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India's generic companies doing their bid to reduce the Indian population explosion.

Sanofi Drug Hits New Hurdle With Indian Knockoffs (Update1)

By Jason Gale and Angela Cullen


Slimona brand Rimonabant diet pills Aug. 9 (Bloomberg) -- Sanofi-Aventis SA'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 U.S., where it's been delayed by regulators.

Cipla Ltd. and Ranbaxy Laboratories Ltd. are among six drugmakers exploiting a loophole in India patent laws, selling copies of the medicine under names like 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 U.S. Food and Drug Administration's opposition may stiffen. The drugmaker's shares, 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 like the sleep-pill Ambien.

The Paris-based company's shares fell 76 cents, or 1.2 percent, to 60.59 euros at 10:39 a.m. in Paris, and have dropped 14 percent since reaching this year's high of 71.66 euros May 31. Sanofi withdrew its U.S. marketing application for Acomplia on June 29 after the FDA raised safety concerns.

Slower Growth

Growth at the maker of the Plavix blood thinner probably will remain slower than that of other European drugmakers, according to Alexandra Hauber, a Bear Stearns & Co. analyst in London.

Under Indian intellectual property law, pharmaceutical companies can use a process called reverse engineering to manufacture drugs patented before 1995. The patent on Acomplia, which regulates hunger impulses, dates to 1994.

Sanofi hasn't heard from Indian authorities on some of the company's patent applications filed after 2000, spokesman Jean- Marc Podvin said.

Sanofi received approval to sell Acomplia in India in May, the same month as the generic-drug makers. The company hasn't decided whether to sell its branded version there. ``We're evaluating our options,'' Podvin said. ``Of course, it's a concern.''

A pharmacy in New Delhi's commercial center sells the pills for the equivalent of 22 cents apiece. At another in Mumbai, the tablet can be bought for 5 rupees (12 cents).

No Warning

The Indian regulator approved rimonabant, or generic Acomplia, requiring patients get a prescription and medical advice on its risks. Those include depression and anxiety --side effects that were serious enough to prompt an FDA panel of advisors to reject the pill. Both stores sold the medicine without an explanatory leaflet or a doctor's note.

European regulators, who approved the medicine last year, tightened prescribing rules last month to say Acomplia shouldn't be used by those taking antidepressants or who have depression.

``There is a risk that if you can just buy it over the counter and really want to lose weight for that wedding, you may end up committing suicide before you get married,'' said Stephen Bloom, a professor of metabolic medicine at London's Imperial College. ``The rest of the world will watch. It's very kind of the Indian nation to be testing drugs for us like this.''

India is growing obese. Almost a third of women and more than a fifth of men living in urban areas are considered overweight, according to a government survey last year.

Obesity and Diabetes

Obesity can lead to high blood pressure and diabetes, to which South Asians have a genetic predisposition. Indian men are three to four times more likely than East Asian, African American, Hispanic or Caucasian men to develop insulin resistance that leads to diabetes, according to a study last year in the Proceedings of the National Academy of Sciences.

Unregulated use of the medicine that leads to reports of serious side effects could spell trouble for Sanofi, researchers say.

``Doctors should be very careful because in all the clinical trials, there was a slight increase in anxiety and depression,'' said Andre Scheen, head of diabetes, nutrition and metabolic disorders at the University of Liege, Belgium, who led a clinical trial on Acomplia.

Sanofi says it still plans to make the drug available in the U.S. In a statement Aug 1, the drugmaker said the drug has a ``positive risk benefit ratio'' when used in the ``appropriate population.''

Selected Patients

Torrent Pharmaceuticals Ltd. started selling its version, Rimoslim, two months ago and aims to sell 100 million rupees worth within 12 months. Rimoslim is ``an extremely affordable therapy for the masses,'' the Ahmedabad-based company said in a statement on its Web site in May. Asked via e-mail whether there were concerns about patient safety, Ruchir Modi, Torrent's vice president of marketing, said ``we can only wait and see how this unfolds'' with the FDA.

S.K. Wangnoo, a senior consultant endocrinologist at Indraprastha Apollo Hospital in New Delhi, says the medicine should only be used by ``a selected group of patients who are not able to control their appetite despite all efforts by diet counselors, behavior therapy or psychotherapy.''

Those patients ``must be told about the side effects and be checked by a doctor every month,'' according Wangnoo, who says he's cautious about prescribing the medicine, especially after it wasn't approved by the FDA.

G.R. Sumathi, who runs Cash Pharmacy in downtown Bangalore, says he's selling at least one box of Defat every day.

To contact the reporters on this story: Jason Gale in Singapore at [e-mail] ; Angela Cullen in Frankfurt at [e-mail]

Last Updated: August 9, 2007 04:43 EDT