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Alkermes to Present Clinical Data on ALKS 8700 at Annual Meeting of the Consortium of Multiple Sclerosis Centers

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Alkermes plc (NASDAQ:ALKS) today announced that data from its phase 1, randomized, double-blind clinical study of ALKS 8700, a novel monomethyl fumarate (MMF) molecule in development for the treatment of multiple sclerosis (MS), is scheduled to be presented at the 2015 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC) being held in Indianapolis, Ind., May 27-30, 2015. ALKS 8700 is designed to rapidly and efficiently convert to MMF in the body and offer differentiated features as compared to the currently marketed dimethyl fumarate, TECFIDERA(R).

The study evaluated the safety, tolerability and single-dose pharmacokinetics (PK) of oral formulations of ALKS 8700 compared to both placebo and active control groups in healthy volunteers. Data from the study showed that ALKS 8700 was generally well tolerated and provided MMF exposures comparable to TECFIDERA, with less variability and favorable gastrointestinal (GI) tolerability. The most common adverse events (AEs) were flushing and GI-related. Based on the positive results from the study, Alkermes plans to advance ALKS 8700 with twice-daily dosing into pivotal development in 2015.

“The data being presented during the CMSC annual meeting demonstrated that ALKS 8700 efficiently converts to MMF following oral administration with the potential to offer favorable GI tolerability for patients with MS,” said Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. “We are committed to bringing this innovative potential new treatment option to patients and remain on track to initiate pivotal development of ALKS 8700 later this year.”

A poster on the phase 1 data, titled “Safety, Tolerability and Pharmacokinetics of ALKS 8700, a Novel Oral Therapy for Relapsing-Remitting Multiple Sclerosis in Healthy Subjects” (P# DX37) will be presented on Friday, May 29, 2015, 12:00 – 2:00 p.m. EDT. For more information including a complete list of abstract titles, please visit the CMSC website at http://annualmeeting.mscare.org.

About ALKS 8700

ALKS 8700 is an oral, novel and proprietary monomethyl fumarate (MMF) molecule in development for the treatment of multiple sclerosis (MS). ALKS 8700 is designed to rapidly and efficiently convert to MMF in the body and to offer differentiated features as compared to the currently marketed dimethyl fumarate, TECFIDERA(R).

About Multiple Sclerosis

Multiple sclerosis (MS) is an unpredictable, often disabling disease of the central nervous system (CNS), which interrupts the flow of information within the brain, and between the brain and body.1 MS symptoms can vary over time and from person to person. Symptoms may include extreme fatigue, impaired vision, problems with balance and walking, numbness or pain and other sensory changes, bladder and bowel symptoms, tremors, problems with memory and concentration and mood changes, among others.1 Approximately 400,000 individuals in the U.S. and 2.5 million people worldwide have MS, and most are diagnosed between the ages of 15 and 50.2

About Alkermes

Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in 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: the therapeutic value, development plans and commercial potential of ALKS 8700. You are cautioned 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 expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: whether preclinical and early clinical results for ALKS 8700 will be predictive of future clinical study results; whether future clinical trials for ALKS 8700 will be initiated or completed on time or at all; changes in the cost, scope and duration of the ALKS 8700 clinical trials; whether ALKS 8700 could be shown ineffective or unsafe during clinical studies, and whether, in such instances, the company may not be permitted by regulatory authorities to undertake new or additional clinical studies of ALKS 8700; and those risks and uncertainties described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K for the fiscal year ended Dec. 31, 2014, and in any other subsequent filings made by the company with the U.S. Securities and Exchange Commission (“SEC”), which are available on the SEC’s website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. 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.

TECFIDERA(R) is a registered trademark of Biogen MA Inc.

1National Multiple Sclerosis Society. Multiple Sclerosis: Just the Facts. Accessed from http://www.nationalmssociety.org/NationalMSSociety/media/MSNationalFiles/Brochures/Brochure-Just-the-Facts.pdf on May 28, 2015.
2Multiple Sclerosis Association of America. MS Overview. Accessed from http://mymsaa.org/about-ms/overview/ on May 28, 2015.

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