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Zydus Pioneers a Breakthrough With LIPAGLYN, India's First NCE to Reach the Market


6/5/2013 9:59:39 AM

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MUMBAI, India, June 5, 2013 /PRNewswire/ --

Lipaglyn™ is the first Glitazar to be approved in the world and the first NCE discovered and developed indigenously by an Indian Pharma Company.

The Zydus Group announced a breakthrough in its research efforts with Lipaglyn™ (Saroglitazar), a novel drug targeted at treating Diabetic Dyslipidemia or Hypertriglyceridemia in Type II diabetes, not controlled by statins alone. The drug has been approved for launch in India by the Drug Controller General of India (DCGI). With a novel action that offers lipid and glucose lowering effects in one molecule, Lipaglyn™ is the first Glitazar to be approved anywhere in the world.

Diabetic Dyslipidemia is a condition where a person is diabetic and has elevated levels of the total cholesterol, the "bad" low-density lipoprotein (LDL) cholesterol and the triglycerides and a decrease in the "good" high-density lipoprotein (HDL) cholesterol concentration in the blood. Almost 85 to 97% of all diabetics are estimated to suffer from diabetic dyslipidemia. Lipaglyn - a non-thiazolidinedione, is the first therapy to be approved for this condition.

"Lipaglyn™ provides patients suffering from diabetic dyslipidemia the option of a once-daily oral therapy that has a beneficial effect on both lipid parameters as well as glycemic control," said Mr. Pankaj Patel, Chairman and Managing Director, Zydus Cadila. "It has always been our dream to take a molecule right from the concept stage up to its launch. Today, we have realized this dream. It is an important breakthrough and I would like to dedicate this to all the Indian research scientists in the field of drug discovery," Mr. Patel added.

Discovered by the Zydus Research Centre, the dedicated NCE research arm of the group, Lipaglyn™ is a best-in-class innovation, designed to have a unique cellular mechanism of action. With a predominant affinity to PPAR alpha isoform and moderate affinity to PPAR gamma isoform of PPAR nuclear receptor subfamily, the molecule has shown beneficial effects on lipids and glycemic control without side effects. The IND was submitted in the year 2004.

The New Drug Application for Lipaglyn™ was based on a comprehensive clinical development programme Phase-I, Phase-II and Phase-III clinical trials, spanning eight years. Results from the first Phase III programme with Pioglitazone as a comparator drug in diabetes patients showed that the 4 mg dose of Lipaglyn™ led to a reduction of triglycerides and LDL cholesterol, and an increase in HDL cholesterol and also showed a reduction in Fasting Plasma Glucose and glycosylated haemoglobin (HbA1c) thereby confirming its beneficial effects of both lipid and glycemic control in diabetic patients. Lipaglyn™ is recommended as 4 mg tablets.

About Zydus Cadila

Zydus Cadila is a global pharmaceutical company headquartered in Ahmedabad, India. The group discovers, develops, manufactures and markets a broad range of healthcare therapies. With 20 discovery research programmes under various stages of clinical development, the group invests 7% of its turnover on research. The Zydus Research Centre has over 400 research scientists engaged in NCE research.

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