Updated on 15 June 2016
Singapore: Tokyo-based Acucela Inc has received a written termination notice from Otsuka Pharmaceutical Co Ltd for the co-development and commercialization agreement between the Company and Otsuka Pharmaceutical relating to the company's product candidate emixustat hydrochloride and the development and collaboration agreement between the company and Otsuka Pharmaceutical relating to Otsuka Pharmaceutical's product candidate OPA-6566.
Acucela says that the receipt of this Notice will impact the company's preparation of its proxy materials for its annual meeting of shareholders and, therefore, the Company has decided to postpone its annual meeting of shareholders, previously scheduled for August 2, 2016, to a later date that has yet to be determined. A new record date will also be determined, indicated Acucela.
Otsuka Pharmaceutical and the company entered into the Emixustat Agreement in September 2008. In May 2016, the company announced that the Phase 2b/3 clinical trial (S.E.A.T.T.L.E. study) for the treatment of geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD) did not meet its primary endpoint.
The Notice was received by the company on June 13, 2016 and the termination of the Emixustat Agreement will be effective fourteen days from the date of the Notice. The company will discontinue further analysis of the clinical data from the S.E.A.T.T.L.E. study pertaining to GA secondary to dry AMD, which study was conducted in collaboration with Otsuka Pharmaceutical.
Acucela also indicated that it will continue its ongoing research to explore the benefits of emixustat for the treatment of retinal diseases. Currently, there is an ongoing Phase 2 trial of emixustat addressing proliferative diabetic retinopathy and the Company plans to initiate a clinical trial evaluating emixustat in patients with Stargardt disease by the end of 2016.