Vivus says that its pivotal trials for the experimental weight-loss drug Qnexa hit their primary endpoints, providing the data the developer says it needs to win regulatory approval and sending its shares up 74 percent in early trading. Analysts say that the trial outcomes give Vivus a big advantage as it races other developers to win FDA approval for a drug that could earn $3 billion a year in one of the last big untapped drug markets.
Vivus mounted two late-stage, 56-week trials of Qnexa, tracking the percentage of subjects who lost five percent of their body weight among 3,750 people. The Qnexa groups scored 67 percent and 70 percent success rates, compared to 17 percent and 21 percent for the placebo arm. And in one group the average weight loss was an impressive 14.7 percent. The drug is a combo therapy that mixes the generic drug phentermine with the generic anticonvulsant topiramate.
"Obesity is one of the last true, broad-based consumer markets where you can get significant revenue," analyst Michael King tells Bloomberg. A drug that can spur 10 percent weight loss would have a big impact on a market that could potentially be worth $10 billion, a figure that has helped lure Orexigen Therapeutics and Arena Pharmaceuticals into the race for a new therapy.
- check out the Vivus release
- read the story from Bloomberg