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May 2007
Sanofi's Acomplia Is Beaten to Market in India by Generics
May 24, 2007
Sanofi-Aventis SA, whose obesity drug Acomplia has been held up in the U.S., is already facing generic versions in India, where at least two companies have begun selling cut-rate versions for as little as 14 U.S. cents a pill.
Ahmedabad, India-based Cadila Healthcare Ltd. and Torrent Pharmaceuticals Ltd. began marketing versions of the drug under the names of Slimona and Rimoslim earlier this month. Torrent expects sales of 100 million rupees ($2.5 million) in the first year, spokesman Susim Mohanty said in a telephone interview today.
Paris-based Sanofi, which won approval in Europe for Acomplia last year, is still waiting for U.S. regulators to clear the medicine, which competes with Roche Holding AG's Xenical and Abbott Laboratories' Meridia. France's largest drugmaker hasn't obtained approval to sell the drug in India after submitting an application to drug authorities there last summer. Acomplia has no patent protection in India.
``It's too soon to tell what will be our strategy regarding the launch of Acomplia in India,'' said Sanofi spokesman Jean- Marc Podvin in a telephone interview. ``We've applied for registration. It has not been approved yet.''
Cadila began selling its version earlier this month for 5.50 rupees, according to a May 15 statement that was confirmed by the company. Torrent's pill sells for 8 rupees, the company said in a statement the same day.
Sales Target
Sanofi has said it is targeting sales of at least $3 billion a year from Acomplia and is counting on the medicine to drive profit growth. The drugmaker's three biggest products, the Lovenox anti-clot treatment, the Plavix blood-thinner and the Ambien sleep pill, are under threat from generics. The company's first-quarter profit fell 2.6 percent.
Acomplia, approved in Europe as a weight-loss aid for obese patients and people whose weight puts them at risk of diabetes and heart disease, has been delayed three times by U.S. regulators after being deemed approvable in February 2006.
Sanofi had wanted to introduce the drug under the name of Zimulti in the U.S. last year until the Food and Drug Administration said it needed more time to complete its review. A public hearing in June will discuss the drug's safety and efficacy as the first in a new class of obesity treatments. The FDA is expected to give its decision in July.
Acomplia belongs to a class of compounds called CB1 antagonists, which work through previously untried molecular pathways that help patients shed weight and control health risks linked to overweight. The medicine blocks receptors that regulate hunger and food intake in the brain as well as directly on fat cells. Sanofi used data from more than 10,000 patients to apply for approval.
Torrent did its own tests on more than 200 patients, concluding that the drug reduced weight by 6 kilograms (13 pounds) on average ``in the first few weeks'' of treatment.
Rimoslim ``is an extremely affordable therapy for the masses, unlike others that service on the niche, upwardly mobile population,'' Torrent said in its statement.
The Indian drugmaker estimates the market for anti-obesity products in its home country is growing at almost 50 percent a year.
Source: - http://www.bloomberg.com
