Alkermes Announces Notice of Allowance of Key U.S. Patent for Aripiprazole Lauroxil, a New Schizophrenia Drug Candidate
— 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)--Jan. 3, 2013--
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
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.
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
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.
Source: Alkermes plc
Peterson, +1 781-609-6378