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European Boost For Bangalore Pharma Firm

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European Medicines Agency (EMA), the drug regulator of the European Union (EU), has granted orphan drug designation for Stempeucel, a medicine developed by Bangalore-based Stempeutics Research, for a rare illness affecting blood vessels and legs. 
 
The "orphan drug" status will help Stempeutics enjoy a 10 year market exclusivity in the EU as and when it launches the product. The illness, Thromboangiitis obliterans or Buerger's Disease, is a rare and severe disease affecting the blood vessels of the legs. It is characterized by inflammation and occlusion of the vessels of extremities resulting in reduced blood flow to these areas, thus leading to severe pain and ulcers or necrosis, which finally may require amputation.
 
The Stempeucel treatment is designed to enhance the body's limited capability to restore blood flow in ischemic tissue by reducing inflammation and improving neovascularization.
 
Commenting on the ODD status, BN Manohar, CEO of Stempeutics said, "Obtaining Orphan Designation for Stempeucel in the EU is an important regulatory milestone for Stempeutics. The benefits include 10 years of market exclusivity from product launch in the EU, fee reductions, as well as access to the central authorization procedure. This orphan drug designation supports Stempeutics global development strategy for Stempeucel drug and the goal of providing improved therapies for patients with Thromboangiitis Obliterans."
 
Stempeutics Research is joint venture between Manipal Education & Medical Group and domestic pharmaceutical major Cipla. Watch Video: 'We Have Already Got Patents From NZ, South Africa'
 
"We are pleased to have been granted the benefits of orphan drug designation in Europe," said Chandru Chawla, head of Cipla New Ventures.
 
"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. This significantly increases the commercial potential of our ground breaking therapy."
 
Stempeutics was founded by Manipal Education and Medical Group in 2006 and later entered into a strategic alliance with Cipla in 2009. The company claims to be in the business of developing innovative stem cell products by nurturing cutting edge research and clinical applications. Its goal is to develop novel stem cell drugs addressing major unmet medical needs with an India first global next approach.


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