Sanofi Bets Sales Growth on Pill to Curb Fat, Smoking
August 25, 2004
By Rohner, Gregori
Bob Berckman couldn't stop smoking for 31 years; 213-pound Karen Helmick was a chronic overeater. A new pill from Sanofi-Aventis SA quashed both habits, they said.
The experimental medicine, called rimonabant, controls cravings by blocking signals to the brain. Berckman, 44, a collection manager for Provident Bank in Cincinnati, and Helmick, 49, a grandmother from West Virginia, joined clinical trials for the treatment a year ago. He beat his pack-of-Marlboros-a-day addiction. She lost 30 pounds.
``I want a lifetime supply of this stuff,'' Helmick said in a telephone interview. ``It really works.''
Sanofi, the world's third-biggest drugmaker after taking over Aventis SA, estimates rimonabant may exceed 3 billion euros ($3.7 billion) in peak annual sales. Sanofi-Aventis, based in Paris, will show results Sunday from the largest rimonabant study to date, a 1,507-patient weight-loss trial, at the European Society of Cardiology conference in Munich.
Sanofi is looking to rimonabant to keep profits rising as its No. 2 product, the blood thinner Plavix, faces patent challenges, Chief Executive Officer Jean-Francois Dehecq said in April.
``There are a number of challenges to their portfolio, and they need something to take the focus away,'' said Morten Herholdt, a fund manager at Barclays Private Clients in London, which oversees $45 billion, including Sanofi shares.
Sanofi plans to seek U.S. Food and Drug Administration approval of rimonabant next year, after completing four more studies, said Douglas Greene, Sanofi's vice president of regulatory affairs, in a phone interview from Malvern, Pennsylvania.
Sanofi's 53.4 billion-euro purchase of Aventis adds a U.S. sales force of 4,400 to market rimonabant in the world's largest drug market. A successful introduction in the U.S. would help the company catch up with competing drugmakers, such as Pfizer Inc.
Catching Up
Aventis's sales per employee fell to $280,036 last year from $313,743 in 2002, while Sanofi got $273,064 in sales per employee in 2002, the last year data is available. New York-based Pfizer increased its revenue per employee to $370,390 last year from $330,340 in 2002, according to data compiled by Bloomberg.
Rimonabant, which Sanofi plans to sell with the brand name Acomplia, is at least two years from the market, as trials are completed. The most frequent side effect seen is nausea, which ``is usually transient and in the early part of treatment,'' Greene said.
Rimonabant targets two of heart disease's biggest risk
factors: obesity
and smoking. The market for heart medicines is worth
an estimated $73 billion, according to London-based
Datamonitor Plc.
``This drug has garnered a lot of interest from cardiologists,'' said Christopher Cannon, a cardiologist at Brigham and Women's Hospital in Boston and an associate professor of medicine at Harvard University. ``The reason is that it treats several cardiovascular risk factors for which we have very few treatments.''
Obesity, Smoking
Obesity
is closing in on smoking as a leading cause of death
in the U.S., where about 130 million people are overweight
or obese -- more than 20 percent over their ideal weight.
Obesity led to 400,000, or 16 percent of deaths in 2000
in the U.S., according to the U.S. Centers for Disease
Control and Prevention. Tobacco, the No. 1 killer, accounted
for 435,000 deaths.
``If this medicine is approved it will be a breakthrough in the way we treat cardiac risk factors,'' said Robert Anthenelli, associate professor of psychiatry at the University of Cincinnati Medical College, a lead researcher on early smoking-cessation studies of rimonabant.
Data from a U.S. study this year showed rimonabant helped obese patients lose an average of 20 pounds, compared with five pounds for patients on placebos.
More Positive Results
``There's no reason not to believe the European study will show at least as good results or may be even more effective,'' said rimonabant researcher Nick Finer, obesity specialist at Addenbrooke Hospital and research associate at Cambridge University in England, in an interview.
Rimonabant is the first of a class of drugs designed to block receptors of a substance called cannabinoid 1, suppressing the urge to overeat and other cravings. CB1 receptors are found in the brain and in fat cells, which also play a role in the complex signaling system urging the body to eat more than it needs.
Drug Difficulties
Sanofi won't disclose the costs of developing rimonabant. Drugmakers spend on average about $897 million to develop a new drug, according to the Tufts Center for the Study of Drug Development. They have struggled to come up with effective weight- loss medications. Treatments such as Roche Holding AG's Xenical and Abbott Laboratories' Meridia have side effects, such as diarrhea or constipation, that limit sales. Xenical sales have declined by a third since the drug was approved in 1999.
Sanofi wants to persuade doctors that rimonabant is more than a weight-loss or stop-smoking drug by keeping the focus on the medicine's heart benefits.
Studies show the medicine also raises levels of HDL, the so- called good cholesterol, Greene said. Targeting heart disease is also key to Sanofi's eventual marketing strategy, and the company is working with health authorities to get an FDA approval ``that reflects the medical utility,'' he said.
``They are certainly trying to medicalize the condition,'' said Denise Anderson, an analyst with Kepler Equities in Zurich. ``Reimbursement is not available if it's considered a cosmetic condition.''
Source:http://quote.bloomberg.com
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