DUBLIN, Nov. 17, 2020 /PRNewswire/ -- Alkermes
plc (Nasdaq: ALKS) today announced that it received a Complete
Response Letter (CRL) from the U.S. Food and Drug Administration
(FDA) regarding its New Drug Application (NDA) for ALKS 3831
(olanzapine/samidorphan) for the treatment of adults with
schizophrenia and adults with bipolar I disorder. Following a
remote review of manufacturing records, FDA stated that resolution
of certain conditions related to the tablet coating process at the
company's Wilmington, OH facility
is required before ALKS 3831 may be approved. The CRL did not
identify or raise any concerns about the clinical or non-clinical
data in the NDA and the FDA has not asked Alkermes to complete any
new clinical trials to support approval of the application.
The observations noted in the CRL were specific to certain
development batches of ALKS 3831. The company believes this issue
has since been resolved and that sufficient data is available to
address these observations. Alkermes is preparing those data for
submission and plans to work closely with the Agency to resolve
these items in a timely manner and complete labeling discussions
for the application.
Consistent with FDA's August 2020
Guidance for Industry related to manufacturing
inspections during the COVID-19 global pandemic, the Agency
did not conduct an on-site Pre-Approval Inspection (PAI) at the
company's Wilmington, OH
manufacturing facility during its review of the NDA, and instead
conducted a remote review of records under section 704(a)(4)
of the Federal Food, Drug, and Cosmetic Act. FDA confirmed receipt
of the requested records provided by Alkermes on Sept. 11, 2020 and, since that date, no report or
feedback from this records review was provided to Alkermes until
receipt of the CRL.
"We will continue to work closely with the Agency in an
expeditious manner to support approval of ALKS 3831 for the
treatment of schizophrenia and bipolar I disorder and believe
we have a clear path to resolution. Importantly, there were no
clinical issues identified in the CRL pertaining to ALKS 3831's
efficacy or safety, and no new studies were requested for approval
of the application," said Craig
Hopkinson, M.D., Chief Medical Officer and Executive Vice
President of Research & Development at Alkermes.
The NDA submission for ALKS 3831 was based on data from 27
clinical studies, including 18 studies evaluating ALKS 3831 and
nine studies evaluating samidorphan alone, and pharmacokinetic
bridging data comparing ALKS 3831 and ZYPREXA®.
Throughout the clinical development program, ALKS 3831 demonstrated
a consistent antipsychotic efficacy, safety, and tolerability
profile in patients with schizophrenia.
In October 2020,
the Psychopharmacologic Drugs Advisory
Committee and the Drug Safety and
Risk Management Advisory Committee appointed
by the FDA jointly voted that samidorphan meaningfully
mitigates olanzapine-associated weight gain (16 yes, 1 no) and that
the safety profile of ALKS 3831 has been adequately characterized
(13 yes, 3 no, 1 abstention). The committees also jointly voted
that labeling is sufficient to mitigate the risks related to the
opioid antagonist action of samidorphan (11 yes, 6 no).
Conference Call
Alkermes will host a conference call for analysts and investors
on Tuesday, Nov. 17, 2020, at
8:00 a.m. ET (1:00 p.m. GMT). The webcast player may be
accessed on the Investors section of Alkermes' website at
www.alkermes.com. To participate in the question and answer
session, please dial in to the conference call, which may be
accessed by dialing +1 877-407-2988 for U.S. callers and +1
201-389-0923 for international callers. In addition, a replay of
the conference call may be accessed by visiting Alkermes' website
or by dialing +1 877-660-6853 for U.S. callers and +1 201-612-7415
for international callers, using replay access code 13713465. The
conference call replay will be available from 11:00 a.m. ET (4:00 p.m.
GMT) on Tuesday, Nov. 17, 2020
through Tuesday, Nov. 24, 2020.
About Schizophrenia
Schizophrenia is a serious brain disorder marked by positive
symptoms (hallucinations and delusions, disorganized speech and
thoughts, and agitated or repeated movements) and negative symptoms
(depression, blunted emotions and social
withdrawal).1 An estimated 2.4 million American
adults have schizophrenia,2 with men and women
affected equally.
About Bipolar I Disorder
Bipolar disorder is a brain disorder that causes shifts in a
person's mood, energy and ability to function. Individuals with
this brain disorder may experience debilitating mood shifts from
extreme highs (mania) to extreme lows (depression). Bipolar I
disorder is characterized by the occurrence of at least one manic
episode, with or without the occurrence of a major depressive
episode, and affects approximately one percent of the adult
population in the United States in any given
year.3
About ALKS 3831 (olanzapine/samidorphan)
ALKS 3831 is an investigational, novel, once-daily, oral atypical
antipsychotic drug candidate for the treatment of adults with
schizophrenia and for the treatment of adults with bipolar I
disorder. ALKS 3831 is composed of samidorphan, a novel, new
molecular entity, co-formulated with the established antipsychotic
agent, olanzapine, in a single bilayer tablet.
About Alkermes plc
Alkermes plc is a fully
integrated, global biopharmaceutical company developing innovative
medicines in the fields of neuroscience and oncology. The company
has a portfolio of proprietary commercial products focused on
addiction and schizophrenia, and a pipeline of product candidates
in development for schizophrenia, bipolar I disorder,
neurodegenerative disorders and cancer. 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 potential
therapeutic and commercial value of ALKS 3831 for the treatment of
adults with schizophrenia and the treatment of adults with bipolar
I disorder; the company's expectations regarding next steps for the
NDA for ALKS 3831, including its plans to engage with the FDA to
resolve any outstanding FDA requests; and the company's belief in
its ability to expeditiously complete labeling discussions with the
FDA and resolve any outstanding items required by the FDA to
support approval of the NDA for ALKS 3831. The company cautions
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 company will be
able to sufficiently resolve all FDA requests to meet the FDA's
requirements for approval in a timely manner or at all; whether
data from the company's manufacturing processes may be interpreted
by the FDA in different ways than the company interprets it;
potential changes in the cost, scope and duration of the ALKS 3831
development and regulatory program following receipt of the FDA's
CRL; whether the FDA will approve the NDA for ALKS 3831 in a timely
manner or at all; if approved, whether the FDA will impose
conditions on the marketing of ALKS 3831, such as a risk evaluation
and mitigation strategy; whether future clinical trials for ALKS
3831, if any, will be completed on time or at all; unanticipated
impacts of the COVID-19 pandemic on the operations of the company
and on the operations of the regulatory agencies involved in the
review and potential approval of ALKS 3831; whether ALKS 3831 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, 2019, the company's Quarterly Report on Form
10-Q for the quarter ended June 30, 2020 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.
ZYPREXA® is a registered trademark of Eli Lilly
& Company.
1American Psychiatric Association. Schizophrenia
Spectrum and Other Psychiatric Disorders. Diagnostic and
Statistical Manual of Mental
Disorders. 5th ed. Washington,
DC: American Psychiatric Publishing; 2013.
2 National Institutes of
Health. Schizophrenia. Accessed on Nov. 16,
2020 from
https://archives.nih.gov/asites/report/09-09-2019/report.nih.gov/nihfactsheets/Pdfs/Schizophrenia(NIMH).pdf.
3 Merikangas et al. Lifetime and 12-Month
Prevalence of Bipolar Spectrum Disorder in the National Comorbidity
Survey Replication. Arch Gen Psychiatry, 2007 May;
64(5):
543-552. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1931566/
Alkermes
Contacts:
|
For
Investors:
|
Sandy
Coombs,
|
+1 781 609
6377
|
For Media:
|
Eva
Stroynowski,
|
+1 781 609
6823
|
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SOURCE Alkermes plc