Celixir has agreed a deal with the Daiichi Sankyo that will see all of its advanced cell therapy medicine developed and distributed in the Japanese markets.
The deal between the firms would allow the Japanese company with the license for Heartcel, one of Cell Therapy’s innovative cardiac regeneration medicines.
Daiichi Sankyo will take care of all the development, regulatory and commercial activities for Heartcel in Japanese territory only, while Cell Therapy would take care of the same in rest of the world. As per the agreement, Cell Therapy will receive an upfront licensing fee of £12.5m along with additional royalties and payments.
Talking in the same context, Cell Therapy’s chief executive Ajan Reginald said: “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.
A firm founded by a Nobel Laureate
Cell Therapy was founded by Sir Martin Evans, a Nobel Prize winner for medicine in 2007 for his research into stem cells, along with Mr. Ajan Reginald, who has previously served as the global head, emerging technologies at Roche.
The Firm is chaired by UK trade minister and CBI director general Lord Digby Jones along with former First Minister Rhodri Morgan also sits on the board. Speaking in regards to the license agreement, Sir Martin, Cell Therapy’s chief scientific officer, added: “This allows us to focus on US and European Phase 3 trials and accelerating the development of our pre-clinical pipeline.
“[Our] in-house technology focuses on the discovery of novel tissue-specific cellular medicines. We are delighted that Daiichi Sankyo shares our belief in [Heartcel’s] potential in heart regeneration.
Clinical Trials
The Heartcel product includes the injection of modified cells into a patient’s heart tissue in order to repair the scarring out of a heart failure. The medical condition impacts more than 26 million people worldwide.
During the Phase 2 clinical trial, the modified cells got injected into the cardiac scar during bypass surgery of 11 patients with severe heart failure.
After duration of one year, the trial patients showed an improvement of 30% in heart functioning, along with a 40% decline in cardiac scar area and noteworthy improvement in quality of life. Moreover, all of the patients remained alive after three years of treatment.
“This partnership is a validation of Cell Therapy’s novel approach and discovery technology.”
It was last year when Cell Therapy secured the permission from the European Medicines Agency to initiate with the application process for “conditional approval of the treatment based on its early trial results”. This further allowed the company to market Heartcel while securing more evidence regarding its safety and effectiveness.
Fast-track approval
Japanese authorities have proposed for the fast-track approval for cell therapies in an effort to encourage the development of regenerative medicines.
Mr. Ajan Reginald said he expected Heartcel to make its place in European or Japanese markets by late 2017 or 2018, depending on the results of further trials.
Lord Jones further stated that the deal with Daiichi Sankyo would facilitate the Cell Therapy with more funds in order to expand and commercialize its product for the American and European markets.
He quoted: “It validates our science and increases the confidence we have going into our next stage of development.”
He also said that the company will be coming along with an initial public offering in the coming future but they still have enough cash to make it going for the next two years at least.
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