–– 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 ––
DUBLIN--(BUSINESS WIRE)--Mar. 2, 2015--
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.
Source: Alkermes plc
Alkermes
For Investors:
Rebecca
Peterson, +1-781-609-6378
or
For Media:
Jennifer Snyder,
+1-781-609-6166