New Drug Application Submitted for Dapoxetine for Premature Ejaculation

Main Category: Erectile Dysfunction / Premature Ejaculation
Article Date: 28 Dec 2004 - 17:00 PDT

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ALZA Corporation today announced that it has submitted a new drug application to the U.S. Food and Drug Administration (FDA) for dapoxetine hydrochloride a new treatment for premature ejaculation (PE). Premature ejaculation is the most common male sexual dysfunction, affecting as many as one-third of men worldwide at some time in their lives.

"Premature ejaculation is a frequent and distinct medical condition that can severely impact quality of life, affecting the physical and emotional well-being of patients and their partners," says James H. Barada, M.D., urologist at the Center for Male Sexual Health, Albany, NY, and board member of the Sexual Medicine Society of North America (SMSNA).

If approved by the FDA, dapoxetine hydrochloride would be the first prescription treatment designed specifically to treat PE and will be marketed in the U.S. by Ortho-McNeil Pharmaceutical, Inc.

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.

Ortho-McNeil Pharmaceutical, Inc. markets prescription drugs in the areas of women's health, infectious disease, central nervous system, pain treatment, urology and migraine headaches.

For more information, visit the Ortho-McNeil Pharmaceutical Web site at http://www.orthomcneil.com or ALZA's Web site at http://www.alza.com. For more information on Johnson & Johnson, please visit the Company's Web site at http://www.jnj.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 the Company'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 the Company's Annual Report on Form 10-K for the fiscal year ended December 28, 2003. Copies of this Form 10-K 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.)

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