India Approves First Stem Cell-based Drug For Buerger's Disease

The drug controller general of India (DCGI) has granted limited approval to Stempeutics Research, a joint venture between drug maker Cipla and Manipal Group for manufacturing and marketing its stem cell based biological drug Stempeucel for the treatment of Buerger’s Disease. It is India’s first therapeutic product for this rare disease, which was unaddressed by modern medicine so far.

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. With no effect treatments available till now, the patient in most case would require amputation.

According to Cipla, the Stempeucel treatment is designed to enhance the body's limited capability to restore blood flow in ischemic tissue by reducing inflammation and improving neovascularisation or new blood vessel formation in abnormal tissue.

"Obtaining DCGI approval for Stempeucel is an important and historic milestone for Stempeutics and we are the first company in India to achieve this approval,” said B N Manohar, CEO of Stempeutics.

It took almost 9 years to develop Stempeucel for the treatment of Buerger’s Disease, he added.

EU drug regulator European Medicinal Agency had earlier classified Stempeucel as an advanced therapeutic medicinal product (ATMP) and designated it as an orphan drug (The drug developed to address rare diseases) for the treatment of Buerger’s Disease.

“Our goal is to globalize Stempeucel for Buerger’s Disease and the market size is approximately $ 1.5 Billion worldwide,” says Chandru Chawla, head, Cipla New Ventures, a business division of Cipla which invests in new and innovative technologies and therapeutic products.

Buerger’s Disease, a very rare disorder that, in most cases, affects young or middle-aged male cigarette smokers with onset of symptoms before 40-45 years of age, is increasingly found in smoking women in the recent times. While the disease is very rare in the US and Europe, it’s more common in other parts of the world, especially in parts of Asia and the Far and Middle East. The incidence in the US has been estimated at 12.6-20 per 100,000 people in the general population. The disease occurs with greater frequency in countries that have heavy tobacco use.

Prevalence of this disease is estimated to be at least a million (10 lakh) in India.

The Bangalore-based Stempeutics Research, an advanced clinical stage biotech company, was founded by Manipal Group in 2006 and it entered into a strategic alliance with Cipla in 2009.