Global pharma giant Sun Pharmaceutical Industries Limited announced on Thursday that it had entered into a licence agreement with American biopharmaceutical company Pharmazz Inc to commercialise an innovative drug, Tyvalzi (Sovateltide) in India.
Sovateltide, developed by Pharmazz for potential global use, is intended for treating cerebral ischemic stroke. Under the agreement, Sun Pharma obtained the rights to market Sovateltide in India under the brand name Tyvalzi (Sovateltide). Pharmazz will receive upfront and milestone payments, including royalties, as part of this collaboration, Sun Pharma said in a statement.
"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 their use in most patients," Kirti Ganorkar, CEO, India Business, Sun Pharma, said.
Sun Pharmaceutical is the proprietor of the brand name Tyvalzi, which is a pioneering drug for treating acute cerebral ischemic stroke, a condition where reduced blood supply to the brain can lead to brain damage, neurological issues, or even death. Tyvalzi has the ability to work on neural progenitor cells. It encourages the growth of new neurons and blood vessels while safeguarding neural mitochondria and supporting their development.
Dr. B. S. Paul, a neuro-physician at Dayanand Medical College & Hospital in Ludhiana and part of the Tyvalzi (Sovateltide) clinical trials, highlighted the urgent need for new stroke treatments.
"For over two decades, no new drug, except rTPA, has been approved for stroke treatment. The limited 4.5-hour window for rTPA use excludes many stroke patients. Stroke is a major global health issue, and Sovateltide (Tyvalz), a new drug, can be given within 24 hours of a stroke," said Paul.
Stroke ranks as the fourth leading cause of death and the fifth leading cause of disability in India, according to research studies.
Studies within the country suggest that the incidence of stroke varies from 116 to 163 cases per 100,000 people.
Looking ahead to 2050, it's anticipated that over 80% of the projected 15 million new stroke cases worldwide will occur in low- and middle-income countries, according to health experts.
"Clinical trials showed it significantly improves neurological outcomes at 90 days, as measured by various scales. Sovateltide (Tyvalzi) acts by promoting brain cell growth and blood vessel development, offering promise as an effective and well-tolerated treatment for stroke patients," he said.
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