Sun Pharma to Invest Up to $15 Million in Pharmazz Inc.

Pharmazz, Inc., a biopharmaceutical firm centered on critical care therapeutics, has entered into a strategic agreement with Sun Pharmaceutical Industries Limited to further the development of Sovateltide. This innovative drug is designed to treat acute cerebral ischemic stroke. Under this collaboration, Sun Pharma will invest $15 million in two tranches to support the pivotal Phase 3 trial of Sovateltide in the United States.

Sovateltide is a groundbreaking drug for treating acute cerebral ischemic stroke, a condition characterized by the disruption of blood supply to the brain, leading to potential brain damage or death. This drug can be administered up to 24 hours after stroke symptoms begin. The U.S. Food and Drug Administration (FDA) has agreed to the study design and statistical analysis plan for the Phase 3 clinical trial of Sovateltide under a Special Protocol Assessment (SPA). The trial, identified with ClinicalTrials.gov ID: NCT05691244, is a multicentric, double-blind, placebo-controlled study aimed at evaluating the safety and efficacy of Sovateltide in stroke patients.

Sovateltide's mechanism involves neurovascular remodeling through the formation of new neurons and blood vessels. Additionally, it protects neural mitochondria and enhances their biogenesis. This drug has shown promise and has already been used to treat approximately 30,000 acute cerebral ischemic stroke patients in India.

Pharmazz had previously partnered with Sun Pharma to commercialize Sovateltide in India under the brand name Tyvalzi™. The new agreement expands this partnership to include certain additional Emerging Market countries. Sun Pharma’s investment not only provides financial backing but also brings operational expertise and strategic guidance to Pharmazz's management.

Pharmazz is a privately held company specializing in critical care medicine. It has secured marketing authorizations in India for Centhaquine and Sovateltide, drugs developed for hypovolemic shock and acute cerebral ischemic stroke, respectively. The FDA has also approved Phase 3 Investigational New Drug (IND) applications for these drugs in the United States.

Sun Pharma, the world's leading specialty generics company, has a significant presence in specialty, generics, and consumer healthcare products. It is the largest pharmaceutical company in India and a key player in the U.S. and global emerging markets. Sun Pharma’s global specialty portfolio, which includes products in dermatology, ophthalmology, and onco-dermatology, accounts for over 18% of the company’s sales. The company operates manufacturing facilities across six continents and serves physicians and consumers in more than 100 countries.

The strategic alliance between Pharmazz and Sun Pharma is expected to accelerate the development and commercialization of Sovateltide, potentially offering a new treatment option for patients suffering from acute cerebral ischemic stroke. This collaboration underscores the potential of Sovateltide as a first-in-class therapeutic, supported by Sun Pharma's substantial investment and Pharmazz's innovative research.