Zydus IND application of ZYGK1 for treating diabetes receives USFDA approval

Zydus’ IND application of ZYGK1 for treating diabetes receives USFDA approval Ahmedabad, April 07, 2011 Zydus Cadila, a global healthcare provider and one of India’s leading healthcare companies announced that it has received an approval from the USFDA for its IND application of ZYGK1. Designed and developed at the Zydus Research Centre, the NME is a potent and orally administered small molecule glucokinase activator. The company will now initiate Phase I clinical trials for ZYGK1. Glucokinase (GK) is the enzyme that acts as a glucose sensor in the pancreas and regulates glucose metabolism in the liver. When, circulating glucos e levels rise above a certain thresh old, the glucokinase enzyme enhances insulin release from pancreas and d ecreases glucose production in liver. In normal individuals, the pancreas secrete insulin in response to increased levels of glucose in the blood. In patients with Type 2 diabetes, there is a reduction of GK activity in the pancreas and the liver. Speaking on the new development, Mr. Pankaj R. Patel, Chairman and Managing Dire ctor, Zydus Cadila, said, “We have been building a promising pipeline of new molecu lar entities at the Zydus Research Centre and with each step forward, we are moving closer to our goal of becoming a research driven pharma major. We believe that these sustained efforts will help us address unmet healthcare needs in the focus areas of metabolic disorders and cardiovascular diseases.” In multiple preclinical models of Type 2 diabetes, ZYGK1 was found to be effective in controlling both fasting and non-fasting blood glucose. ZYGK1 showed very good safe ty profile in preclinical studies. Activating GK with small molecules such as ZYGK1 lower blood glucose levels by enhancing the abili ty of the pancreas to sense glucose, which leads to increased insulin produc tion. Simultaneously, glucokinase activators increase the net uptake of blood glucose by the li ver. Glucokinase activators, such as ZYGK1, represent a promising new class of drugs for the treatment of Type 2 diabetes. Starting with its first IND filing in 2005, Zydus today has several NMEs in various stages of clinical trials. The NME - ZYH1, for treating dyslipidemia is undergoing Phase III clinical trials and ZYI1, the anti-inflammatory and pain management compound is currently in Phase II clinical trials . ZYOG1, a oral GLP-1 agonist for treating diabetes, ZYH7, a novel drug candidate for treating dyslipidemi a and ZYH2, the novel agent for treating diabetes have completed Phas e I clinical trials. ZYO1, a novel dr ug candidate for treating obesity and related disorders, ZYD1, a GLP-1 a gonist to treat diabetes and ZYT1, a novel TR-beta agonist for treating dyslipidemia are in Phase 1 clinical trials. The Zydus Research Centre has over 20 discovery progra mmes on with several candid ates in the pre-clinical development stage focused on metabolic, cardiovascular , pain and inflammation therapeutic areas. With over 400 research professionals spearheading its research programme, Zydus has in-hous e capabilities to conduct discovery research from concept to IND enabling pre-clinical development and human proof-of-concept clinical trials. ### Filename: PressNote07-04-11 Directory: D:\ZydusCadila\Zydus Website\PressRelease Template: C:\Documents and Settings\Administrator\Application Data\Microsoft\Templates\Normal.dot Title: Zydus’ novel orally administered GLP-1 agonist – ‘ZYOG1’ to treat Diabetes and Obesity enters Phase I clinical trial Subject: Author: rashmi.nair Keywords: Comments: Creation Date: 06/04/2011 1:02 PM Change Number: 6 Last Saved On: 06/04/2011 3:39 PM Last Saved By: Rashmi Nair Total Editing Time: 33 Minutes Last Printed On: 07/04/2011 1:43 PM As of Last Complete Printing Number of Pages: 1 Number of Words: 491 (approx.) Number of Characters: 2,717 (approx.)

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