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High-profile, quick-growing IBS drug shelved because of cardio risks.
FDA has asked Novartis to pull Zelnorm (tegaserod) from the market five years after its approval, eliciting a swift and surprised reaction from the Street and prompting debate about the role that DTC marketing might have played in the agency's decision.
Patients with severe cases of irritable bowel syndrome with constipation (IBS-C) might still be allowed to take the drug, and Novartis is stressing that there is "no causal relationship" between Zelnorm and heart attacks and stroke. "Even FDA said that this drug is appropriate for certain people with IBS-C," said Les Funtleyder, an analyst at Miller Tabak. "That sort of conciliatory tone right out of the gate kind of suggested that even they think it's a good drug."
In a research note, Funtleyder wrote, "We suspect it has as much to do with the company overmarketing the drug to consumers as it has to do with safety." Zelnorm became a household name when the Swiss drug giant began its visceral ad campaign featuring women baring their bloated stomachs with statements such as "Give me something different" penned in black Magic Marker. Bloating is one of the hallmarks of IBS-C, and patients were intended to make an immediate connection to the images. The fact that Zelnorm sales grew 37 percent in 2006 suggests that the ads hit the spot.
But not everyone agrees that the DTC ads were the culprit. "This category has had a difficult past--Lotronex, which also treats IBS, was pulled from the market and then reinstated," said Mark Senak, who specializes in regulatory issues at Fleishman-Hillard. GlaxoSmithKline's Lotronex (alosetron) was withdrawn in 2000 only to return two years later with promotion restrictions after patients protested. "I wouldn't be surprised if the same thing happens for Zelnorm. Patients in this space don't have a lot of treatment options."
Novartis is yanking Zelnorm from US and Canadian pharmacy shelves after a retrospective analysis of 18,645 patients showed more cardio events in the Zelnorm group than a placebo group (0.1 percent vs. 0.01 percent, respectively). But there are questions about the data. The rate of cardio events linked to the IBS treatment was no higher than what doctors expect to see in the general population, and occurred in patients already at high risk for heart attack and stroke.
Analysts removed Zelnorm sales from their models but were generally optimistic about its long-term prospects. "We believe the suspension of Zelnorm from the market will likely be temporary and is the result of a hyper-vigilant FDA in the post-Vioxx era," wrote A.G. Edwards analyst Joseph Tooley in a research report.
But Heather Brilliant, an analyst at Morningstar, cautioned that the sort of follow-up studies that FDA might request could take years to conduct. "This is a drug to treat a condition that's not life-threatening or severe," said. "There's no reason to take any kind of risk with a drug like this."
Still, she called the market reaction "severe"--Novartis stocks closed down 3.44 percent at $55.44 in Zurich on Monday--considering that the $561 million drug represents only about 1.5 percent of Novartis' revenue. But she added that it had been growing "very rapidly."
Funtleyder pointed to Novartis' recent approval setback with diabetes drug Galvus (vildagliptin) and generic competition to hypertension drug Lotrel (amlodipine). "You have to put this in perspective," he said. "There are a lot of other things going on."