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to lose weight before agreeing to pay for an obesity drug, then Orexigen intends to be on its toes. That’s because of that earlier clinical trial, the one with 793 patients, that Wall Street didn’t like at first blush, Narachi says.
That trial disappointed Wall Street because it showed that patients taking the Orexigen drug, a combination of bupropion and naltrexone, when combined with intense diet and exercise, helped patients lose a median of 9.3 percent of their body weight. That outcome was just shy of 5 percentage points better than a group of patients who lost 5.1 percent of their body weight on an intense diet and exercise alone. The FDA has said that’s the sort of difference it wants to see between from a new obesity drug.
That study met another FDA criterion for effectiveness, so it wasn’t a bust. But more importantly, the study’s use of intense diet and exercise could provide an important benchmark. It showed that the Orexigen drug could help people lose weight even beyond what they can achieve in a highly disciplined, clinical setting.
Obesity drug marketing used to be about pitching a product to people who mostly just wanted to shed some pounds. Now it’s mostly about affecting all the downstream consequences of obesity, and proving that a drug is most effective when combined with diet and exercise.
“We need to change the game,” Narachi says. “I want our team to think long-term about how we’re going to change the game, and it will take creative thinking.”
At times, the Orexigen CEO sounds more like a physician than a drug salesman. “We don’t expect it to go to people who are just overweight,” Narachi says. “Those patients should continue to try diet and exercise. Any pharmacological option needs to be considered carefully.”
Orexigen isn’t the only company with this idea. San Diego-based Arena Pharmaceuticals (NASDAQ: ARNA) also contends that its obesity drug can have beneficial effects on the heart while also helping people shed some pounds. “Now everybody is doing the right thing,” Narachi says.
Orexigen also still has a long way to go before its drug is on the market—it is still working on putting together what it hopes will be a bulletproof application to the FDA in the first half of 2010. While that’s ongoing, it’s talking to potential partners about co-marketing agreements, and drawing up its own marketing plans. It could be several years from now before we know if this strategy is really going to work in the marketplace. Narachi wasn’t about to make any big predictions on sales or market share.
“One year from now, we’re going to be closer to the market launch. We’re going to have a quality NDA [new drug application] filed,” Narachi says, adding that he’ll have more market research, cost-benefit analyses, and support from governments and payers.
Culturally, he hopes to see an even bigger shift away from the relentless search to lose weight for cosmetic reasons, and toward losing weight for important health reasons.
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