Collaboration covering Acucela’s early-stage AMD therapy is worth up to $258 million.

Acucela and Otsuka Pharmaceutical are joining forces to develop Acucela’s Phase I drug for age-related macular degeneration (AMD) and Otsuka’s Phase III treatment for dry eye. Otsuka will initially pay $5 million for the AMD compound plus an additional amount upfront in relation to the dry eye collaboration.

Acucela could earn $258 million in success-based fees for its AMD therapy, ACU-4429, as well as milestones related to Otsuka’s Rebamipide ophthalmic suspension for dry eye.

Otsuka shall be responsible for all clinical development and commercialization expenses for Rebamipide. The companies will partner on development efforts, with Acucela heading the regulatory strategy in the U.S. Upon regulatory approval of Rebamipide, the parties may negotiate the terms under which Acucela may copromote Rebamipide with Otsuka in the U.S. Otsuka will pay Acucela a royalty on sales of Rebamipide. During the course of development, the companies will negotiate on a possible development strategy outside of the U.S., according to Ryo Kubota, M.D., Ph.D., CEO of Acucela.

With regard to ACU-4429 in dry AMD, Otsuka will fund development activities through to Phase II testing. The firms will then equally share development costs. Otsuka will provide Acucela with a loan facility to enable it to fund its share of clinical investigation.

Dr. Kubota says that Acucela will conduct Phase I trials and expects to begin a Phase II study by 2009. He anticipates that the drug could complete clinical development by 2014.

The companies will also work together to advance ACU-4429 in dry AMD as well as other potential indications 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.

Upon commercialization of ACU-4429, the parties may copromote the product in North America and equally share all expenses and profits from sales of the product in this region. 

“Otsuka is an ideal partner for Acucela, as we believe that their strong international presence and commercialization expertise will enable us to maximize the productdevelopment opportunity that lies ahead of us for ACU-4429,” notes Ryo Kubota, M.D., Ph.D., CEO of Acucela.

ACU-4429 is small molecule nonretinoid visual cycle modulator. The compound is expected to slow the regeneration of 11-cis-retinal in the retina and has shown beneficial effect in preclinical models of retinal degeneration by stopping the accumulation of retinoid-related toxic byproducts including A2E, according to the companies. A2E is known for its toxicity to retinal cells and activates complement factor, which is also believed to play a significant role in the pathogenesis of AMD.

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