Alkermes Unveils Three New Drug Candidates Demonstrating Productivity of Its R&D Capabilities

  Alkermes Unveils Three New Drug Candidates Demonstrating Productivity of Its
  R&D Capabilities

 – New Molecular Entities Advancing for the Treatment of Multiple Sclerosis,
                              Pain and Cancer –

   – Company Also Highlights Late-Stage CNS Clinical Candidates, Including
               Aripiprazole Lauroxil, ALKS 5461 and ALKS 3831 –

Business Wire

DUBLIN -- July 17, 2013

Alkermes plc (NASDAQ: ALKS) today will present an overview of its proprietary
pipeline portfolio at its Research and Development (R&D) Day meeting for
analysts and investors. For the first time, the company will discuss three new
drug candidates including: a monomethyl fumarate (MMF) prodrug program for the
treatment of multiple sclerosis; ALKS 7106 for the treatment of pain; and RDB
1419, a cancer immunotherapy candidate based on interleukin-2 (IL-2) and its
receptors, Alkermes’ first proprietary biologic. These drug candidates
demonstrate Alkermes’ focus on unmet medical needs in specific patient
populations and show the productivity of the company’s expanded R&D
capabilities.

In addition to the three newly unveiled drug candidates, the company will
provide details on its later-stage pipeline candidates, specifically:
commercial plans for aripiprazole lauroxil, a once-monthly, long-acting
atypical antipsychotic currently in phase 3 development for the treatment of
schizophrenia; review of the phase 2 data for ALKS 5461, a proprietary opioid
modulator with a novel mechanism for the treatment of major depressive
disorder (MDD); and the clinical rationale and development plan, including
initiation of a phase 2 clinical study, for ALKS 3831, a proprietary oral
compound designed as a broad spectrum antipsychotic treatment for
schizophrenia.

“During this R&D Day, a more complete picture of our growth strategy will
emerge,” commented Richard Pops, Chief Executive Officer of Alkermes. “Today
we will be presenting a deeper look into our unique R&D engine that is
powering one of the most diverse and exciting pipelines in the biotechnology
industry, and bringing to light three innovative product candidates in
important therapeutic fields. These new candidates are expected to follow our
later-stage CNS product candidates: aripiprazole lauroxil for schizophrenia,
ALKS 5461 for major depressive disorder and ALKS 3831 for schizophrenia, which
represent growth opportunities over and above our five key commercial
products.”

“The three new drug candidates that we are unveiling today exemplify the
productivity of R&D at Alkermes – which now spans small molecules and
biologics – and represent significant opportunities for us to address unmet
needs for patients with major, chronic diseases: multiple sclerosis, pain and
cancer,” stated Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. “Our
distinctive approach is to build on a foundation of known pharmacology and
clinical practice, then apply our R&D expertise and novel insights to create
proprietary medicines with real value for patients and treatment systems. We
will highlight for investors at our R&D Day how Alkermes employs a rigorous
clinical development process that incorporates state-of-the-art clinical trial
techniques and robust study designs so we can obtain data early in the
development process to make rapid decisions about the most promising
candidates in our pipeline.”

R&D Highlights

Alkermes today will provide details on the following new proprietary
candidates:

  *MMF Prodrug Program for the Treatment of Multiple Sclerosis: The company’s
    MMF prodrug program has resulted in novel, small-molecule prodrugs of
    monomethyl fumarate for the treatment of multiple sclerosis. Alkermes’ MMF
    prodrugs are designed to rapidly and efficiently convert to MMF in the
    body and to offer advantages over the currently marketed dimethyl fumarate
    prodrug, TECFIDERA^®. Alkermes expects to file an Investigational New Drug
    (IND) application and initiate a phase 1 study in mid calendar 2014.
  *ALKS 7106 for the Treatment of Pain: ALKS 7106 is Alkermes’ novel,
    small-molecule drug candidate derived from the company’s opioid modulator
    platform. ALKS 7106 is a potent, oral opioid analgesic designed for the
    treatment of pain with intrinsically low potential for abuse and overdose
    death, two liabilities associated with other opioid medicines. Alkermes
    will present preclinical data showing that ALKS 7106 had more potent
    analgesic properties than morphine and was well tolerated at doses far in
    excess of those required for analgesic action. Additional preclinical data
    for ALKS 7106 demonstrated a ceiling effect on neurotransmitter release
    over a broad concentration range, suggesting low potential for abuse and
    overdose death. Alkermes expects to file an IND and initiate a phase 1
    study of ALKS 7106 in mid calendar 2014.
  *RDB 1419, a Cancer Immunotherapy Based on IL-2 and its Receptors: Alkermes
    will present preclinical data showing that RDB 1419, a novel biologic
    based on IL-2 and its receptors, preferentially expanded the number of
    tumor-killing cells involved in immunotherapeutic effects on cancer.
    Additional preclinical data demonstrated that RDB 1419 inhibited lung
    metastases in a model of lung cancer. The company will describe how RDB
    1419 was engineered using its proprietary fusion protein technology
    platform to modulate the natural mechanism of action of a biologic and to
    provide safety and tolerability advantages over existing therapies.
    Alkermes expects to conduct IND-enabling activities for RDB 1419 in
    calendar 2014.

Webcast

A live webcast of the company's R&D Day will begin today at 1:00 p.m. EDT
(6:00 p.m. BST). The webcast will be available on the Investors tab of the
company’s website at www.alkermes.com. To ensure a timely connection to the
webcast, it is recommended that users register 15 minutes prior to the
scheduled webcast. This webcast will be archived on Alkermes’ website for one
month.

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, development plans, and commercial potential of the company’s products,
including aripiprazole lauroxil, ALKS 5461, ALKS 3831, ALKS 7106, RDB 1419 and
the MMF prodrug program. 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: clinical trials of our products may be unsuccessful or not initiated
or conducted in a timely manner; regulatory submissions, including INDs, may
not occur or be submitted in a timely manner; our products may not show
sufficient therapeutic effects or acceptable safety profiles; adverse
decisions by regulatory authorities; existing clinical and preclinical data
with respect to our products may not be indicative of future clinical or
commercial results; and our inability 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.

TECFIDERA^® is a registered trademark of Biogen Idec.

Contact:

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