-- Conference Call Scheduled for Today at 8:30 a.m. ET --
DUBLIN, April 2, 2018 /PRNewswire/ -- Alkermes plc
(Nasdaq: ALKS) today announced that it received a Refusal to File
letter from the U.S. Food and Drug Administration (FDA) regarding
its New Drug Application (NDA) for ALKS 5461, a once-daily, oral
investigational medicine with a novel mechanism of action for the
adjunctive treatment of major depressive disorder (MDD) in patients
with an inadequate response to standard antidepressant
therapies.
Upon its preliminary review, the FDA has taken the position that
it is unable to complete a substantive review of the regulatory
package, based on insufficient evidence of overall effectiveness
for the proposed indication, and that additional well-controlled
clinical trials are needed prior to the resubmission of the NDA for
ALKS 5461. In addition, FDA has requested the conduct of a
bioavailability study to generate additional bridging data between
ALKS 5461 and the reference listed drug, buprenorphine.
Alkermes strongly disagrees with the FDA's conclusions and plans
to appeal the FDA's decision. The company intends to seek immediate
guidance, including requesting a Type A meeting with the FDA, to
determine appropriate next steps and what additional information
may be required to resubmit the NDA.
"We are extremely disappointed with this decision and the
implications for patients in the U.S. suffering from major
depressive disorder, a serious disease where there is a clear and
urgent need for new treatment options for patients and their
families," said Richard Pops, Chief Executive Officer of Alkermes.
"We strongly believe that the clinical development program,
including data from more than 1,500 patients with MDD, provides
substantial evidence of ALKS 5461's consistent antidepressant
activity and a favorable benefit-risk profile."
Alkermes is evaluating the impact of this update on its
previously-issued financial guidance for 2018; any update will be
provided in its first quarter 2018 financial results
disclosures.
Conference Call Information
Alkermes will host a
conference call at 8:30 a.m. ET
(1:30 p.m. BST) on Monday, April 2, 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 2, 2018, through 5:00 p.m. ET (10:00 p.m.
BST) on Monday, April 9, 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: the therapeutic value,
development and regulatory plans, 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: the timing, occurrence and outcome of the
Type A meeting to discuss the refusal to file letter from the FDA;
whether filing over protest is a viable path; whether discussions
with the FDA will impact the likelihood of acceptance, and if
accepted, approval, of the NDA for ALKS 5461 by the FDA; if
approved, whether ALKS 5461 will be commercialized successfully;
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; 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 1, 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:
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For
Investors:
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Eva
Stroynowski,
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+1-781-609-6823
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Sandy
Coombs,
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+1-781-609-6377
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For Media:
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Jennifer
Snyder,
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+1-781
609-6166
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