New Delhi: Biotech firm Stempeutics Research said it has inked an out-licensing deal with drug major Cipla for its stem cell therapy product Stempeucel, indicated for treating critical limb ischemia.
“Under this agreement, Cipla will get exclusive marketing rights for five years in India for critical limb ischemia due to atherosclerotic peripheral arterial disease (CLI-PAD) with Stempeutics manufacturing and supplying the product to Cipla,” the company said in a statement.
CLI-PAD is characterised by narrowing of arteries in the legs limiting blood flow to the muscles due to the build-up of fatty deposits called plaque, Stempeutics said.
“The product is expected to be available in the Indian market in the beginning of 2020 after undergoing the phase 3 clinical trial in India, which is expected to commence in 2018,” it added.
Stempeutics CEO BN Manohar said, “Although alternate treatments exist for CLI-PAD, only 50 percent of patients can be managed with contemporary vascular techniques, while satisfactory clinical outcomes are evident in about 25 percent of the patients,” Manohar said.
Stempeucel has significant potential to overcome limitations of traditional treatment approaches for CLI due to anti-inflammatory properties, ability to promote neovascularisation and promote healing of non-healing ischemic ulcers, he added.
Founded in 2006 by Manipal Education and Medical Group (MEMG), Stempeutics later entered into an alliance with Cipla in 2009. It is an advanced clinical stage biotech firm.