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Indian rimonabant generic launches worry sanofi-aventis

Two Indian pharmaceutical companies have already copied and marketed sanofi-aventis' Acomplia weight-loss drug, which has yet to gain patent protection in the country

Two Indian pharmaceutical companies have already copied and marketed sanofi-aventis' (S-A) Acomplia (rimonabant) weight-loss drug, which has yet to gain patent protection in the country.

Torrent Pharmaceuticals and Zydus Cadila are already selling rimonabant as Rimoslim and Slimona, respectively, in India for under USD 6 per month, compared with the EU market rate of over USD 100 a month. Both companies say that the Indian market for rimonabant is significant, as it has a growing urban, middle-class obesity problem which may turn out to be a bigger earner than S-A initially believed.

French newspaper, Les Echo, reported that a third Indian company, Sun Pharmaceutical, had developed its own generic version of rimonabant. India is not obliged under World Trade Organisation rules to respect patents on molecules developed prior to 1995: rimonabant was registered in 1994, according to the report.

According to Indian analysts, S-A was focused on getting approval to sell the drug in the EU and the US (where it is still awaiting FDA approval), which made the French pharmaceutical giant late to file for marketing authorisation in India. S-A may have thought that the Indian consumer could not afford the treatment.

S-A has filed Acomplia with India's Central Drugs Standard Control Organisation which regulates the market authorisation of new drugs, but the drug is still awaiting approval.

Last week, S-A said it was examining all legal options, as the Indian generic situation could place the French pharmaceutical company in the unusual position of facing global generic competition as Acomplia starts to sell in Europe.

In other bad news for S-A, although trials of rimonabant demonstrated that it helped obese patients lose weight, the secondary claim that it reduced cardiometabolic risks is being questioned. The risk factors under doubt were obesity, low density lipoproteins high blood pressure and insulin resistance.

An article in the most recent edition of Drug and Therapeutics Bulletin said: "It is not known whether rimonabant's effects on individual risk factors translate into a reduced long-term likelihood of cardiovascular events."

In 2006, the Medicines and Healthcare products Regulatory Agency (MHRA) cleared S-A over a complaint that claims for its obesity treatment were misleading. Acomplia was launched in the UK in June 2007.

Swiss pharmaceutical firm, Roche, already has its obesity treatment, Xenical (orlistat), available in the EU and the US. GlaxoSmithKline (GSK) sells orlistat over-the-counter (OTC) in the US as Alli. Edward Jones analysts have estimated that the drug could generate US sales of USD 200m annually. GSK should receive OTC approval for Alli in the UK by the end of 2007.

30th May 2007

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