Stempeutics' Stempeucel gets Orphan Drug status in Europe

Drug major Cipla today said its JV firm Stempeutics Research has received Orphan Drug designation from European Medicines Agency (EMA) for stem cell drug Stempeucel, aimed at treatment of Thromboangiitis Obliterans, a disease affecting blood vessels of the legs.
Stempeutics CEO BN Manohar said: "The benefits include 10 years of market exclusivity from product launch in the EU, fee reductions, as well as access to the central authorisation procedure."
The Bengaluru-based Stempeutics Research was founded by Manipal Education and Medical Group (MEMG) in 2006 and later entered into a strategic alliance with Cipla in 2009.
An orphan designation allows a company to benefit from incentives from the European Union to develop a medicine for a rare disease, such as reduced fees and protection from competition once the medicine is placed on the market.

Stempeucel will offer new hope to patients suffering from Thromboangiitis Obliterans (also known as Buerger's Disease) a major unmet medical need in Europe, Stempeutics Research and Cipla said in a joint statement.
"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," Cipla New Ventures Head Chandru Chawla said.
Shares of Cipla were trading at Rs 669.05 per scrip in the afternoon trade on BSE, up 2.86 per cent from its previous close.