Life would be wonderful at Arena Pharmaceuticals if it truly were the biggest loser, to borrow a phrase from the NBC reality TV show on people who are trying to lose weight. But no matter how hard you look at it, the clinical trial data just doesn’t say Arena’s weight loss pill that helps people shed more pounds than rival treatments from San Diego-based Orexigen Therapeutics (NASDAQ: OREX) or Mountain View, CA-based Vivus (NASDAQ: VVUS).
So if you’re Arena, and you’ve invested 12 years and about $1 billion in developing a potential multi-billion dollar weight-loss pill, what do you do? The strategy is becoming clearer by the day. Arena (NASDAQ: ARNA) is talking a lot about its squeaky-clean safety profile suitable for a broad market, enough weight loss to get the attention of most primary care doctors, and a unique claim that its medicine is the only one that won’t raise patients’ blood pressure.
“We saw patients’ blood pressure actually decrease, which is unique in obesity studies,” says Jack Lief, Arena’s CEO. I spoke to Lief by phone yesterday during a break at The Obesity Society meeting in Washington, DC. “Doctors have told us that lowering the cardiovascular risk factors associated with obesity is very important.”
Advances like Arena’s in the battle against excess fat have been one of the big stories in biotech this year. Obesity is one of the nation’s biggest public health problems, with two-thirds of the U.S. population considered overweight. As I wrote last month, drug companies know the winner in this market might dominate the biggest pharmaceutical market ever. Public health officials say obesity often leads to diabetes, cardiovascular disease and all kinds of other ailments that cost the country billions of dollars, so there is sure to be some debate about how much bang society might get for the many bucks it will be asked to shell out for these drugs.
Whether any of the three companies can even reach the market is still an open question, because this market has also been a graveyard since Wyeth’s fen-phen drug combination was pulled from the market after patients suffered damaged heart valves in the 1990s. The most-prescribed treatment for obesity today is the 50-year-old generic stimulant phentermine, which raises blood pressure and can cause insomnia, Lief says. While Arena’s competitors appeared to show a greater magnitude of weight loss when they were compared with placebos, Arena says its drug can still compete, partly because the market is so big and underserved beyond the traditional diet and exercise regimens.
“We hear it from doctors over and over again, they need more tools in their toolbox,” says Dominic Behan, Arena’s chief scientific officer. Based on Arena’s market research surveys of physicians, they have found doctors want “something to help patients lose weight fast, it’s got to be safe, and you have to be able to stay on it long enough to achieve progress on the cardiovascular [goals].”
Arena announced fairly detailed results of two major clinical trials this year—one called Bloom back in March, and another called Blossom last month. The Bloom study enrolled 3,182 patients, and Blossom enrolled 4,008, so this combined database is what Arena plans to package together in its application to the FDA by the end of this year. Arena hasn’t yet said anything groundbreaking about the studies being presented at The Obesity Society, but I was curious what questions Lief and Behan were getting most often from physicians at the conference.
Unlike investors, who tend to focus on the percentage of body weight loss in relation to placebo, the doctors wanted to know how many pounds lorcaserin patients actually lost. The quick answer to that was 17.9 pounds on average for patients who stayed on lorcaserin a full year in the Bloom study, compared with 7.3 pounds in the placebo group. The Blossom study confirmed that figure, with 17 pounds of average weight loss among those who stayed on the drug a full year, compared with 8.7 pounds on the placebo.
The average weight loss numbers were more modest when researchers factored in the total patient population, including almost half of patients who dropped out early.
Even though Arena is maneuvering its drug so that it stands out for safety first, and its ability to help improve diabetic and cardiovascular health markers, Lief definitely doesn’t want to cede too much ground to his rivals when the discussion turns to raw weight loss. That’s going to be a big part of the equation that the FDA considers—along with safety—when it combs through all of the new drug applications. And so will doctors.
“Investors have it all wrong when they think lorcaserin had modest efficacy. It’s not true,” Lief says. “This is not a wimpy weight loss drug. It’s an effective agent.”
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