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news.US-based biotechnology company Acucela and Japan-based healthcare company Otsuka Pharmaceutical have entered into a definitive agreement to co-develop Acucela's lead compound ACU-4429 which is currently in Phase I clinical development for the dry form of age-related macular degeneration in the US.
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Under the agreement, the parties will co-develop ACU-4429 in dry age-related macular degeneration (AMD) as well as other potential indications in North America. Upon commercialization of ACU-4429, the parties may co-promote the product in North America and equally share all expenses and profits from sales of the product in North America.
Acucela retains all rights to ACU-4429 in Europe, and Otsuka owns the exclusive development and commercialization rights to the product in Asia and selected markets in the rest of the world.
Otsuka shall pay Acucela a $5 million cash upfront payment, and potential milestone payments totaling $258 million. In addition, Otsuka will fund all clinical development activities through Phase II clinical testing.
Beginning with Phase III clinical testing, the parties will share equally in all future clinical development expenses. Otsuka will provide Acucela with a loan facility to enable it to fund its share of the development expenses through to launch of the product in North America.
Taro Iwamoto, president and representative director of Otsuka Pharmaceutical, said: “We are pleased to be partnering with Acucela. Acucela’s proprietary drug discovery platform fits well within our emerging ophthalmology franchise. We are hopeful that Otsuka and Acucela will learn and work together, and to be successful in developing ACU-4429 as an efficacious treatment for dry AMD.”