-- FDA Action Expected by Jan.
31, 2019 --
-- Conference Call Scheduled for Today at 8:30 a.m. ET --
DUBLIN, April 16, 2018 /PRNewswire/ -- Alkermes plc
(Nasdaq: ALKS) today announced that the U.S. Food and Drug
Administration (FDA) has accepted for review the New Drug
Application (NDA) for ALKS 5461, a novel, once-daily, oral
investigational medicine for the adjunctive treatment of major
depressive disorder (MDD) in patients with an inadequate response
to standard antidepressant therapies. FDA's target action date for
the ALKS 5461 NDA is Jan. 31,
2019.
FDA's acceptance of the ALKS 5461 NDA and rescission of the
Refusal to File letter issued March 30,
2018 follows productive interactions with the Agency in
which Alkermes clarified certain aspects of the NDA submission. No
additional data or analyses were submitted by Alkermes to FDA.
"FDA's filing of the ALKS 5461 application is a positive step
forward for patients suffering from major depressive disorder, a
serious disease where inadequate response to existing
antidepressants remains a well-known and significant treatment
limitation, and where there have been no new pharmacological
treatment approaches in 30 years," stated Craig Hopkinson, M.D., Chief Medical Officer and
Senior Vice President of Medicines Development and Medical
Affairs at Alkermes. "We will continue to engage with the FDA
throughout the review process, as we work to bring this important
medicine to patients."
The NDA filing for ALKS 5461 is based on results from a clinical
efficacy and safety package with data from more than 30 clinical
trials and more than 1,500 patients with MDD. Throughout the
clinical development program, ALKS 5461 demonstrated a consistent
profile of antidepressant activity, safety and tolerability in the
adjunctive treatment of MDD.
Conference Call Information
Alkermes will host a
conference call at 8:30 a.m. ET
(1:30 p.m. BST) on Monday, April 16, 2018, to discuss this update.
The conference call may be accessed by visiting Alkermes' website
or by dialing +1 888 424 8151 for U.S. callers and +1 847 585 4422
for international callers. The conference call ID number is
6037988. In addition, a replay of the conference call will be
available from 11:00 a.m. ET
(4:00 p.m. BST) on Monday, April 16, 2018, through 5:00 p.m. ET (10:00 p.m.
BST) on Monday, April 23,
2018, and may be accessed by visiting Alkermes' website or
by dialing +1 888 843 7419 for U.S. callers and +1 630 652 3042 for
international callers. The replay access code is 6037988.
About ALKS 5461
ALKS 5461 is a proprietary,
investigational, once-daily oral medicine that acts as an opioid
system modulator and represents a novel mechanism of action for the
adjunctive treatment of major depressive disorder (MDD) in patients
with an inadequate response to standard antidepressant therapies.
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.
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 16.2 million people in the U.S. suffered
from MDD in 2016,1 the majority of whom may not
adequately respond to initial antidepressant
therapy.2
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: potential approval by
the FDA of ALKS 5461 and the anticipated timing of such approval;
and the therapeutic value and commercial potential of ALKS 5461.
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 the preclinical and clinical results of ALKS 5461 will meet
the regulatory requirements for approval by the FDA; whether the
FDA's bases for the rescinded Refusal to File letter or other bases
will cause the FDA to require more data or information prior to
approval; whether ALKS 5461 will be approved by the FDA in a timely
manner or at all; if approved, whether ALKS 5461 will be
commercialized successfully; whether the preclinical and clinical
results for ALKS 5461 will be predictive of commercial potential of
ALKS 5461; whether future clinical trials for ALKS 5461, if any,
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; 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, 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 National Institutes of Mental Health: Major
Depression. Accessed on April 15,
2018 from
https://www.nimh.nih.gov/health/statistics/major-depression.shtml.
2 Rush AJ et al (2007) Am J.
Psychiatry, 163:11, pp. 1905-1917 (STAR*D Study).
Alkermes
Contacts:
|
For
Investors:
|
Eva
Stroynowski,
|
+1-781-609-6823
|
|
Sandy
Coombs,
|
+1-781-609-6377
|
For Media:
|
Jennifer
Snyder,
|
+1-781-609-6166
|
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