Healthcare Industry News:  paliperidone 

Biopharmaceuticals Regulatory

 News Release - April 27, 2007

INVEGA(R) Receives Positive Opinion From European Committee for Human Medicinal Products for Treatment of Schizophrenia

BEERSE, Belgium, April 27 (HSMN NewsFeed) -- Janssen-Cilag International NV announced today that the Committee for Human Medicinal Products (CHMP) in the European Union, has granted a positive opinion recommending approval of INVEGA® (paliperidone prolonged release tablets). INVEGA® is a new, once-daily, prolonged release oral medication, for the treatment of schizophrenia.

The CHMP is the committee responsible for the scientific assessment of products seeking one centralised marketing authorisation applicable throughout the European Union. Janssen-Cilag anticipates receiving the Marketing Authorisation from the European Commission by mid-year 2007.

The recommended indication is: "paliperidone prolonged release tablets is indicated for the treatment of schizophrenia".

The paliperidone prolonged release tablets marketing authorisation application is based on an extensive global clinical development program that involved more than 1,600 patients in 23 countries. paliperidone prolonged release tablets uses the OROS extended-release technology developed by ALZA Corporation. This technology is designed to release medication in a uniquely designed pattern over a 24-hour period, leading to smooth blood plasma levels.

"I am pleased to learn that paliperidone prolonged release tablets has received a positive opinion from the European Committee for Human Medicinal Products, because we still need more treatment options for schizophrenia. In clinical trials, paliperidone prolonged release tablets has demonstrated good efficacy and favourable safety and tolerability. Importantly, paliperidone prolonged release tablets also showed significant improvement in patient functioning and that is an important aspect in the treatment of schizophrenia," said Professor Andreas Heinz, M.D., Director, Department of Psychiatry, Charite University Medical Center CCM, Berlin, Germany.

As with all medications, patients may experience certain side effects that must be weighed against potential benefits when considering taking INVEGA®.

Worldwide, it is estimated that one person in every 100 develops schizophrenia, one of the most serious types of mental illness. It is marked by positive symptoms (hallucinations and delusions) and negative symptoms (depression, blunted emotions and social withdrawal), as well as by disorganised thinking.

paliperidone prolonged release tablets was developed by Johnson & Johnson Pharmaceutical Research and Development (J&JPRD). INVEGA(TM) has been approved by the Food and Drug Administration since December 2006 and is marketed by Janssen, L.P. in the United States. Upon approval by the European Commission, paliperidone prolonged release tablets will be marketed in Europe by the Janssen-Cilag companies.

The Janssen-Cilag companies have a long track record in developing and marketing treatments for central nervous system disorders, pain management, oncology, fungal infections and gastrointestinal conditions. Leading products include Concerta® (ADHD), Durogesic® (pain management), Eprex® (anemia),Pariet® (gastroenterology), Topamax® (epilepsy, migraine prevention),Reminyl® (Alzheimer's disease), Risperdal® (schizophrenia, bipolar disorders, disruptive behaviour), Risperdal® Consta® (schizophrenia) and Velcade (multiple myeloma).

More information about Janssen-Cilag, a subsidiary of Johnson & Johnson (JNJ), can be found at

(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Johnson & Johnson's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2006. Copies of this Form 10-K, as well as subsequent filings, are available online at or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statements as a result of new information or future events or developments.)

Source: Janssen-Cilag

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