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Alkermes Reports Achievement of Milestones for CNS Medicines in Proprietary Product, Pipeline Portfolio

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Alkermes plc (NASDAQ: ALKS) today announced new developments and milestones related to its proprietary product and late-stage pipeline portfolio of medicines for the treatment of central nervous system (CNS) diseases. The company has initiated pivotal clinical development programs for two of its pipeline candidates: ALKS 3831, a novel, oral atypical antipsychotic drug candidate designed to be a broad-spectrum treatment for schizophrenia, and ALKS 8700, a novel, oral monomethyl fumarate (MMF) drug candidate for the treatment of multiple sclerosis (MS).

Alkermes also announced positive topline results from a recently-completed human abuse potential study of ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder. Additionally, the company announced a newly issued patent expiring in 2033 that extends patent coverage for ARISTADA™ (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia.

"As we near the end of 2015, Alkermes is aggressively executing on our strategy to build a leading biopharmaceutical company for CNS innovation, characterized by one of the most exciting late-stage CNS pipelines in the industry," said Richard Pops, Chief Executive Officer of Alkermes. "This is a particularly productive time in the company's history, and looking ahead to 2016, we expect significant value-creating milestones as we continue to advance our late-stage pipeline and grow our commercial products, ARISTADA and VIVITROL."

"We are pleased with the rapid progress of our late-stage pipeline, with ALKS 5461 nearing completion of its pivotal phase 3 program, and ALKS 3831 and ALKS 8700 entering registration trials," said Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. "We have successfully hit the key milestones we set out to achieve in 2015 and look forward to data from the core efficacy studies of ALKS 5461 in early 2016."

Highlights of Milestone Achievements

ENLIGHTEN pivotal program initiated for ALKS 3831: The ENLIGHTEN pivotal program for ALKS 3831 is comprised of two key studies. ENLIGHTEN-1, a multicenter, randomized, double-blind phase 3 study to evaluate the antipsychotic efficacy of ALKS 3831 compared to placebo over four weeks in approximately 390 patients experiencing acute exacerbation of schizophrenia, is now underway and enrolling patients. The study will also include an olanzapine comparator arm. ENLIGHTEN-2, a phase 3 study assessing weight gain with ALKS 3831 compared to olanzapine in patients with schizophrenia over six months, is expected to initiate in Q1 2016. The program will also include supportive studies to evaluate the pharmacokinetic and metabolic profile of ALKS 3831, as well as long-term safety. Alkermes expects to use safety and efficacy data from the ENLIGHTEN pivotal program to serve as the basis for a New Drug Application (NDA) to be submitted to the U.S. Food and Drug Administration (FDA), pending study results.
EVOLVE pivotal program initiated for ALKS 8700: EVOLVE-1, a two-year, multicenter, open-label study to assess the safety of ALKS 8700 in approximately 600 patients with MS, is now underway and enrolling patients. This is the first study to initiate from the EVOLVE (Endeavoring to Advance Treatment for Patients Living with Multiple Sclerosis) pivotal program of ALKS 8700 for the treatment of MS. Alkermes plans to include data from EVOLVE-1, as well as pharmacokinetic bridging data from studies comparing ALKS 8700 and TECFIDERA®, to support registration of ALKS 8700, based on feedback from the FDA. In addition, Alkermes intends to initiate EVOLVE-2, a randomized, head-to-head study comparing the gastrointestinal tolerability of ALKS 8700 and TECFIDERA in up to 420 patients with MS, in mid-2016. Alkermes plans to submit the NDA for ALKS 8700 to the FDA in 2018.
Positive topline results announced from human abuse potential study of ALKS 5461: In the study, all doses of ALKS 5461 tested met the trial's primary endpoint and demonstrated a statistically significant and meaningful reduction in abuse potential compared to buprenorphine (p<0.001). Further, no difference was observed in overall drug liking for ALKS 5461 compared to placebo. Data from this study is expected to support the comprehensive data package for ALKS 5461 to be submitted as part of the NDA to the FDA. The three core efficacy studies for ALKS 5461 remain on track to read out in 2016, with data from the first two studies expected in Q1 2016, and data from the third study anticipated in mid-2016.
New patent issued for ARISTADA: The United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 9,193,685 covering ARISTADA. The patent covers drug compositions that confer long-term stability. This patent adds to the robust, existing patent estate for ARISTADA and is expected to extend protection to October 2033.

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