Alkermes Announces New Drug Candidate, ALKS 7119, for Treatment of Alzheimer’s Agitation, Depression and Other CNS Diseases
March 02 2015 - 7:00AM
Business Wire
–– ALKS 7119 to Enter Clinic This Year; Joins
Expanding CNS Pipeline Focused on Major Chronic Diseases ––
–– Company to Provide Update at Analyst and
Investor Event and Outline Commercial Potential for Late-Stage CNS
Portfolio ––
Alkermes plc (NASDAQ: ALKS) today announced a new drug
candidate, ALKS 7119, for the treatment of agitation in patients
with Alzheimer’s disease, major depressive disorder (MDD) and other
central nervous system (CNS) indications. Alkermes has successfully
completed preclinical development and expects to initiate the first
clinical study of ALKS 7119 in the third quarter of 2015.
Additional details about ALKS 7119 will be presented at an Analyst
and Investor Event hosted by Alkermes this afternoon. At the event,
the company will also provide an update and outline the commercial
opportunity for four late-stage product candidates in its emerging
blockbuster portfolio addressing major chronic CNS diseases ––
aripiprazole lauroxil for schizophrenia, ALKS 5461 for MDD, ALKS
3831 for schizophrenia and ALKS 8700 for multiple sclerosis.
ALKS 7119 is the newest candidate in Alkermes’ pipeline of novel
medicines for CNS diseases. ALKS 7119 has a multivalent mechanism
of action that acts on key receptors in the brain involved in
several CNS diseases, including agitation in patients with
Alzheimer’s disease, MDD and others. Alkermes intends to file an
Investigational New Drug (IND) application with the U.S. Food and
Drug Administration (FDA) in the second quarter and begin clinical
trials in the third quarter of 2015. A number of patent
applications have been submitted to the U.S. Patent and Trademark
Office related to ALKS 7119.
“ALKS 7119 exemplifies the continuing productivity of R&D at
Alkermes and our distinctive approach to creating medicines
designed to offer meaningful value for patients, their caregivers
and the healthcare system,” commented Elliot Ehrich, M.D., Chief
Medical Officer of Alkermes. “Based on results and observations to
date, we believe that the multivalent mechanism of ALKS 7119 has
the potential to impact a range of CNS diseases. We will begin with
addressing agitation associated with Alzheimer’s disease and look
forward to beginning our clinical program later this year.”
In addition to presenting information on ALKS 7119, the company
will provide details on its late-stage pipeline candidates at the
Analyst and Investor Event. Management will also present current
epidemiologic data and discuss financial tools that may be useful
in analyzing the economic value of the company’s late-stage product
candidates.
“As we meet with analysts and investors today, our presentations
will focus on the potential medical and economic value of our
late-stage CNS pipeline, which is one of the most diverse and
exciting in the industry,” commented Richard Pops, Chief Executive
Officer of Alkermes. “In addition to introducing our newest
clinical candidate, ALKS 7119, our goal is to provide a more
complete picture of the medical need, human proof-of-concept data
and economic rationale supporting each of our late-stage drug
candidates –– new medicines with the potential to impact millions
of patients suffering from diseases including schizophrenia,
depression, addiction and multiple sclerosis.”
Webcast
A live webcast of the company's Analyst and Investor Event will
begin today at 4:00 p.m. EST (9:00 p.m. GMT). The webcast will be
available on the Investors tab of the company’s website at
www.alkermes.com. To ensure a timely connection to the webcast, it
is recommended that users register 15 minutes prior to the
scheduled webcast. This webcast will be archived on Alkermes’
website for one month.
About Alkermes plc
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, depression 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 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,
development plans and commercial potential, including blockbuster
status, of the company’s product candidates, including aripiprazole
lauroxil, ALKS 5461, ALKS 3831, ALKS 8700 and ALKS 7119; the
clinical development success and timelines of our product
candidates; and the intellectual property protection of ALKS 7119.
You are cautioned 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, among others:
whether preclinical results for ALKS 7119 will be predictive of
future clinical study results; whether future clinical trials for
ALKS 7119 will be completed on time or at all; the company’s
product candidates may not be approved by regulatory authorities;
the company may not be able to successfully commercialize its
products; and 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.
AlkermesFor Investors:Rebecca
Peterson, +1-781-609-6378orFor Media:Jennifer Snyder,
+1-781-609-6166
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