Healthcare Industry News: botulinum toxin Type A
News Release - May 15, 2006
Mentor Begins U.S. Phase 1 Study of Its Botulinum Toxin Product for Spasmodic Torticollis/Cervical Dystonia
SANTA BARBARA, Calif.--(HSMN NewsFeed)--May 15, 2006--Mentor Corporation (NYSE:MNT ), a leading supplier of medical products in the United States and internationally, today announced that it has initiated the Phase 1 study of its proprietary botulinum toxin Type A product, focused on the therapeutic indication of the treatment of pain associated with adult onset spasmodic torticollis/cervical dystonia in the United States."We are pleased with the potential we have to improve the quality of lives for patients," added Drs. Drake Duane and Patrick Parcells, co-principal investigators for Mentor's Phase I study. Dr. Duane is the Chairman of the National Spasmodic Torticollis Association and an Adjunct Professor at Arizona State University. Dr. Parcells is a Clinical Professor of Neurology at Riverside Regional Medical Center, Newport News, Va., and senior neurologist with Hampton Roads Neurology Inc. Both Investigators have over 20 years of experience in the use of botulinum toxin. "We look forward to evaluating the product in the clinical setting and to working with Mentor to support the approval process."
Adult onset spasmodic torticollis/cervical dystonia is a syndrome that causes abnormal involuntary movements or posture of the head and neck, often followed by pain in the back portions of the neck. The relentless nature of the condition can be incapacitating for many patients and result in a deterioration in the quality of life of those afflicted. The Phase 1 safety and dose escalation study will be a placebo controlled, single exposure study with four months follow-up.
"The initiation of the U.S. clinical program for torticollis is another significant milestone for Mentor and our botulinum toxin product development program," commented Joshua H. Levine, President and Chief Executive Officer of Mentor Corporation. "We are aggressively advancing our product development pipeline and will leverage our opportunities broadly to maximize shareholder value."
Mentor established its botulinum toxin program through a broad 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 applications in all markets, worldwide. The Company is currently conducting a phase 2 study for the cosmetic indication of glabellar lines.
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 and urologic specialties markets around the world.
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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. Forward-looking statements in this press release include but are not limited to those statements related to our belief that these products have the potential to improve the quality of lives for patients and our aggressive advancement of our product development pipeline that will leverage our opportunities broadly to maximize shareholder value. Forward-looking statements can often be identified by words such as "anticipates," "expects," "intends," "plans," "predicts," "believes," "seeks," "estimates," "may," "will," "should," "would," "could," "potential," "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.
Source: Mentor
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