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Indian biotech firm Stempeutics Research gets China Patent for its novel stem cell drug

The Economic Times:  April, 2015

Bengaluru: Bengaluru-based Stempeutics Research has been granted a process patent for its stem-cell based drug Stempeucel by the State Intellectual Property Office of the People's Republic of China. Stempeutics said it has become the first company in the world to be granted a patent by the Chinese patent office.

Backed by the Manipal Education and Medical Group and drug maker Cipla, Stempeutics makes stem cell-based drugs or regenerative medicine. It enables living, functional tissues to repair or replace tissue or organ function lost due to age, disease, damage or congenital defects.

The company said the drug will initially be used for the treatment of Critical Limb Ischemia (CLI) as it directly addresses the root cause of the disease, unlike other drugs which typically treat the symptoms and not the disease itself.

"China is a huge opportunity. There are lot of smokers in China who suffer from peripheral artery disease," said B N Manohar, chief executive of Stempeutics. "In India alone we have about one crore patients suffering from Critical Limb Ischemia."

About 20% of elderly urban Chinese suffer from peripheral arterial disease and the prevalence in women is substantially higher than in men. CLI is a progressive form of peripheral arterial disease, which blocks the arteries in the lower extremities, resulting into reduction of the blood flow.

Insufficient supply of blood flow results into the development of sores and wounds in legs and feet and severe pain. If left untreated, patients may finally have to undergo amputation of the affected limb.

In March, Stempeutics was granted a US process patent for its stem-cell based drug Stempeucel by the United States Patent and Trademarks Office. Till now it has invested about Rs 180 crore on the research and development of the drug. The company plans to generate revenues for the first time by selling the drug in India this year and in China in next 24 months. It has already submitted its applications to Drug Controller General of India (DCGI) to obtain marketing authorisation approval for Stempeucel and is waiting for the approvals.

"We are also looking for global strategic partners, as we don't have financial muscle power to do clinical trials in Europe and US," said Manohar whose small company competes with big US companies like Athersys and Mesoblast and Israel's Pluristem Therapeutics