TITUSVILLE, N.J., Nov. 30 /PRNewswire/ -- Johnson & Johnson Pharmaceutical Research & Development, LLC announced that it has submitted a New Drug Application to the United States Food and Drug Administration (FDA) for Paliperidone Extended-Release (ER) Tablets, an investigational extended- release, once daily, oral medication for the treatment of schizophrenia.
Paliperidone ER uses the patented OROS technology, which releases drug into the bloodstream steadily over a 24-hour period. Paliperidone ER will be marketed in the United States by Janssen, L.P., a wholly owned subsidiary of Johnson & Johnson. The trade name for the marketed product has not yet been determined.
The paliperidone ER filing is based on an extensive global clinical development program that involved more than 1,600 patients in 23 countries. Regulatory submissions are expected to follow for paliperidone ER in other countries.
Schizophrenia affects more than 2 million Americans and is characterized by symptoms such as hallucinations, delusions, social withdrawal and a diminished capacity for organized thought.
Janssen, L.P. is based in Titusville, N.J., and focuses exclusively on pioneering solutions for healthy minds and 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(b) of Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 2, 2005. Copies of this Form 10-K 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.)
Johnson & Johnson Pharmaceutical Research & Development, LLC
CONTACT: Media, Srikant Ramaswami, +1-609-730-2612,sramaswa@gpcus.jnj.com; or Investors, Stan Panasewicz, +1-732-524-2524,both for Johnson & Johnson Pharmaceutical Research & Development, LLC
Web site: http://www.janssen.com/
