MOUNTAIN VIEW, Calif., Dec. 1 /PRNewswire/ -- ALZA Corporation today announced that it is modifying the U.S. clinical development program for OROS Hydromorphone (AP-77) for chronic pain. The company is considering different options for moving forward following recent discussions with the U.S. Food and Drug Administration in which it became clear that an additional clinical trial would be required to meet the agency's standards for approval. The decision to modify the clinical development program was not related to any safety issues with the medication.
The clinical development program in other regions of the world will continue, as previously planned. AP-77 is expected to launch in the European Union in 2006.
ALZA Corporation, a wholly owned subsidiary of Johnson & Johnson, is leading the next generation of drug delivery, with the world's broadest array of technology platforms, including oral, transdermal, implantable, and liposomal technologies. ALZA's drug delivery technologies have been incorporated in more than 30 products, which are marketed in more than 80 countries worldwide.
[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 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.]
ALZA CorporationCONTACT: Investors - Stan Panasewicz, +1-732-524-2524, Media - TeresaGaines, 1-908-927-5381
