|[July 09, 2014]
Alkermes Announces Notices of Allowance for U.S. Patents for Four CNS Pipeline Candidates
DUBLIN --(Business Wire)--
plc (NASDAQ: ALKS) today announced that the United States Patent and
Trademark Office (USPTO) has issued Notices of Allowance for four of
Alkermes' pipeline candidates for the treatment of central nervous
system (CNS) disorders: aripiprazole lauroxil, ALKS 5461, ALKS 3831 and
ALKS 7106. A Notice of Allowance is issued after the USPTO makes a
determination that a patent can be granted from an application.
"These patent allowances are a critical component in building a robust
intellectual property portfolio for Alkermes' innovative CNS medicines
and reflect the significant innovations our scientific teams are
making," stated Elliot Ehrich, M.D., Chief Medical Officer of Alkermes.
"Aripiprazole lauroxil, ALKS 5461, ALKS 3831 and ALKS 7106 each
represent novel therapeutic approaches with potential to address unmet
needs in their respective disease areas."
Aripiprazole lauroxil: The USPTO issued a Notice of Allowance for U.S.
Patent Application 13/607,066, entitled "Heterocyclic Compounds for
the Treatment of Neurological and Psychological Disorders." The
allowed claims will cover methods of treating schizophrenia, mania,
bipolar disorder, anxiety or depression by administering a broad class
of compounds, including aripiprazole lauroxil, Alkermes' long-acting
injectable antipsychotic agent designed to provide patients with
once-monthly dosing of a medication that, once in the body, converts
to aripiprazole. Alkermes expects this patent to issue within the next
few months and expire no earlier than September 2030.
ALKS 5461: The USPTO issued a Notice of Allowance for U.S. Patent
Application 13/715,198, entitled "Compositions of Buprenorphine and a
Mu Antagonist." The allowed composition of matter claims will cover
ALKS 5461. ALKS 5461 is Alkermes' once-daily, oral investigational
medicine with a novel mechanism of action for the adjunctive treatment
of major depressive disorder (MDD). Alkermes expects this patent to
issue within the next few months and expire no earlier than December
ALKS 3831: The USPTO issued a Notice of Allowance for U.S. Patent
Application 13/215,718, entitled "Methods for Treating
Antipsychotic-Induced Weight Gain" for ALKS 3831, Alkermes'
broad-spectrum antipsychotic for the treatment of schizophrenia. The
allowed methods of treatment claims will cover the attenuation of
weight gain associated with olanzapine in patients with schizophrenia
by administering the combination of samidorphan (formerly known as
ALKS 33) and olanzapine. Alkermes expects this patent to issue on July
15, 2014 as U.S. Patent No. 8,778,960 and expire no earlier than
ALKS 7106: The USPTO issued a Notice of Allowance for U.S. Patent
Application 14/169,305, entitled "4-Hydroxybenzomorphans" for ALKS
7106, Alkermes' novel, small-molecule drug candidate for pain. The
allowed composition of matter claims will cover ALKS 7106 and salts
thereof. In addition, the Notice of Allowance covers a method of
treating pain by adminitering ALKS 7106. Alkermes expects this patent
to issue within the next few months and expire no earlier than
November 2025. This Notice of Allowance augments the existing patent
portfolio for ALKS 7106 which includes U.S. Patent No. 8,680,112,
which covers broad method of treatment claims through 2029.
About Aripiprazole Lauroxil
Aripiprazole lauroxil is an injectable atypical antipsychotic with
one-month and two-month formulations in development for the treatment of
schizophrenia. Once in the body, aripiprazole lauroxil converts to
aripiprazole, which is commercially available under the name ABILIFY®.
As a long-acting investigational medication based on Alkermes'
proprietary LinkeRx® technology, aripiprazole lauroxil is
designed to have multiple dosing options and to be administered in a
ready-to-use, prefilled product format.
About ALKS 5461
ALKS 5461 is a proprietary investigational oral medicine for the
treatment of major depressive disorder (MDD). ALKS 5461 is designed to
modulate the opioid system in the brain, employing a balanced
combination of agonist and antagonist components that act on opioid
receptors, and includes a novel opioid modulator, samidorphan,
discovered by Alkermes. Samidorphan was formerly referred to as ALKS 33.
In October 2013, the U.S. Food and Drug Administration (FDA) granted
Fast Track status for ALKS 5461 for the adjunctive treatment of MDD in
patients with an inadequate response to standard antidepressant
About ALKS 3831
ALKS 3831 is a proprietary investigational medicine designed as a
broad-spectrum antipsychotic for the treatment of schizophrenia. ALKS
3831 is composed of samidorphan (formerly referred to as 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 whose disease is exacerbated
by alcohol use.
About ALKS 7106
ALKS 7106 is a novel, small-molecule drug candidate derived from the
company's opioid modulator platform. ALKS 7106 is designed to treat pain
with intrinsically low potential for abuse and overdose death, two
liabilities associated with other opioid medicines.
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, as amended, including, but not
limited to, statements concerning: whether Patent Applications
13/607,066, 13/715,198, 13/215,718 and 14/169,305 will issue; if such
Patent Applications are issued, whether the issued patents will
adequately protect aripiprazole lauroxil, ALKS 5461, ALKS 3831 and ALKS
7106; the expiration dates and strength of such patents; and the
therapeutic value, development plans and commercial potential of
aripiprazole lauroxil, ALKS 5461, ALKS 3831 and ALKS 7106. 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: whether the validity and
enforceability of Patent Applications 13/607,066, 13/715,198, 13/215,718
and 14/169,305, if issued, will be challenged by one or more third
parties and upheld; whether preclinical and clinical results for ALKS
5461, ALKS 3831 and ALKS 7106 will be predictive of future clinical
study results; whether ALKS 5461, ALKS 3831 and ALKS 7106 will be shown
to be ineffective or unsafe during clinical studies; decisions by the
U.S. Food and Drug Administration (FDA) or foreign regulatory
authorities regarding aripiprazole lauroxil, ALKS 5461, ALKS 3831 and
ALKS 7106; potential changes in cost, scope and duration of clinical
trials of ALKS 5461, ALKS 3831 and ALKS 7106; and those risks described
in the Alkermes plc Transition Report on Form 10-K for the fiscal period
ended December 31, 2013, and in other subsequent filings made by the
company with the U.S. Securities and Exchange Commission (SEC (News - Alert)), 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 or
revising 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.
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