FDA Approves New Injection Site for RISPERDAL® CONSTA® for Schizophrenia Treatment

Business Wire, Oct 9, 2008

CAMBRIDGE, Mass. -- Alkermes, Inc. (NASDAQ: ALKS) today announced that patients with schizophrenia now have a new administration option for RISPERDAL([R]) CONSTA([R]) [(risperidone) Long-Acting Injection]. The U.S. Food and Drug Administration (FDA) has approved a new injection site, the deltoid muscle in the arm, for RISPERDAL CONSTA for the treatment of patients with schizophrenia. RISPERDAL CONSTA was previously approved as a gluteal injection only.

"RISPERDAL CONSTA serves an important role in the treatment of schizophrenia by providing consistent levels of medication over a two-week period," stated John Kane, M.D., Chairman of Psychiatry at The Zucker Hillside Hospital. "The ability to inject RISPERDAL CONSTA in the upper arm may be easier for some patients and physicians and also gives patients a choice of where to receive their long-acting therapy."

The application was based on a study showing that the deltoid and gluteal injections of RISPERDAL CONSTA were bioequivalent1 routes of administration and thus interchangeable. An additional study was conducted that showed the safety and tolerability of RISPERDAL CONSTA injected into the deltoid muscle were similar to the gluteal injections. Both studies were recently presented at the 161st Annual Meeting of the American Psychiatric Association (APA) in Washington, D.C., 20082,3.

The new RISPERDAL CONSTA dose packs will now include two separate (non-interchangeable) needles for injection and will be available to U.S. physicians by the end of 2008. The needle for deltoid injection is a smaller gauge and is shorter in length than the gluteal needle. Both are administered every two weeks. Not all patients will be appropriate for the deltoid injection site. As with all medications, it's important that patients discuss their treatment options with their healthcare professional.

RISPERDAL CONSTA is marketed in the U.S. by Janssen([R]), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. and manufactured by Alkermes. RISPERDAL CONSTA was initially approved for the treatment of schizophrenia in the U.S. in 2003 and is registered in more than 80 countries worldwide. Using Alkermes' proprietary Medisorb([R]) drug-delivery technology, the RISPERDAL CONSTA formulation encapsulates risperidone in microspheres made of a biodegradable polymer, which are suspended in a water-based solution and injected into the muscle. 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.

Worldwide, it is estimated that one person in every 100 develops schizophrenia4, one of the most serious types of mental illness. An estimated 2.4 million Americans have schizophrenia, with men and women affected equally5. The disease is marked by positive symptoms (hallucinations and delusions) and negative symptoms (depression, blunted emotions, and social withdrawal), as well by disorganized thinking, speech and behavior.

RISPERDAL CONSTA [(risperidone) Long-Acting Injection] is used for the treatment of schizophrenia.

IMPORTANT SAFETY INFORMATION FOR RISPERDAL CONSTA

Elderly Patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. RISPERDAL CONSTA (risperidone) is not approved for the treatment of patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS) is a rare and potentially fatal side effect reported with RISPERDAL CONSTA and similar medicines. Call your doctor immediately if the person being treated develops symptoms such as high fever; stiff muscles; shaking; confusion; sweating; changes in pulse, heart rate, or blood pressure; or muscle pain and weakness. Treatment should be stopped if the person being treated has NMS.

Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect reported with RISPERDAL CONSTA and similar medications. TD includes uncontrollable movements of the face, tongue, and other parts of the body. The risk of developing TD and the chance that it will become permanent is thought to increase with the length of therapy and the overall dose taken by the patient. This condition can develop after a brief period of therapy at low doses, although this is much less common. There is no known treatment for TD, but it may go away partially or completely if therapy is stopped.

High blood sugar and diabetes have been reported with RISPERDAL CONSTA and similar medications. If the person being treated has diabetes or risk factors such as being overweight or a family history of diabetes, blood sugar testing should be performed at the beginning and throughout treatment with RISPERDAL CONSTA. Complications of diabetes can be serious and even life threatening. If signs of high blood sugar or diabetes develop, such as being thirsty all the time, going to the bathroom a lot, or feeling weak or hungry, contact your doctor.