TITUSVILLE, N.J., July 21 /PRNewswire-FirstCall/ -- Johnson & Johnson Pharmaceutical Research and Development, LLC today announced that the Food and Drug Administration's Psychopharmacologic Drugs Advisory Committee's (PDAC) review of the new drug application for paliperidone ER has been canceled. The cancellation came at the request of the Division of Psychiatry Products after communicating it had not identified any issues at this time requiring Advisory Committee feedback.
Paliperidone, a new chemical entity, is the first and only atypical antipsychotic to use the OROS(R) extended release technology. This technology provides a continuous release of medication over a 24-hour period, leading to minimal peaks and troughs in plasma concentrations. Moreover, paliperidone is not extensively metabolized by the liver and is excreted largely unchanged through the kidney.
Johnson & Johnson Pharmaceutical Research and Development, LLC submitted a new drug application to the U.S. Food and Drug Administration (FDA) on November 29, 2005. In May 2006, Janssen-Cilag, NV submitted a Marketing Authorization Application to the European health authorities seeking approval for the treatment of schizophrenia, including acute treatment and prevention of relapse. The paliperidone ER filing is based on an extensive global clinical development program that involved more than 1,600 patients in 23 countries. Upon approval by regulatory authorities, paliperidone ER will be marketed in the United States by Janssen, L.P. and in Europe by Janssen-Cilag. Both companies, and J&JPRD are wholly owned subsidiaries of Johnson & Johnson. The trade name for the product has not yet been determined.
Janssen, L.P., based in Titusville, N.J., is the only large pharmaceutical company in the US dedicated solely to mental health. The company currently markets prescription medications for the treatment of schizophrenia and bipolar mania. For more information about Janssen, L.P. visit http://www.janssen.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 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 January 1, 2006. Copies of this Form 10-K, as well as subsequent filings, are available online at http://www.sec.gov/ or on request from Johnson & Johnson. Johnson & Johnson assumes no obligation to update any forward-looking statements as a result of new information or future events or developments.)
