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INVEGA(TM) Gets Marketing Authority from EU to Treat Schizophrenia

TITUSVILLE, N.J., 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 randomized patients(ii) examining time to relapse, and another double blind, placebo controlled study assessing safety and tolerability in 114 elderly patients suffering from schizophrenia.(iii)

The primary measure of efficacy was the Positive and Negative Syndrome Scale (PANSS), a tool commonly used in schizophrenia research that measures the severity of positive and negative symptoms and general psychopathology. The Personal and Social Performance Scale (PSP), a measure of functional improvement, as well as safety and tolerability assessments, were also included in the trials that supported the approval of INVEGA. The recommended dose of INVEGA is 6 mg per day, with a dose range of 3 mg to 12 mg per day depending on patient need.

Key findings of the program include:

-- In three six-week clinical trials, INVEGA demonstrated statistically significant symptom improvement on the PANSS versus placebo across all doses investigated. INVEGA was also superior to placebo on the PSP in these trials. In a chronic treatment trial, adult patients with schizophrenia who were treated with INVEGA showed a significantly longer time to relapse compared to placebo.
-- From the three six-week clinical trials, treatment-emergent adverse events(iv) (TEAEs) reported in 5% or more of subjects treated with INVEGA and at least twice the placebo rate for at least one dose included: akathisia (i.e. restlessness) and extrapyramidal disorder e.g. involuntary movements, tremors or muscle stiffness).
-- In the three six-week clinical trials, discontinuation rates due to TEAEs for all INVEGA dose groups were low and comparable to placebo (5% for placebo and for INVEGA: 2% for 3 mg, 6% for 6 mg, 4% for 9 mg, 5% for 12 mg).

Worldwide, it is estimated that 1 person in every 100 develops schizophrenia, one of the most serious types of mental illness. In the United States, there are currently 2,000,000 people with schizophrenia, with men and women affected in nearly equal numbers. The disease is marked by positive symptoms (hallucinations and delusions) and negative symptoms (depression, blunted emotions, and social withdrawal), as well as by disorganized thinking.

INVEGA was approved in the U.S. in December 2006, and was the first new prescription treatment for schizophrenia to be approved by the U.S. FDA since 2003. In April 2007, INVEGA was also approved by the FDA for the long -term maintenance treatment of schizophrenia. INVEGA was discovered and jointly developed by ALZA Corporation and Johnson & Johnson Pharmaceutical Research and Development, LLC.
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