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Mentor Begins Phase 2 Study of Botulinum Toxin Type A Product for Cosmetic Indications; Enrollment of All Patients in Study Completed

(press release from Mentor Corporation)

SANTA BARBARA, Calif --Oct. 27, 2005--Mentor Corporation (NYSE:MNT), a leading supplier of medical products in the United States and internationally, announced that it has begun the Phase 2 dose-finding study of its proprietary botulinum toxin type A product, focused on cosmetic indications in the United States, and that all patients in the Phase 2 study have been enrolled.

"We are excited about the opportunity to bring new options to our patients for the treatment of hyperkinetic lines, otherwise known as frown lines," commented Corey S. Maas, M.D., Director of the Maas Clinic and Associate Clinical Professor at the University of California at San Francisco Medical School, and principal investigator of the study. "Mentor's Phase 2 dose-finding study is designed to determine the optimal dose level to move forward into a large registration study to establish product safety and efficacy."

The multi-center Phase 2 dose-finding study includes a six month follow-up period and is based on results from the Phase 1 dose escalation safety study, which was initiated in December 2004.

"Our botulinum toxin program represents a significant opportunity for Mentor and we are pleased with the rapid pace of its advancement through the clinical trial process," commented Joshua H. Levine, President and Chief Executive Officer of Mentor Corporation. "We are building our presence in the area of facial rejuvenation through our dermal filler and botulinum toxin product development programs and expect to have an even broader presence in these markets in the future."

Mentor established its botulinum toxin program through an exclusive licensing agreement with the Wisconsin Alumni Research Foundation in December 2003. Under terms of the agreement, Mentor obtained the exclusive rights to all strains of the botulinum toxin, including botulinum toxin type A, and has the right to manufacture, develop and commercialize the underlying technology for all indications in all markets, worldwide. In November 2004, Mentor announced that it had commissioned its state-of-the-art manufacturing facility in Madison, Wisconsin.

About Mentor Corporation

Founded in 1969, Mentor Corporation is a leading supplier of medical products for the global healthcare market. The Company develops, manufactures and markets innovative, science-based products for the aesthetics, urologic specialties and clinical and consumer healthcare markets around the world. The Company's website is www.mentorcorp.com.

Safe Harbor Statement

All statements included or incorporated by reference in this release, other than statements or characterizations of historical fact, are forward-looking statements. These forward-looking statements are based on our current expectations, estimates and projections about our industry, management's beliefs and certain assumptions made by us. This release contains forward looking statements including, but not limited to, statements related to the significant opportunity that Mentor's botulinum toxin program represents, building our presence in facial rejuvenation, and our expectations that we will have an even broader presence in the market. Forward-looking statements can often be identified by words or phrases such as "anticipates," "scheduled," "expects," "intends," "plans," "predicts," "believes," "seeks," "opportunity," "estimates," "is confident," "may," "will," "should," "would," "could," "potential," "in the future," "continue," similar expressions, and variations or negatives of these words. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. These forward-looking statements speak only as of the date hereof and are based upon the information available to us at this time. Such information is subject to change, and we will not necessarily inform you of such changes. These statements are not guarantees of future results and are subject to risks, uncertainties and assumptions that are difficult to predict. Therefore, our actual results could differ materially and adversely from those expressed in any forward-looking statement as a result of various factors.

The Securities and Exchange Commission filings of Mentor, including, without limitation, its Annual Reports on Form 10-K, subsequent quarterly reports on Form 10-Q, and recent Current Reports on Form 8-K, discuss important risk factors that could contribute to such differences or otherwise affect its business, results of operations and financial condition. Mentor undertakes no obligation to revise or update publicly any forward-looking statement for any reason.

CONTACT: Mentor Corporation
Peter R. Nicholson, 805-879-6082

Mentor Corporation
www.mentorcorp.com

 

     

 
 
 

 

 

 

 

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