Alkermes plc 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:
ALKS 3831
- 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.
Aripiprazole Lauroxil
- 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.
ALKS 5461
- 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/.
Conference Call
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.
About Alkermes
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150616005339/en/
Alkermes
For Investors:
Rebecca
Peterson, +1-781-609-6378
or
For Media:
Jennifer Snyder,
+1-781-609-6166
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