Alkermes, Inc. (NASDAQ: ALKS) announced that it has developed a novel, proprietary LinkeRx™ technology platform to enable the creation of injectable extended-release versions of antipsychotics and other central nervous system (CNS) therapies. The company's lead candidate that leverages this platform, designated as ALKS 9070, is a once-monthly, injectable, extended-release version of aripiprazole for the treatment of schizophrenia. Aripiprazole is commercially available under the name ABILIFY® for the treatment of a number of CNS disorders.

"We are pleased to build upon our expertise in developing long-acting platforms and therapies to bring forward a once-monthly version of aripiprazole, a widely prescribed product with a proven safety and efficacy profile," stated Dr. Elliot Ehrich, Chief Medical Officer of Alkermes. "Multiple studies have shown that long-acting therapies in the treatment of schizophrenia can lead to improved patient outcomes and reduced costs. An additional extended-release injectable medication would provide another valuable option for patients and physicians to manage this serious, chronic disease."

Based on encouraging preclinical results, ALKS 9070 is expected to enter the clinic in the second half of calendar 2010. A number of patent applications have been submitted to the U.S. Patent and Trademark Office to protect the LinkeRx technology and ALKS 9070.

Alkermes' LinkeRx technology uses proprietary linker-tail chemistry to create new molecules derived from known agents. The resulting New Molecular Entities are designed to have improved clinical utility, manufacturing and ease-of-use compared to other long-acting medications. The LinkeRx technology platform has the potential to be applied to a wide range of therapeutic molecules for the treatment of CNS disorders, including schizophrenia, depression and epilepsy, where there is a strong clinical and patient need for long-acting medication options to improve treatment outcomes.

"We are pleased to unveil this novel technology and a compelling lead product candidate because we believe both are valuable assets for the company," commented Richard Pops, Chief Executive Officer of Alkermes. "Alkermes' expertise in developing safe and effective long-acting therapeutics uniquely positions us to develop a once-monthly version of aripiprazole."

Alkermes is a leader in developing long-acting medications and has an established portfolio of CNS products, including RISPERDAL® CONSTA®, VIVITROL®, ALKS 33 and ALKS 36. Alkermes focuses on therapies for widespread, chronic diseases, including CNS disorders such as addiction, pain and mental health disorders, where the company believes there is a strong opportunity for long-acting medications to offer significant new treatment options for patients.

About Schizophrenia

Schizophrenia is a chronic, severe and disabling brain disorder. The disease is marked by positive symptoms (hallucinations and delusions) and negative symptoms (depression, blunted emotions and social withdrawal), as well as by disorganized thinking. An estimated 2.4 million Americans have schizophrenia, with men and women affected equally. Worldwide, it is estimated that one person in every 100 develops schizophrenia, one of the most serious types of mental illness.

Source
Alkermes, Inc.

View drug information on Abilify; Risperdal Oral Formulation; Vivitrol.

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