Behind the Sanofi-Aventis merger, a new blockbuster drug
September 4, 2004
By Mark Landler
FRANKFURT When the French drug company, Sanofi-Synthélabo, vanquished all other players last April with a long-shot takeover bid for a much larger French-German rival, Aventis, much of the commentary centered on the role played by the politicians in Paris.
The French government, determined to create a national champion in the field of pharmaceuticals, all but stage-managed the deal, insuring that the world's third-largest drug company, after Pfizer of the United States and GlaxoSmithKline of Britain, would reside in its backyard.
But this week, as Sanofi released promising test results for a new drug that fights both obesity and smoking, it has become clear that the $65 billion merger was about more than Gaullist bragging rights.
The new drug, which is known as rimonabant and will be marketed as Acomplia, could become one of the industry's once-in-a-decade blockbusters, according to doctors and analysts. Sanofi plans to file for regulatory approval in the second quarter of next year, which could put it on the market in 2006.
With 100 million people in the United States and Europe afflicted by obesity, the drug could generate up to $6 billion a year in sales by the end of the decade, according to some analysts. That would put Acomplia on the top shelf of the medicine cabinet, with the likes of Prozac and Viagra.
To sell such a wonder drug, especially in the huge American market, will demand a much larger sales force than Sanofi has by itself. Today, for example, the company relies on Bristol-Myers Squibb to market its best-selling drug, the blood-thinner Plavix, in the United States.
By acquiring Aventis, with its large U.S. sales force, Sanofi will be able to market Acomplia by itself, retaining all its sales and profits. Scarcely mentioned by Sanofi's executives when they announced the bid, this was one of the driving forces behind the takeover.
"We needed more muscle to sell such a product," Gérard Le Fur, the company's chief scientist and No. 2 executive, said by telephone. "We knew the first results of the trials back in January. Knowing that, it was more or less linked to the deal."
To be sure, Le Fur said, this was not the only reason to acquire Aventis. In a rapidly consolidating industry, Sanofi needed to become bigger anyway - a need underscored by the looming expiration of its trademark on Plavix. And nobody is revising the judgment that Sanofi benefited from old-fashioned industrial policy on the part of the French government.
But the tremendous promise of Acomplia, especially in the United States, adds a twist to the story. France's newest champion, it appears, will stake its claim to industry leadership in no small part by helping bulging Americans to reduce their waist lines and quit smoking.
"We Europeans, whenever we came to America, we always noticed the enormous number of obese people on the streets," said Jean-Pierre Bassand, a cardiologist who chaired the meeting of the European Society of Cardiology in Munich last week, where the results were presented.
"But now obesity is spreading all over the world, like wild fire," Dr. Bassand said. "Fifteen percent of French adolescents are obese. This is potentially a major breakthrough in treating this condition."
The results presented in Munich are striking: patients treated daily for one year with a 20 milligram dose of Acomplia lost an average of 8.6 kilograms, or 19 pounds, and reduced their waistlines by an average of 8.5 centimeters, or 3.5 inches. The drug also increased levels in the blood of HDL cholesterol - the so-called "good" cholesterol - by an average of 27 percent.
The doctors who took part in the trial said they were particularly excited by drug's shrinking effect on waist lines.
"We know that the deep abdominal weight in your belly is the dangerous fat that leads to heart disease and diabetes," said Luc Van Gaal, a professor of medicine at the Antwerp University Hospital in Belgium.
The European trial, involving 1,507 patients, reproduced results obtained in an earlier trial in the United States. Both turned up some evidence of side effects, ranging from nausea to diarrhea. But doctors involved in the tests said the effects were generally mild and transient.
The two other main anti-obesity drugs, Meridia and Xenical, have been hampered by more troublesome side effects: high blood pressure, in the case of Meridia, or soiling oneself, in the case of Xenical.
What makes Acomplia even more tantalizing is a trial in the United States which showed that the drug, taken in daily 20 milligram doses, can nearly double a patient's odds of stopping smoking. Moreover, those who quit gained little weight afterward - avoiding a common after-effect that has been a disincentive for smokers, particularly women, to give up cigarettes.
"It gives us another bullet in the gun," said Dr. Robert Anthenelli, an addiction psychiatrist at the University of Cincinnati and an investigator in the smoking trial. "It is totally unlike other medicines."
Rimonabant works by blocking a receptor, or type of trigger, which governs food intake and tobacco dependency. These receptors are located both in the brain and throughout the body, notably in fat cells. This system of receptors, doctors say, is disrupted by tobacco and chronic over-eating. The drug restores the balance in the system, reducing dependence on tobacco and suppressing appetite.
Since many smokers are also overweight, Acomplia would end up doing double duty in many cases.
"Smoking and obesity are the No. 1 and No. 2 killers in the western world," Dr. Anthenelli said. "This one medication has the power to combat both conditions, and that explains the excitement."
He cautioned that the smoking trial was only a ten-week test. Results from a six-month trial are not yet available. For that matter, Sanofi must still complete two-year tests of the drug's effect on obesity.
That leaves some doctors skeptical.
"I want to know what happens after the patients stop taking the drug," said Kevin Wei, a cardiologist at the University of Virginia. "Do they have a massive rebound in weight, or do they manage to keep it off? To counteract the effects of obesity, you need to keep the weight off for years or even decades."
Sanofi said it was confident that its two-year trial would show that the drug's effects are lasting. It plans to present those results at the annual meeting of the American Heart Association in November.
Still, there are other variables that could determine how profitable Acomplia ends up being. The Food and Drug Administration treats existing anti-obesity medications as lifestyle drugs, making ineligible for reimbursement under health-insurance policies. That has limited their sales.
Dr. Bassand, however, said Acomplia would likely only be prescribed to patients whose weight put them at risk of cardiovascular disease or other illness. "This will not be a Thursday pill for the Sunday beach," he said, referring to the wide array of over-the-counter weight loss remedies.
Noting that obesity was "more than an epidemic" in the United States, Le Fur of Sanofi said he was confident that the drug would be approved by the FDA, and that it would be reimbursed.
Sanofi will not estimate the sales potential of Acomplia, or how the sales will be distributed. Analysts, however, figure it will derive 60 percent of its sales in the United States and 40 percent in Europe.
Marc Booty, a pharmaceutical analyst at Commerzbank Securities in London, said that if Sanofi could sell Acomplia to five percent of the obese population in 2010, at a price equal to that of standard anti-cholesterol drugs, it would generate E5 billion, or $6 billion, a year. The New York Times
Source:www.iht.com
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