Alkermes to Present Data on New Medicines in Development for Schizophrenia and Depression at Upcoming American Society of Clinical Psychopharmacology Annual Meeting

By Business Wire,  June 03, 2014, 07:00:00 AM EDT


— Results of Positive Phase 3 Study for Aripiprazole Lauroxil in Schizophrenia to be Presented —

— ALKS 3831 for the Treatment of Schizophrenia and Co-Occurring Alcohol Use, and ALKS 5461 for the Treatment of Major Depressive Disorder, Will Also be Highlighted —

HOLLYWOOD, Fla., & DUBLIN--(BUSINESS WIRE)-- Alkermes plc (NASDAQ:ALKS) today announced that data from studies of the company's pipeline of drug candidates in schizophrenia and depression will be presented at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting in Hollywood, Florida, June 16-19, 2014.

Schizophrenia

Comprehensive data from the recently completed phase 3 study of aripiprazole lauroxil in patients with schizophrenia will be presented. The ASCP scientific committee has nominated this data presentation as a best poster, which will appear in the online 2014 ASCP Poster Session:

Wednesday, June 18, 2014, 12:00 - 2:00 p.m. ET

  • Poster 75: Safety and Efficacy of Aripiprazole Lauroxil: Results From a Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study in Subjects With Acute Exacerbation of Schizophrenia.

Alkermes will also present data related to the company's state-of-the-art clinical trial methodologies in schizophrenia as well as data pertaining to the company's development of ALKS 3831, a new investigational medication designed to address important unmet medical needs of patients with schizophrenia:

Tuesday, June 17, 2014, 3:30 - 4:30 p.m. ET

  • The oral presentation, "Analysis and Missing Data Handling in Psychiatry Trials With Inevitable, High, Differential and Informative Discontinuations," will be presented during a symposium entitled, "Statistical Methods, Personality Disorders, Substance Abuse, and Comorbidity Presentations."

Wednesday, June 18, 2014, 12:00 - 2:00 p.m. ET

  • Poster 73: Prevalence, Healthcare Utilization and Cost of Patients Dual Diagnosed With Schizophrenia and an Alcohol Use Disorder.

Depression

Data relating to ALKS 5461, the company's development candidate for the treatment of major depressive disorder (MDD), will be presented. This presentation has also been nominated as a best poster, and will appear in the online 2014 ASCP Poster Session.

Tuesday, June 17, 2014, 11:15 a.m. - 1:00 p.m. ET

  • Poster 44: ALKS 5461, a Novel Opioid Modulator as Adjunctive Treatment for Depression.

Alkermes will also present data related to the company's state-of-the-art clinical trial methodologies in depression. Key presentations include:

Wednesday, June 18, 2014, 12:00 - 2:00 p.m. ET

  • Poster 26: Feasibility, Integrity and Efficiency of the Sequential Parallel Comparison Clinical Trial Design.
  • Poster 27: Blinded Dual Ratings Confirm Primary Site-Based Ratings in an MDD Trial.

A full list of all Alkermes abstracts being presented at the ASCP meeting is available at: http://ascpmeeting.org/.

About Aripiprazole Lauroxil

Aripiprazole lauroxil, which utilizes Alkermes' proprietary LinkeRx® technology, is an injectable atypical antipsychotic with one-month and two-month 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®.

About ALKS 5461

ALKS 5461 is a proprietary investigational oral medicine for the treatment of major depressive disorder (MDD). ALKS 5461 is designed to modulate the opioid system in the brain, employing a balanced combination of agonist and antagonist components that act on opioid receptors, and includes a novel opioid modulator, samidorphan, discovered by Alkermes. Samidorphan was formerly referred to as ALKS 33. 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.

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, and to have utility in patients with schizophrenia whose disease is exacerbated by alcohol use.

About Alkermes

Alkermes plc is a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to develop innovative medicines that improve patient outcomes. The company has a diversified portfolio of more than 20 commercial drug products and a substantial clinical pipeline of product candidates that address central nervous system (CNS) disorders such as addiction, schizophrenia and depression. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and manufacturing facilities in Gainesville, Georgia and 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 projected or suggested in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include those risks described in the Alkermes plc Transition Report on Form 10-K for the fiscal period ended December 31, 2013, and in 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 publicly updating or revising such forward-looking information.

LinkeRx® is a registered trademark of Alkermes Pharma Ireland Limited Corporation. ABILIFY® is a registered trademark of Otsuka Pharmaceutical Co., Ltd.

Source: Alkermes plc



This article appears in: News Headlines

Referenced Stocks: ALKS


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