Dr Reddy’s Labs (DRL) is scouting for partners in the US and Europe to market Balaglitazone, its potential molecule for diabetes, which is yet to complete phase III human trials. The molecule, which is still undergoing multi-centre trials in India, the US and Europe, was supposed to be marketed by DRL and its development partner, Rheoscience in the US and Europe respectively.
Balaglitazone (DRF 2593) is being developed under a co-development agreement between DRL and Denmark-based Rheoscience. As per the deal, Rheoscience would retain the marketing rights to the European Union and China and DRL would retain the marketing rights in the US and the rest of the world.
However, the high potential of the drug is learnt to have compelled DRL to give the marketing rights to other companies having strong marketing and distribution strength.
GV Prasad, vice chairman & CEO, Dr Reddy’s Labs, told FE, ?Citing the huge potential for the molecule, we are looking for companies with strong marketing background to sell our drug in the US and Europe each.” Informal talks are on with a number of companies, he added without naming the firms. The drug is expected to enter the market by 2012, if the trials are completed successfully.
According to the US FDA, new compounds entering phase I trials have only 8% chance of reaching the market against a 14% chance 15 years ago. Also, the phase III failure rate has risen to 50% versus 20% just ten years ago. For the year 2007, the US FDA has given approvals for 15 new molecular entities (NMEs), against 22 in 2006.
Balaglitazone, named after Lord Balaji, is developed for the treatment of type 2 diabetes. The World Health Organization (WHO) estimates that more than 180 million people worldwide have diabetes. This number is likely to more than double by 2030.
