Drug major Cipla today said its joint venture firm Stempeutics Research has received approval from the European Medicines Agency (EMA) for its stem-cell based drug Stempeucel, which is used to treat Thromboangiitis Obliterans (TAO).
Stempeutics Research, which was founded by Manipal Education and Medical Group (MEMG) in 2006 and later entered into a strategic alliance with Cipla in 2009, has received Advanced Therapy Medicinal Product (ATMP) classification for Stempeucel from EMA, the company said in a statement.
The ATMP classification, approved by the committee for Advanced Therapies (CAT) of the EMA will allow the Bengaluru- based Stempeutics to commercialise Stempeucel across the European Union region, it added.
"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," Stempeutics CEO B N Manohar said.
TAO 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.
Stempeucel drug is expected to address the root cause of the disease through anti-inflammatory and immune-modulatory mechanisms, the company said.
"Stempeuce will be a blessing for European patients who have been suffering with the rare disease -Thromboangiitis Obliterans. Cipla's front-end presence in Europe will help in creating the right momentum for Access across Europe," Cipla New Ventures Head Chandru Chawla said.
ATMP classification regulates cell and gene therapy and tissue engineered medicinal products, providing a benchmark for a level of quality compliance for pharmaceutical practices in EU countries.
