-- Clinical Data and Health Economics and Outcomes Research
to be Presented
May 18-22, 2019 at APA and ISPOR
Annual Meetings --
DUBLIN, May 13, 2019 /PRNewswire/ -- Alkermes plc
(Nasdaq: ALKS) today announced that it will present data from its
mental health portfolio at the American Psychiatric Association
(APA) Annual Meeting in San
Francisco and the International Society for
Pharmacoeconomics and Outcomes Research (ISPOR) 2019
Conference in New Orleans; both
scientific conferences will be held May
18-22, 2019. These presentations underscore Alkermes'
growing scientific and clinical presence in the mental health space
broadly, and specifically in schizophrenia, and demonstrate the
company's commitment to developing new treatment options for
patients that aim to provide both strong antipsychotic efficacy and
patient-focused safety and tolerability attributes.
"APA and ISPOR are two of the most important meetings of the
year for mental health experts and health economics leaders to
engage in scientific exchange," said Kanchan Relwani, Vice President of Medical
Affairs at Alkermes. "Alkermes has a strong legacy in schizophrenia
and addiction, two critical and urgent public health issues in the
U.S., and we remain committed to developing new therapies that help
address patient needs in these important areas. We look forward to
presenting new data to key decision-makers, thought leaders and
practitioners."
Highlights of the upcoming presentations at APA include a
poster reviewing antipsychotic efficacy results from three
double-blind, olanzapine-controlled randomized clinical studies of
ALKS 3831 (olanzapine/samidorphan), as well as posters relating to
addiction and major depressive disorder. At ISPOR, Alkermes will
share insights on the economic burdens of schizophrenia and bipolar
I disorder from systematic literature reviews, and will present
findings from two qualitative studies exploring patients' treatment
experiences with oral antipsychotic medications in individuals with
schizophrenia or bipolar I disorder.
"There is increasing recognition in the healthcare community and
society at large of the tremendous toll that mental health
disorders place on all layers of the healthcare ecosystem, from
individual patients, to caregivers, providers and insurers," said
Amy O'Sullivan, Vice President of
Health Economics and Outcomes Research at Alkermes. "Today,
innovators must consider not only the direct clinical impact of new
treatment options for patients, but also the potential economic
impact of such medications in addressing the costs of previously
untreated or undertreated diseases. These economic and patient
considerations help inform our development programs, and we look
forward to sharing new insights at ISPOR that underscore the
ongoing need for new disease management options for patients with
schizophrenia and bipolar disorder."
Presentations at the APA Annual Meeting will include:
Schizophrenia
- Poster #P6-090: "Antipsychotic Efficacy of a Combination of
Olanzapine and Samidorphan Across Three Olanzapine-Controlled
Clinical Studies," will be presented by Adam Simmons, Alkermes, Inc., on Monday, May 20, 2019, 2:00 – 4:00 p.m. PT
- Poster #P7-063: "A Combination of Olanzapine and Samidorphan
Mitigates Weight Gain Observed With Olanzapine: Results From the
Phase 3 ENLIGHTEN-2 Schizophrenia Study," will be presented by
Christoph Correll, M.D., Psychiatry
and Molecular Medicine at Hofstra Northwell School of Medicine, on
Tuesday, May 21, 10:00 a.m. – 12:00 p.m.
PT
Alcohol and Opioid Use Disorder
- Poster #P6-032: "Transition From Buprenorphine Maintenance to
Extended-Release Naltrexone: Hybrid Residential-Outpatient
Randomized Controlled Trial," will be presented by Paolo Mannelli, M.D., Duke
University School of Medicine, on Monday, May 20, 2019, 2:00 – 4:00 p.m. PT
- Poster #P6-034: "Opioid Overdose in Patients Treated With
Extended-Release Naltrexone: Postmarketing Data From 2006 to 2018,"
will be presented by Kimberley
Marcopul, Alkermes, Inc., on Monday,
May 20, 2019, 2:00 – 4:00 p.m.
PT
Major Depressive Disorder
- Poster #P6-092: "Long-Term Treatment With Adjunctive
Buprenorphine/Samidorphan Combination in Patients With Major
Depressive Disorder: Phase 3 Study Results," will be presented by
Michael E. Thase, M.D., Perelman
School of Medicine at the University of
Pennsylvania, on Monday, May 20,
2019, 2:00 – 4:00 p.m. PT
- Poster #P6-094: "Evaluating the Safety of
Buprenorphine/Samidorphan for Adjunctive Treatment of Major
Depressive Disorder: A Focus on Buprenorphine-Related Concerns,"
will be presented by Andrew Cutler,
M.D., Meridien Research, on Monday, May 20,
2019, 2:00 – 4:00 p.m. PT
- Poster #P6-095: "The Safety of Buprenorphine/Samidorphan
Combination as Adjunctive Therapy for Major Depressive Disorder: A
Pooled Analysis of 4 Clinical Trials," will be presented by
Andrew Cutler, M.D., Meridien
Research, on Monday, May 20, 2019,
2:00 – 4:00 p.m. PT
Presentations at ISPOR 2019 will include:
- Podium Presentation, "Treatment Experiences of Patients With
Schizophrenia: Findings From a Qualitative Focus Group Study," will
be presented by Leona Bessonova,
Ph.D., Alkermes, Inc., on Monday, May 20,
2019, 5:00 – 6:00 p.m. CT
- Poster PMH21, "The Economic Burden of Illness of Schizophrenia
in the U.S.," will be presented by Leona
Bessonova, Ph.D., Alkermes, Inc., on Monday, May 20, 2019, 3:30 – 7:00 p.m. CT
- Poster PMH64, "Treatment Experiences of Patients With Bipolar I
Disorder: A Qualitative Focus Group Study," will be presented by
Amy O'Sullivan, Ph.D., Alkermes,
Inc., on Monday, May 20, 2019, 3:30 –
7:00 p.m. CT
- Poster PMH20, "The Economic Burden of Bipolar Disorder in
the United States: Results From a
Systematic Literature Review," will be presented by Leona Bessonova, Ph.D., Alkermes, Inc., on
Monday, May 20, 2019, 3:30 –
7:00 p.m. CT
Visit the APA and ISPOR annual meeting websites for a list of
all presentations taking place at each conference.
About ALKS 3831
ALKS 3831 is an investigational, novel, once-daily, oral atypical
antipsychotic drug candidate for the treatment of schizophrenia.
ALKS 3831 is composed of samidorphan, a novel, new molecular
entity, co-formulated with the established antipsychotic agent,
olanzapine, in a single bilayer tablet.
About ALKS 5461
ALKS 5461 is a fixed-dose combination
of buprenorphine, a partial mu-opioid receptor agonist and
kappa-opioid receptor antagonist, and samidorphan, a mu-opioid
receptor antagonist. ALKS 5461 is a proprietary, investigational,
once-daily oral medicine that acts as an opioid system modulator
and is being studied for the adjunctive treatment of major
depressive disorder (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, multiple sclerosis and
oncology. 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 potential therapeutic
value of the company's approved products and investigational
product candidates and the company's plan for presentations of
results from studies of its approved products and 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 year ended Dec. 31,
2018, and in 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.
Alkermes Contacts:
For
Investors:
|
Sandy
Coombs
|
+1 781 609
6377
|
For Media:
|
Marisa
Borgasano
|
+1 781 609
6659
|
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