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ALZA Corporation Resubmits US New Drug Application for IONSYS(TM)

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ALZA Corporation Resubmits US New Drug Application for IONSYS(TM) ALZA Corporation Resubmits U.S. New Drug Application for IONSYS(TM) (Fentanyl HCl Patient-Activated Transdermal System) MOUNTAIN VIEW, Calif., Nov 28, 2005 /PRNewswire via COMTEX News Network/ -- ALZA Corporation, a wholly owned subsidiary of Johnson & Johnson, today announced that in response to an approvable letter from the U.S. Food and Drug Administration received in mid-2004, it has resubmitted a New Drug Application (NDA) for IONSYS(TM) (Fentanyl hydrochloride (HCl) Patient-Activated Transdermal System (PATS) 40 mcg/dose). IONSYS(TM) is an investigational iontophoretic transdermal system for acute postoperative pain. IONSYS(TM) is the first product in development to incorporate the proprietary E-TRANS(R) iontophoretic transdermal drug delivery system developed by ALZA. The system delivers drug systemically by using low-level electrical energy to actively transport drugs through intact skin. The active ingredient of IONSYS(TM) is an opioid analgesic, fentanyl hydrochloride. ALZA originally submitted the application for licensure of IONSYS(TM) to the FDA in September 2003. If the NDA resubmission is accepted as satisfying the requirements for a complete response, the FDA could complete its review within six months, under the Prescription Drug User Fee Act (PDUFA). Pending FDA approval, IONSYS(TM) will be marketed in the United States by Ortho- McNeil, Inc, a wholly owned subsidiary of Johnson & Johnson. IONSYS(TM) also is awaiting approval in the European Union. This October, the European Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency, adopted a positive opinion recommending marketing authorization for the product in the 25 member states of the European Union. If approved, the product will be marketed throughout the European Union by Janssen-Cilag companies, also Johnson & Johnson affiliates. ALZA Corporation 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 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.] SOURCE ALZA Corporation Investors: Stan Panasewicz, +1-732-524-2524, Media: Paul Minehart, +1-908-927-3715, both for ALZA Corporation http://www.prnewswire.com Copyright (C) 2005 PR Newswire. All rights reserved. News Provided by COMTEX.
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