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ALZA Corporation Receives Letter From FDA on Dapoxetine Application

Posted on: Wednesday, 26 October 2005, 18:00 CDT

MOUNTAIN VIEW, Calif., Oct. 26 /PRNewswire/ -- ALZA Corporation announced today that it has received a not approvable letter from the U.S. Food and Drug Administration (FDA) on their New Drug Application for dapoxetine hydrochloride, an investigational compound for the treatment of premature ejaculation (PE).

ALZA Corporation is committed to developing safe and effective medicines that address important unmet medical needs. The company continues to believe that dapoxetine provides important benefits for men who suffer from PE. ALZA plans to address questions raised in the FDA letter and continue the global development program.

PE is a distinct medical condition that has been recognized by the American Urological Association (AUA), the American Psychiatric Association (APA) and the World Health Organization (WHO). PE can have a significant impact on many aspects of a man's life, including his and his partner's sexual satisfaction, the ability to build and maintain relationships, and a general sense of confidence. Currently, there are no drugs approved by the FDA for the treatment of PE. Traditional methods of PE treatment rely heavily on behavioral therapy and/or off-label use of older drugs that are approved for other conditions, all of which yield limited success.

ALZA Corporation, headquartered in Mountain View, California, is leading the next generation of drug delivery, with the world's broadest array of technology platforms, including oral, transdermal, implantable, and liposomal technologies. More than 30 products marketed in over 80 countries worldwide now incorporate ALZA's drug delivery technologies.

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 (Johnson & Johnson) 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 the Company's Annual Report on Form 10-K for the fiscal year ended January 2, 2005. Copies of this Form 10-K, as well as subsequent filings, are available online at http://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.

ALZA Corporation

CONTACT: Media: Bonnie Jacobs, +1-215-273-8994, or Julie Keenan,+1-908-704-4564; Investors: Helen Short, +1-732-524-6491, or Stan Panasewicz,+1-732-524-2454, all for ALZA Corporation

Source: PRNewswire

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