Pharmazz Inc. and Dr. Reddy's Laboratories have entered into a licensing agreement to market Centhaquine (Lyfaquin) as a resuscitative agent for hypovolemic shock in India
Centhaquine is a first-of-its-kind resuscitative agent to treat hypovolemic shock by increasing stroke volume and cardiac output due to an increase in (preload) venous blood return to the heart and a decrease in (afterload) due to arterial dilatation
India is the first global territory where Centhaquine is being launched immediately
WILLOWBROOK, Ill., March 22, 2024 (GLOBE NEWSWIRE) -- Pharmazz, Inc. ("Pharmazz"), a biopharmaceutical company developing and commercializing drug products to treat critically ill patients, announced that it has entered into a license agreement with Dr. Reddy's Laboratories Limited ("Dr. Reddy's"), a global pharmaceutical company, to commercialize a first-in-class innovative drug Centhaquine in India. Developed by Pharmazz for potential global use, Centhaquine is a resuscitative agent presently indicated for treating hypovolemic shock by Drugs Controller General of India (DCGI).
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.
The inventor, Dr. Prof. Anil Gulati, M.D., Ph.D., who is the CEO and Chairman of the Board 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."
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.”
Centhaquine 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 hemorrhage, diarrhea, or vomiting can cause hypovolemic shock. About 1.9 million people worldwide die because of hemorrhagic 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 was approved in India by Drugs Controller General of India following a successful Ph III clinical trial there, the results of which are published in a manuscript titled "A Multicentric, Randomized, Controlled Ph III Study of Centhaquine (Lyfaquin, as a Resuscitative Agent in Hypovolemic Shock Patients." The manuscript is published in DRUGS and is available at: https://link.springer.com/article/10.1007/s40265-021-01547-5.
Pharmazz received permission from the U.S. 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.
The Phase III clinical trial is registered at clinicaltrials.gov (NCT05251181), providing details of the trial design and all the endpoints. U.S. FDA clearance of our Phase III IND is an important milestone for Pharmazz and the potential future treatment of hypovolemic shock patients.
About Pharmazz, Inc.
Pharmazz is a privately held company developing novel products in critical care medicine. Pharmazz, Inc. obtained marketing authorization for two of its first-in-class drug molecules, Centhaquine and Sovateltide, for hypovolemic shock and ischemic stroke, respectively, in India. In addition, the U.S. Food and Drug Administration (FDA) has approved two phase III INDs for Centhaquine as an agent for hypovolemic shock and Sovateltide for cerebral ischemic stroke. Additional information may be found on the Company's website, www.pharmazz.com.
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About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of ‘Good Health Can’t Wait’, we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: www.drreddys.com.
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