July 28, 2006
Harriet Krivit has struggled for 50 years with a compulsion to overeat. She says she’ll try almost anything to control it, even if dropping a few pounds is the best she can hope for.
Sanofi-Aventis SA’s prescription drug, Acomplia, may end her search. The pill, the first to damp food cravings by blocking signals in the brain, goes on sale in the U.K. this week, and Paris-based Sanofi says U.S. regulators will probably approve it this year.
“I’ve tried doctors, diets, Weight Watchers since its inception, and just go down the list of diet drugs,'’ says Krivit, 71, a retired publisher from Massachusetts whose weight fluctuates from 130 to 172 pounds. “Acomplia sounds like the kind of aid I’ve longed for.'’
While studies show Acomplia users only shed 14 pounds (6.3 kilos) on average, the drug may generate sales of more than $5.5 billion a year if Krivit is typical of those frustrated by failed weight-loss attempts. The growing number of overweight men and women bodes well for the pill, even though it may cause side effects such as depression.
“People think that there’s going to be some kind of magic pill they’re going to be able to take to lose weight or keep it off,'’ said Denise Simons-Morton, a researcher at the National Heart, Lung, and Blood Institute in the U.S. “They realize that diet and exercise are important, they just don’t want to do it.'’
Sanofi is relying on Acomplia to help offset revenue it may lose as early as 2008. The world’s third-largest drugmaker faces generic competition on products that make up about 40 percent of its operating profit, including the blood thinner Plavix, according to analysts at Deutsche Bank AG. Sanofi’s first-quarter earnings rose 54 percent to 2.17 billion euros ($2.72 billion).
`Truly Massive Market’
People who took Acomplia and cut their calorie intake shed an average of 14 pounds after a year and 2.4 pounds the second year, according to the largest study of the drug. That’s less than what people achieve by exercising and improving their diets, Simons-Morton said.
Patients who took part in the study had a body mass index of at least 27, which translates into a weight of more than 188 pounds for someone who is 5 feet 10 inches tall.
The drug industry hasn’t introduced a new diet pill since 1999, when Roche Holding AG received approval to sell Xenical.
“If there was a pill available that was safe, effective and made it easy to lose any weight at all, there would be a truly massive market,'’ said Dr. Steve Bloom, a researcher at Imperial College in London.
Doctors will probably face “extremely strong'’ pressure from patients to prescribe Acomplia, Bloom says. The demand is such that counterfeiters have already started selling fake versions of the medicine on the Web, the European Commission warned in March.
High Cholesterol
Acomplia sales may be bolstered by evidence that it can help with obesity-related problems such as high cholesterol, as well as the number of people who must slim down.
Sanofi insists Acomplia is meant to help people suffering from those deadly diseases, not as a way to fit into more fashionable clothes. The company says it plans, at the start, to limit sales of the medicine to patients who have high cholesterol or diabetes and monitor their reaction to the drug.
“It’s for obese or overweight patients with associated risk factors,'’ says Sanofi spokesman Jean-Marc Podvin. “It’s definitely not a cosmetic drug.'’
Sanofi shares have risen 6.8 percent in the past 12 months, compared with an 11 percent gain in the 15-member Bloomberg Europe Pharmaceutical Index. The stock fell 0.3 percent to 73.1 euros yesterday in Paris.
European Approval
Consumers spend about $30 billion a year to shed weight, according to the American Obesity Association. The estimate includes spending on diet foods, appetite suppressants, books and videos. About 40 percent of women are attempting to lose weight at any given point in time, the group says.
Jean-Francois Dehecq, chief executive officer of Sanofi, said in February he expects the medicine to generate about $3 billion in sales. Sanofi also wants to sell Acomplia to help people quit smoking, though regulators have rejected the company’s request for that use. Gbola Amusa, an analyst at Sanford C. Bernstein Ltd. in London, forecasts revenue of 4.4 billion euros by 2010.
Discount Pharmacy - Buy Pharmacy at discount prices including free shipping.Discount Pharmacy provides confortable and easy way to order discount pharmacy online.
European regulators approved Acomplia on June 21. After the U.K., where it goes on sale this week, the drug will become available in Denmark, Ireland and Germany, Sanofi said. The U.S. Food and Drug Administration has asked for more information before approving the pill.
Rising Obesity
In their recommendation, scientists who reviewed the drug for European regulators said patients showed improvements in blood-sugar levels and fat content that went beyond those attributable to weight loss. This suggests that the medicine itself leads to these results.
“If it helps overweight people with the other health problems they have, the drug has a good chance to be seen as a therapeutic medication,'’ said Orun Palit, who helps oversee $1.2 billion, including Sanofi shares, at AIG Private Bank Ltd. in Zurich. “With that in mind, the sales forecasts seem credible.'’
Almost 67 percent of U.S. adults are overweight, up from about 45 percent in the early 1960s, according to the U.S. Centers for Disease Control. A third of Americans between the ages of 20 and 74 are now considered obese, compared with 13 percent in the early 1960s.
Across the Atlantic, the trend is the same. The number of obese people has increased between 10 percent and 40 percent in most countries over the past decade, according to the European Commission.
Side Effects
Other weight treatments have failed to meet expectations. Xenical, developed by Switzerland’s Roche, also was hailed as a potential blockbuster, with analysts predicting annual revenue of more than $1 billion when the drug was introduced.
Xenical, hampered by embarrassing side-effects such as some patients’ inability to control bowel movements, generated sales of 635 million Swiss francs ($511 million) last year.
Acomplia hasn’t been linked to digestive disturbances like Xenical, which works by blocking fat absorption in the gut, but research indicates there are other side effects.
The Acomplia studies show users regain the weight lost once they stop taking the medicine, suggesting the drug may have to be taken for life.
Long-Term Use
Doctors say prescribing any treatment for long-term use is a concern. This may be especially true with Acomplia, because it works by blocking receptors throughout the body, which means people lose the urge to eat. Receptors that govern other functions also get shut down, Imperial College’s Bloom says.
“That’s one reason that some people get depression,'’ he said. “The worry is that there might be a Vioxx situation where you have a set of side-effects that are not seen in the clinical trials in limited numbers of people.'’
Merck & Co. withdrew its Vioxx painkiller in 2004 after a long-term study showed that the medicine was linked to a higher risk of heart attacks and strokes when taken over 18 months.
“Acomplia’s been given to 13,000 people but you just don’t completely know what happens when you give it to a million,'’ said Louis Aronne, a professor at Cornell University who does research on obesity medicines.
Doctors may hesitate to prescribe Acomplia to patients like Krivit, who suffers from neither diabetes nor high blood pressure, and wouldn’t be considered overweight at the moment, with about 140 pounds on her 5-foot-4-inch frame.
`No Quick Fix’
She says she will try to get the pill prescribed nonetheless — because controlling her weight has been a lifelong struggle.
“The amount of energy, effort and stress and cost that goes into preventing myself from expanding into a large, unhealthy person is enormous,'’ said Krivit, who lives in Nantucket, Massachusetts.
Krivit says she “walks everywhere'’ and tries to watch what she eats. People struggling to lose weight need to realize Acomplia is only an aid to help them achieve their goals, said JoAnne Foody, a cardiologist at Yale University in New Haven, Connecticut.
“Lifestyle interventions including exercise, behavior modification and reduced caloric intake should be mainstays in the battle against obesity,'’ Foody said. “Unfortunately, there is no quick fix.'’
Posted by toshko under Xenical News | Comments (0)
