Even as it awaits regulatory approvals in India on its novel product targeting a limb disorder, Stempeutics Research has crossed a milestone in China with this product.

The company has received a process patent on its stem-cell based drug Stempeucel in China, to be initially used in treating Critical Limb Ischemia (CLI), B N Manohar, Stempeutics Chief Executive told BusinessLine . The treatment is novel, in that it targets the cause of the disease, unlike drugs that treat the symptoms, he explained.

Stempeutics is part of the Manipal Education and Medical Group and drugmaker Cipla entered into a joint alliance with it in 2009.

Six regions including the US, Europe, Australia, New Zealand, and Singapore have granted similar patents on the product, he said. The company expects to get regulatory approvals in India to make and market the product by March 2016, he indicated.

CLI is a progressive form of peripheral arterial disease that blocks arteries in the lower extremities, resulting in reduced blood flow and causing severe pain in the feet or toes. If left untreated, the last option is often amputation, the company said.

In China too, the most common current treatments for CLI were characterised by high rates of primary amputations, multiple procedures, and high rates of procedure-related complications, the company said, affecting patients economically as well.


Though commercialisation in India and other markets is still 12–24 months away, Stempeutics is gearing up for it.

Stempeucel is got from a specific type of stem cell taken from the healthy bone marrow of adult voluntary donors and banked in Manipal, he said. The company’s proprietary “pooling” approach allows manufacturing with minimum wastage of resources to make it cost-effective, the company said.

The samples for the clinical trials were made in India in technical collaboration with multinational Lonza, he said. The two are now exploring the requirements to scale up production, he added.

In India, Stempeutics will soon take a decision whether to work with a contract manufacturer or make the novel product at its new facility being set up in Bangalore. Accordingly, its investment would vary from $3 million to $5 million, respectively, he said. The Bangalore plant is expected to be up in 12 months.


For overseas distribution, Manohar said they would scout for large companies as partners. In India, the product would be marketed by Cipla. The advantage with making the product in India would be reduced prices for local patients, he indicated, where a vial for instance priced at $10,000 could cost $2,000 here.