Sanofi drug hits new hurdle

Sanofi-Aventis's Acomplia weight-loss pill, linked to suicide, is becoming popular in generic form in India. That may end the product's chances of ever reaching the US, where it's been delayed by regulators.

Cipla and Ranbaxy Laboratories are among six drugmakers exploiting a loophole in the India patent laws, selling copies of the medicine under names such as Slimona and Defat. The pills are sold without prescription for as little as 12 cents.

Should the knockoffs, used without supervision, lead to an increase in suicides, the US Food and Drug Administration's opposition might stiffen. The drugmaker's share, near the lowest in two years, won't rise anytime soon because the company has few medicines to replace Acomplia's lost sales, analysts said. Sanofi had predicted Acomplia would generate $3 billion a year.

"This is going to be potentially disastrous,'' said Jeffrey Mechanik, an endocrinologist at Mt Sinai Hospital in New York.

People are going to be over-dosing if generics flood the market and people take them inappropriately, he said.

Sanofi's earnings have dropped for four straight quarters. The drugmaker is losing patent protection on older medicines such as the sleep-pill Ambien.