The European Medicines Agency (EMA) has put Cell Therapy's Heartcel on its conditional approval pathway, raising the possibility the allogeneic stem cell therapy could come to market in 2017. And with the drug now nearing the market, Cell Therapy has begun to sound out investors about an IPO.
|Cell Therapy co-founder Sir Martin Evans|
Winning conditional approval would allow Cell Therapy to begin selling Heartcel on the basis of data from a comparatively small number of patients. Cardiff, Wales-based Cell Therapy would then gather more safety and efficacy data to support an application to upgrade to a full approval. EMA opened the conditional approval pathway to Cell Therapy on the strength of data published in June from a trial of Heartcel in 11 people advanced heart failure. After two years, all 11 of the participants are still alive, a far greater proportion than is typical when existing therapeutic pathways are followed.
"Other drugs work by making the remaining healthy heart beat harder but that's like over-revving a car," Cell Therapy CEO Ajan Reginald told The Financial Times. "Ours would be the first that restores the damaged heart to health." Heartcel, which is based on work by Cell Therapy's Nobel Prize-winning CSO Sir Martin Evans, consists of Cell Therapy's immunomodulatory progenitor cells. The cells, which are administered during bypass surgery, are designed to reduce scarring and improve heart function by facilitating the regeneration of tissue.
The regulatory and commercial success of the product is by no means assured. But, with EMA seeing enough potential in the limited data to date to open the conditional approval pathway, Cell Therapy has started to consider how it will finance its future activities. The firm pulled in almost £700,000 ($1 million) in a crowdfunding campaign earlier this year but the scaling up of its goals is necessitating a shift in its financial strategy. Reginald met with potential investors in New York last week ahead of a possible IPO, although the timing and location of the float--and even if it will happen--are uncertain.
Stock exchanges on both sides of the Atlantic are still in the running. And with Reginald in no rush to take the company public, a lot will depend on market conditions over the coming year. While keeping tabs on financing options, Cell Therapy will work on its regulatory filing ahead of a planned submission in the middle of next year.
- read the release
- and the FT's article