Sun Pharma secures marketing rights for stroke drug Tyvalzi from Pharmazz

Sun Pharmaceutical Industries Limited has entered into a license agreement with U.S.-based biopharmaceutical company Pharmazz Inc. for the commercialization of the first-in-class innovative drug, Tyvalzi (Sovateltide), in India. The deal terms include undisclosed upfront and milestone payments, as well as royalties to Pharmazz. Sovateltide is indicated for treating cerebral ischemic stroke and has recently been approved for the condition.

Tyvalzi’s Role in Advancing Stroke Treatment in India

Tyvalzi, known as Sovateltide in its developmental phase, is a revolutionary drug aimed at treating cerebral ischemic stroke, a condition characterized by the sudden loss of blood flow to the brain, leading to potential brain damage or death. According to Kirti Ganorkar, CEO – India Business, Sun Pharma, “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 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.”

Clinical Insights into Tyvalzi (Sovateltide) for Stroke Treatment

Dr. B. S. Paul, a neuro-physician at Dayanand Medical College & Hospital who was part of the clinical trials, elaborated on Tyvalzi’s efficacy. He said, “Sovateltide (Tyvalzi) produced statistically significant and clinically meaningful improvements in neurological outcomes at 90 days post-treatment in clinical trials. Sovateltide (Tyvalzi) is a neuronal progenitor cell therapy that promotes neurogenesis, angiogenesis, and synaptogenesis, thereby inducing neurovascular remodeling. I believe that Sovateltide (Tyvalzi) is an exciting new, approved, effective, and well-tolerated therapy for treating cerebral ischemic stroke patients.”

What Makes Tyvalzi a Unique Treatment for Cerebral Ischemic Stroke?

Unlike other treatments, Tyvalzi’s unique mechanism of action targets neural progenitor cells. The drug induces neurovascular remodeling by forming new neurons (neurogenesis) and blood vessels (angiogenesis). It also protects neural mitochondria and enhances their biogenesis, making it a potentially transformative treatment for stroke patients. The licensing of Tyvalzi to Sun Pharma is seen as a significant step toward providing more comprehensive and effective stroke treatment options in India.