Dr Reddy's plans diabetic molecule pact with US firm

Dr Reddy's Laboratories (DRL) is planning to tie up with a US-based pharma company to take up further development and clinical research of its new diabetic molecule DRF 2593-Balaglitazone - an oral treatment for patients with type 2 diabetes.

This drug candidate was earlier licensed out to the Danish pharmaceutical major Novo Nordisk. However, the multinational company had returned the molecule to DRL without proceeding on further development due to strategic reasons.

DRL is currently in an advanced stage of negotiations with the US company to sign the co-development agreement, said Dr Anji Reddy, chairman, Dr Reddy's Lab. "We will announce the development alliance for Balaglitazone with a multinational company very shortly," he said.

Balaglitazone, the drug candidate, a partial Peroxisome Proliferator Activated Receptor (PPAR) gamma agonist, was second in line in the DRL research portfolio, and is likely to be a blockbuster drug, if it enters the commercialisation stage successfully. The molecule is currently undergoing carcinogenic study by Covans, the multinational contract research company.

Novo Nordisk decided to terminate further clinical development of Balaglitazone, as the preclinical results did not suggest a sufficient competitive advantage for Balaglitazone compared to similar, marketed products within this therapeutic category.

Dr Reddy's Lab had, in October 2004, announced that Novo Nordisk terminated further clinical development of Balaglitazone.

However, it had said that it is committed to the research and development of new medicines to address unmet medical needs in the areas of diabetes and metabolic disorders.

Balaglitazone is an insulin sensitizer, which acts as a partial PPAR gamma agonist for the oral treatment of patients with type 2 diabetes. Dr Reddy's had licensed this molecule to Novo Nordisk in 1997.

With the co-development agreement with the overseas company, DRL will take up the further development activities for Balglitazone like phase 2 and 3 trials, which include human trials globally. However, the company officials did not confirm whether it is planning to license it out again after the completion of the trials.

Dr Reddy's has been engaged in drug discovery of PPAR activators for the treatment of diabetes for more than a decade. The company's scientists were the first to design a dual PPAR activator for the treatment of high glucose and lipids in type 2 diabetics.

Since DRL is now floating a separate drug development company with private participation from venture capital companies, it will be transferring four new chemical entities (NCEs) from its research portfolio to this company.

The NCEs, which will be transferred to the new company include DRF 10945, a drug candidate for the treatment of high triglycerides and low HDL, RUS 3108 - a drug for the treatment of atheroscelerosis and heart diseases, DRL 11605 - another drug for treatment of type 2 diabetes and the Adenosine Mono Phosphate Kinase (AMPK), which is an important enzyme sensor that regulates body's flow of ebergy by controlling glucose and lipid metabolism.