Press Releases

WALTHAM, Mass. & NEW YORK, Apr 26, 2010 (BUSINESS WIRE) --Alkermes, Inc. (NASDAQ: ALKS) today will present an update on the progress of its late-stage and emerging clinical product candidates from the company's proprietary technology platforms at its Research and Development (R&D) Day for analysts and investors in New York.

As part of the update on late-stage development programs, Alkermes will announce the royalty rate to be received on sales of BYDUREON(TM) (exenatide for extended-release injectable suspension). Alkermes will also highlight key product candidates, including the announcement of a second long-acting antipsychotic candidate to emerge from the LinkeRx(TM) technology platform, as well as the clinical progress of phase 2 product candidates ALKS 37 and ALKS 33. Alkermes will detail the underlying science and drug discovery potential of the company's opioid modulator, LinkeRx and Medifusion(TM) platforms.

"We are excited to present our diverse and value-creating R&D platforms and clinical programs, which will provide the foundation for future growth at Alkermes," commented Richard Pops, Chief Executive Officer of Alkermes. "This is a particularly productive time in the company's history, as we expect significant inflection points on most of our key product candidates by the end of 2010."

"We are pleased with the rapid progress of our pipeline, with clinical candidates in all stages of development," stated Elliot Ehrich, Chief Medical Officer of Alkermes. "Our pipeline is based upon innovative science, novel proprietary platforms and proven development experience."

R&D Day Highlights

Alkermes today will provide details on the following product programs at its R&D day:

• Announcement of BYDUREON royalty rate.
  • Alkermes will provide an update on its late-stage development programs, including the announcement of the royalty rate for BYDUREON sales to be received by Alkermes from its partner, Amylin Pharmaceuticals, Inc. Alkermes will receive 8% of net sales from the first 40 million units of BYDUREON sold in any particular year and 5.5% of net sales from units sold beyond the first 40 million for that year. In addition, Alkermes will receive a $7 million milestone payment upon the first commercial sale of BYDUREON in the U.S. and an additional $7 million milestone upon the first commercial sale in Europe.
• Growing product portfolio of long-acting antipsychotic medicines based on LinkeRx platform.
  • Alkermes will unveil a long-acting olanzapine candidate, ALKS 7921, the second candidate from the LinkeRx platform.ALKS 7921 is a once-monthly, injectable, extended-release version of olanzapine for the treatment of schizophrenia. Olanzapine is commercially available under the trade name ZYPREXA^(R). Alkermes is engineering ALKS 7921 to prevent early, inadvertent release of free olanzipine into systemic circulation. Based on encouraging preclinical results, ALKS 7921 is expected to enter the clinic in calendar 2011.
    
    As an extended-release medication, ALKS 7921 is designed to provide another valuable option for patients and physicians to manage schizophrenia and be responsive to the growing body of clinical studies that have shown that the use of long-acting medications for the treatment of schizophrenia can improve patient outcomes and reduce costs.ALKS 7921 builds on Alkermes' unique expertise and insight in developing effective long-acting medications, including RISPERDAL^(R) CONSTA^(R).
• Advancement of two proprietary new chemical entities into phase 2 development for the treatment of opioid-induced constipation and reward disorders.
  • Initiated phase 2 study of ALKS 37 for the treatment of opioid-induced constipation. Alkermes will announce the initiation of a phase 2 clinical study of ALKS 37, an orally active, peripherally-restricted opioid antagonist with potential to block the effects of opioid agonists on gastrointestinal motility, commonly referred to as opioid-induced constipation (OIC). The multicenter, randomized, double-blind, placebo-controlled, multidose study will evaluate the efficacy, safety and tolerability of ALKS 37 in approximately 60 patients with OIC. According to IMS Health, over 200 million prescriptions were written for opioids in 2007 in the U.S. Many studies indicate that a high percentage of patients receiving opioids are likely to experience side effects affecting gastrointestinal motility. Alkermes expects to report preliminary results from the phase 2 study of ALKS 37 in the first quarter of calendar 2011.
  • Expanded development of ALKS 33 for the treatment of reward disorders.Alkermes will provide details on the advancing clinical program for ALKS 33, an oral opioid modulator for the treatment of reward disorders and impulse control disorders. Alkermes will outline plans for the development of ALKS 33 for the treatment of binge eating disorder and as a combination therapy with buprenorphine for the treatment of addiction and mood disorders. Alkermes is also testing ALKS 33 in a phase 2 study in alcohol dependent patients.

Webcast

A live webcast of the company's R&D Day will begin today at 12:30 p.m. ET and will run until approximately 3:00 p.m. ET. The webcast will be available on the investor relations section of the company's website at www.alkermes.com. To ensure a timely connection to the webcast, it is recommended that users register 15 minutes prior to the scheduled webcast. This webcast will be archived on the Alkermes website.

About Alkermes

Alkermes, Inc. is a fully integrated biotechnology company committed to developing innovative medicines to improve patients' lives. Alkermes developed, manufactures and commercializes VIVITROL^(R) for alcohol dependence and manufactures RISPERDAL^(R) CONSTA^(R) for schizophrenia and bipolar I disorder. Alkermes' robust pipeline includes extended-release injectable and oral products for the treatment of prevalent, chronic diseases, such as central nervous system disorders, addiction and diabetes. Headquartered in Waltham, Massachusetts, Alkermes has a research facility in Massachusetts and a commercial manufacturing facility in Ohio.

Certain statements set forth above may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to the timing and success of development activities for the company's programs, including BYDUREON, ALKS 7921, ALKS 33 and ALKS 37 and the potential therapeutic value of Alkermes' proprietary molecules. 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 the company's business is subject to significant risk and uncertainties and there can be no assurance that its actual results will not differ materially from its expectations. These risks and uncertainties include, among others: whether the clinical trials discussed in this press release will be completed on time or at all; potential changes in cost, scope and duration of the clinical trials; whether the company's product candidates will demonstrate sufficient efficacy and safety; decisions by the U.S. Food and Drug Administration regarding such product candidates; and whether the company's product candidates may prove difficult to manufacture on a large scale, be uneconomical, or be precluded from commercialization by proprietary rights of third parties. For further information with respect to factors that could cause the company's actual results to differ materially from expectations, reference is made to the reports the company filed with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended. The forward-looking statements made in this release are made only as of the date hereof and the company disclaims any intention or responsibility for updating predictions or financial expectations contained in this release.

VIVITROL^(R), LinkeRx(TM) and Medifusion(TM) are trademarks of Alkermes, Inc. RISPERDAL^(R) CONSTA^(R) is a trademark of Janssen-Cilag group of companies. BYDUREON(TM) is a trademark of Amylin Pharmaceuticals, Inc. ZYPREXA^(R) is a trademark of Eli Lilly and Company.

SOURCE: Alkermes, Inc.

Alkermes, Inc.
For Investors:
Rebecca Peterson, 617-899-2447
or
For Media:
Jennifer Snyder, 617-448-0281