Cell Therapy Ltd. (CTL) has sold the Japanese rights for its cardiac regeneration medicine Heartcel to Daiichi Sankyo. CTL, which was cofounded by Nobel laureate Sir Martin Evans, is pocketing £12.5 million ($18.1 million) upfront and potentially more in milestones in exchange for the rights to the cell therapy.
Cardiff, Wales-based CTL landed the deal on the strength of data generated to date, the centerpiece of which is a Phase II trial that reported results last year. The clinical trial gave Heartcel, an allogeneic therapy made up of CTL’s immuno-modulatory progenitor cells, to 11 severe heart failure patients. After an average of two years of follow up, all of the patients were alive and free from major adverse cardiac events. Under standard of care, CTL would have predicted a mortality rate of up to 70% for the patients.
The data enabled CTL to apply for conditional marketing authorization in Europe and underpinned a Japan-focused dealmaking strategy. “We identified Japan as a key market because there's a very innovative and appealing regulatory pathway for regenerative medicines which allows for accelerated access for patients to get lifesaving medicines,” CTL CEO Ajan Reginald told FierceBiotech. “So Japan became a strategic priority for us.” This led CTL to talk to multiple potential partners before choosing Daiichi.
“We really liked Daiichi. We think that there's a great technical expertise, there's a great scientific expertise but there's also a great cultural fit,” Reginald said. “They've been looking into stem cell research for over a decade through one of their subsidiaries.”
Daiichi will now apply this experience and its knowledge of the regulatory setup in Japan to advance Heartcel toward approval. CTL is retaining global manufacturing responsibilities, as well as the rights to the cell therapy outside of Japan. Deals for other regions could follow the Daiichi hookup. “We remain agnostic,” Reginald said. “There are territories where we can certainly launch products and there are territories where we need partners.”
The next deal could involve CTL’s other clinical-stage product, Tendoncel. Reginald, who first told FierceBiotech of his intent to partner the product last year, said talks with potential collaborators in Europe are ongoing. In parallel, CTL is gearing up to move Tendoncel into Phase III in Europe, while also working toward the filing of an IND with FDA.
CTL, which has previously indicated its interest in an IPO, is comfortable with its financial position as it moves into the next stage of its development. “We were adequately funded prior to this deal,” Reginald said. “We didn't want to start a deal process where we'd be under financial pressure.”