India’s first stem cell drug, called Stempeucel, is expected by its supplier to be on the market by the end of this year. Stempeucel is made from stem cells in the bone marrow and is manufactured by Stempeutics Research, a firm owned, in part, by Cipla Ltd. The drug is intended to treat Buerger’s Disease, a rare condition marked by a reduced blood flow to the limbs. About a million people in India are affected by this ailment.
“We are waiting for the conditional approval from the Drug Controller General of India (DCGI). Once the approval is in place, we are planning to launch the product in the Indian market”, said B.N. Manohar, Stempeutics managing director and chief executive officer.
According to Shine Jacob, writing for the publication Live Mint, the company is set to start phase III trials in the U.S. and Europe to prove the drug’s efficacy and determine its dosage. Stempeutics’ aim is to launch the product in Europe by 2018. It plans to seek permissions from the European regulator European Medicines Agency (EMA) to conduct a trial on 200 patients in Europe.
The EMA has already granted Stempeucel an orphan drug designation which means that no other drug is available for that disease and it is an unmet medical need. This development is expected, by its producers, to fast track its clearances. The company can get a 10-year market exclusivity if awarded an orphan drug status and clears trials. Out of the 18 countries in which Stempeutics has applied for patents, seven countries—the U.S., Australia, New Zealand, China, Japan, Singapore and South Africa—have granted the drug patents.
About 200, 000 people are estimated to suffer from Buerger’s Disease in the U.S. and Europe combined. Currently, only painkillers are used to treat the condition, in which the patient’s blood vessels become inflamed, and blocked with blood clots. Manohar said, “Currently, there is no drug available in the world for this treatment. Stempeucel’s second phase clinical trial was the largest one in the world for Buerger’s Disease.” According to Manohar, about 90 patients involved in this trial across 11 hospitals saw pain reduction, increased blood flow and ulcer reduction.
According to the company, it is also set to start phase II trials in India for using Stempeucel for diabetic foot ulcers. Since the drug has already passed safety trials for Buerger’s Disease, it can directly start Phase II trials for diabetic foot ulcer.
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