— Following Pre-NDA Meeting With FDA, Company Plans to Submit
New Drug Application for Schizophrenia and Bipolar I Disorder
Indications in the Fourth Quarter of 2019 —
DUBLIN, July 15, 2019 /PRNewswire/ -- Alkermes plc
(Nasdaq: ALKS) today provided an update on its regulatory strategy
for ALKS 3831 (olanzapine/samidorphan), the company's
investigational, novel, once-daily, oral atypical antipsychotic
drug candidate designed to provide the efficacy of olanzapine while
mitigating olanzapine-associated weight gain. Following a pre-New
Drug Application (NDA) meeting with the U.S. Food and Drug
Administration (FDA), the company plans to expand the NDA for ALKS
3831 to encompass the treatment of bipolar I disorder in addition
to the treatment of schizophrenia. The ALKS 3831 NDA, which the
company now plans to submit in the fourth quarter of 2019, will
include data from the completed ALKS 3831 ENLIGHTEN clinical
development program in patients with schizophrenia as well as
pharmacokinetic (PK) bridging data comparing ALKS 3831 and
ZYPREXA® (olanzapine).
"Bipolar I disorder is a complicated and often misdiagnosed
disease, characterized by severe shifts in mood and energy that can
impact a person's ability to complete day-to-day activities.
Antipsychotics are a mainstay treatment option for many people
living with bipolar I disorder; however, new treatments with
differentiated efficacy and tolerability profiles are needed," said
Roger S. McIntyre, M.D., Professor
of Psychiatry and Pharmacology at the University of Toronto, Head of the Mood Disorders
Psychopharmacology Unit at the University Health Network in
Toronto and Director for the
Depression and Bipolar Support Alliance (DBSA). "A potential new
medication like ALKS 3831 would be a meaningful addition to the
bipolar I disorder treatment landscape."
"As a longstanding leader dedicated to developing new medicines
to treat schizophrenia and other serious mental health disorders,
we are gratified to now extend that commitment to people living
with bipolar I disorder," said Craig
Hopkinson, M.D., Chief Medical Officer and Senior Vice
President of Medicines Development and Medical Affairs at Alkermes.
"We are pleased to have met with FDA to align on this regulatory
review pathway for ALKS 3831 for the treatment of bipolar I
disorder, based on pharmacokinetic bridging data and results from
our ENLIGHTEN program for schizophrenia. Our NDA preparation is
well underway and we anticipate submitting a single NDA for ALKS
3831 later this year for the treatment of schizophrenia and bipolar
I disorder."
The ALKS 3831 NDA will include data to support an indication for
the treatment of manic or mixed episodes associated with bipolar I
disorder as a monotherapy or adjunct to lithium or valproate and
for maintenance treatment of bipolar I disorder; and an indication
for the treatment of schizophrenia. The proposed fixed dosage
strengths for ALKS 3831 include 10 mg of samidorphan co-formulated
with 5 mg, 10 mg, 15 mg or 20 mg of olanzapine.
About the ENLIGHTEN Clinical Development Program
The
ENLIGHTEN clinical development program for ALKS 3831 comprises two
key studies in patients with schizophrenia: the ENLIGHTEN-1 study
evaluating the antipsychotic efficacy of ALKS 3831 compared to
placebo over four weeks and the ENLIGHTEN-2 study assessing weight
gain with ALKS 3831 compared to olanzapine over six months. The
program also includes supportive studies to evaluate the
pharmacokinetic and metabolic profile and long-term safety of ALKS
3831, and pharmacokinetic bridging data comparing ALKS 3831 and
ZYPREXA.
About ALKS 3831
ALKS 3831 is an investigational,
novel, once-daily, oral atypical antipsychotic drug candidate for
the treatment of schizophrenia and 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 Bipolar I Disorder
Bipolar disorder is a brain disorder that causes unusual shifts
in a person's mood, energy and ability to function. Patients with
this brain disorder often experience debilitating mood swings 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.1
About Schizophrenia
Schizophrenia is a chronic, severe and disabling brain disorder.
The disease is marked by positive symptoms (hallucinations and
delusions) and negative symptoms (depression, blunted emotions and
social withdrawal), as well as by disorganized thinking. An
estimated 2.4 million American adults have
schizophrenia,2 with men and women affected equally.
About Alkermes
Alkermes plc is a fully
integrated, global biopharmaceutical company developing innovative
medicines for the treatment of central nervous system (CNS)
diseases and oncology. The company has a diversified commercial
product portfolio and a substantial clinical pipeline of product
candidates for chronic diseases that include schizophrenia,
depression, addiction, multiple sclerosis 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
schizophrenia and the treatment of bipolar I disorder; and timing
and expectations regarding interactions with the FDA
and submission of an NDA for ALKS 3831, including the expected
data to be contained in such NDA, the adequacy of such data to
serve as the basis of an NDA for ALKS 3831 for the treatment of
schizophrenia and the treatment of bipolar I disorder, and the
proposed fixed dosage strengths 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 NDA for ALKS 3831
will be submitted in a timely manner; once an NDA is submitted,
whether the preclinical and clinical results of the ALKS 3831
studies and the PK bridging data will meet the regulatory
requirements for approval by the FDA for either, or both, of the
proposed schizophrenia and bipolar I disorder indications;
potential changes in cost, scope and duration of the ENLIGHTEN
clinical development program and the broader ALKS 3831 regulatory
program; 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, 2018 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.
1 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/
2 National Institutes of Health.
Schizophrenia. Accessed on July 8,
2019 from
http://report.nih.gov/NIHfactsheets/ViewFactSheet.aspx?csid=67&key=S#S.
Alkermes Contacts:
For Investors: Sandy Coombs +1 781 609 6377
For Media: Gretchen Murphy +1 781 609 6419
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