Sun Pharma has entered into a license agreement with Pharmazz Inc, a US-based biopharmaceutical company, to commercialise Tyvalzi (Sovateltide) in India.
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), the company said in the press statement. Pharmazz will be entitled to upfront and milestone payments, including royalties, the statement added.
Kirti Ganorkar, CEO (India Business) of Sun Pharma said, “The Phase III clinical trial for Tyvalzi conducted in India demonstrated statistically and clinically meaningful improvement in neurological outcomes in ischemic stroke. Tyvalzi helps 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.”
"There is an urgent need for new therapies to treat stroke, the 2nd leading cause of mortality & morbidity worldwide," BS Paul, a neuro-physician who
was a part of the clinical trials of Tyvalzi Sovateltide (TyvalziTM). "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," he added.
The US Food and Drug Administration (FDA), on February 14, 2023, issued a proceed forward letter for Pharmazz’s investigational new drug (IND) application to commence Phase III clinical trial of Sovateltide (PMZ-1620).
According to the company press release, the ‘Global Burden of Disease Project’ estimated the number of incident cases of stroke in India to be 117.5 million. In India, studies estimate that the incidence of stroke population varies from 116 to 163 per 10 million population.
Citing the survey, the press statement stated that by 2050, more than 80 percent of the predicted global burden of new strokes of 15 million will occur in low and middle-income countries.
Earlier this year, in May, Sun Pharma entered into a licensing agreement with Philogen SpA for commercialising Philogen’s specialty cancer product, Nidlegy (Daromun) in Europe, Australia, and New Zealand.
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