• 27 Mar 2024
• Admin
• News Article

Dr Reddy's Soon to Market Pharmazz’s Centhaquine in India

Dr Reddy's to market Pharmazz’s centhaquine in India for the treatment of hypovolemic shock

Overview

Dr Reddy’s Laboratories Ltd., a global pharmaceutical company, has entered into a license agreement with Pharmazz, Inc. (Pharmazz), a US based biopharmaceutical company, to commercialise the first-in-class innovative drug centhaquine in India.

Indication

Developed by Pharmazz, centhaquine is a resuscitative agent presently indicated for the treatment of hypovolemic shock by the Drugs Controller General of India (DCGI).

About Agreement

• As per the agreement, Dr. Reddy's has received exclusive rights to market and distribute centhaquine in India. Pharmazz will be entitled to upfront payments and royalties. 
• Dr Reddy’s will market the product under the brand name Lyfaquin, which it shall own. 
• In addition to India, Dr Reddy’s also receives marketing rights for Lyfaquin from Pharmazz for Nepal.

Words from Dr Reddy’s

M V Ramana, chief executive officer, branded markets (India and Emerging Markets), Dr Reddy’s, said: “The partnership with Pharmazz and launch of this first-in-class drug marks the latest in our effort to enter into strategic collaborations to bring novel molecules to India to meet genuine unmet patient needs. The clinical studies for Lyfaquin have demonstrated significantly better and promising outcomes, making it as a potential add-on drug in the management of hypovolemic shock and enhancing the current standard of care for its treatment in India.”

Words from CEO: Pharmazz

Dr Prof Anil Gulati, M.D., Ph.D., inventor, CEO, and chairman of the board of directors of Pharmazz, said: “India's emergence as a hub for developing and introducing innovative medicines is a remarkable achievement. It reflects the country's growing capabilities in research and development within the pharmaceutical sector. It is a large step for Pharmazz to partner with Dr Reddy's, a leading global pharmaceutical company from India. For patients with hypovolemic shock, I believe Dr Reddy's is the best partner for Pharmazz to market centhaquine, an innovative, first-in-class novel resuscitative agent, in India.""

Hypovolemic Shock

• Hypovolemic shock is a life-threatening and often a fatal condition. 
• 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. 
• 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% in traumatic haemorrhages despite the existing standard of care. 
• This suggests a need for a novel resuscitative agent which can improve the existing standard of care.

About Centhaquine

• Centhaquine (Lyfaquin in India) is a frontline therapy used along with the standard of care and is well positioned to a critical unmet need as a pharmacologically active resuscitative agent. 
• A decrease in the volume of blood circulation from blood or fluid loss due to trauma, gastrointestinal bleeding, major surgery, postpartum haemorrhage, diarrhoea, or vomiting can cause hypovolemic shock. 
• About 1.9 million people worldwide die because of haemorrhagic shock every year, most dying within the first 6 hours. 
• Centhaquine activates venous alpha2B adrenergic receptors to increase cardiac preload and activates central alpha2A adrenergic receptors to decrease cardiac afterload. 
• Thereby, centhaquine converts the venous unstressed blood volume to stressed blood volume and improves cardiac output and blood circulation, making it an ideal candidate for the resuscitation of patients with hypovolemic shock.

Centhaquine: Ssuccessful Trial’s Result

• Centhaquine was approved in India by Drugs Controller General of India following a successful phase III clinical trial. 
• The results of are published in a manuscript entitled ""A Multicentric, Randomized, Controlled Ph III Study of Centhaquine (Lyfaquin), as a Resuscitative Agent in Hypovolemic Shock Patients”. The manuscript is published in DRUGS.

Upcoming Phase III Study

• Pharmazz received permission from the US Food and Drug Administration (FDA) to conduct a phase III clinical trial of centhaquine in hypovolemic shock patients. 
• It assesses the safety and efficacy of centhaquine in patients with hypovolemic shock. The phase III randomized double-blind, placebo-controlled study will be conducted in 430 patients where patients will receive either an intravenous infusion of 0.01 mg/Kg of centhaquine or a placebo. 
• All patients will receive the standard of care. A 28-day all-cause mortality is the primary endpoint.

Currently, Centhaquine is also under development for septic shock.

Dr Reddy’s Laboratories

Dr Reddy’s Laboratories Ltd. is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines.