Dr Reddy’s sees 70% chance of selling diabetes drug

Balaglitazone does not have any side effects, says Anji Reddy

HYDREBAD: Balaglitazone, the type-2 diabetes drug being co-developed by Dr Reddy’s and Danish drug major Rheoscience, has a 60-70% chance of making it to the market by 2011, K Anji Reddy, founder-chairman, Dr Reddy’s Labs, said on Thursday.

The company is also planning to raise its R&D spend on new drug development to $100 million per year.

An oral anti-diabetic drug (OAD), Balaglitazone has successfully completed Phase-II trials while the first of the six planned global Phase III trials has been initiated.

The second was to be kicked off in the second half of this year, while the remaining four is expected to commence in 2008.

GlaxoSmithKline Plc’s Avandia and Japanese Takeda Pharmaceutical’s Acots are the only drugs in this class. They command a combined market share of over $7 billion annually.

Reddy’s statement assumes significance in the light of the global controversy over the efficacy of the class of glitazones and particularly Avandia, after a meta-analysis of the research on the drug reported a high risk of heart attack in patients using it.

Subsequently, Avandia sales plummeted 48% since May in the US alone in the quarter ended September, compared to the same quarter last year. This has helped rival drug Actos of Takeda.

Avandia sold $3.3 billion globally in 2006.

Both Avandia and Actos carry a USFDA mandated black-box warning about the side-effects of the drug, leading to heart failure, a chronic condition in which the heart has trouble pumping blood.

But the US regulator reportedly decided on Wednesday to impose a second more serious warning of a possible heart attack, which is more serious than heart failure, given that it can come with a warning and be immediately fatal.

However, Reddy expressed confidence that the controversy would not limit the chances of success for Balaglitazone.

“We are meeting the FDA soon to get clarity on the issue, and moreover, evidence shows it is better than both Actos and Avandia, which also have side-effects on bones,” he said. Balaglitazone does not have any side-effects.

The fact that Actos has gained market share shows that patients will go for a better alternative, he said on the sidelines of the TiE-ISB Connect conclave here.

“Balaglitazone has taken several turns, but we are confident that it will be out in the market by when the Phase-III clinical trials will be completed in 2010,” he added.

As per the agreement, while Rhoescience will retain the rights for Europe and China, Dr Reddy’s will hold the rights for the rest of the world, which is 60% of the market including the US.

Dr Reddy’s has 70% chance of diabetes drug by 2011

Talking about Dr Reddy’s new drug discovery pipeline, the veteran drug developer said the company was working on at least eight new chemical compounds, which were at the pre-clinical stage of research.

While there are some successes to its credit, Dr Reddy’s would like to increase focus on R&D for new drug development and has accordingly proposed increased the funding to $100 million per year.

“I have asked CEO GV Prasad to provide $100 million for it and it is up to him to decide,” he said. Asked when this fund would be available, he said we would like to ramp up gradually, he responded.

Dr Reddy’s has spent $44 million on R&D up to September 2007 and is likely to end around $80 million for the whole year. It has spent $20 million last year on new drug development alone.