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Cell Therapy licenses heart failure therapy in Japan

EMA may grant Welsh-based biotech a marketing application in mid-2016

Cell Therapy licenses heart failure therapy in Japan 

Welsh biotech Cell Therapy has bagged a licensing deal with Japan's Daiichi Sankyo for its stem cell therapy for heart failure.

Cell Therapy - headed by Nobel laureate and stem cell scientist Sir Martin Evans - will receive £12.5m upfront from Daiichi Sankyo in return for Japanese rights to the HeartCel therapy, which is based on a type of stem cell known as immune-modulatory progenitor (iMP) cells. 

Additional undisclosed payments will also be forthcoming if HeartCel passes other development and regulatory milestones, as well as royalties on any future sales.

HeartCel has been clinically tested with heart failure patients who undergo bypass surgery or coronary stenting and has successfully completed a phase II trial in 11 patients. The iMP cells are injected into the heart muscle by the cardiac surgeon during the procedure, with the aim of repairing damaged tissue and stimulating regeneration of myocardial cells.

Data reported last year showed that all patients receiving the therapy were still alive and had not suffered a heart attack or stroke two years later - a remarkable result as typically the annual mortality rate in this patient group is around 70%.

While small, the trial was sufficiently impressive to encourage the European Medicines Agency (EMA) to put HeartCel in the conditional marketing authorisation process - setting up the possibility of a marketing application in mid-2016 and approval the following year. Via this route the company could start selling the drug while collating further evidence of its safety and efficacy.

Cardiff-based Cell Therapy - which is chaired by former UK trade minister Sir Digby Jones and has ex-Roche emerging technologies chief Ajan Reginald as its chief executive - retains all commercial rights outside Japan under the terms of the new deal.

"The accelerated regulatory pathway for regenerative medicines in Japan enables faster patient access, making it a natural priority for us," said Reginald, adding that having Daiichi Sankyo on board will allow the company to focus on its US and EU phase III trials programme.

The first stem cell therapy to be approved in Europe was Chiesi's Holoclar - an autologous human corneal epithelial cell preparation containing stem cells - that is used to treat people with damaged eyes. It was launched last year and remains the only approved cell therapy in the EU.

Cell Therapy had been eyeing an initial public offering (IPO), but now has sufficient cash in hand for at least two years of operations. The company took the unusual step among life science companies of fundraising via a crowdfunding drive last year, which brought in £691,000 (almost $1m).

Article by
Phil Taylor

11th May 2016

From: Regulatory



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