Alkermes receives Notices of Allowance for US patents for four CNS pipeline candidates

Represent novel therapeutic approaches with potential to address unmet needs in their respective disease areas

Alkermes has announced that the United States Patent and Trademark Office (USPTO) has issued Notices of Allowance for four of its 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,' said Dr Elliot Ehrich, 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 US 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.

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.

ALKS 5461: The USPTO issued a Notice of Allowance for US 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 2032.

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 US Food and Drug Administration granted Fast Track status for ALKS 5461 for the adjunctive treatment of MDD in patients with an inadequate response to standard antidepressant therapies.

ALKS 3831: The USPTO issued a Notice of Allowance for US 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 15 July, 2014 as US Patent No 8,778,960 and expire no earlier than August 2031.

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.

ALKS 7106: The USPTO issued a Notice of Allowance for US 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 than November 2025. This Notice of Allowance augments the existing patent portfolio for ALKS 7106 which includes US Patent No 8,680,112, which covers broad method of treatment claims through 2029.

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.

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