Janssen Statement RISPERDAL® (risperidone) Full US Prescribing Information RISPERDAL® CONSTA® Full US Prescribing Information JANSSEN, L.P. Offers Perspective on CATIE 2 Results 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® and RISPERDAL® CONSTA® Titusville, N.J., April 3, 2006 - Results from the second phase of the CATIE trial -- the Clinical Antipsychotic Trials of Intervention Effectiveness, published in the April issue of the American Journal of Psychiatry -- reinforce the need for patients with schizophrenia to have multiple medication options. It is well known that medications that may work well for one patient may not work as well for another. The newly published second phase of the CATIE trial consisted of two separate studies originally intended to assess the effectiveness of various atypical antipsychotic medications in patients who either required a switch to another medication because their symptoms weren?t being controlled, or due to tolerability issues. The primary outcome measure in both studies was time to stopping treatment for any reason (including lack of efficacy or intolerability). In the larger, double-blinded study, the RISPERDAL arm was shown to be among the best of the studied antipsychotics in the measure of both efficacy and tolerability. Specifically, on the study?s primary endpoint, RISPERDAL was associated with the longest time remaining on treatment. In the second trial, a smaller, open-label comparison, clozapine was found to be the most effective agent in treating a relatively small group of seriously ill patients who both failed prior treatment due to lack of efficacy and were willing to be randomly assigned to a study including clozapine. Clozapine is the only atypical antipsychotic approved for use in treatment-refractory patients, in part because of potentially life-threatening complications that can occur with its use. It is associated with many serious safety and tolerability problems, but has been found to be the most effective treatment for severe refractory patients in a number of previously conducted double blind controlled trials. Because of safety issues associated with clozapine?s use, patients in this study who took clozapine required frequent blood monitoring, something the other medications used in the CATIE study did not. "CATIE 2 found that RISPERDAL was among the most effective and tolerable of the atypical antipsychotic medications, according to the measures the investigators used," said Ramy Mahmoud, M.D., M.P.H., Vice President of Medical Affairs, Janssen, L.P., which develops, manufactures and markets RISPERDAL. "One of the limitations of CATIE 1 was that the dose of RISPERDAL used was too low. In CATIE 2, RISPERDAL was used at doses closer to the doses successfully used in previously published comparative trials. It therefore is not surprising that the comparative efficacy and tolerability benefits of RISPERDAL are better illustrated in CATIE 2." Dr. Mahmoud continued, "We don?t think physicians will be surprised by the strong performance of RISPERDAL in this new CATIE data, as it is consistent with more than 12 years of experience and multiple controlled clinical trials. The real important takeaways from both phases of CATIE are that individuals respond to different therapies, and the availability of various treatment choices is essential. The CATIE data really emphasize that every patient and every medication is different. Doctors and patients must work together, often attempting a series of medications, to find what works best to meet a specific patient?s needs." Dr. Mahmoud commented that continued innovation has resulted in new products to treat schizophrenia, including a long-acting injectable form of risperidone. Janssen, L.P. is the only major pharmaceutical company in the United States focused solely on mental health. The company is a long-time leader in providing prescription medications that address the unmet need in schizophrenia. Janssen continues to innovate and focus on newer treatment options so that patients and healthcare professionals can improve care. 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, 2 mg, 3 mg and 4 mg doses, and an oral solution in a 1.0 mg/mL dose. RISPERDAL and RISPERDAL CONSTA are indicated for the treatment of schizophrenia. As with all other psychotropic medications, RISPERDAL is associated with side effects. Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. In the United States, 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 US Prescribing Information including the Boxed Warning for RISPERDAL and RISPERDAL CONSTA. 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, 2 mg, 3 mg and 4 mg doses, and an oral solution in a 1.0 mg/mL dose. 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. Janssen, L.P. is exclusively dedicated to mental health and currently markets prescription medications for the treatment of schizophrenia and bipolar mania. ###