“Time ripe for Indian stem cells industry to regenerate its strength”

Mr B N Manohar, Chief Executive Officer, Stempeutics dismisses the claims that Indian stem cells industry hasn’t achieved much and is at the verge of fading out. In an exclusive interaction with the BioVoice News, Mr Manohar shared his deep insights on the latest trends in the stem cell industry as well as his company. Read the detailed interview below:

Critics say that the stem cell industry has failed to take off and this is the beginning of its end in India.  Do you consider this as a realistic assessment? What opportunities and trends do you see in Indian stem cell industry?

We believe stem cell industry in India is pointing up. World’s first stem cell drug “Prochymal® approved in Canada in 2012 took 20 years for the product development. Compared to that, the progress made by a decade old Indian stem cell industry is commendable.  Thanks to Ministry of Health, recently Drug Controller General of India (DCGI) has given marketing authorization for three new drugs in the stem cell therapy area. Stempeutics’ has received manufacturing and marketing authorization (Form 46) for its flagship product, Stempeucel® for the treatment of Critical Limb Ischemia due to Buerger’s (CLI) disease in March 2017. First allogeneic stem cell drug to be approved by DCGI and First allogenic stem cell product to be approved in the world for the treatment of CLI. This is a historic moment in India’s nascent drug development history. This Novel Treatment is a fruition of a decade of development work wholly done in India. This is truly a remarkable “Made in India” moment for the Indian biopharmaceutical industry.

This is just the beginning of product approvals for Indian stem cell industries and this will surely lead to many more product approvals soon. A few people who have embraced failure for a considerable period might have expressed their dismay in Indian stem cell industry, but it is truly the time to regenerate hope and show our strength in the global forum.

Do stem cells still hold the promise of future healthcare? Why aren’t we seeing more products off the shelves?

Yes. India is already seen as the world’s low cost pharmacy as far as conventional therapies are concerned and the recent economic and epidemiological changes present a lucrative opportunity for the Indian biotechnology industry to replicate this success in the field of novel and innovative healthcare therapies like stem cell therapies. The hope that stem-cell therapies will repair and regenerate diseased organs and tissue “goes beyond what pills and scalpels can ever do.” We believe that Stem cells would be a major branch of medical treatments and would be a standard of cure and practice in the years to come. Stem Cells will be available as off-the-shelf product soon for treating various unmet medical needs.

As we mentioned earlier, the DCGI has approved three products recently. Stempeucel® will be available off the shelves in 2018. The average product development period for the novel therapeutics is about 10-15 years, so we are just in the cusp of witnessing more product approvals soon in India. We will see at least five new products on the shelves in the next two to three years’ time.

“The average product development period for the novel therapeutics is about 10-15 years, so we are just in the cusp of witnessing more product approvals soon in India. We will see at least five new products on the shelves in the next two to three years’ time”

The DCGI’s limited approval to Stempeucel® in 2016 is being seen as a boost to the company. What has been the progress so far?

As mentioned earlier, we have received manufacturing and marketing approval in Form 46 from DCGI this year. This is a historic moment in the world of drug discovery in India with DCGI granting marketing approval to Stempeucel®-India’s FIRST biologic drug made using stem cells. This is the key mile stone achieved by Stempeutics in the last 10 years. The company has successfully put India on the global map for cutting edge drug discovery in the area as Stempeucel® is only the 4th off-the-shelf stem cell product to be approved by a regulatory body, anywhere in the world- others being Cartistem (Korea), Prochymal (Canada), Temcell (Japan).

With Stempeucel® declared as new drug by the regulatory body for treating CLI -> Stempeucel® injection will be covered under medical insurance. Also, the drug will be eligible for exports. We are looking for a strategic pharma partner in India to market the product for CLI treatment in 2017. Stempeutics uses a novel patented technology in the manufacture of Stempeucel® that has many advantages over other stem cell based products.

Stempeutics has also published Phase 1 data in Journal of Translational Medicine, Phase 2 data in Stem Cell Translational Medicine and CLI potency paper in Stem Cell Research Therapy journal.

Please tell us about the latest activities in terms of new research and product development at Stempeutics?

Stempuetics is working on two more innovative products. The second innovative product being developed by is Stempeucare® range of cosmetics. It is developed from adult stem cells derived Growth Factors/Cytokines cocktail for various derma applications including rejuvenation of aging skin, hair fall control and hair growth, under eye cream etc. First product which has gone to the market is an intensive firming skin care cosmetic product, branded as Cutisera™. Cutisera™ product has 5 distinct benefits i.e. (1) reduction of lines and wrinkles (2) lightning of dark spots (3) evenness of skin tone (4) improvement in skin firmness (5) improvement in skin hydration. It has been launched in India through partnership with Cipla in January, 2016.

Other products in the pipe line are (a) Trichosera for Hair application and (b) Optisera for under eye application. Stempeutics is looking for strong, strategic partner to market these innovative products developed from Growth Factors/Cytokines secreted by adult stem cells

The third product Stempeutics is developing is Stempeutron™ medical device. It is a point-of-care, closed system, automated medical device for the isolation of stromal vascular fraction (SVF) cells from human adipose tissue for addressing the need in the broad field of regenerative medicine. Stempeutron™ is the first product to use novel robotic and filtration technology to isolate clinical grade SVF from adipose tissue. SVF has broad clinical utility in regenerative medicine for repair of diseased organs as well as in plastic and reconstructive surgery. The device is under development.

“The main regulatory challenges facing us is harmonization of guidelines on stem cells by different regulatory agencies in our country. It becomes difficult to follow each and every guideline as they are different from each other in several aspects”

How do you look at the policy and regulatory environment in India? What are the challenges?

The regulatory environment is evolving in our country. There are existing National Stem Cell Guidelines by Indian Council for Medical Research (ICMR) and the Guidance Document for Regulatory Approvals of Stem Cell and Cell Based Products (SCCPs) by CDSCO. Both these documents are in the process of revision and we hope that the revised document will be available this year.

We need to appreciate the efforts taken by DCGI and ICMR in this area. But the main regulatory challenges facing us is harmonization of guidelines on stem cells by different regulatory agencies in our country. It becomes difficult to follow each guideline as they are different from each other in several aspects. These guidelines should be harmonized. Also, these guidelines should be converted to legislation so that unethical use of stem cells which is prevailing in our country can be curbed. Other challenges in the field are lack of trained manpower, keeping pace with technological advancement and getting funding from external agencies in this niche area of development.

What are the key goals of the company in next five years?

Our key business goals for the next five years includes establishing strategic alliance with pharma companies in India and out-license Stempeucel® drug for key indications addressing unmet medical needs and generate significant revenue. Apart from that we also aim to work on globalizing Stempeucel® drug in key markets like US and Europe.  For that get necessary regulatory approvals from FDA & EMA. Also, it is important for us to generate significant revenue through Stempeucare® range of cosmetics products in India besides complete Stempeutron™ device development and commercialization in India. Our long term vision is to make the Stempeutics a significant player in the area of stem cells in Asia.