Stempeutics out licenses its novel stem cell product “Stempeucel-DFU”

by Shrutee K/DNS

Diabetic foot is one of the most significant and devastating complications of diabetes

Out of approx. 70 million diabetics in India, 25% develop DFUs, of which 50% contact infection and require hospitalization while 20% undergo amputation

Evidence from published literature shows 100,000 leg amputations/year due to diabetes related problems & an expense of approx. Rs 1.40 Lakhs for complete treatment of DFUs

Stempeucel-DFU - a stem cell therapy product, promises significant therapeutic effect due to its strong angiogenic and anti-inflammatory properties

DCGI has approved the conduct of Phase 3 clinical trial

Bengaluru, September 16, 2019: Stempeutics Research, a group company of Manipal Education and Medical Group (MEMG), announced that it has signed an out-licensing deal with Cipla for Stempeucel-DFU product for Diabetic Foot Ulcer indication. Out-licensing deal comprises of upfront payment and various milestones based payments. Under this agreement, Cipla will get the exclusive marketing rights for five years in India for DFU product with Stempeutics manufacturing & supplying the product to Cipla. The product is expected to be available in Indian market in the beginning of 2021 after undergoing the Phase 3 Clinical trial in India, which is expected to commence in October 2019.

Commenting on the tie up with Stempeutics Mr Nikhil Chopra, Head, Cipla India Business said, “We are pleased to partner with Stempeutics in bringing the next generation of biologics to address unmet medical needs in India. DFU is a serious condition that requires immediate treatment to re-establish blood-flow to the affected area to prevent the leg from amputation. Stempeucel-DFU offers a novel treatment approach to the physicians in India to treat DFU andwill substantially improve the quality of life of thousands of patients suffering from this painful disease.”

Mr BN Manohar, CEO of Stempeutics said, “We are extremely happy to collaborate with Cipla in developing cell therapy product for non-healing DFU. DCGI approved Phase 3 clinical trial is a placebo controlled, double blind study consisting of 84 patients. Study will be conducted across India consisting of 17 hospitals. To show the effect of Stempeucel-DFU product, only patients not getting cured with the existing standard of care will be included in the clinical trial. Stempeucel-DFU will be injected in and around the wound bed, in order to accentuate the healing process.”

Speaking on the Stempeucel-DFU product, Dr Pawan Gupta, Senior Vice President, Medical and Regulatory Affairs, Stempeutics, said “Current standard of care for treating non-healing diabetic ulcer includes local wound care with sterile dressings, repeated debridement of necrotic tissues, and pressure off- loading. However, most resulare far from satisfactory, and about 20% of patients with DFU undergo limb amputation. Since DFU is a complex clinical condition, current approaches endeavour to address one single approach, which leads to the failure of complete healing. Cell therapy-based approaches have several advantages compared to others, as it allows therapeutic targeting of different phases of wound healing. Multiple mechanisms of action of these cells can address both cellular and growth factor defects in the non-healing wounds.”

About Non-Healing Diabetic Foot Ulcer (DFU): DFU is a non-healing or poorly healing full-thickness wound, through the dermis, below the ankle in an individual with diabetes. One of the major reasons for chronic diabetic wound is due to faulty wound healing process, whereas a normal wound healing involves an orchestrated interplay between connective tissue formation, cellular activity, and growth factor activation. Alterations in the above physiological activities result in nonhealing ulcers. A few recent studies have investigated these physiological alterations to understand wound healing abnormalities in diabetes. Some of the underlying reasons are (a) decreased secretion of collagen resulting in chronic connective tissue complications and delayed wound healing, (b) impaired cellular activity due to hyperglycemia resulting in the transformation of macrophages and decreased proliferation of keratinocytes, and (c) altered secretion or absence of key growth factors in diabetic wound, impairing the wound healing process .

About Stempeutics: Stempeutics is an advanced clinical stage Biotech Company based out of Bangalore. It was founded by Manipal Education and Medical Group (MEMG) in 2006 and later entered into strategic alliances with Cipla in 2009 and with Kemwell in 2019. Stempeutics strength lies in developing innovative stem cell products by nurturing cutting edge research and clinical applications through dedicated efforts of its highly qualified team. Its goal is to develop novel stem cell drugs addressing major unmet medical needs with an India first global next approach.

About Cipla Limited: Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in our home markets of India, South Africa, North America, and key regulated and emerging markets. Our strengths in the respiratory, anti- retroviral, urology, cardiology, anti-infective and CNS segments are well-known. Our 46 manufacturing sites around the world produce 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to our 80+ markets. Cipla is ranked 3rd largest in pharma in India (IQVIA MAT June’19), 3rd largest in the pharma private market in South Africa (IQVIA MAT June’19). For over eight decades, making a difference to patients has inspired every aspect of Cipla’s work. Our paradigm changing offer of a triple anti-retroviral therapy in HIV/AIDS at less than a dollar a day in Africa in 2001 is widely acknowledged as having contributed to bringing inclusiveness, accessibility and affordability to the centre of the HIV movement. A responsible corporate citizen, Cipla’s humanitarian approach to healthcare in pursuit of its purpose of ‘Caring for Life’ and deep-rooted community links wherever it is present make it a partner of choice to global health bodies, peers and all stakeholders. For more, please visit www.cipla.com.