Dr Reddy's Phase III drug stumbles

The much-hyped anti-diabetic drug Balaglitazone of the pharma major Dr Reddy’s Laboratories (DRL) seems to be in trouble with the company not able to find a partner to take the discovery of the molecule forward.

“It is becoming difficult for us to find a partner for the drug research,” K Anji Reddy, DRL’s chairman, said.

Balaglitazone is a type-2 diabetic controller molecule, which is going through Phase-III trials. The Danish research company Rheoscience is already partnering with DRL for the drug development.

“Drug discovery is a high risk business where failure is more the norm than exception. We have to accept failures. Ten years of work has gone into flames,” Reddy said.

DRL has already announced that the drug met its primary endpoint of lowering blood sugar with few adverse events.

However, a similar compound was banned in Europe recently making it difficult for DRL to find a partner to take the research forward. This is said to have affected the progress of the research.

“We could not find partners for the drug,” Reddy said.

In 1997, Dr Reddy’s licensed Balaglitazone to Novo Nordisk. But in 2004, after Phase II studies, Novo Nordisk decided to terminate further clinical development of Balaglitazone as the Phase II results did not suggest a sufficient competitive advantage compared to the existing products.

Later the company entered into an agreement with Rheoscience for taking the research forward. However, the company in a statement on the status of the research said, “Additional clinical studies would depend on the breadth of the labelling sought feedback from the regulators. Dr Reddy’s and Rheoscience intend to seek an additional partner to complete the required phase III studies prior to approval. The strategy would be finalised with the partner.”