After nine years in the works and 15 months to get regulatory approvals in India, Stempeutics is set for a limited rollout of its regenerative medicine Stempeucel, touted to be a milestone for the company and science in the country.

It is an inflection point for the biotech industry, BN Manohar, Stempeutics Chief Executive told BusinessLine , after the company got a limited approval from the Drug Controller General of India (DCGI) to sell its cell-based therapy.

Stempeutics is part of the Manipal Education and Medical Group, and drugmaker Cipla entered into a joint alliance with it in 2009. Its product Stempeucel is the fifth off-the-shelf stemcell product to be approved in the world, the company says.

The product is made from stemcells taken from healthy volunteers and is used to treat Critical Limb Ischemia due to Buerger’s disease — where blood supply to the lower extremities of the body is cut off. This happens due to smoking or fatty deposits and so on and is characterised by severe pain and ulcers, leading often to amputation, company representatives explained.

The regenerative properties of the product helps develop new blood vessels and improve blood flow, Manohar says, adding that it is an unmet medical need. The product has potential in conditions like the diabetes foot, he indicated.

Clinical trials It is an “orphan drug” indication, which means the illness prevalence may be low, with no product to treat it. The limited approval, a first time where the Government has okayed a product after Phase II trials (to check safety and efficacy) would mean it needs to be given to 200 more people. Full approvals should be by 2018, Manohar says.

Commending the DCGI’s “bold decision” to give a limited approval on this new biological entity, he said, it has taken nine years from bench to bedside. Even the first phase of clinical trials (the products first exposure to humans) was done in India.

Coming at a time when clinical trials are viewed with suspicion, Manohar agrees it was a “struggle” but they worked with the regulator, and gradually, the guidelines for stemcell and cell-based therapies were also put into place. Explaining the process, Manohar says that healthy volunteers are put through a battery of tests, 29 to be precise, to check for infectious diseases etc. Stempeutics’ “unique” technology helps isolate the particular cells they are looking for, culture them and scale up, he says, adding that three donors contribute about one million dozes or vials.

Stempeutics is evaluating whether it would make the product on its own or tie-up with contract producers like Syngene, he said.  

Cipla’s new ventures  Sharing Manohar’s optimism on the product, Cipla’s head of New Ventures, Chandru Chawla, said this was the second product from the venture, the first being cosmetic anti-ageing product Cutisera, a year ago.

“But this one’s a drug, a one-time injection,” he said, that has shown in 110 patients that it significantly reduces the pain and improves the ability to walk in the stated medical condition. With the roll-out still being “work in progress,” there was no clarity on the product pricing.

 Stempeutics officials have in the past indicated that it would be sold at about $2000.

The product requires several skills to take it global, said Chawla, adding that they were looking at partnerships for distribution in different markets and intelligent capital to grow it further.  

Other investments from Cipla’s new ventures, include the US-based Chase Pharmaceuticals, whose product targeting Alzheimer’s is entering Phase III trials, he said.

Cipla’s biotech venture is also looking at new partnerships and to raise capital, he indicated. In fact, the company’s consumer care business, incubated under New Ventures had taken a similar path and attracted investments last year from the Fidelity Growth Partners. The health tech space was another segment the company was watching, Chawla said, of an area getting much attention from other pharma big-guns, including Dr Reddy’s Laboratories.

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