Recently, Stempeutics observed the First Stem Cell Awareness Day in India with a public event to explain stem cell therapy options and sought to dispel misconceptions about the use of stem cells as therapy. M Neelam Kachhap spoke to BN Manohar, CEO, Stempeutics to know more about its novel products and business plans
How is the partnership with Cipla shaping up?
Stempeutics had entered into strategic alliance with Cipla for marketing its products in 2009. We are pleased with the partnership and hope that it will bear fruits soon. Cipla and Stempeutics were founded by great visionaries who have realised the potential of India to take on the world in healthcare and education. Both the organisations share common ideals and values of their founders.
Cipla brings to the table its expertise in terms of go to market strategies, marketing and sales. They also follow good manufacturing practices and lead us through the regulatory pathway. While we are very strong in basic science and research they bring expertise in other fields.
Can you throw some light on the recently received patent for your stem cell product?
We are the first company in the world to get a patent for pooled stem cell technology and process to make a novel stem cell entity called stempeucel. It is derived from allogeneic pooled mesenchymal stromal cells extracted from the bone marrow of healthy, adult voluntary donors. Our process has a unique advantage. Stem cells are already available, there is no innovation there. The innovation is in the new biological entity. We pool multiple donor cells to create the end product. It is the way in which we isolate and bank it and we are the only company that uses pooling technology. The company’s proprietary pooling approach allows an efficient manufacturing process with minimum wastage of resources in order to provide the product at an affordable cost to patients.
We can create more than a million patient doses from a single set of master cell banks which is unique in regenerative medicine. This means that life-cycle of our cells line is much longer than our competitors. We can produce a number of batches with consistent characteristics that are very critical for good therapeutic effect. Our product has better immuno-modulatory properties and broader array of cytokine production capacity. Our technology produces a unique investigational medicinal product (IMP) which is characterised using a variety of parameters necessary to establish the sterility, identity and potency of the product.
How is this pool of stem cells used? What are the indications it can be used for?
It can be used for a number of diseases but we have conducted trials and will market the product for Thromboangiitis obliterans and critical limb ischemia. Thromboangiitis obliterans is an autoimmune disorder with recurring progressive inflammation and thrombosis (clotting) of small and medium arteries and veins of the feet. It is strongly associated with use of tobacco products primarily from smoking, but also from smokeless tobacco. Patient experiences severe pain.
Critical limb ischemia (CLI) is a progressive form of peripheral arterial disease, which blocks the arteries in the lower extremities, resulting into reduction of the blood flow. Peripheral arterial disease is caused by atherosclerosis, the hardening and narrowing of the arteries over time due to the build-up of fatty deposits called plaque. It is a debilitating disease which affects patients with severe pain in the feet or toes. Insufficient supply of blood flow results into the development of sores and wounds in legs and feet. If left untreated, patients may finally have to undergo amputation of the affected limb as the last treatment option. In the US, most common current treatments for CLI are characterised by high rates of primary amputations, multiple procedures and high rates of procedure-related complications. In such cases, the disease not only affects the quality of life but also increases the economic burden of patients.
Stempeucel drug is expected to address the root cause of the disease through anti-inflammatory and immune-modulatory mechanisms. It is expected to induce angiogenesis through release of vascular endothelial growth factors, epithelial growth factors, angiopoietin and improve the perfusion and help the repair and regeneration of the ischemic muscle tissue.
Tell us about the clinical trial being conducted for this product.
We are at an advanced stage of a clinical trial for CLI. We have completed phase-2 trial and are going for phase-3. Being an unmet medical need or what we call orphan indication where no treatment is available to cure the disease, only symptomatic relief is provided, we have proposed our product to be used as investigational medicinal product (IMP). Stempeutics has already submitted its applications to Drug Controller General of India (DCGI) to obtain marketing authorisation approval for Stempeucel. The availability of the product in the market is subjected to DCGI approvals.
We have trial sites at12 hospitals across India. These include AIIMS, KEM, MS Ramaiah, CMC Vellore, PGI Chandigarh and Stanley Medical College, Chennai to name a few.
What are your plans for this product launch?
It will be launched first in India. India first, global next. Our motto is win locally, play globally. So, first we will make the drug available in India then only we will take it to other geographies.
Tell us about the investments into this product.
We have been spending money (investing) for the past nine years, so far investment of about Rs 200 crores has gone into the company through various stakeholders. We believe that by next year we will start earning as this drug goes to the market.
What is the size of Stempeutics today?
Stempeutics is based at two locations in India and has a manpower strength of 40. We have 65 patents filed, 8 granted, 62 peer review articles published. Our innovative stem cell product is patented in US, Australia, New Zealand, South Africa, Singapore and recently in China. The European Medicines Agency (EMA) has granted Advanced Therapy Medicinal Product classification for our novel stem cell drug ‘Stempeucel’ which will be used for the treatment of Thromboangiitis Obliterans (TAO) in the European Union. And hopefully we will have good news from DCGI soon.
So what does 2015 look like for you?
Well, we have put in a lot of hard work and I hope we can enjoy the fruits of our labour now. We believe that the benefit of regenerative medicine should go to the people. It is too premature to talk about the revenue for Stempeucel but there are a many patients suffering with CLI in India. The market is easily worth $100 million every year.
Tell us about your product pipeline.
For this product, we are looking at CLI as an indication, but besides this we are also looking at osteoarthritis, liver cirrhosis, etc. Since the drug is working on the vascular cite we are looking at expanding it for peripheral artery disease and most importantly, diabetic foot ulcer.
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