Press Releases

— Company Plans to Initiate Clinical Development of Immuno-Oncology Candidate in Third Quarter 2015 —

DUBLIN--(BUSINESS WIRE)--Apr. 13, 2015-- Alkermes plc (NASDAQ: ALKS) today announced that preclinical data from studies of the company’s selective effector cell activator (SECA™) immuno-oncology drug candidate, RDB 1450 (formerly referred to as RDB 1419), will be presented at the American Association for Cancer Research (AACR) Annual Meeting in Philadelphia, Pa., April 18-22, 2015. Based on the preclinical data for this program to date, Alkermes plans to initiate a phase 1 clinical study of RDB 1450 in the third quarter of 2015.

The poster presentations at AACR on Alkermes’ SECA immuno-oncology program include:

Tuesday, April 21, 2015, 8:00 a.m. – 12:00 p.m. EDT

• “Ex Vivo Expansion and Activation of Human Lymphocytes With a Selective Agonist of the Intermediate-Affinity IL-2 Receptor.” Abstract Number: 3158, Location: Poster Section 12.

Tuesday, April 21, 2015, 1:00 p.m. – 5:00 p.m. EDT

• “Utilizing a Selective Agonist of the Intermediate-Affinity IL-2 Receptor With an Improved Pharmacokinetic Profile Leads to an Enhanced Immunostimulatory Response With Reduced Toxicity in Mice.” Abstract Number: 4280, Location: Poster Section 24.
• “Determination of the Relative Potency of a Selective Agonist of the Intermediate-Affinity IL-2 Receptor on Lymphocytes from Human, Cynomolgus Monkey and Mouse.” Abstract Number: 4281, Location: Poster Section 24.

For more information, please visit the AACR website at www.aacr.org.

About the SECA™ Immuno-Oncology Program

Alkermes’ selective effector cell activator (SECA™) proteins are designed to harness a patient’s immune system to preferentially activate and increase the number of tumor killing immune cells. SECA proteins are selectively targeted to avoid expansion of immune regulatory cells which interfere with the anti-tumor response. SECA molecules are engineered using Alkermes’ proprietary PICASSO^TM circular permutation technology leveraging human protein biology to achieve their unique mechanism of action.

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 of and clinical development plans for our immuno-oncology drug candidate RDB 1450. 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 are subject to a variety of risks and uncertainties, many of which are beyond the company’s control, which could cause actual results to differ materially from those expressed or implied in the forward-looking statements. These risks and uncertainties include, among others, whether preclinical and clinical results for the immuno-oncology drug candidate RDB 1450 will be predictive of future clinical study results; whether the immuno-oncology drug candidate RDB 1450 could be shown to be unsafe or ineffective; whether future clinical trials for the immuno-oncology drug candidate RDB 1450 will be initiated on time or at all; and those risks described in the Alkermes plc 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. 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.

PICASSO™ and SECA™ are trademarks of Alkermes, Inc.

Source: Alkermes plc

Alkermes Contacts:
For Investors:
Rebecca Peterson, +1 781-609-6378
or
For Media:
Jennifer Snyder, +1 781-609-6166