Vivus
The FDA's endocrinology and metabolic drug advisory panel will get to weigh the evidence for and against Vivus' combination treatment of phentermine and topiramate (Qnexa) at the Hilton in Gaithersburg, MD. The FDA has the final say on whether Vivus will be able to start selling this drug, and although it isn't required to follow the panel's advice, it usually does.
The tenor of the meeting, and the direction of the vote, will have a huge impact on the prospects for not just Vivus, but for a pair of feisty competitors from San Diego -- Orexigen Therapeutics
While diet and exercise are the mainstay treatments recommended by doctors, the drug industry longs to offer obese patients an easier (and more profitable) solution. Unfortunately, obesity drugs have proved to be a graveyard for innovation. The history dates back to the 1990s debacle Wyeth (now Pfizer) suffered with the fen-phen combo that damaged heart valves and created a multi-billion legal liability. One of the great hopes of the '90s, Amgen's leptin, went down in infamy (although it is being rekindled in a new combination by San Diego-based Amylin Pharmaceuticals). Another sad chapter was written a few years ago when Sanofi-Aventis failed to win FDA clearance for a weight loss drug because of rare cases of suicidal thinking in patients.
So if Vivus can persuade the FDA advisory panel that its drug is truly safe enough to be taken by millions of people with a chronic condition that isn't immediately life-threatening, and that the drug offers enough weight loss benefit to outweigh the side effects, it could have profound implications for anyone else developing weight loss drugs. Neither Vivus, nor Arena, nor Orexigen has a marketed product of their own, so their futures are riding on whether they can get FDA approval, and whether they can generate significant sales of these products.
"There's no obvious clear winner," Leerink Swann analyst Steve Yoo said, according to a post from Healthcare Digital on Monday. "If you look at different aspects, each drug shines."
Officials from Vivus weren't made available for interviews this week in advance of the big meeting.
The fact that Vivus isn't talking today hardly matters, because they'll have a lot to say tomorrow, and there's already a load of information on the drugs that is now public. I first wrote about Vivus' drug last September, when its stock boomed on results from a pair of clinical trials of more than 3,750 patients. The treatment helped patients lose an average of more than 10 percent of their body weight on a high dose, compared with less than 2 percent on a placebo in a pair of trials after a year of observation. The FDA typically likes to see at least a 5 percentage point advantage for obesity drugs over a placebo, so that beat an important FDA benchmark. The most common side effects were dry mouth, tingling, constipation, altered taste, and insomnia, Vivus said at the time. FDA staff reviewers, in briefing documents posted yesterday, said Qnexa helped people lose weight, but, as noted by Reuters, the FDA also pointed to the drug's possible effects on heart rate, depression and pregnancy.
It's the FDA staff's job to look as hard as they can for the fly in the ointment, and when the briefing document came out, Wall Street generally exhaled. Cory Kasimov, an analyst with JP Morgan who follows Vivus, wrote yesterday that FDA staff were "far more benign" in their questioning of the Vivus application than most investors were expecting. Vivus stock shot up 17% yesterday on five times the normal trading volume to close at $12.44, heading into tomorrow's panel meeting.
Besides tomorrow's panel, the next most important date to watch for Vivus followers is Oct. 28, the FDA's deadline to complete its review of its application.
The agency has its hands full reviewing this current crop of obesity drugs. Arena, which was the first to sign up a Big Pharma partner, is gearing up for its appearance before an FDA panel on Sept. 16, followed by its FDA review deadline of Oct. 22. Orexigen's big days on the calendar are a little further behind -- Dec. 7 for the advisory panel, and Jan. 31 for the FDA deadline.
As Leerink Swann's Yoo says, each of these drugs has advantages that it will use to try to persuade physicians that its drug is the best-in-class. There is going to be fierce jockeying in the marketing world over how to position these products in the minds of physicians and consumers. As I pointed out in this feature story last September, the companies were already rehearsing their TV commercial lines then. Vivus was positioning its product as the one likely to help people lose the most weight, Orexigen is hoping to say it helps treat related illnesses that stem from obesity (like diabetes), while Arena wants to pitch itself as the safest option for the masses.
I am not planning to cover the blow-by-blow of tomorrow's FDA advisory meeting, what with a bunch of other deadlines, and the fact that all the major newspapers and wire services will be sure to keep you informed about what the FDA panel has to say about the Vivus drug. I will plan to write a wrap-up story shortly after the wires move their headlines tomorrow afternoon. But this will be a major ongoing story we at Xconomy plan to watch in the months ahead, so stay tuned.
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