Bangalore-based firm Stempeutics Research said the Drug Controller General of India gave a conditional approval to manufacture and market what would be the first allogeneic cell treatment in the country for Buerger’s disease.
The company, backed by Mumbai-based drugmaker Cipla's New Ventures unit, said the treatment, Stempeucel, for the disease which causes progressive swelling in the feet and is linked to tobacco use, has gone through Phase I and Phase II trials in India.
It also received orphan drug status from the European Union in late 2015.
Details on sales and marketing plans were not immediately available, but the company noted other indications related to swelling from diabetes and cardiovascular damage are under review and outlined a potential global market value.
"Our goal is to globalize Stempeucel for Buerger’s Disease and the market size is approximately $1.5 billion worldwide."
Stempeutics was started by Manipal Education and Medical Group in 2006 and initiated work with Cipla in 2009. The work on the therapy has caught wider attention in India, which has more than 7 times the number of people affected by rare diseases than the United States.
But off-the-shelf stem cell products are still few and far between globally by such as Mesoblast and Pluristem Therapeutics.
- here's the release