28.03.2005 15:02:00

Allergan and Sanwa Kagaku Kenkyusho Co., Ltd. Sign Exclusive Licensing

Allergan and Sanwa Kagaku Kenkyusho Co., Ltd. Sign Exclusive Licensing Agreement to Develop and Market POSURDEX-R- in Japan


    Pharmaceutical Writers/Business Editors

    IRVINE, Calif.--(BUSINESS WIRE)--March 28, 2005--Allergan, Inc. (NYSE:AGN) today announced it has entered into an exclusive licensing agreement with Sanwa Kagaku Kenkyusho Co., Ltd. (Sanwa) to develop and commercialize POSURDEX(R) for the ophthalmic specialty market in Japan. POSURDEX(R) is an investigational, bioerodable, extended release implant that delivers dexamethasone to the targeted disease site at the back of the eye for the treatment of macular edema. The companies currently estimate Japan's annual macular edema market could be over $100 million.
    Under the terms of the agreement, Sanwa will be responsible for the development and commercialization of POSURDEX(R) in Japan and will incur associated costs. Sanwa will pay Allergan a royalty based on net sales of POSURDEX(R) in Japan, make development and commercialization milestone payments and reimburse Allergan for certain expenses associated with Allergan's continuing conduct of POSURDEX(R) Phase III pivotal studies outside of Japan. Allergan and Sanwa will work collaboratively on the clinical development of POSURDEX(R), as well as overall product strategy and management.
    "Retinal diseases are currently the leading cause of blindness in developed countries and represent the largest unmet need in eye care," said David E.I. Pyott, Allergan's Chairman of the Board, President and Chief Executive Officer. "We are pleased to be working with Sanwa to bring our POSURDEX(R) technology to the Japanese market. We expect Sanwa to maximize the potential of this exceptional technology, which ultimately may benefit millions of patients."
    Kazuo Yamamoto, President of Sanwa, commented, "We are very pleased to be collaborating with Allergan on the development and marketing of POSURDEX(R) in Japan. We hope this product will improve the quality of life of many patients with retinal disease that existing therapies do not treat. We will use our best efforts to bring this innovative product to patients as quickly as possible."
    Allergan is currently conducting two Phase III clinical programs worldwide with POSURDEX(R) focusing on macular edema associated with diabetes and other conditions. In Japan, Sanwa is expected to begin Phase I/II development with POSURDEX(R) later this year.
    By 2010, the global ophthalmic market for retinal diseases is currently estimated to be over $3.7 billion annually. Aging populations are anticipated to lead to increasing numbers of patients at risk for these diseases. Japan's elderly population is currently the largest among industrialized nations (18.5%, Ministry of Health, Labour and Welfare (MHLW), 2002) and projected to account for more than 33% of Japan's total population by 2050. The increasing incidence of diabetes is also significantly adding to the retina market's growth potential. A 2002 survey by the World Health Organization estimates there will be as many as 300 million diabetics worldwide by 2025, up from approximately 50 million in 2002. In Japan, 7.4 million people are suspected to have diabetes (MHLW, 2002).
    Macular edema is a sight-threatening condition that results from the swelling of the central retina, or macula, and is associated with diseases such as diabetic retinopathy, retinal vein occlusion and uveitis. Macular edema is a major cause of visual disabilities and blindness among individuals with diabetes. Allergan estimates that macular edema currently affects more than 750,000 people in the United States, and over 2.5 million people worldwide. A significant share of these patients has persistent macular edema that has failed to respond to the current standard of care.

    About Allergan, Inc.

    Allergan, Inc., with headquarters in Irvine, California, is a technology-driven, global health care company providing specialty pharmaceutical products worldwide. Allergan develops and commercializes products in the eye care, neuromodulator, skin care and other specialty markets that deliver value to its customers, satisfy unmet medical needs, and improve patients' lives.

    About Sanwa Kagaku Kenkyusho Co., Ltd.

    Sanwa, a division of Suzuken, the second largest pharmaceutical wholesaler in Japan, is a fully-integrated pharmaceutical company headquartered in Nagoya, Japan with established therapeutic and diagnostic products serving the diabetes, cardiovascular, and inflammation marketplaces. Sanwa's mission is to develop and bring to the patients "patient-friendly" medicines that contribute to an improved quality of life on a cost-effective basis.

    Forward-Looking Statements

    This press release contains "forward-looking statements," including the statements by Messrs. Pyott and Yamamoto, statements regarding research and development outcomes, efficacy, and market and product potential. 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 Allergan's and Sanwa's expectations and projections. Risks and uncertainties include, among other things, general industry and pharmaceutical market conditions; general domestic and international economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product marketing such as the unpredictability of market acceptance for new pharmaceutical and biologic products and/or the acceptance of new indications for such products; potential difficulties in manufacturing a new product formulation; domestic and foreign health care reforms; the timing and uncertainty of the research and development and regulatory processes; trends toward managed care and health care cost containment; and governmental laws and regulations affecting domestic and foreign operations. Additional information concerning these and other risk factors can be found in press releases issued by Allergan, as well as Allergan's public periodic filings with the Securities and Exchange Commission, including the discussion under the heading "Certain Factors and Trends Affecting Allergan and its Businesses" in Allergan's 2004 Form 10-K. Copies of Allergan's press releases and additional information about Allergan is available on the World Wide Web at www.allergan.com or you can contact the Allergan Investor Relations Department by calling 1-714-246-4636.

--30--SP/np*

CONTACT: Allergan, Inc. Jim Hindman (Investors), 714-246-4636 Joann Bradley (Investors), 714-246-4766 Ashwin Agarwal (Investors), 714-246-4582 Stephanie Fagan (Media), 714-246-5232 or Sanwa Tadashi Miyahara (Japan), 81-3(3232)2601 Masuo Kato (International), 81-52(951)8130

KEYWORD: CALIFORNIA JAPAN INTERNATIONAL ASIA PACIFIC INDUSTRY KEYWORD: PHARMACEUTICAL MEDICAL MEDICAL DEVICES PRODUCT MARKETING AGREEMENTS SOURCE: Allergan, Inc.

Copyright Business Wire 2005

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