Alkermes Announces Completion of Patient Enrollment in Pivotal Phase 3 Study of Aripiprazole Lauroxil

  Alkermes Announces Completion of Patient Enrollment in Pivotal Phase 3 Study
  of Aripiprazole Lauroxil

- Prespecified Interim Analysis of Sample Size Indicates Study Well-Powered to
                         Evaluate Primary Endpoint –

Business Wire

DUBLIN -- October 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 performedbyanindependentstatistical
center,indicatedthatasample size of 540 patientsormorewould
havesufficientstatisticalpower toevaluate 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
schizophrenia^1, 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

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 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

LinkeRx^® is a registered trademark of Alkermes, Inc. ABILIFY^® is a
registered trademark of Otsuka Pharmaceutical Co., Ltd.


For Investors:
Rebecca Peterson, +1-781-609-6378
For Media:
Jennifer Snyder, +1-781-609-6166
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