[Updated: 3:06 pm Pacific] Vivus will be the biotech company everybody’s watching tomorrow. That’s when the Mountain View, CA-based company (NASDAQ: [[ticker:VVUS]]) will go before a panel of expert advisers to the FDA, who will recommend to regulators whether Vivus has created a new obesity drug that’s good enough to be sold on the U.S. market, or whether it still has more work to do.
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 (NASDAQ: [[ticker:OREX]]) and Arena Pharmaceuticals (NASDAQ: [[ticker:ARNA]]). These three companies are in a heated race to break into what could be the mother of all pharmaceutical markets—obesity. An estimated two-thirds of Americans are overweight or obese, which costs the healthcare system billions of dollars, and puts people at increased risk for a host of related ailments like diabetes, heart attack and stroke, and depression, to name a few.
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 significant 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
