INDIA – Sun Pharma and Pharmazz Inc., a biopharmaceutical company based in the United States, have signed an exclusive license agreement to bring a first-in-class innovative drug, Tyvalzi (sovateltide), to the Indian market.

Sovateltide is designed to treat cerebral ischemic stroke and is a first-in-class innovative drug developed by Pharmazz Inc. for potential global use.

Under the recent license agreement, Sun Pharma has been granted rights for marketing Pharmazz’s Sovateltide in India under the brand name Tyvalzi.

Pharmazz will be entitled to upfront and milestone payments, including royalties, as part of the exclusive license agreement with Sun Pharma.

In a press release, Dr. Prof. Anil Gulati, M.D., Ph.D., inventor, Chief Executive Officer and Chairman of the Board of Directors of Pharmazz, said: “It is a significant step for Pharmazz to partner with Sun Pharma, the largest pharmaceutical company in India.”

Through the license agreement signed between Sun Pharma and Pharmazz, India is now the first global territory where Tyvalzi (Sovateltide) is being introduced.

The exclusive license agreement is based on the detailed results from the Phase 3 clinical trial for Tyvalzi conducted in India.

Tyvalzi demonstrated statistically and clinically meaningful improvements in neurological outcomes in ischemic stroke.

For patients with cerebral ischemic stroke, I believe Sun Pharma is the best partner for Pharmazz to market this innovative, first-in-class novel treatment for cerebral ischemic stroke, in India,” stated Dr. Anil Gulati.

Sovateltide, a selective endothelin B receptor agonist, can be administered up to 24 hours after the onset of symptoms of cerebral ischemic stroke.

The innovative drug produced meaningful improvements in neurological outcomes at 90 days post-treatment in clinical trials as measured by the NIHSS, mRS, and B.I. scales.

It is worth highlighting that the current treatment options provide a narrow time window of 4-5 hours limiting its use in most patients with ischemic stroke.

On his part, Dr. B. S. Paul, a leading neurophysician at Dayanand Medical College & Hospital, Ludhiana, who was a part of the clinical trials of Tyvalzi (Sovateltide), stated: “I believe that Sovateltide (Tyvalzi) is an exciting new, approved, effective, and well-tolerated therapy for treating cerebral ischemic stroke patients.”

Sun Pharma, in collaboration with Pharmazz, will work closely to enhance access to the first-in-class drug, Tyvalzi (sovateltide), for the treatment of ischemic stroke in India.

Notably, Pharmazz obtained marketing authorization for two of its first-in-class drug molecules, centhaquine, and sovateltide, for hypovolemic shock and ischemic stroke, respectively, in India.

It could pave the way for drug discovery and the development of innovations that are not only suitable but also available to the majority of people suffering from ischemic stroke.

Sovateltide is a neuronal progenitor cell therapy that promotes neurogenesis, angiogenesis, and synaptogenesis, and ultimately, induces neurovascular remodeling.

Analyses of the Phase 3 clinical trial show that the innovative drug can help improve the quality of life of stroke patients.

The positive results from the Phase 3 clinical trial mark a step forward in illuminating a path toward enhanced therapeutic outcomes.

Moreover, it charts an illuminating path forward for a potential extension of survival since stroke is the second leading cause of mortality and morbidity worldwide.

The recent report, titled The Global Burden of Disease Study 2016, published by Lancet shows data on the global, regional, and national burden of stroke for the period between 1990 and 2016

The Global Burden of Disease project estimated the number of incident cases of stroke in India to be 1,175,778.

In India, studies estimate that the incidence of stroke population varies from 116 to 163 per 100,000 population.

Stroke is the fourth leading cause of death and the fifth leading cause of disability in India, according to the publicly available statistics published by Lancet.

By 2050, more than 80% of the predicted global burden of new strokes of 15 million will occur in low and middle-income countries.

Commenting on the disease burden, Dr. B. S. Paul said: “No new drug other than rTPA has been approved for the treatment of stroke for more than two decades. The narrow time window of rTPA of 4.5 hours limits its use in a vast majority of patients with cerebral ischemic stroke. There is an urgent need for new therapies to treat stroke.”

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