Dr Reddy’s plans to file an Investigational New Drug Application (INDA) in Canada for its PPAR alpha agonist, DRF 10945 this month, revealed Dr Anji Reddy, chairman, Dr Reddy's Laboratories (DRL).

Speaking in an international symposuim 'Pharmacophore 2004' organized by Dr Reddy’s Research Foundation (DRF) at Hyderabad, he said the expertise DRL gained in PPAR research has underscored the fact that raising HDL levels was the next frontier in cholesterol management.

“We are in a position to discover and develop a predominantly PPAR alpha agonist that could fulfill this unmet medical need. DRF 10945 was the direct outcome of this conviction,” Dr Reddy explained.

In 3 years from inception, DRF discovered one of the most potent glitazones and on 1st March 1997, licensed the molecule – now called Balaglitazone – to the world leader in diabetes, Novo Nordisk of Denmark. The two glitazones now in the market have sales of nearly $3 billion and growing at more than 25 per cent annually. Both the glitazones are potent PPAR gamma agonists and have the problem of weight gain and oedema. Balaglitazone is a partial PPAR gamma agonist and phase II results indicate that it has a better side-effect profile than the existing glitazones. Balaglitazone is expected to enter phase III clinical development in 2004, he said

“Our continued foray into PPAR research resulted in a dual PPAR-gamma, alpha compound – Ragaglitazar. On 1st June 1998, we again licensed this to Novo Nordisk,’’ he said.

Ragaglitazar did live up to its promise in phase III, but unfortunately the dose at which it reproduced the animal data in humans also caused unacceptable side effects and as a consequence, development of Ragaglitazar was suspended in December 2002.

DRL jumped into discovery research with a budget of about Rs.6.5 crores. In the current financial year the company has budgeted an expenditure of Rs.165 crores ($36 million), a 25-fold increase in the R&D spending,” Dr Reddy added.