CORONA, Calif., April 22 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that it has entered into an exclusive licensing agreement with Kissei Pharmaceutical Co., Ltd. to develop and market KMD-3213, Kissei’s novel agent for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
KMD-3213, silodosin, is a highly selective alpha-1a adrenoceptor antagonist that relaxes smooth muscles at the prostate and bladder neck, thereby decreasing urinary resistance and improving dysuria associated with BPH. Kissei, in partnership with Daiichi Pharmaceutical Co., Ltd., has completed clinical development of KMD-3213 in Japan and is currently preparing a New Drug Application (NDA) for the Japanese market. Kissei has completed a Phase II clinical study in the United States.
Under the terms of the agreement, Watson will have exclusive rights to develop and commercialize KMD-3213 in the United States, Canada and Mexico. Kissei will receive payments based on achievement of certain milestones, and royalties based on Watson’s sales of the product. Watson will be responsible for conducting Phase III clinical studies and preparing and submitting the NDA to support U.S. Food and Drug Administration (FDA) approval.
“Kissei is a well respected partner in the pharmaceutical industry and we are delighted to have the opportunity to collaborate with them for the commercialization of this BPH product,” said Allen Chao, Watson’s chairman and chief executive officer. “KMD-3213 represents a significant new product opportunity, as we look to supplement our product portfolio with late-stage product candidates that fit within our urology therapeutic focus area. Kissei has demonstrated the product’s safety and efficacy through a successful clinical program in Japan. Watson will be able to directly enter Phase III clinical trials in the U.S. to support the U.S. NDA filing, thus reducing the risks associated with early-stage product development.”
Benign prostatic hyperplasia, found only in men, is characterized by enlargement of the prostate gland surrounding the lower bladder and urethra, leading to urinary difficulty, urinary frequency and an inability to complete bladder emptying. The number of BPH patients has been increasing with the expansion of the elderly population. Alpha blockers, such as KMD-3213, are the most popular therapy for BPH, as they can quickly improve patient symptoms. Preclinical studies confirmed an improved uroselectivity of KMD-3213 compared to tamsulosin, demonstrated by a greater relative binding affinity to prostatic alpha-1a receptors as compared to the vascular alpha-1b receptors. Total U.S. sales of BPH drug therapies were approximately $1 billion in 2003, according to IMS Health data.
About Kissei
Kissei Pharmaceutical Co., Ltd., with headquarters in Nagano, Japan, is a discovery and research and development-oriented pharmaceutical company that contributes to the health of people around the world through the development of innovative drugs. In implementing the company’s strategies, Kissei continually emphasizes the patient’s perspective. Kissei is aiming to globalize and expand its revenue from foreign markets through out licensing of original compounds.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc., headquartered in Corona, CA, is a leading specialty pharmaceutical company that develops, manufactures, markets, sells and distributes brand and generic pharmaceutical products. Watson pursues a growth strategy combining internal product development, strategic alliances and collaborations and synergistic acquisitions of products and businesses.
For press releases and other company information, visit Watson Pharmaceuticals’ Web site at http://www.watsonpharm.com/.
Forward-Looking Statement
Statements contained in this press release that refer to future events or other non-historical facts about Watson are forward-looking statements that reflect Watson’s current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Watson’s current expectations depending upon a number of factors affecting Watson’s business. These factors include, among others, the outcome of the Phase III clinical trial of KMD-3213; the difficulty of predicting the timing or outcome of product development efforts and regulatory agency approvals and actions; market acceptance of and continued demand for Watson’s products, including the impact of competitive products and pricing; patents and other intellectual property rights held by competitors and other third parties; successful compliance with governmental regulations; and other risks and uncertainties detailed in Watson’s periodic public filings with the Securities and Exchange Commission, including but not limited to Watson’s Annual Report on Form 10-K for the year ended December 31, 2003.
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