Mumbai: Sun Pharma, including its subsidiary companies, announced today that one of its wholly-owned subsidiaries has entered into a licensing agreement with Pharmazz Inc., a biopharmaceutical firm based in the United States. The purpose of this agreement is to facilitate the commercialization of an innovative drug called Tyvalzi™ (Sovateltide) in the Indian market. Sovateltide, developed by Pharmazz with potential global applications, is designed for the treatment of cerebral ischemic stroke.
Under the terms of the agreement, Sun Pharma has been granted the rights to market Sovateltide in India using the brand name Tyvalzi™ (Sovateltide). In return, Pharmazz will receive upfront payments, milestone payments, and royalties as stipulated in the agreement.
Kirti Ganorkar, CEO, India Business, Sun Pharma said, “The Phase III clinical trial for Tyvalzi™ conducted in India demonstrated statistically and clinically meaningful improvement in neurological outcomes in ischemic stroke. Tyvalzi™ is a first-in-class innovative drug that can help improve the quality of life of stroke patients. The drug can be administered within 24 hours for the treatment of ischemic stroke. The current treatment options provide a narrow time window of 4-5 hours limiting its use in most patients.”
The Global Burden of Disease Project’s research revealed that India had an estimated 1,175,778 incident cases of stroke. Studies conducted in India suggest that the incidence of stroke within the population ranges from 116 to 163 per 100,000 individuals. Stroke ranks as the fourth leading cause of death and the fifth leading cause of disability in the country. Projections indicate that by the year 2050, over 80 per cent of the anticipated global increase in new stroke cases, totaling 15 million, will occur in low and middle-income nations. The brand name Tyvalzi™ is owned by Sun Pharmaceutical.
Dr B S Paul, neuro-physician, Dayanand Medical College and Hospital, Ludhiana, who was a part of the clinical trials of Tyvalzi™ (Sovateltide), said, “No new drug other than rTPA has been approved for the treatment of stroke for more than two decades. The narrow time window of rTPA of 4.5 hours limits its use in a vast majority of patients with cerebral ischemic stroke. There is an urgent need for new therapies to treat stroke. As it is the second leading cause of mortality and morbidity worldwide. Sovateltide (TyvalziTM), a selective endothelin B receptor agonist, a new first-in-class drug recently approved for treating cerebral ischemic stroke, can be administered up to 24 hours post cerebral ischemic stroke.”Dr Paul also stated that Sovateltide (TyvalziTM) produced statistically significant and clinically meaningful improvements in neurological outcomes at 90 days post-treatment in clinical trials as measured by the NIHSS, mRS, and B.I. scales. Sovateltide (TyvalziTM) is a neuronal progenitor cell therapy that promotes neurogenesis, angiogenesis, and synaptogenesis, thereby inducing neurovascular remodeling.