Banglaore-based Stempeutics Research, a group company of Manipal Education and Medical Group (MEMG), has signed an out-licensing deal with Alkem Laboratories, Mumbai for a potential osteoarthritis knee therapy Stempeucel.
The product, which will undergo Phase 3 clinical trials in India soon is expected to be made available in the market by 2020. The out licensing deal comprises of upfront payment, royalties and various regulatory and sales based milestones payments. Alkem will get the exclusive marketing rights for Stempeucel in India for Osteoarthritis, once the approval process is over.
"We are pleased to be associated with Stempeutics and the Manipal Group in bringing the next generation of biologics to address unmet medical needs in India. Stempeucel offers a novel treatment approach to the physicians in India to treat Osteoarthritis and will substantially improve the quality of life of millions of patients suffering from this painful disease", Sandeep Singh, MD, Alkem said.
Osteoarthritis is a common and debilitating chronic degenerative disease of large joints, especially the hip and knee, characterized by a loss of articular cartilage, subchondral sclerosis, and marginal osteophyte formation. Worldwide, approximately 9.6% of men and 18% of women aged ?60 years have symptomatic osteoarthritis.
Stempeutics has successfully completed a Phase 2 clinical trial in India and the outcomes have been published in the peer-reviewed indexed journal Arthritis Research & Therapy, UK. The Phase 2 trial data showed that a single intra articular injection of Stempeucel with 25 million cell dose was well tolerated and had positive effects on long term pain reduction and overall improvement in WOMAC scores which measures Pain, Stiffness and Physical Function of the patient, the company claimed.
According to BN Manohar, CEO of Stempeutics, Stempeucel drug has a potential to address the root cause of the disease. "In Phase III trial we are going to administer Stempeucel using ultrasound guidance and use new MRI techniques called T2 mapping to assess the quality of articular cartilage and also to assess the quantitative analyses of articular cartilage. We are extremely happy to collaborate with Alkem in developing Stempeucel for OA treatment", he said.
Allogeneic Stem Cell therapy currently dominates the Global Stem Cells Market with a share of almost 63% compared to the autologous market (37%). The potential for stem cell therapy market in India is about $ 540 million and expected to grow rapidly, states the company.