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FDA fears may prevent a showdown between two weight-loss heavyweights.
Last week brought bad news for Sanofi-Aventis's weight-loss drug Acomplia, which, in turn, was good news for the launch of GlaxoSmithKline's over-the-counter competitor, Alli. FDA's advisory committee unanimously voted against approval for Zimulti last Wednesday, but GSK's celebration may be cut short if the same curse that hangs over Acomplia--hard-to-market side effects--turns around and bites Alli in the butt.
The two drugs couldn't be more different. GSK's Alli (orlistat) inhibits the body's ability to absorb fat, while Sanofi-Aventis' Acomplia (rimonabant) checks the mind's urges toward excess eating. Both are vying for a big, fat piece of the $46 billion diet pie.
Approved for OTC use earlier this year, GSK's new golden child is really just a half-dose of Roche's Xenical, which showed only modest weight-loss benefits to begin with. Not that customers were unduly worried: On Thursday, its first day of national sales, shoppers were snatching up the $60 packs of Alli as fast as they could. Most buyers of the antiobesity pill were women--"and they're not fat," one pharmacist told the Los Angeles Times.
The Sanofi diet drug--renamed Zimulti after FDA nixed Acomplia as too close to accomplish--was the first in its class, though, blocking the same brain receptors marijuana chemical THC acts on. With its novel mechanism of action and solid efficacy data, this anti-munchies med was the talk of the industry, generating enormous media and consumer interest.
And that was music to the struggling French drug maker's ears. "Sanofi needs a new blockbuster to boost its future, and Zimulti was going to be it," said Hoover's Finance and Health Care Editor Nell Newton. In Europe, Acomplia sales topped $41 million last year, but the US market, with its high rate of obesity, promised to deliver that and more.
"The buzz was so positive that it was hard to believe," said University of the Sciences in Philadelphia professor Dr. Daniel Hussar. "This was going to be a miracle--it had to be too good to be true."
Meanwhile, Sanofi's supposed savior has been sitting on FDA's to-do list for a year and a half now--the agency must make a decision by July 26--and the future looks grim. Some panelists are even calling for a deadline extension until 2010. Sanofi shares plunged following the FDA committee's announcement.
All the hullabaloo stems from data that indicate suicidal thoughts, depression, and other mental problems were twice as prevalent in subjects on Zimulti. The FDA report also notes a risk of adverse neurological events like seizures, which is triggering a second look at the drug by the European Medicines Agency. Sanofi officials, not surprisingly, are offering a more positive take on the results, pointing out that there's no proof of a causal relationship between Zimulti and psychological malfunction. Still, they say they'll now give each subject in current studies a suicidality questionnaire at every checkup.
Newton isn't surprised by Zimulti's failure. "But I am still rather appalled by the stubbornness with which Sanofi is defending its product," she said, though she does understand the company's need for a cash cow to replace its blockbuster Plavix, which faces generics threats.
Even if Zimulti is eventually approved, a host of marketing issues lie in wait. There are already jokes about the difficulty of advertising a drug that makes you lose weight--and your mind.
While less serious, Alli's side effect is so unpleasant that Sanofi may be set to enjoy a tasty dish of schadenfreude. Because Alli prevents fat absorption, undigested fat passes through the body in some unappetizing ways. Glaxo has put $150 million toward marketing Alli, giving customers a flurry of recipes, online tools to record eating and lifestyle habits, and a blog (www.alliconnect.com)--not to mention some creative ways to soften the blow of the product's downside. The "bowel movement changes" that can result from eating too many French fries are not side effects, says the company; they're "treatment effects." GSK marketers, ever optimistic, are informing consumers that this is a sign they should be cutting back on the amount of fat in their diets.
Though the product is flying off shelves right now, Glaxo might need another $150 million round of advertising to coax dieters back. Even now, they're advising Alli takers to wear dark clothing and carry a spare pair of underwear--not necessarily a lifestyle change that dieters may want to make.
"Face it," Newton said, "anything that causes folks to have greasy skidmarks in their underpants is likely to bring with it some marketing headaches."