Pharma major Dr. Reddy’s has signed an agreement with US pharma company Pharmazz, Inc. (“Pharmazz”) to commercialise the latter’s Centhaquine in India and Nepal. A resuscitative agent, centhaquine, is indicated for the treatment of hypovolemic shock by the Drugs Controller General of India (DCGI).

Pharmazz will be entitled to upfront payments and royalties. Dr. Reddy’s will market the product under the brand name Lyfaquin, which it will own. 

Severe loss of blood or fluids due to traumatic haemorrhage, postpartum haemorrhage, gastrointestinal bleeding, post-surgical bleeding, diarrhoea, or vomiting can cause hypovolemic shock, which may lead to multi-organ failure and death. Hypovolemic shock can be a life-threatening condition.

“The partnership is the latest in our effort to enter into strategic collaborations to bring novel molecules to India to meet genuine unmet patient needs,” MV Ramana, Chief Executive Officer, Branded Markets (India and Emerging Markets), Dr. Reddy’s, said.

Clinical studies

“The clinical studies for Lyfaquin have demonstrated significantly better and more promising outcomes, making it a potential add-on drug in the management of hypovolemic shock and enhancing the current standard of care for its treatment in India,” he said.

“It is a large step for Pharmazz to partner with Dr. Reddy’s, a leading global pharmaceutical company from India,” Anil Gulati, CEO and Chairman of the Board of Directors of Pharmazz, said.

“India has a high prevalence of these conditions and high mortality due to these conditions. Data from various Indian studies and registries suggests a mortality rate of around 10 to 15 per cent in traumatic haemorrhages, despite the existing standard of care. This suggests a need for a novel resuscitative agent that can improve the existing standard of care,” Dr. Reddy’s said in a statement here on Friday.

“About 1.9 million people worldwide die because of hemorrhagic shock every year, most dying within the first six hours,” it said.

Centhaquine was approved in India by the Drugs Controller General of India following a successful phase III clinical trial.

“Pharmazz received permission from the US Food and Drug Administration (FDA) to conduct a Phase III clinical trial of centhaquine in hypovolemic shock patients. Currently, centhaquine is also under development for septic shock,” it said.