Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals
June 14, 2016

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.