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P.T. Jyothi Datta

Mumbai, Sept. 21 Safety concerns linked to medicines will increasingly be a spanner in the works for domestic drug companies already bogged down by pricing pressures and intense competition in global markets.

Following recent reports on heart-risks linked to GlaxoSmithKline’s diabetes-drug Avandia or Amgen’s anemia-drug Epogen, for instance, a shadow has indeed been cast on domestic drug companies harbouring plans in these segments, say industry watchers.

The potential heart risk linked to GSK’s Avandia (Rosiglitazone) had lead to the United States regulatory authority recommending the highest level of warning on the medicine. And while this was expected to have repercussions on a handful of Indian drug companies making generic copies of Rosiglitazone, an indirect impact is expected on Dr Reddy’s Laboratories’ (DRL) plans in this segment, says a pharma analyst.

DRL had a Para-IV filing on Rosiglitazone and was expecting a 180-day exclusivity on the drug in the US market, the analyst said. A Para IV filing involves a patent challenge, based on an innovation that DRL would have made on Rosiglitazone. Such challenges involve a windfall gain to the challenging drug company, if the court rules in its favour. But, if the court rules against it, the patent challenger not only loses the case but has also incurs a litigation cost.

The safety-risk on Rosiglitazone has not only shrunk the size of the market for GSK, which has been selling the drug in the US since 1999, but it also casts a shadow on investments made by DRL on it’s version of Rosiglitazone, said the analyst. Responding to the observation, a DRL spokesperson told Business Line that DRL had been sued in September 2003 and the case against it has been dismissed. Exclusivity on its version of Rosiglitazone will begin March 2012, depending on the outcome of product patent litigation with Teva, the company said.

Besides Roziglitazone, DRL is also working on another anti-diabetic drug Balaglitazone, which is headed towards its final stage of human testing. But, since it belongs to the same class of drugs as Rosiglitazone, pharma analysts say that plans for Balaglitazone to enter the commercial market by 2011 may now witness several hurdles.

DRL’s spokesperson points out that all phase III studies are being conducted in line with the protocol discussed and agreed upon with the regulatory authorities in Europe and the US. Rheoscience, DRL’s partner on Balaglitazone, is conducting and funding the trial.

Similar safety issues arise in the biotech segment as well, over anemia drugs Aranesp and Epogen from Amgen and Procrit from Johnson and Johnson. The medicines have been have been linked to serious complications in cancer and kidney patients, leading to regulators recommending warning labels.

And while Amgen and J&J feel the heat of this safety catch, Indian companies such as Biocon and Wockhardt, for example, have invested heavily to target this market, points out the analyst. And by the time these companies receive approval to enter the US market, the available market for these drugs is likely to shrink significantly. And this raises the question again, whether investments made by these companies will generate sufficient returns, says the analyst.

More Stories on : Pharmaceuticals | Standards & Benchmarks | Glaxosmithkline Pharmaceuticals Ltd

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