Stempeutics Research Pvt Ltd on 1 June 2015 announced that its stem cell drug, Stempeucel, received Orphan Drug Designation (ODD) from the European Medicines Agency (EMA).
By virture of being an ODD, it will have 10 years of market exclusivity from product launch in the European Union (EU), fee reductions and access to the central authorisation procedure.
An orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease.
Stempeucel, will offer new hope to patients suffering from Thromboangiitis Obliterans (also known as Buerger's Disease) a major unmet medical need in Europe.
The Bengaluru-based Stempeutics Research Pvt Ltd was founded by Manipal Education and Medical Group (MEMG) in 2006 and has been jointly owned along with the Cipla Limited since the MEMG entered into a joint venture in 2009.
Cipla Limited is an Indian multinational pharmaceutical and biotechnology company, headquartered in Mumbai.
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When: Announced on 1 June 2015