SEATTLE, WA, USA I June 13, 2016 I Acucela Inc. (Tokyo: 4589) (the “Company”), a clinical-stage ophthalmology company that specializes in identifying and developing novel therapeutics to treat and slow the progression of sight-threatening ophthalmic diseases, announced today that the Company received a written termination notice (the “Notice”) from Otsuka Pharmaceutical Co., Ltd. (“Otsuka Pharmaceutical”) for the co-development and commercialization agreement between the Company and Otsuka Pharmaceutical relating to the Company’s product candidate emixustat hydrochloride (“emixustat”) (the “Emixustat Agreement”) and the development and collaboration agreement between the Company and Otsuka Pharmaceutical relating to Otsuka Pharmaceutical’s product candidate OPA-6566 (the “OPA-6566 Agreement”).
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.
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.
The Company 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 the Company entered into the OPA-6566 Agreement in September 2010. In 2012, the Company 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 the Company’s annual meeting of shareholders, the Company is also delaying its previously announced redomicile transaction, whereby the Company 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 the Company’s common stock.
The Company 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 the Company’s Board of Directors.
The Company will also disclose updates to its FYE2016 forecasted financials as soon as practicable.
About Acucela Inc.
Acucela Inc. (http://www.acucela.com/ or http://www.acucela.jp) is a clinical-stage ophthalmology company that specializes in identifying and developing novel therapeutics to treat and slow the progression of sight-threatening ophthalmic diseases affecting millions of people worldwide. The Company’s pipeline includes drug candidates and therapeutics for the treatment of retinitis pigmentosa, proliferative diabetic retinopathy, Stargardt disease and cataracts.
SOURCE: Acucela
Post Views: 111
SEATTLE, WA, USA I June 13, 2016 I Acucela Inc. (Tokyo: 4589) (the “Company”), a clinical-stage ophthalmology company that specializes in identifying and developing novel therapeutics to treat and slow the progression of sight-threatening ophthalmic diseases, announced today that the Company received a written termination notice (the “Notice”) from Otsuka Pharmaceutical Co., Ltd. (“Otsuka Pharmaceutical”) for the co-development and commercialization agreement between the Company and Otsuka Pharmaceutical relating to the Company’s product candidate emixustat hydrochloride (“emixustat”) (the “Emixustat Agreement”) and the development and collaboration agreement between the Company and Otsuka Pharmaceutical relating to Otsuka Pharmaceutical’s product candidate OPA-6566 (the “OPA-6566 Agreement”).
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.
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.
The Company 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 the Company entered into the OPA-6566 Agreement in September 2010. In 2012, the Company 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 the Company’s annual meeting of shareholders, the Company is also delaying its previously announced redomicile transaction, whereby the Company 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 the Company’s common stock.
The Company 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 the Company’s Board of Directors.
The Company will also disclose updates to its FYE2016 forecasted financials as soon as practicable.
About Acucela Inc.
Acucela Inc. (http://www.acucela.com/ or http://www.acucela.jp) is a clinical-stage ophthalmology company that specializes in identifying and developing novel therapeutics to treat and slow the progression of sight-threatening ophthalmic diseases affecting millions of people worldwide. The Company’s pipeline includes drug candidates and therapeutics for the treatment of retinitis pigmentosa, proliferative diabetic retinopathy, Stargardt disease and cataracts.
SOURCE: Acucela
Post Views: 111
