Alkermes, Inc. announced that Janssen Pharmaceutica K.K. received approval from the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan to market Risperdal Consta [(risperidone) long-acting injection] for the treatment of schizophrenia.

Risperdal Consta is the first long-acting atypical antipsychotic to be available in Japan. Janssen Pharmaceutica K.K. expects to launch the product in Japan promptly after its listing on Japan's National Health Insurance (NHI) Drug Price Standard.

"The approval of Risperdal Consta in Japan represents another important market opportunity for the product," commented David Broecker, chief executive officer of Alkermes. "As the first and only long-acting atypical antipsychotic approved for use in Japan, Risperdal Consta could provide a valuable new treatment option for patients managing this serious, chronic disease."

Under the development and supply agreement between Janssen-Cilag and Alkermes for Risperdal Consta, Janssen-Cilag is responsible for worldwide sales and marketing of the product. Alkermes is responsible for worldwide manufacturing and receives manufacturing fees and royalties on product sales. Risperdal Consta was initially approved for the treatment of schizophrenia by the US Food and Drug Administration in 2003 and is registered in more than 80 countries worldwide.

Risperdal Consta is a long-acting injectable form of risperidone that was developed utilizing Alkermes' proprietary Medisorb drug-delivery technology. Using this technology, risperidone is encapsulated in microspheres made of a biodegradable polymer, which are suspended in a water-based solution and administered to patients by intramuscular injection once every two weeks. Laboratory and clinical research has shown that the microspheres gradually degrade at a set rate to provide therapeutic blood levels of the drug in the bloodstream for an extended period. The polymer from which the microspheres are made breaks down into two naturally occurring compounds that are then eliminated by the body.

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.