India's Stempeutics gets EMA advanced therapy designation for Stempeucel

Cipla-backed Stempeutics, an Indian advanced clinical stage biotech company based in Bangalore, said the European Medicines Agency has granted Advanced Therapy Medicinal Product classification for its novel stem cell drug Stempeucel.

The drug used to treat thromboangiitis obliterans, or Buerger's Disease is now eligible for a path to commercialization across the European Union region, the company said.

Stempeutics was founded by Manipal Education and Medical Group in 2006 and later entered into a strategic alliance with Cipla in 2009 with a goal to develop novel stem cell drugs addressing major unmet medical needs with an India first global next approach.

"We are happy to receive ATMP status from the EMA," said B.N. Manohar, CEO of Stempeutics.

"We view this as an important milestone to further develop our novel stem cell biological drug Stempeucel in the EU for treating Thromboangiitis Obliterans indication. Additionally, we interpret this as a favorable indication for how the European regulators view our therapy."

- here's the release from Stempeutics