- Company's Lead Candidate, ALKS 9070, is an Extended-Release, Once-Monthly Version of Aripiprazole -
- Platform Expands CNS Franchise and Leverages Expertise in Extended-Release Medications -
WALTHAM, Mass., Feb 04, 2010 (BUSINESS WIRE) -- Alkermes, Inc. (NASDAQ: ALKS) today announced that it has developed a novel, proprietary LinkeRx(TM) 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.
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® for alcohol dependence and manufactures RISPERDAL® CONSTA® for schizophrenia and bipolar I disorder. Alkermes' robust pipeline includes extended-release injectable, pulmonary 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, those relating to: the patentability of the company's new LinkeRx technology platform and ALKS 9070, development activities for ALKS 9070, including its entering the clinic in the second half of 2010, and the therapeutic potential of ALKS 9070 for the treatment of schizophrenia. 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 company will continue to pursue the development of the new proprietary platform; whether the patent applications underlying the new LinkeRx technology and ALKS 9070 will be issued and enforceable against competing products; whether the clinical development discussed in this release will be completed on time or at all; potential changes in cost, scope and duration of such clinical development; whether ALKS 9070 will demonstrate sufficient efficacy and safety; and decisions by the U.S. Food and Drug Administration regarding the product candidate. 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® is a registered trademark and LinkeRx(TM) is a trademark of Alkermes, Inc.; RISPERDAL® CONSTA® is a registered trademark of Janssen-Cilag group of companies and ABILIFY® is a registered trademark of Otsuka Pharmaceutical Co., Ltd.
SOURCE: Alkermes, Inc.
Alkermes, Inc.
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