The Hindu Business Line : Sanofi-Aventis puts off plans to launch weight-loss drug

Mumbai, May 10 Drugmaker Sanofi-Aventis seems to have shed weight-loss drug Acomplia (Rimonabant) from its India plans, at least for now. This comes despite Sanofi-Aventis having the regulatory approval to sell Acomplia in the local market.

Generic similars of Acomplia which have been present in the local market for about a year now are part of the reason why Sanofi-Aventis put its Acomplia plans on the backburner for now, the company’s Managing Director in India, Dr Shailesh Ayyangar told Business Line.

“Currently, there are ongoing global trials (part of which are conducted in India) on additional indications for this product in the cardio-metabolism area, including cardiovascular and diabetes area,” he said.

The company would look to launch the product after these studies are completed, to get these additional indications for treatment of patients in India, he added.

Acomplia was projected to touch global revenues of about $3 billion, but psychiatric concerns regarding the medicine that emerged last year took their toll on sales. Launched first in Europe in 2006, Acomplia clocked net sales of €79 million in 2007. The company does not yet have approval to sell the drug in the US.

But the generic Rimonabant market in India is estimated at about Rs 11 crore, with about 15 brands in the fray from companies including Zydus, Torrent, Cipla, Sun Pharma, Ranbaxy, Lupin, Unichem, Intas and Alkem, said an industry representative familiar with the drug.

Rimonabant is a pre-1995 molecule and so would not get product patent protection in India, according to local norms. This accounts for why generic companies continue to sell their versions of Rimonabant locally.

Though safety concerns had cast a shadow on Acomplia globally, in India it does not appear to have disrupted local sales.

Prescribing doctors are aware of the side-effect profile, an industry hand said. Rimonabant is a serious drug and its usage is selective, for patients where the benefits of weight-loss are in the interest of their long-term health, the representative added.

There is a slow, but steady, growth in the market and the molecule seems free of the sort of hype seen with quasi-OTC (over-the-counter) products, the industry hand added.

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