Sun Pharmaceutical Industries Limited announced that one of its wholly-owned subsidiaries has entered into a license agreement with Pharmazz Inc., (Pharmazz), a U.S. based biopharmaceutical company to commercialise a first-in-class innovative drug, Tyvalzi™ (Sovateltide) in India. Developed by Pharmazz for potential global use, Sovateltide is indicated for treating cerebral ischemic stroke.

As per agreement terms, Sun Pharma is granted rights for marketing Sovateltide in India under the brand name Tyvalzi™ (Sovateltide). Pharmazz will be entitled to upfront and milestone payments, including royalties.

Kirti Ganorkar, CEO – India Business, Sun Pharma said, “The Phase 3 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 which 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.”

Dr. B. S. Paul, a leading neuro-physician at Dayanand Medical College & 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, the 2nd leading cause of mortality & 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. 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. I believe that Sovateltide (TyvalziTM) is an exciting new, approved, effective, and well-tolerated therapy for treating cerebral ischemic stroke patients. "

Dr. Prof. Anil Gulati, M.D., Ph.D., inventor, CEO, and Chairman of the Board of Directors of Pharmazz, said: "It is a significant step for Pharmazz to partner with Sun Pharma, the largest pharmaceutical company in India. For patients with cerebral ischemic stroke, I believe Sun Pharma is the best partner for Pharmazz to market TyvalziTM (Sovateltide), an innovative, first-in-class novel treatment for cerebral ischemic stroke, in India."

The global burden of disease project1 estimated the number of incident cases of stroke in India to be 1,175,778. In India, studies estimate that the incidence of stroke population varies from 116 to 163 per 100,000 population2. Stroke is the fourth leading cause of death and the fifth leading cause of disability3 in India. By 2050, more than 80% of the predicted global burden of new strokes of 15 million will occur in low and middle-income countries.

Sun Pharmaceutical is the owner of the brand name Tyvalzi™.