Alkermes to Present Data From Late-Stage CNS Portfolio at Upcoming American Society of Clinical Psychopharmacology Annual Mee...
June 16 2015 - 7:00AM
Business Wire
— Company to Host Conference Call on Tuesday,
June 23 to Discuss Six-Month Data of ALKS 3831 for Treatment of
Schizophrenia —
— Data on Aripiprazole Lauroxil for Treatment
of Schizophrenia and ALKS 5461 for Treatment of Major Depressive
Disorder Will Also be Presented at Meeting —
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:
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 CallAlkermes 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 3831ALKS 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
LauroxilAripiprazole 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 5461ALKS 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 AlkermesAlkermes
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
StatementsCertain 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20150616005339/en/
AlkermesFor Investors:Rebecca
Peterson, +1-781-609-6378orFor Media:Jennifer Snyder,
+1-781-609-6166
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