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June 14, 2016

Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals

Announcement of Termination of Co-Development and Co-Commercialization Agreements with Acucela, Inc.

Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that it has decided to terminate its agreements with Acucela for the co-development and co-commercialization of the drug candidates ACU-4429 and OPA-6566.

ACU-4429 (emixustat hydrochloride) is an Acucela-discovered drug candidate for treatment of the dry form of age-related macular degeneration (AMD). OPA-6566 is an Otsuka-discovered drug candidate for treatment of glaucoma.

Otsuka signed a co-development and co-commercialization agreement with Acucela on ACU-4429 in September, 2008; however, Acucela recently announced that the study primary endpoint was not met in a Phase IIb/III clinical trial of the compound in the U.S. Following a review of the clinical trial data, Otsuka decided to end its participation in further development activities for ACU-4429 and informed Acucela of its decision to terminate the agreement upon the lapse of a pre-determined notification period.

In addition, Otsuka simultaneously informed Acucela of its decision to end their collaboration for OPA-6566 for glaucoma, exercising its contractual right to terminate the agreement upon the lapse of a pre-determined notification period. The two companies originally signed a co-development and co-commercialization agreement for the compound in September 2010. Otsuka OPA-6566 is in development in the U.S., where a Phase I/II clinical trial has been completed.

Otsuka will continue its vigorous research programs on new treatments for patients with unfulfilled medical needs who eagerly await new treatment choices.


Information in this news release was current as of the original release date.

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