U.K. biotech Cell Therapy has granted a Japanese license for its experimental cardiac regeneration medicine Heartcel to Tokyo’s Daiichi Sankyo as it looks to push on into late-stage trials.
Under the terms of the deal, Daiichi will undertake all development, regulatory and commercial activities for iMP cells in Japan--while Cell Therapy retains its worldwide rights outside of the country, as well as global manufacturing responsibilities.
The Cardiff, Wales-based company will also get a much needed £12.5 million upfront licensing fee, as well as additional milestone payments and royalties.
Heartcel--immuno-modulatory progenitor [iMP] cells--are an advanced therapeutic medicinal product (ATMP) and investigational allogeneic regenerative medicine.
In its recent midstage trial, iMP cells were injected into the cardiac scar during bypass surgery in 11 severe heart failure patients at high risk of incomplete re-vascularisation.
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 (characterized by a 50% increase in ‘Minnesota Living with Heart Failure’ score). At 36 months following treatment, all patients remained alive.
"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, CEO, of Cell Therapy.
He added that the cash boost will also allow the company to focus on U.S. and European Phase III trials, while also looking to speed up some targets in its 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,” added Professor Sir Martin Evans, Nobel Laureate and the biotech’s CSO.
“This partnership is a validation of Cell Therapy’s novel approach and discovery technology.”
-check out the release
Picture from TKNY_photo, Flickr