Sun Pharmaceutical has entered into a licence agreement with US-based Pharmazz Inc to commercialise Tyvalzi (Sovateltide), in India.

Developed by Pharmazz, Sovateltide is indicated for treating cerebral ischemic stroke. Sun Pharma has been granted rights for marketing Sovateltide in India under the brand name Tyvalzi (Sovateltide) and Pharmazz will be entitled to upfront and milestone payments, including royalties, a note from Sun Pharma said.

Kirti Ganorkar, Sun Pharma’s Chief Executive (India Business), 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 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.”

New therapies

BS Paul, a neuro-physician at Ludhiana’s Dayanand Medical College & Hospital, who was a part of the clinical trials on the drug, added that there was a need for  new therapies to treat stroke, the second leading cause of mortality and  morbidity worldwide. In India, studies estimate the incidence of stroke to vary from 116 to 163 per 100,000 population, the note said.

Pharmazz is a privately held company that develops novel products in critical care medicine. It obtained marketing authorization for two of its first-in-class drug molecules, Centhaquine and Sovateltide, for hypovolemic shock and ischemic stroke, respectively, in India.