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PS12.5m Japan rights deal for cell therapy company.

Byline: Chris Kelsey Assistant head of business chris.kelsey@walesonline.co.uk

ALIFE sciences company has agreed a deal that will see its advanced cell therapy medicine developed and commercialised for the Japanese market.

The deal between Cardiff-based Cell Therapy and pharmaceuticals group Daiichi Sankyo grants the Japanese company the licence for Heartcel, Cell Therapy's innovative cardiac regeneration medicine.

Daiichi Sankyo will undertake all development, regulatory and commercial activities for Heartcel in Japan, while Cell Therapy retains its worldwide rights outside of Japan as well as global manufacturing responsibilities.

Under the terms of the agreement, Cell Therapy will receive a PS12.5m upfront licensing fee and additional milestone payments and royalties.

Cell Therapy 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.

Cell Therapy was founded in 2009 by Sir Martin Evans, who won the Nobel Prize for medicine in 2007 for his research into stem cells, and Mr Reginald, who was previously global head of emerging technologies at Roche.

It is chaired by former UK Trade Minister and CBI director general Lord Digby Jones, and former First Minister Rhodri Morgan also sits on the board.

Speaking about the licensing 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 tissuespecific cellular medicines. We are delighted that Daiichi Sankyo share our belief in [Heartcel's] potential in heart regeneration.

"This partnership is a validation of Cell Therapy's novel approach and discovery technology."

The Heartcel product involves the injection of modified cells into a patient's heart tissue to repair the scarring associated with heart failure, which affects about 26 million people worldwide.

In a Phase 2 clinical trial it has been injected into the cardiac scar during bypass surgery of 11 severe heart failure patients.

A year after the trial patients showed a 30% improvement in heart function, a 40% decrease in cardiac scar area and significant improvement in quality of life, while three years after treatment all patients remained alive.

This is a significant improvement on existing treatments for similar heart failure patients where a 70% annual mortality rate is typical.

Last year Cell Therapy secured consent from the European Medicines Agency to start the application process for conditional approval of the treatment based on its early trial results. This allows the company to begin marketing Heartcel while gathering more evidence of its safety and effectiveness.

Japanese authorities are also offering fast-track approval for cell therapies as part of efforts to promote the development of regenerative medicines.

Mr Reginald said he hoped Heartcel would be on the market in Europe or Japan by late 2017 or 2018, depending on the results of further trials.

Lord Jones said the deal with Daiichi Sankyo would provide more funds for Cell Therapy to develop and commercialise its product for the European and American markets.

He said: "It validates our science and increases the confidence we have going into our next stage of development."

He added that the company could make an initial public offering in the future but has enough cash to keep going for at least two years.

Cell Therapy is one of two businesses in South Wales working in the regenerative therapy field, along with ReNeuron, which is relocating from its Surrey base to the Welsh Government's new Advanced Therapies Medicinal Products facility at Pencoed.

The AIM-listed company is taking over the entire 25,000 sq ft ground floor of Therapia - a state-of-the-art facility equipped with research and development laboratories, clean rooms designed for automated cell culture, and office accommodation.

The move follows a PS25m equity fund-raising round in 2013 with the lead investor being the Welsh Government's Wales Life Sciences Investment Fund.

Last July ReNeuron raised PS68.4m to fund its ongoing operations including a further investment by the Wales Life Sciences Investment Fund.

The company is relocating its existing staff and hopes to create up to a further 70 highly skilled jobs in Wales over time.

CAPTION(S):

Ajan Reginald of Cell Therapy with board member, former First Minister Rhodri Morgan
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Title Annotation:Business
Publication:Western Mail (Cardiff, Wales)
Geographic Code:9JAPA
Date:May 18, 2016
Words:719
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