“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
-
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 thanSeptember 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 thanDecember 2032 . -
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 onJuly 15, 2014 as U.S. Patent No. 8,778,960 and expire no earlier thanAugust 2031 . -
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 administering ALKS 7106.
Alkermes expects this patent to issue within the next few months and expire no earlier thanNovember 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
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
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
LinkeRx® is a registered trademark of
Source:
Alkermes Contacts:
For Investors:
Rebecca Peterson,
+1-781-609-6378
or
For Media:
Jennifer Snyder,
+1-781-609-6166