Allergan, Inc. announced it has entered into an exclusive licensing agreement with Sanwa Kagaku Kenkyusho Co., Ltd. (Sanwa) to develop and commercialise Posurdex for the ophthalmic specialty market in Japan.

Posurdex 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 commercialisation of Posurdex in Japan and will incur associated costs. Sanwa will pay Allergan a royalty based on net sales of Posurdex in Japan, make development and commercialisation milestone payments and reimburse Allergan for certain expenses associated with Allergan's continuing conduct of Posurdex phase III pivotal studies outside of Japan. Allergan and Sanwa will work collaboratively on the clinical development of Posurdex, 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 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 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 focusing on macular edema associated with diabetes and other conditions. In Japan, Sanwa is expected to begin phase I/II development with Posurdex 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 per cent, Ministry of Health, Labour and Welfare (MHLW), 2002) and projected to account for more than 33 per cent 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.