- Prespecified Interim Analysis of Sample Size Indicates Study
Well-Powered to Evaluate Primary Endpoint –
DUBLIN--(BUSINESS WIRE)--Oct. 8, 2013--
Alkermes
plc (NASDAQ: ALKS) today announced completion of patient enrollment
in the pivotal, multinational phase 3 study evaluating aripiprazole
lauroxil in patients with schizophrenia. Aripiprazole lauroxil is
designed to provide patients with once-monthly dosing of a medication
that, once in the body, converts into aripiprazole, a molecule that is
commercially available under the name ABILIFY®. Alkermes
continues to expect topline results from the phase 3 study in the first
half of 2014.
Enrollment was completed following a prespecified interim analysis of
sample size. This analysis, designed to preserve the integrity of the
final efficacy analysis and performed by an independent statistical
center, indicated that a sample size of 540 patients or more would
have sufficient statistical power to evaluate the primary endpoint. The
study continues to be blinded until completion.
“There is a clear and compelling need for long-acting injectable
medicines for patients with schizophrenia,” said Elliot Ehrich, M.D.,
Chief Medical Officer of Alkermes. “We are excited to complete
enrollment in this carefully conducted, multinational study and look
forward to reporting the results in the first half of 2014.”
The phase 3 pivotal clinical trial of aripiprazole lauroxil is a
12-week, multicenter, double-blind, placebo-controlled study designed to
assess the efficacy, safety and tolerability of aripiprazole lauroxil in
patients experiencing acute exacerbation of schizophrenia. The primary
endpoint is the change from baseline in Positive and Negative Syndrome
Scale (PANSS) total score, which is a standard outcome measure in the
evaluation of schizophrenia treatment. The clinical data from this study
will form the basis of a New Drug Application (NDA) to the U.S. Food and
Drug Administration (FDA) for aripiprazole lauroxil for the treatment of
schizophrenia.
About Aripiprazole Lauroxil and LinkeRx®
LinkeRx is a novel, proprietary technology platform developed by
Alkermes that enables the creation of injectable extended-release
atypical antipsychotics and other central nervous system
therapies. Aripiprazole lauroxil, which utilizes the LinkeRx technology,
is a once-monthly, injectable atypical antipsychotic in phase 3 clinical
development for the treatment of schizophrenia. Once in the body,
aripiprazole lauroxil converts to aripiprazole, which is commercially
available under the name ABILIFY. Aripiprazole lauroxil was formerly
referred to as ALKS 9070.
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 Americans have schizophrenia1, with men and women
affected equally. Worldwide, it is estimated that one person in every
100 develops schizophrenia, one of the most serious types of mental
illness.
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, including, but not limited to,
statements concerning the sufficiency of the prespecified interim
analysis and sample size to evaluate the primary endpoint; the timing of
receipt and disclosure of topline phase 3 study results; and that the
phase 3 results will form the basis of an NDA to the FDA. 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: the phase 3 study of
aripiprazole lauroxil may be unsuccessful or not completed in a timely
manner; regulatory submissions may not occur or be submitted in a timely
manner; the company’s products may not show sufficient therapeutic
effects or acceptable safety profiles; adverse decisions by regulatory
authorities may occur; existing clinical and preclinical data with
respect to our products may not be indicative of future clinical
results; the company may be unable to manufacture successfully our
products; and those risks described in the Alkermes plc Annual Report on
Form 10-K and Form 10-K/A for the year ended March 31, 2013, and in
other filings made by the company with the U.S. Securities and Exchange
Commission (SEC), which are available at 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 any
forward-looking information contained in this press release.
1National Institutes of Health. Accessed on Oct. 7, 2013 from http://report.nih.gov/NIHfactsheets/ViewFactSheet.aspx?csid=67&key=S#S.
LinkeRx® is a registered trademark of Alkermes, Inc. ABILIFY®
is a registered trademark of Otsuka Pharmaceutical Co., Ltd.
Source: Alkermes plc
Alkermes:
For Investors:
Rebecca
Peterson, +1-781-609-6378
or
For Media:
Jennifer Snyder,
+1-781-609-6166