BEERSE, Belgium, May 5 /PRNewswire-FirstCall/ -- Janssen-Cilag International NV, has submitted a Marketing Authorization Application to the European Medicines Evaluations Agency for Paliperidone Prolonged Release Tablets, an investigational prolonged release, once daily, oral medication for the treatment of schizophrenia.
Paliperidone uses OROS technology, which releases drug into the bloodstream steadily over a 24-hour period. The trade name for the marketed product has not yet been determined.
“Enhancing patient care for people with schizophrenia is something we strive for every day as physicians treating this illness,” said Andreas Heinz, M.D., Director, Department of Psychiatry, Charite University Medical Center, Berlin. “We hope more options become available to meet the needs of patients with this complex and debilitating disease.”
The paliperidone filing is based on an extensive global clinical development program that involved more than 1,600 patients in 23 countries. Regulatory submissions for paliperidone have been filed in the United States and other regions of the world are expected to follow.
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 disorganized thinking.
Upon approval, paliperidone will be marketed in Europe by the Janssen-Cilag companies, subsidiaries of Johnson & Johnson, the world’s most comprehensive manufacturer of health-care products and related services. More information about the company can be found at www.janssen-cilag.com.
(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 the Company’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 the Company’s Annual Report on Form 10-K for the fiscal year ended January 1, 2006. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov or on request from the Company. The Company assumes no obligation to update any forward-looking statements as a result of new information or future events or developments.)
Johnson & Johnson
CONTACT: Media: Europe: Brigitte Byl in Belgium, +32-0-2-749-2772, or USMedia Contact: Srikant Ramaswami, +1-609-730-2612, or Investors: StanPanasewicz, +1-732-524-2524, or Louise Mehrotra, +1-732-524-6491, all ofJohnson & Johnson
Web site: http://www.janssen-cilag.com/
