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Janssen Statement

JANSSEN, L.P. Offers Perspective on CATIE-Cost Effectiveness Analysis Results

The following statement is being issued 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., December 6, 2006 — Results from the cost-effectiveness analysis (CEA) of the Clinical Antipsychotic Trial of Intervention Effectiveness (CATIE) in schizophrenia were published in the December 1 issue of The American Journal of Psychiatry. The results of this study 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 extensive switching of therapies from perphenazine to atypical antipsychotics, as well as the methods used to collect usage data, limit the ability to gather useful information on the effectiveness of individual medicines.

The high dropout rate by 18 months — 74.1 percent of all patients did not complete their initial drug treatment assignments — further highlights the need for newer therapies that can improve adherence to medication and address other unmet needs of patients who battle this lifelong disease.

As with previous CATIE publications, this analysis adds new information to a large, pre-existing body of literature on the risks and benefits of antipsychotic medication treatment.

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 increase 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 patients 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 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 symptoms associated with autistic disorder, schizophrenia and bipolar mania.