India’s first stem cell drug Stempeucel to hit market by fiscal end4 min read . Updated: 13 Nov 2015, 11:10 PM IST
Drug, made by Stempeutics Research, a firm part-owned by Cipla, will treat Buerger's Disease, a rare condition of reduced blood flow to limbs
New Delhi: India’s first stem cell drug Stempeucel could be in the market by the end of the financial year. The drug, made by Stempeutics Research, a firm part-owned by Cipla Ltd, will treat Buerger’s Disease, a rare condition of reduced blood flow to limbs that affects a million people in the country.
“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 by the end of this financial year," Stempeutics managing director and chief executive officer B.N. Manohar said.
Stempeucel is made from stem cells in the bone marrow. Stem cell therapies are a developing branch of medicine and clinical trials have proven their utility in repairing tissues.
The company is set to start its phase three trials in the US and Europe. While phase one is to prove safety, phases two and three are to prove the drug’s efficacy and determine its dosage. Stempeutics’ aim is to launch the product in Europe by 2018. It will soon seek permissions from the European regulator European Medicines Agency (EMA) to conduct a trial on 200 patients in that continent. The EMA has already granted an orphan drug designation (which means that no other drug is available for that disease and it is an unmet medical need) for Stempeucel, which is expected to fast track its clearances. The company can get a 10-year market exclusivity if awarded an orphan drug status and clears trials.
Stempeutics is also looking for strategic partners to conduct its trials in Europe. Out of the 18 countries in which Stempeutics has applied for patents, seven countries—the US, Australia, New Zealand, China, Japan, Singapore and South Africa—have so far granted patents for Stempeucel.
About 200,000 people are estimated to suffer from Buerger’s Disease in the US and Europe put together. Currently, only painkillers are used to treat the disease, in which the patient’s blood vessels become inflamed, and can become blocked with blood clots.
According to Chandru Chawla, head of Cipla New Ventures, “Stempeutics is well-positioned in niche areas like Buerger’s Disease, where there are clear unmet medical needs and conventional options (for treatment) do not exist. Limb amputation is often the only option Buerger’s Disease."
“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. About 90 patients involved in this trial across 11 hospitals saw pain reduction, increased blood flow and ulcer reduction," Manohar added.
Stempeutics was founded in 2006 by Manipal Education and Medical Group. Cipla joined in 2009 with an investment of ₹ 50 crore. Manipal Group owns 51% in Stempeutics and the remaining 49% is owned by Cipla.
“This is going to replace conventional medicines as it can be a more safe and advanced alternative," said Sarabjit Kour Nangra, vice president, research, pharma, at Angel Broking. “The cost of these medicines will be higher. Moreover, technology and manufacturing process will take time to settle and get popular," she added.
The company is also set to start phase II trials in India for using Stempeucel for diabetic foot ulcer. Some people with diabetes develop foot ulcers. A foot ulcer is prone to infection. Since the same drug has already passed safey trials for Buerger’s Disease, it can directly start Phase II trials for diabetic foot ulcer, the company said. Stempeutics has already spent around ₹ 200 crore for research on this medicine.
One potential side effect of drugs made from stem cells is that if embryonic cells (from human embryos) are used to produce those drugs, it may cause tumour.
Stempeutics says it doesn’t use embryonic cells. Instead, it uses mesenchymal stem cells (multipotent stromal cells that can differentiate into a variety of cell types, including bone cells, cartilage cells, muscle cells and fat cells).
The safety of embryonic and mesenchymal stem cells depend on the dosage used, says Polani B. Seshagiri, a professor at the Indian Institute of Science (Bengaluru).
A Cipla spokesperson said the company expects rapid penetration of the stem cell medicine in the market. “Our products will be allogenic stem cell based products and like any off-the-shelf injectable product, will be for in clinic use. Our vast network into ‘critical care’ segment will ensure rapid penetration."
Some of the top global stem cell drugs are made by Asian companies: Australia’s Mesoblast Ltd. makes Prochymal, a drug used in acute graft versus host disease (a common complication following an allogeneic tissue transplant) and Korean company Medipost Co. Ltd makes Cartistem used to treat knee cartilage defects.
Meanwhile, Stempeutics is also planning to launch an innovative stem cell medical device ‘Stempeutron’ in India by the middle of next year. The device can obtain a population of cells collectively known as the stromal vascular fraction (SVF) from fat tissues, to be used for treatment of osteoarthritis and diabetic foot ulcer. “The device, which will be priced at $50,000 is likely to be launched in August," Manohar added.