Alkermes Initiates Rolling Submission of ALKS 5461 New Drug Application for Major Depressive Disorder
August 21 2017 - 7:00AM
Business Wire
— Company Expects to Complete Submission for
Fast Track Designated Medicine by Year-End 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).
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