The agreement provides Sun Pharma with rights to commercialise Tyvalzi (Sovateltide) for the treatment of acute cerebral ischemic stroke, while Pharmazz will receive upfront and milestone payments, along with royalties
US-based biopharmaceutical company Pharmazz has signed a licence agreement with India’s Sun Pharmaceutical Industries to commercially launch its Tyvalzi (sovateltide) in India.
Developed by Pharmazz, Tyvalzi is indicated for the treatment of acute cerebral ischemic stroke, which may result in potential brain damage, neurological deficits, or death.
Under the terms of the agreement, the Indian drugmaker will obtain rights to commercialise sovateltide in India, under the brand name Tyvalzi (Sovateltide).
In exchange, Pharmazz will receive upfront and milestone payments, along with royalties.
Sun Pharma India business CEO Kirti Ganorkar 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.”
The acute cerebral ischemic stroke is caused due to the loss of blood supply to the brain, which prevents the supply of oxygen and nutrients to the brain tissue.
Tyvalzi is a selective endothelin B receptor agonist with a unique site of action, the neural progenitor cells, recently approved for treating cerebral ischemic stroke.
The neuronal progenitor cell therapy promotes neurovascular remodelling through neurogenesis, angiogenesis, and synaptogenesis, and also protects neural mitochondria.
In the clinical trials, Tyvalzi produced statistically significant and clinically meaningful improvements in neurological outcomes, as measured by the NIHSS, mRS, and BI scales.
Pharmazz CEO, inventor and board of directors chairman Anil Gulati 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 Tyvalzi (Sovateltide), an innovative, first-in-class novel treatment for cerebral ischemic stroke, in India.”