Alkermes Announces Notice of Allowance of Key U.S. Patent for Aripiprazole Lauroxil, a New Schizophrenia Drug Candidate

Thu Jan 3, 2013 7:01am EST

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- Patent Protection Expected Into Late 2030 for Extended-Release, Once-Monthly
Prodrug of Aripiprazole - 

- Aripiprazole Lauroxil Designated as Generic Name for ALKS 9070 - 
DUBLIN--(Business Wire)--
Alkermes plc (NASDAQ: ALKS) today announced that the United States Patent and
Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent
Application 12/823,007, titled "Heterocyclic Compounds for the Treatment of
Neurological and Psychological Disorders." The allowed claims will cover a class
of compounds that includes aripiprazole lauroxil, a proprietary Alkermes
molecule formerly referred to as ALKS 9070, which is in development for the
treatment of 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® for the treatment of a number of central nervous system (CNS)
disorders. 

Given this action, Alkermes expects the patent to issue within the next month
and provide a patent term that would expire no earlier than 2030. A Notice of
Allowance is issued after the USPTO makes a determination that a patent can be
granted from an application. 

"Alkermes` expertise in developing safe and effective long-acting therapeutics
uniquely positions us to develop a once-monthly atypical antipsychotic
medication that delivers aripiprazole, a widely prescribed oral product with an
established safety and efficacy profile," stated Elliot Ehrich, M.D., Chief
Medical Officer of Alkermes. "With data from our phase 3 study for aripiprazole
lauroxil anticipated in late 2013 and expected patent protection into late 2030,
we look forward to advancing aripiprazole lauroxil as a potential new treatment
option for patients with schizophrenia." 

In December 2011, Alkermes announced the initiation of a phase 3 clinical trial
of aripiprazole lauroxil for the treatment of schizophrenia. The 12-week,
multicenter, double-blind, placebo-controlled study is designed to assess the
efficacy, safety and tolerability of aripiprazole lauroxil in approximately 690
patients experiencing acute exacerbation of schizophrenia. The clinical data
from this study, expected in late calendar 2013, 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 CNS therapies. Aripiprazole lauroxil, which leverages the LinkeRx
technology, is a once-monthly, injectable atypical antipsychotic in development
for the treatment of schizophrenia. Once in the body, aripiprazole lauroxil
converts to aripiprazole. Aripiprazole is commercially available under the name
ABILIFY® for the treatment of a number of CNS disorders. 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, 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 above may constitute forward-looking statements
within the meaning of the Private Securities Litigation Reform Act of 1995,
including, but not limited to: whether Patent Application 12/823,007 will issue;
whether such patent will adequately protect the pharmaceutical composition of
aripiprazole lauroxil against competition; the expiration date and strength of
such patent; the timing and successful completion of the phase 3 trial of
aripiprazole lauroxil for the treatment of schizophrenia; and the therapeutic
value and potential of aripiprazole lauroxil. 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. The company`s business is subject to
significant risk and uncertainties and there can be no assurance that its actual
results will not differ materially from its expectations. 

These risks and uncertainties include, among others: whether Patent Application
12/823,007 will issue and, if issued, whether the validity and enforceability of
the patent will be challenged by one or more third parties and upheld; whether
preclinical and early clinical results for aripiprazole lauroxil will be
predictive of future clinical study results; whether aripiprazole lauroxil will
be shown to be ineffective or unsafe during clinical studies; decisions by the
FDA or foreign regulatory authorities regarding aripiprazole lauroxil for the
treatment of schizophrenia; potential changes in cost, scope and duration of the
phase 3 clinical trial of aripiprazole lauroxil for the treatment of
schizophrenia; and those risks described in the Alkermes plc Annual Report on
Form 10-K for the year ended March 31, 2012, 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. 

LinkeRx® is a registered trademark of Alkermes Pharma Ireland Limited. ABILIFY®
is a registered trademark of Otsuka Pharmaceutical Co., Ltd.

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

Copyright Business Wire 2013
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