BENGALURU: Bengaluru-based Stempeutics Research Pvt Ltd is trying to push its stem-cell based drug Stempeucel into the European markets. Stempeucel has been developed to treat the Buerger’s disease which is a very rare condition which can cause inflammation and thrombosis in blood vessels, typically in the legs and can lead to gangrene which will require amputation.
Officials from Stempeutics, a company part-owned by Cipla Ltd and which was started by the Manipal Group in 2006, on January 11 met the European Union’s (EU) drug regulator European Medicines Agency. The company claimed that it had presented the credentials and results from clinical research done in India of its stemcell-based drug Stempeucel.
In India’ a vial of the drug today costs about Rs 1.5 lakh and the company hopes to manufacture 50,000 bottles of it in the first year.
It has now been given the green signal to do a clinical research across the continent. “As it will have to do clinical research across the continent, it has appointed a German company Ecron to do an initial survey to study the prevalance of the Buerger’s disease,” said B N Manohar, MD & CEO, Stempeutics. The company will be doing surveys across Ukraine, Poland, Romania and Hungary in eastern Europe. In western Europe it will conduct the surveys across Germany, Italy and France.
The European Union’s (EU) drug regulator European Medicines Agency (EMA) had earlier extended the orphan drug status to Stempeucel. An orphan drug is a pharmaceutical agent developed specifically to treat a rare medical condition, with the condition itself being referred to as an orphan disease. With this status, the company had got a smoother road to securing regulatory and marketing approvals for drugs being developed to treat the rare disease.
Instead of the eight to nine years that a drug would take to get through Phase 1, 2 and 3 trials, in case of Stempeucel, as it has been given the status of an orphan drug, it will be able to go to market in about a year and a half, believes Manohar.
Once the drug establishes itself in Europe, Stempeutics, which has so far seen investments of about Rs 200 crore, will take it to the US as it will be easier for it to gain access there. Even as it will be trying to gain access to European markets, it will begin working towards getting the necessary permissions in the US.
Stempeucel has patent rights in the US, China, Australia, New Zealand, Singapore and South Africa. The company hopes to sell the drug mostly in the US and Europe because “that’s where the big money is”.