INVEGA(TM) Receives Marketing Authorization In European Union For Treatment Of Schizophrenia.

First Oral Prolonged Release Medication to Treat Schizophrenia

TITUSVILLE, N.J., June 28 /PRNewswire/ -- The European Commission granted marketing authorization for INVEGA(TM) (paliperidone prolonged release tablets), an atypical antipsychotic medication for the treatment of schizophrenia. This once-daily medication is specifically designed to deliver paliperidone - the active ingredient in INVEGA - through the innovative osmotic delivery system (OROS(R)). In clinical trials, INVEGA demonstrated significant efficacy as compared to placebo in helping many patients control the symptoms of schizophrenia, and it was generally well tolerated.

INVEGA (paliperidone prolonged release tablets) will be marketed in Europe by Janssen-Cilag. In the U.S., this product is marketed by Janssen, L.P. as INVEGA (paliperidone) Extended-Release Tablets. This approval represents another important milestone in the company's long-standing commitment to develop new treatment options for serious mental illnesses.

INVEGA is the first and only treatment for schizophrenia to receive marketing authorization in the EU that uses the osmotic delivery system (OROS(R)).

The decision of the European Medicines Agency to grant marketing authorization for INVEGA in Europe is based on efficacy and safety results of an extensive clinical development program that included: three six-week, placebo controlled clinical studies involving more than 1,600 patients with acute schizophrenia in 23 countries,(i) a longer-term (up to 40 weeks) double blind, placebo controlled study in 207…