The Hindu Business Line : Safety not a concern yet for generics of Acomplia

Mumbai June 19 Psychiatric concerns such as depression and suicide may have cast a shadow on Sanofi-Aventis' weight-loss drug Acomplia in the US and Europe, but not on local drug-makers making generic copies of the same medicine.

Torrent Pharma, Sun Pharmaceuticals and Zydus Cadila have been locally marketing Rimonabant, the generic version of Acomplia, since late May. And this had upset Sanofi-Aventis, as it still had to get its marketing approval in a significant market like the US. Sanofi sells Acomplia in 18 countries and had projected global revenues of about $3 billion from this drug.

But Sanofi's worries on its anti-obesity drug seem to extend beyond dealing with generic competition on the drug from India. Safety concerns on Acomplia have held back a marketing approval in the US, with a US Food and Drug Administration panel recently voting against giving approval for Acomplia in the US. Taking its cue, regulators in Europe too are set to review their authorisation of the medicine. The USFDA, usually believed to go with recommendations of its panel, will give its final ruling later next month.

But the regulatory Drug Controller General of India (DCGI) has decided to hold its horses and watch developments, as more safety-related data is generated on Acomplia.

New class

The drug belongs to a new class and local drug companies had done clinical trials and got permission to market their generic versions of the drug in India, a senior official with the regulatory office told Business Line.

Sanofi too has the approval to market the drug locally, and the company has indicated that it would import the drug and sell here, he said. A Sanofi-Aventis spokesperson did not comment on the issue.

At the time of launch, Torrent Pharma had said that Rimonabant had undergone extensive trials where the drug was tested on humans. The results of these phase III studies in Europe and North America had indicated significantly more weight loss with Rimonabant, the company had said. Priced at Rs 8 for a tablet, the company expected to clock Rs 10 crore from the drug in its first year of launch. Other generics are priced similarly, and are waiting for a cue from the DCGI, an industry representative said.

Rimonabant is a pre-1995 molecule and so would not get patent protection in India, according to local norms. This would mean, that generic companies can sell their version of Rimonabant, after safety concerns have been brought to a logical conclusion, the representative added.

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