Daiichi buys Japanese rights to CTL’s innovative cardiac regeneration medicine, Heartcel

May 11 2016

Cell Therapy Ltd. (CTL) today announced the granting of the Japan license for its innovative cardiac regeneration medicine, Heartcel™ (immuno-modulatory progenitor [iMP] cells) to Daiichi Sankyo. Daiichi Sankyo will undertake all development, regulatory and commercial activities for iMP cells in the territory of Japan only, while CTL retains its worldwide rights outside of Japan as well as global manufacturing responsibilities. Under the terms of the agreement, CTL receives a £12.5 million upfront licensing fee and additional milestone payments and royalties.

"After a competitive process, we are delighted to partner with Daiichi Sankyo in Japan. The accelerated regulatory pathway for regenerative medicines in Japan enables faster patient access, making it a natural priority for us," said Ajan Reginald, Chief Executive Officer, CTL. "This allows CTL to focus on U.S. and European Phase 3 trials and accelerating the development of our pre-clinical pipeline."

“CTL’s in-house technology focuses on the discovery of novel tissue-specific cellular medicines. We are delighted that Daiichi Sankyo share our belief in iMP cells’ potential in heart regeneration,” commented Professor Sir Martin Evans, Nobel Laureate and CTL’s Chief Scientific Officer. “This partnership is a validation of Cell Therapy’s novel approach and discovery technology.”

iMP cells are an advanced therapeutic medicinal product (ATMP) and investigational allogeneic regenerative medicine. Heart failure affects approximately 26 million people worldwide. The condition features a progressive degenerative scarring of the heart associated with significant mortality and morbidity. iMP cells were injected into the cardiac scar during bypass surgery in a Phase 2 clinical trial of 11 severe heart failure patients at high risk of incomplete re-vascularisation (ICR). At 12 months following treatment, results demonstrated the following change from baseline: a 30% improvement in heart function (left ventricular ejection fraction), a 40% decrease in cardiac scar area and significant improvement in quality of life (characterised by a 50% increase in ‘Minnesota Living with Heart Failure’ score). At 36 months following treatment, all patients remained alive.