Founded on the vision of ethically and scientifically exploring the full potential of stem cells for transforming medicine and offering new hope to millions of people, Stempeutics Research Pvt. Ltd. is striving ceaselessly on its path towards developing innovative stem cell products that address prominent unmet medical needs with an ‘India first, global next’ approach.
Stempeutics, founded by the Manipal Group in 2006, is a late stage life science company focused on developing and commercializing novel therapeutics based on adult stem cells. Stempeutics’ strength lies in developing innovative stem cell based products by nurturing cutting edge research and clinical applications through dedicated efforts of its highly qualified team. Scientists working at Stempeutics have filed over 65 patents and have published over 75 peer reviewed international publications.
The company’s flagship product, Stempeucel® drug, is an on-demand, off-the-shelf product based on pooled, allogeneic Mesenchymal Stromal Cells (MSC) derived from bone marrow of healthy, adult volunteers.
Research conducted at Stempeutics has shown that pooling technology balances out variations observed with individual donor cells, resulting in a product with strong immune-modulatory properties, broader cytokine/growth factors array, longer lifespan, and consistent clinical outcomes.
Stempeucel® is being developed for the treatment of Critical Limb Ischemia (CLI), Osteoarthritis (OA), Diabetic Foot Ulcer (DFU), Perianal Fistula (PAF) and Acute Respiratory Distress Syndrome (ARDS) due to COVID-19 pneumonia.
In August 2020, Drug Controller General of India (DCGI) granted the manufacturing and marketing approval of Stempeucel® product for the treatment of CLI. Stempeucel® thus became the first allogeneic cell therapy product to be approved for commercial use in India and the first stem cell product to be approved globally for CLI indication.
Stempeucel® has been licensed to Cipla for CLI & DFU indication and to Alkem Labs for OA indication for the India territory. Stempeucel® has strong patent protection with 18 patent applications filed across the globe out of which 16 have been granted.
The core Stempeucel® patent has been granted in USA, Australia, New Zealand, South Africa, Japan, China, Singapore, UK, France, Germany, Italy, and Philippines. Stempeucel® has been classified as an ATMP product by EMA and designated as an Orphan Drug for the treatment of CLI due to Buerger’s Disease.
Stempeutics’ proprietary pooling approach provides for an efficient manufacturing process thereby enabling the products to be made accessible to patients at an affordable cost. More than one million doses can be produced from a single set of master cell banks, which is unique in regenerative medicine, thus providing consistent product to patients. The proprietary technology also helps Stempeucel® extend the therapeutic potential of the drug across multiple disease categories.
In Critical Limb Ischemia, Stempeucel® directly addresses the root cause of the disease by reducing inflammation, stimulating growth of collateral blood vessels, and repairing damaged muscle, thereby reducing the pain, healing the ulcers, and salvaging the affected limb.
“Our company strongly believes in ‘Science Driving the Business’. While there are many companies around the world focusing on ‘Mesenchymal Stromal Cells’, the stem-cell technology platform what we have adopted is unique and novel for the development of treatment for immune-mediated and inflammatory diseases,” says Mr. BN Manohar – the MD and CEO of Stempeutics Research.
Mr. Manohar has transformed Stempeutics – a life science start-up from R&D to commercialization stage with Global recognition. Under Manohar’s leadership Stempeutics has been recognized as India’s hottest startup by Business Today in 2008 and Karnataka Government bestowed “Emerging Company of the Year Award” in 2011 and 2013.
In 2017 Manohar was awarded “Biotechnologist of the Year” award by Wockhardt Foundation, India. He raised US$ 10M in 2009 by establishing strategic alliance with Cipla and US$ 13M in 2019 by establishing strategic alliance with Kemwell Biopharma.
Stempeutics Research believes that 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 that include biopharmaceuticals, vaccines, and regenerative medicine etc.
“In 2021 Union Budget, Kiran Mazumdar-Shaw, is seeking measures that can help India transition from being a volume player to being a substantial value player in the global market. She has also sought ways to incentivize investments for start-ups and to support risk capital,” comments Mr. Manohar.
To catch up to these significant opportunities, Stempeutics’ growth objectives for the next few years include:
- Revenue generation in India and Exports: Commercialization of Stempeucel® cell therapy product for three key indications – Critical Limb Ischemia in 2021, Knee Osteoarthritis in 2021 and non-healing Diabetic Foot Ulcer in 2022
- Expansion to other countries where Indian regulatory approval is accepted.
- Globalizing Stempeucel® product for a select indication. Cross key regulatory milestones in Japan (PMDA), EU (EMA) & US (FDA) for commercializing Stempeucel® product for the select indication.
- Scaling Commercial manufacturing with 3D technology and make the product affordable in India.