1) Evaluating Two Titration Schedules,” will be presented on Tuesday, June 23, 2015, 3:30 p.m. – 4:30 p.m. EDT.
- Poster #W36, “Combinations of Buprenorphine and Samidorphan Modulate Glutamate and GABA Transmission in the Medial Prefrontal Cortex and Ventral Hippocampus of Male Wistar Rats,” will be available during Poster Session II, Wednesday, June 24, 2015, 12:00 p.m. – 2:00 p.m. EDT.
A full list of all presentations at the ASCP meeting is available at: http://ascpmeeting.org/.
Alkermes will host a conference call on Tuesday, June 23, 2015, at 8:00 a.m. EDT (1:00 p.m. BST), to discuss the six-month data of ALKS 3831 for the treatment of schizophrenia. The data will be reviewed by management, followed by a discussion with Dr. Peter Weiden, Professor of Psychiatry at the University of Illinois Medical Center, on the treatment landscape for schizophrenia. The conference call may be accessed by dialing +1 888 424 8151 for U.S. callers and +1 847 585 4422 for international callers. The conference call ID number is 6037988. The conference call will also be webcast on the Investors section of Alkermes’ website at www.alkermes.com. In addition, a replay of the conference call will be available from 10:30 a.m. EDT (3:30 p.m. BST) on Tuesday, June 23, 2015, through 5:00 p.m. EDT (10:00 p.m. BST) on Tuesday, June 30, 2015, and may be accessed by visiting Alkermes’ website or by dialing +1 888 843 7419 for U.S. callers and +1 630 652 3042 for international callers. The replay access code is 6037988.
About ALKS 3831
ALKS 3831 is a proprietary, investigational medicine designed as a broad-spectrum antipsychotic for the treatment of schizophrenia. ALKS 3831 is composed of samidorphan, a novel, potent mu-opioid antagonist, in combination with the established antipsychotic drug, olanzapine. ALKS 3831 is designed to attenuate olanzapine-induced metabolic side effects, including weight gain, in patients with schizophrenia and to have utility in the treatment of schizophrenia in patients with alcohol use.
About Aripiprazole Lauroxil
Aripiprazole lauroxil is an injectable atypical antipsychotic with one-month and extended-duration formulations in development for the treatment of schizophrenia. Once in the body, aripiprazole lauroxil converts to aripiprazole, which is commercially available under the name ABILIFY®. As a long-acting investigational medication based on Alkermes’ proprietary LinkeRx® technology, aripiprazole lauroxil is designed to have multiple dosing options and to be administered in a ready-to-use, pre-filled product format.
About ALKS 5461
ALKS 5461 is a proprietary, oral investigational medicine for the treatment of major depressive disorder (MDD). ALKS 5461 acts as a balanced neuromodulator in the brain and represents a new approach with a novel mechanism of action for treating MDD. In October 2013, the U.S. Food and Drug Administration (FDA) granted Fast Track status for ALKS 5461 for the adjunctive treatment of MDD in patients with an inadequate response to standard antidepressant therapies.
Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.
Note Regarding Forward-Looking Statements
Certain statements set forth in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning the therapeutic value of our investigational product candidates. The company cautions that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include those risks described in the Alkermes plc Annual Report on Form 10-K for the fiscal year ended Dec. 31, 2014, and in any other subsequent filings made by the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC’s website at www.sec.gov. The information contained in this press release is provided by the company as of the date hereof, and, except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking information contained in this press release.
LinkeRx® is a registered trademark of Alkermes Pharma Ireland Limited Corporation. ABILIFY® is a registered trademark of Otsuka Pharmaceutical Co., Ltd.