Janssen News Release Statement for Media Regarding CATIE Trial More Information For Healthcare Professionals NIMH Perspective The following statement is being issued today by Janssen, L.P., a leader in the research, development and marketing of leading prescription treatments for schizophrenia, including RISPERDAL® (risperidone) and RISPERDAL® CONSTA® (risperidone) Long-Acting Injection. Titusville, N.J., September 19, 2005 - Results from the National Institutes of Mental Health Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) trial, published in the September 22 issue of the New England Journal of Medicine, underscore that people with schizophrenia need many medication options because what works well for one patient may not work as well for another. The efficacy results for RISPERDAL® (risperidone) did not demonstrate the full efficacy of RISPERDAL® because many patients in the CATIE trial received doses that were too low. Further, the study highlights the need for newer therapies that can improve adherence to medication and address other unmet needs of these patients who battle this lifelong disease. RISPERDAL® has been studied in thousands of patients, accumulating among the largest amount of data of any currently available prescription anti-psychotic medication. For example, one large study previously published in the NEJM demonstrated the advantage of RISPERDAL® over the most commonly used conventional antipsychotic, Haldol, and an even larger study which showed that under naturalistic ?real world? treatment conditions, RISPERDAL® was better than a combined group of physician-selected conventional antipsychotics. Authors of the CATIE trial acknowledge that dose could have been a factor in the performance of the studied medications. Based on the reported average dose and the dosage strengths of capsules made available in the study, many patients receiving RISPERDAL® in this trial were treated with sub-therapeutic or minimally effective doses. As a long-time leader in providing prescription medications that address the unmet needs of chronic schizophrenia, we recognized the unmet need highlighted by the CATIE study. And in 2003, subsequent to the initiation of the CATIE study, we introduced the first long-acting atypical injectable treatment. RISPERDAL® CONSTA® (risperidone) long-acting injection is intended to help address the unmet needs underscored by the results of CATIE. RISPERDAL® has been marketed in tablet form in the United States by Janssen, L.P., since 1994. It is available as a standard, oral tablet in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg doses; a quick-dissolving tablet (RISPERDAL® M-Tab®) in 0.5 mg, 1 mg and 2 mg doses and an oral solution in a 1.0 mg/mL dose. RISPERDAL® is indicated for the treatment of schizophrenia. As with all other psychotropic medications, RISPERDAL® is associated with side effects. RISPERDAL® CONSTA® (risperidone) long-acting injection is the first and only long-acting, atypical antipsychotic to be approved by the U.S. Food and Drug Administration and now is approved in more than 57 countries worldwide. The treatment uses advanced technology to deliver and maintain therapeutic medication levels in the body through just one injection every two weeks. RISPERDAL® CONSTA® is manufactured and marketed in the United States by Janssen, L.P. The delivery system for RISPERDAL® CONSTA® is manufactured by Alkermes, Inc. Available in 25 mg, 37.5 mg and 50 mg dose units, it is approved for the treatment of schizophrenia. Elderly Patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. RISPERDAL® and RISPERDAL® CONSTA® are not approved for the treatment of patients with Dementia-Related Psychosis. The most common side effects that occurred with RISPERDAL® and RISPERDAL® CONSTA® in the treatment of schizophrenia were: anxiety, sleepiness, restlessness, tremors and muscle stiffness, dizziness, constipation, nausea, indigestion, runny nose, rash, rapid heartbeat, feeling tired, weight increases and dry mouth. Studies suggest an increased risk of elevated blood sugar-related side effects, and sometimes potentially fatal, in patients treated with this class of medications, including RISPERDAL®. Some people may need regular blood sugar testing. Some people may have heard the term "tardive dyskinesia." These are usually persistent, uncontrollable, slow or jerky facial or body movements that can be caused by all medications of this type. A rare but serious side effect that has been reported with this kind of medicine, including RISPERDAL® and RISPERDAL® CONSTA®, is known as NMS or neuroleptic malignant syndrome. NMS is characterized by muscle rigidity, fever and can be serious. For more information, read the full U.S. Prescribing Information including the Boxed Warning for RISPERDAL and RISPERDAL CONSTA. Janssen, L.P. is exclusively dedicated to mental health and currently markets prescription medications for the treatment of schizophrenia and bipolar mania. For more information, please visit www.janssen.com. ###