Mr BN Manohar, CEO, Stempeutics
Stempeutics Research, a group company of Manipal Education and Medical Group and a JV with Cipla Group, announced that the European Medicines Agency (EMA)
has granted Advanced Therapy Medicinal Product classification for its novel stem cell drug 'Stempeucel', which will be used for the treatment of Thromboangiitis Obliterans (TAO).
The Advanced Therapy Medicinal Product (ATMP) classification, approved by the committee for Advanced Therapies (CAT) of the European Medicines Agency, will allow Stempeutics to commercialize the product 'Stempeucel' across the European Union region.
Commenting on the ATMP classification, Mr B N Manohar, CEO, Stempeutics said, "We are happy to receive ATMP status from the EMA. 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 favourable indication for how the European regulators view our therapy."
Thromboangiitis Obliterans is a recurring progressive inflammation and thrombosis
(clotting) of small and medium arteries and veins of the feet.
It is strongly associated with use of tobacco products primarily from smoking, but also from smokeless tobacco.