— Potential To Give Patients and Physicians a New, Long-Acting
Injectable Medicine With More Flexibility in Dosing Intervals, Beyond
Once-Monthly Aripiprazole Lauroxil —
DUBLIN--(BUSINESS WIRE)--Dec. 15, 2014--
Alkermes
plc (NASDAQ: ALKS) today announced the initiation of a phase 1
clinical study of extended dosing intervals of aripiprazole lauroxil,
the company’s investigational, novel, long-acting injectable atypical
antipsychotic for the treatment of schizophrenia. The randomized,
open-label study of approximately 140 patients with schizophrenia will
evaluate the pharmacokinetics, safety and tolerability of aripiprazole
lauroxil administered over two new extended durations – once every six
weeks, and once every two months. A New Drug Application (NDA) for
aripiprazole lauroxil one-month is currently under review with the U.S.
Food and Drug Administration (FDA) and has been assigned a Prescription
Drug User Fee Act (PDUFA) date of Aug. 22, 2015.
“Building upon our longstanding expertise with multiple long-acting
atypical antipsychotics available today, Alkermes recognizes the value
of flexibility of dosing for both patients and healthcare providers. Our
goal is to continue to move the frontier by creating the first
long-acting atypical antipsychotic designed to be dosed every six weeks
or every two months,” said Elliot Ehrich, M.D., Chief Medical Officer of
Alkermes. “We believe there are compelling needs in the mental illness
community to improve treatment outcomes for patients, and our aim is to
continue to apply our innovative technology to bring forward options for
the treatment of schizophrenia.”
The phase 1, randomized, open-label study will evaluate the
pharmacokinetics, safety and tolerability of aripiprazole lauroxil when
administered at one-month, six-week and two-month intervals. Following a
30-day screening period, approximately 140 patients with stable
schizophrenia will be randomized to receive one of four different dosing
regimens of aripiprazole lauroxil (441 mg once per month, 882 mg every
six weeks, or one of two formulations of 1064 mg every two months) for a
total of six treatment months. Results from this phase 1 study are
expected mid 2016.
About Aripiprazole Lauroxil
Aripiprazole lauroxil is an injectable atypical antipsychotic with
one-month and extended-duration formulations in development for the
treatment of schizophrenia. Once in the body, aripiprazole lauroxil
converts to aripiprazole, which is commercially available under the name
ABILIFY®. As a long-acting investigational medication based
on Alkermes’ proprietary LinkeRx® technology, aripiprazole
lauroxil is designed to have multiple dosing options and to be
administered in a ready-to-use, pre-filled product format.
About Schizophrenia and Long-Acting Medicines
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,1 with men and
women affected equally. Worldwide, it is estimated that one person in
every 100 develops schizophrenia, which is one of the most serious types
of mental illness. Long-acting injectable antipsychotics provide
patients with blood concentrations of active drug that remain within a
therapeutic range for an extended period of time2 and allow
healthcare providers to track patient adherence.3
About Alkermes
Alkermes plc is a fully integrated, global biopharmaceutical company
that applies its scientific expertise and proprietary technologies to
develop innovative medicines that improve patient outcomes. The company
has a diversified portfolio of more than 20 commercial drug products and
a substantial clinical pipeline of product candidates that address
central nervous system (CNS) disorders such as addiction, schizophrenia
and depression. Headquartered in Dublin, Ireland, Alkermes plc has an
R&D center in Waltham, Massachusetts; a research and manufacturing
facility in Athlone, Ireland; and manufacturing facilities in
Gainesville, Georgia and 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 company’s expectations and
timeline for regulatory action by the FDA relating to the NDA for
aripiprazole lauroxil one-month for the treatment of schizophrenia; the
potential therapeutic value, attributes and commercial potential of
aripiprazole lauroxil one-month and extended-duration formulations of
aripiprazole lauroxil; and the clinical development timelines of
extended-duration formulations of aripiprazole lauroxil. 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 projected or suggested in the
forward-looking statements due to various risks and uncertainties. These
risks and uncertainties include, among others: whether preclinical and
early clinical results for aripiprazole lauroxil will be predictive of
future clinical study results; whether future clinical trials for
aripiprazole lauroxil will be completed on time or at all; changes in
the cost, scope and duration of the aripiprazole lauroxil clinical
trials; whether aripiprazole lauroxil could be shown ineffective or
unsafe; whether aripiprazole lauroxil one-month will be approved by
regulatory authorities for the treatment of schizophrenia by Aug. 22,
2015 or at all; if approved, whether aripiprazole lauroxil will be
commercialized successfully; and those risks described in the Alkermes
plc Transition Report on Form 10-K for the fiscal period ended Dec. 31,
2013, and in other 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.
The information contained in this press release is provided by the
company as of the date hereof, and, except as required by law, the
company disclaims any intention or responsibility for updating or
revising any forward-looking information contained in this press release.
LinkeRx® is a registered trademark of Alkermes Pharma Ireland
Limited. ABILIFY® is a registered trademark of Otsuka
Pharmaceutical Co., Ltd.
1National Institutes of Health. Accessed on Dec. 12, 2014
from http://report.nih.gov/NIHfactsheets/ViewFactSheet.aspx?csid=67&key=S#S.
2Patel MX and David AS. Why aren’t depot antipsychotics
prescribed more often and what can be done about it? Adv Psychiatr
Treat, 2005; 11: 203-213.
3Kane JM et al. Guidelines for depot antipsychotic treatment
in schizophrenia. Eur Neuropsychopharmacol, 1998; 8(1):
55-66.
Source: Alkermes plc
Alkermes Contacts:
Alkermes plc
For
Investors:
Rebecca Peterson, +1-781-609-6378
or
For Media:
Jennifer
Snyder, +1-781-609-6166
