Celixir’s CEO talks about his Agreement with Japanese Firm to Distribute its Heart Failure Drug

Days after the news broke out regarding Cardiff-based cell therapy company Cell Therapy Ltd (CTL) signing a partnership agreement with Japan’s Daiichi Sankyo, whilst giving them the rights to its heart failure drug Heartcel, the company’s chief executive, Ajan Reginald, spoke to leading news daily in the same context. Heartcel, an immune-modulatory progenitor (iMP), comes as the first allogeneic stem cell therapy to redevelop the human heart. It has confirmed a two-year MACE-free survival for all patients in a Phase II clinical trial studying myocardial regeneration. As a part of the new agreement, Daiichi Sankyo will be taking care of the development, regulatory approval and marketing of Heartcel in Japan, while CTL holds the full rights for rest of the globe. Mr. Ajan Reginald, the co-founder of CTL, said the deal comes as the first step towards their global mission of bringing company’s life-saving drugs to world markets as soon as possible. “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 further quoted that the company is ‘agnostic’ towards its strategy to bring these medicines to global market swiftly and are open to all the 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 only October last year when CTL was given the nod to propose a conditional marketing authorization for Heartcel in Europe. “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 further quoted that CTL is keenly looking for a partner in the US on Heartcel and there are further discussions in pipeline for a European partnership on its second asset, Tendoncel. This topical regenerative medicine which is helpful in repairing severe tendon injury is all set to enter its Phase III trials, after getting positive results from Phase II. Mr Ajan Reginald also confirmed that the company is in a healthy financial state. “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 expects that an initial public offering (IPO) can be looked forward to anytime next year around Ajan concluded the discussion whilst stating “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,”