TOKYO - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., 'Astellas') and University of Pittsburgh (Chancellor: Patrick Gallagher, Ph.D., 'Pittsburgh') have entered into a research collaboration agreement focused on the discovery and optimization of clinical candidates for the treatment of dry age-related macular degeneration (dry AMD), a back-of-the-eye disease, utilizing the AAV-based gene therapy approach.

Among back-of-the-eye diseases, age-related macular degeneration is one of the leading causes of acquired blindness in the elderly. Dry AMD, in particular, is a disease in which retinal pigment epithelial cells gradually degenerate in the macula of the retina, and visual acuity deteriorates significantly as the disease advances to a severe stage. However, the mechanism leading to such lesions has not been fully elucidated, and no clinically effective treatment has yet to be established.

In this collaboration, Debasish Sinha, Ph. D., Jennifer Salvitti Davis, M.D. Chair in Ophthalmology Research and Professor of Ophthalmology, Cell Biology and Developmental Biology in University of Pittsburgh School of Medicine, a world-renowned authority in the research field of back-of-the-eye diseases, and Astellas, who has capabilities in drug discovery, will work jointly to evaluate and optimize the drug candidates with an aim to provide new treatment options that help recover and maintain vision for the patients suffering from dry AMD. Astellas has the exclusive negotiation right for further development and commercialization pertaining to clinical candidates obtained in this collaboration.

'With the population aging, the negative health impacts and costs of the disease will increase dramatically over the next decade. While effective treatment has been developed for advanced wet AMD, currently there is no treatment or prevention for dry AMD. We look forward to working with Astellas to advance the development of innovative treatments,' said Dr. Sinha.

'At Astellas, Blindness & Regeneration and Genetic Regulation are Primary Focus of our research and development strategy. We are engaged in drug discovery research with new modalities such as cell and gene therapies. In addition to the cell therapy program that is currently being developed, we are confident that this collaboration with Pittsburgh will enable us to accelerate our efforts to deliver innovative treatments for patients with back-of-the-eye diseases who have high unmet medical needs. Through alliances and partnerships with academia and bioventures, and more, Astellas will proactively incorporate various superior capabilities and aim to create innovative medical solutions that will turn innovative science into VALUE for patients,' said Akihiko Iwai, Ph.D., President of Drug Discovery Research at Astellas.

About University of Pittsburgh

Founded in 1787, the University of Pittsburgh is a state-related research university, one of the oldest institutions of higher education in the United States. Pitt is a member of the Association of American Universities (AAU), which comprises 63 preeminent doctorate-granting research institutions in North America. Pitt people have defeated polio, unlocked the secrets of DNA, lead the world in organ transplantation, and pioneered TV and heavier-than-air flight, among numerous other accomplishments.

About Astellas

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+ healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients.

Cautionary Notes

In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.

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