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 TITUSVILLE, N.J., Jan. 3 /PRNewswire/ - Janssen Pharmaceutica, Inc., a subsidiary of Johnson & Johnson (NYSE: JNJ), today announced that the U.S. Food and Drug Administration has granted marketing approval for RISPERDAL (risperidone) tablets, a new antipsychotic medication.
 RISPERDAL, at its optimal dose of 6 mg per day, was proven in clinical trials to significantly reduce both the positive and negative symptoms of schizophrenia.
 A person exhibiting schizophrenia's positive symptoms may hear voices, have delusions of grandeur, and suffer from hallucinations or acute paranoia. Someone suffering from the less apparent but equally debilitating negative symptoms might be depressed, socially withdrawn, apathetic or emotionally unresponsive. Negative symptoms are strongly related to poor social functioning and inability to hold a job. Conventional antipsychotic agents have not demonstrated effectiveness in negative symptoms.
 Clinical studies have also shown RISPERDAL (6 mg per day) to cause a low incidence of extrapyramidal symptoms (EPS), a complex of side effects commonly seen with antipsychotics. A person suffering from EPS might experience uncontrollable muscle rigidity, tremors and body shakes -- embarrassing and debilitating effects that often impair one's ability to function in an everyday environment.
 "Given its broad efficacy and low potential for side effects, RISPERDAL may become a treatment of choice for schizophrenia," said Mark A. Klausner, M.D., Vice President, Medical Affairs, Janssen Research Foundation. "RISPERDAL, unlike some newer antipsychotic agents, has not shown any adverse reactions that would require blood monitoring. The drug was classified as a '1P' priority product by the FDA, which allowed for a rapid review process."
 Paulo Costa, President, Janssen Pharmaceutica U.S., said: "Bringing a new therapy to schizophrenia patients and their families to help deal with this tragic disease is a source of great satisfaction for our company. In other countries where RISPERDAL is already available, it has shown the potential to greatly benefit patients afflicted with schizophrenia and other psychotic disorders."
 Novel Mechanism of Action
 RISPERDAL belongs to a new class of drugs, the serotonin/dopamine antagonists.
 Researchers consider the drug's clinical benefits to derive from a novel mechanism of action that blocks serotonin and dopamine -- two neurotransmitter chemicals found in the brain. Conventional antipsychotics block primarily dopamine receptors.
 Serotonin/dopamine antagonism is also theorized to be the mechanism of action in another very effective antipsychotic agent, clozapine. Clozapine's use, however, is restricted to a small population of treatment-resistant patients and requires frequent and expensive blood monitoring.
 Potential Savings to the Health Care System
 Schizophrenia is a socially and financially devastating disease. Usually diagnosed in the late teens or early 20s, patients are robbed of their most productive years of life. Frequently, family members are also unable to work due to their role in providing constant care and supervision for these patients. The estimated total cost to the United States is $33 billion annually and at any given time, 25% of hospital beds are occupied by schizophrenia patients. Hospitalization costs are estimated to exceed $100,000 annually for chronic inpatient treatment and up to $10,000 per relapse.
 In a published retrospective study conducted in Canada, RISPERDAL has shown the potential to reduce the number of hospital days by 20%. Studies will be conducted to confirm the amount and type of savings to the United States health care system.
 The recommended dosing of RISPERDAL will be 4-6 mg daily. At these doses, the annual price for RISPERDAL will range from $1,900 to $2,400. The annual price of RISPERDAL will be substantially lower than the total costs for patients being treated with clozapine.
 Under an agreement announced in June, Janssen and SmithKline Beecham will co-promote RISPERDAL in the United States. RISPERDAL will be available in U.S. hospitals and pharmacies by February 1994.
 Janssen is a subsidiary of Janssen Pharmaceutica of Beerse, Belgium, a wholly owned subsidiary of Johnson & Johnson. Janssen was founded in 1953. In 1958, the company developed haloperidol, the most widely used antipsychotic worldwide. Janssen researchers continued their arduous search for an improved antipsychotic for nearly 30 years before developing RISPERDAL.
 Janssen conducts research and markets products in a wide range of medical fields, including psychiatry, allergy, gastroenterology, anesthesiology, dermatology, oncology and infectious disease.
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 /CONTACT: Jeffrey J. Leebaw, 908-524-3350, or home, 908-821-6007, or (investors) Annie Lo, 908-524-6491, or home, 908-580-1258, both of Johnson & Johnson/

CO: Janssen Pharmaceutica, Inc.; Johnson & Johnson ST: New Jersey IN: MTC SU:

LG-TW -- NY014 -- 8435 01/03/94 10:13 EST
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Publication:PR Newswire
Date:Jan 3, 1994

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