Acucela Inc., a clinical-stage ophthalmology company, announced that it received a written termination notice from Otsuka Pharmaceutical Co., Ltd. (Otsuka Pharmaceutical) for the co-development and commercialization agreement between Acucela and Otsuka Pharmaceutical relating to Acucela’s product candidate emixustat hydrochloride (emixustat) (the Emixustat Agreement) and the development and collaboration agreement between Acucela and Otsuka Pharmaceutical relating to Otsuka Pharmaceutical’s product candidate OPA-6566.
Receipt of this Notice will impact Acucela’s preparation of its proxy materials for its annual meeting of shareholders and, therefore, Acucela 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.
Otsuka Pharmaceutical and Acucela entered into the Emixustat agreement in September 2008. In May 2016, Acucela 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 Acucela on June 13, 2016 and the termination of the Emixustat agreement will be effective fourteen days from the date of the notice. Acucela 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 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.
Otsuka Pharmaceutical and Acucela entered into the OPA-6566 Agreement in September 2010. In 2012, Acucela conducted a phase 1/2 clinical trial in patients with glaucoma and had been evaluating potential next steps for the program. The OPA-6566 Agreement will also be terminated upon this notice, and the termination will be effective fourteen days from the date of the notice.
In connection with the postponement of Acucela’s annual meeting of shareholders, Acucela is also delaying its previously announced redomicile transaction, whereby Acucela would effect a merger transaction with its wholly-owned Japanese subsidiary, effectively changing the jurisdiction of incorporation of the corporate parent from Washington to Japan. Among other requirements, the proposed redomicile transaction requires the affirmative vote of a majority of the outstanding shares of Acucela’s common stock.
Acucela will announce a new record date and the schedule for its annual meeting of shareholders and the anticipated completion date of the proposed redomicile transaction as soon as practicable following a determination by Acucela’s Board of Directors.
Acucela will also disclose updates to its FYE2016 forecasted financials as soon as practicable.