“Safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attacks and heart-related deaths in patients taking Avandia,” the FDA said.
HYDERABAD: Prospects of a potential upside for Dr Reddy’s on Glaxo SmithKline’s type 2 diabetes medicine Avandia (generic rosiglitazone) have come into doubt, with the USFDA issuing a safety warning on the drug which clocked sales of $2 billion in 2006.
“Safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attacks and heart-related deaths in patients taking Avandia,” the FDA said.
However, it said that other research, including an interim analysis of data from a large, ongoing randomised open label trial, and unpublished re-analyses of data provide contradictory evidence.
“We will complete our analysis and make the results available as soon as possible. The FDA will take the issue of cardiovascular risks associated with Avandia and other drugs in this class to an advisory committee as soon as one can be convened,” Steven Galson, director of FDA’s Center for Drug Evaluation and Research said in a statement.
A negative finding by the proposed committee could even result in a possible withdrawal of the drug from the market in the worst-case scenario, which means that Dr Reddy’s, which enjoys a first-to-file status (FTS) on its patent challenge and has a shared exclusivity with Israeli giant Teva, stands to lose potential upsides from it.
Coming close on the heels of the Achiphex loss, this would be a considerable blow to the company, which is looking at major upsides from 18 FTS over the next few years.
A Dr Reddy’s spokesperson said the company would not like to comment on the issue without first studying the matter thoroughly.
Citigroup analyst Prashant Nair, however, felt the matter may not be too serious as its US analyst Kevin Wilson, who covers GSK, believes a study by the New England Journal of Medicine has significant limitations, including pooling of data from trial not originally intended to explore cardiovascular outcomes.
The paper Journal concludes that Avandia treatment was associated with a significant (30-40%) increased risk of heart attack and an increase in the risk of death from cardio-vascular events that has borderline significance. It is also not clear if the research would have any implications on the prospects of other glitazones, including Dr Reddy’s own Balaglitazone, which is ready to go into Phase III trials.
Citigroup’s price target includes an option value of Rs 6 per share built in for balaglitazone. Interestingly, generic rosiglitazone is a commonly sold drug in India and has been in the market for some time now. According to industry-watchers, while Dr Reddy’s had launched the drug in the country under the brand name RedLet in 2001-02, the company withdrew it from the market within one year as the response was not good enough.
However, according to the sources, Sun Pharma and Torrent continue to sell it in the market under the brand names Rezult and Encelin, respectively.
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
)
){kind=small}
){kind=small}
)
)
)
)
)
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}