— Company Expects to Complete Submission for Fast Track Designated
Medicine by Year-End 2017 —
DUBLIN--(BUSINESS WIRE)--Aug. 21, 2017--
Alkermes
plc (NASDAQ:ALKS) today announced the initiation of its rolling
submission of a New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA), seeking marketing approval of ALKS 5461, a
once-daily, oral investigational medicine with a novel mechanism of
action, for the adjunctive treatment of major depressive disorder (MDD).
The company expects to complete the submission of the NDA for this Fast
Track designated medicine by year-end 2017.
“The initiation of the rolling submission for ALKS 5461 is an important
first step in the registration process for ALKS 5461, as we work to
bring this potential new medicine to patients suffering from major
depressive disorder. ALKS 5461 represents a novel mechanism of action
for the treatment of MDD, a condition for which millions of patients in
the U.S. do not achieve an adequate response to standard antidepressant
therapies,” stated Elliot Ehrich, M.D., Executive Vice President,
Research and Development of Alkermes. “We expect to complete the
submission of the NDA by year-end 2017 and will continue to collaborate
closely with the FDA as we work expeditiously toward making ALKS 5461
available to patients and their healthcare providers.”
The FDA Fast Track designation is designed to facilitate the development
and expedite the review of medicines that are intended to treat serious
conditions and address unmet medical needs. Fast Track designation
allows for the submission of completed portions of the NDA on a rolling
basis as well as eligibility for Priority Review. At a pre-NDA
interaction with FDA in July, the company and FDA agreed upon the
proposed content and timing of the ALKS 5461 NDA submission.
About ALKS 5461
ALKS 5461 is a proprietary, investigational, once-daily oral medicine
that acts as a balanced neuromodulator in the brain and represents a
novel mechanism of action for the adjunctive treatment of MDD. ALKS 5461
consists of samidorphan and buprenorphine, and is designed to rebalance
brain function that is dysregulated in the state of depression. In
October 2013, the 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 MDD
According to the DSM-5® (Diagnostic
and Statistical Manual of Mental Disorders, Fifth Edition),
major depressive disorder (MDD) is a condition in which patients exhibit
depressive symptoms, such as a depressed mood or a loss of interest or
pleasure in daily activities consistently for at least a two-week
period, and demonstrate impaired social, occupational, educational or
other important functioning. An estimated 17 million people in the U.S.
suffer from MDD in a given year,1,2 the majority of whom may
not adequately respond to initial antidepressant therapy.3
About Alkermes plc
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 and commercial
potential of ALKS 5461, and the development and regulatory plans and
timelines for ALKS 5461, including the timing of submission of the NDA
and whether it will receive Priority Review designation from FDA. 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 and clinical
results for ALKS 5461 will be predictive of future clinical study
results and commercial potential of ALKS 5461; whether future clinical
trials for ALKS 5461 will be completed on time or at all; potential
changes in cost, scope and duration of the ALKS 5461 clinical
development program; whether ALKS 5461 could be shown ineffective or
unsafe during clinical studies; whether the preclinical and clinical
results of ALKS 5461 will meet the regulatory requirements for approval;
whether regulatory submissions may occur or be submitted in a timely
manner; whether the company will receive Priority Review designation
from FDA; and those risks and uncertainties described under the heading
“Risk Factors” in the company’s Annual Report on Form 10-K for the year
ended Dec. 31, 2016 and Quarterly Reports on Form 10-Q for the quarters
ended March 31, 2017 and June 30, 2017 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.
Existing and prospective investors are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the
date hereof. Except as required by law, the company disclaims any
intention or responsibility for updating or revising any forward-looking
statements contained in this press release.
DSM-5® is a registered trademark of
the American Psychiatric Association.
1 Kessler RC et al (2005) Archives of General
Psychiatry, Jun; 62 (6), pp. 617-27.
2 U.S. Census.
3 Rush
AJ et al (2007) Am J. Psychiatry, 163:11, pp. 1905-1917
(STAR*D Study).
View source version on businesswire.com: http://www.businesswire.com/news/home/20170821005216/en/
Source: Alkermes plc
Alkermes:
For Investors:
Eva
Stroynowski, +1 781-609-6823
or
Sandy Coombs, +1 781-609-6377
or
For
Media:
Jennifer Snyder, +1 781-609-6166