June 14, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Seattle-based Acucela announced today that Otsuka Pharmaceutical Co. had terminated their co-development and collaboration deal for OPA-6566 (emixustat).
The two companies inked the deal in September 2010. Otsuka and Acucela started a Phase I/II clinical trial in glaucoma patients with the drug in 2012. They previously signed the Emixustat Agreement in September 2008. In May 2016, they announced that the SEATTLE study, a Phase IIb/III trial of emixustat in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) failed to meet its primary endpoint. None of the treatment groups showed a significant change in lesion growth rate compared to placebo.
“We are carefully reviewing the data in geographic atrophy before we decide on our next steps with emixustat in this indication,” said Ryo Kubota, chairman, president and chief executive officer of Acucela, in a statement at the time. “We will continue to advance our in-licensed projects as well as our in-house research.”
Acucela plans to continue its research of emixustat to treat retinal diseases. There is currently a Phase II trial of the drug in proliferative diabetic retinopathy, and plans to launch a trial of the drug in patients with Stargardt disease by the end of 2016.
“We terminated two agreements with Acucela after the outcome that Acucela announced on 26 May, according to the condition we made in advance,” said Miyuki Nishioka, a spokeswoman at Otsuka told Bloomberg.
Several other key points were announced. Acucela is delaying the preparation of its proxy materials for its annual meeting, which was scheduled for August 2, 2016. A new date has not been set.
Acucela also had a plan to change its domicile, moving its “jurisdiction of incorporation” from Washington to Japan. That has also been delayed and has yet to be rescheduled.
In an article updated shortly after midnight today, Bloomberg noted that was expected to drop as much as 24 percent in Tokyo, which is its daily limit. As of that publication time, the stock hadn’t opened yet “because of a trading imbalance, with sell offers outnumbering bids by 21-to-1.”
is currently listed at 1,253 Japanese Yen, or $11.83 (US). Over the last month, in response to its failed trial, company stock has dropped more than 50 percent.
Whether related to Acucela is unclear, but several small-cap biotech stocks dropped “as investors dumped some of the high-flyers on the Tokyo Stock Exchange Mothers Index amid a global equities selloff,” reported Bloomberg.
“Triggered by the big fall yesterday, individuals got pessimistic with the Japan market and started selling shares including pharma sector,” said Mitsushige Aikino, an executive officer based in Tokyo with Ichiyoshi Asset Management Co.
Examples include Sosei Group Co., which dropped almost 12 percent, PeptiDream Inc., which fell almost 7.1 percent, and Reprocell Inc., which dropped 8.2 percent.
Bloomberg notes that, “Japan Exchange Group Inc., the operator of the Tokyo and Osaka stock exchanges, is examining movement in Acucela shares for possible insider trading after they fell by the limit on May 25, a day before the Seattle-based company said the emixustat eye treatment failed to meet objectives, a person familiar with the situation said last month.”
