Celixir’s CEO discuss about his agreement with the Japanese firm to distribute its heart failure drug

Just days after the Cardiff-based cell therapy company Cell Therapy Ltd (CTL) signed an agreement with Japan’s Daiichi Sankyo, providing them with the rights to its heart failure drug Heartcel, the company’s chief executive, Ajan Reginald, got interviewed by one of the leading dailies.

Heartcel, an immune-modulator progenitor (iMP), can be considered as one of the allogeneic celixir stem cells therapy which posses the power to redevelop the human heart. The same therapy has confirmed two-year MACE-free survival for all the tested patients in the Phase II clinical trial studying myocardial regeneration. As per the agreement, Daiichi Sankyo will take care of the development, regulatory approval and marketing of Heartcel in the Japanese territory, while CTL will still holds the rights for the rest of the world.

Mr. Ajan Reginald, the co-founder of CTL, quoted that the deals comes as a future step towards accomplishing the global mission of bringing company’s life-saving drugs to the world’s markets within a short period of time.

“Japan was a natural priority because it has an accelerated pathway that allows innovative regenerative medicines to reach patients much faster,” he said. “It is also very important commercially because it is the world’s second biggest pharmaceutical market.’

He also said that the company is ‘agnostic’ towards bringing these medicines to the global markets within a short period and they are open to all the available options in the same regards.

“Partnerships are a tool, but sometimes we are the best company to do it. It varies by territory. In Japan Daiichi Sankyo was identified as the best partner”, he added.

It was October last year when CTL received the permission for the conditional marketing authorization for Heartcel in European region.

“There are multiple ways of bringing life-saving medicines to market, conditional approval is one way but there is also the Phase III route which is what we will do in the US,” he explains.

He also confirmed that CTL is currently looking for a partner in the US on Heartcel and various other discussions are in pipeline for a European partnership for its second asset named, Tendoncel.

This topical regenerative medicine which is quite helpful in treating certain severe tendon injury is geared up to enter its Phase III trials, after receiving positive results from Phase II.

Mr. Ajan Reginald also puts his stamp on the healthy financial state of the company. “It is a private company, still managed by the founders, so we have been prudent in our use of funds and also prudent in our fundraising. We were well-capitalized ahead of this partnership.” he said

He further expects an initial public offering (IPO) to be coming out anytime around next year.

Ajan Reginald concluded the interview whilst saying, “I think we have a strategy which is to fund the company until the innovation and product revenues can drive sustainable development of our pipeline. We are not against an IPO but we won’t consider it until next year,”