Alkermes Announces Initiation of Phase 2 Clinical Study of ALKS 3831, Designed to Be a Broad Spectrum Oral Antipsychotic for the

  Alkermes Announces Initiation of Phase 2 Clinical Study of ALKS 3831,
  Designed to Be a Broad Spectrum Oral Antipsychotic for the Treatment of
  Schizophrenia

   – Study Will Evaluate ALKS 3831’s Safety, Tolerability and Effect on the
           Attenuation of Weight Gain Associated With Olanzapine –

Business Wire

DUBLIN -- July 17, 2013

Alkermes plc (NASDAQ:ALKS) today announced the initiation of a phase 2 study
of ALKS 3831, a novel oral atypical antipsychotic drug candidate designed to
be a broad spectrum treatment for schizophrenia. The double-blind,
active-controlled, dose-ranging study in approximately 400 patients with
schizophrenia will assess ALKS 3831, a proprietary combination of a novel
opioid modulator, ALKS 33, and olanzapine, an approved atypical antipsychotic
medicine, compared to olanzapine alone. In addition to safety and
tolerability, the phase 2 study is designed to evaluate the impact of ALKS
3831 on weight and other metabolic factors in patients and confirm the
attenuation of olanzapine-induced weight gain observed in the phase 1 study of
ALKS 3831.

“We have designed ALKS 3831 as a broad spectrum schizophrenia agent addressing
two specific patient subpopulations: patients who may benefit from attenuation
of the significant weight gain often associated with olanzapine treatment; and
patients with a dual diagnosis of substance abuse disorder, which often
exacerbates their schizophrenia,” said Elliot Ehrich, M.D., Chief Medical
Officer of Alkermes. “This large, well-designed phase 2 study will provide
data necessary for us to determine ALKS 3831’s ability to attenuate weight
gain commonly associated with olanzapine treatment.”

The ALKS 3831 comprehensive phase 2 clinical program is comprised of two
separate studies, including the study announced today focused on the
attenuation of weight gain associated with olanzapine. Weight gain is a common
and clinically relevant metabolic side effect of atypical antipsychotic
medications, and olanzapine has one of the highest incidences and greatest
amounts of weight gain among the widely prescribed products in this class of
drugs.^1 The second phase 2 study will investigate the potential utility of
ALKS 3831 for the large number of patients with the dual diagnosis of
schizophrenia and substance abuse disorder, a group representing as many as
50% of patients with schizophrenia.^2

Phase 2 Study Design

The phase 2, double-blind, active-controlled, dose-ranging study is designed
to assess the safety and tolerability of ALKS 3831, as well as evaluate the
impact of ALKS 3831 on weight and other metabolic factors in comparison to
olanzapine alone in approximately 400 adult patients with schizophrenia. In
the study, following a one-week oral lead-in of olanzapine, patients will be
randomly assigned to olanzapine or three different doses of ALKS 3831 for a
period of 12 weeks, followed by a 12-week period in which all patients will
receive ALKS 3831. Alkermes expects to provide topline results from the study
in the first half of 2015.

About ALKS 3831

ALKS 3831 is a proprietary investigational medicine designed as a broad
spectrum treatment for schizophrenia. ALKS 3831 is composed of ALKS 33, a
novel potent mu-opioid antagonist, in combination with the established
antipsychotic drug, olanzapine. ALKS 3831 is designed to attenuate
olanzapine-induced metabolic side effects, including weight gain, and to have
utility in patients with schizophrenia and comorbid substance abuse disorder.

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,
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 plc

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 therapeutic
value of ALKS 3831 and clinical development plans for ALKS 3831. You are
cautioned 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 clinical results for ALKS 3831 will be predictive of future
clinical study results; whether the company will initiate studies for ALKS
3831 for dual-diagnosis patients; whether future clinical trials for ALKS 3831
will be completed on time or at all; potential changes in cost, scope and
duration of the ALKS 3831 clinical development program; whether ALKS 3831
could be shown ineffective or unsafe during clinical studies; 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 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 any
forward-looking information contained in this press release.

^1Komossa K, Rummel-Kluge C, Hunger H, Schmid F, Schwarz S, Duggan L, Kissling
W, Leucht S. Olanzapine versus other atypical antipsychotics for
schizophrenia. Cochrane Database of Systematic Reviews. 2010, Issue 3. Art.
No.: CD006654.

^2Koola M, Wehring H, Kelly D. The Potential Role of Long-acting Injectable
Antipsychotics in People with Schizophrenia and Comorbid Substance Use.
Journal of Dual Diagnosis. 2012, 8(1): 50–61.

Contact:

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