Vivus, Rival to Arena and Orexigen, Nails Big Results in Clinical Trials of Obesity Drug
The obesity drug competition just got tougher for a pair of San Diego-based companies. Shares of Mountain View, CA-based Vivus (NASDAQ: VVUS) shot up this morning after it said its experimental obesity drug helped people lose a substantial amount of weight in a pair of clinical trials with more than 3,750 patients.
Vivus reported the detailed results on its drug, a combination of phentermine and topiramate that it hopes to market as Qnexa, on a conference call with analysts this morning. 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, so these findings at first glance anyway, appear to clear that bar easily. The most common side effects were dry mouth, tingling, constipation, altered taste, and insomnia, Vivus said in a statement. People on the drug also saw improvements in the related health threats from obesity—high blood pressure, blood sugar, and cholesterol.
Vivus CEO Leland Wilson called the results “unprecedented.”
“This morning, Vivus released highly impressive Phase 3 results that exceeded our already high expectations and significantly differentiated Qnexa from the competition,” said Cory Kasimov, an analyst with JP Morgan, in a note to clients this morning.
Vivus shares rocketed more than 55 percent in pre-market trading after the announcement to $10.90. The news wasn’t as good for Vivus’s top two competitors in the obesity drug field—San Diego-based Arena Pharmaceuticals (NASDAQ: ARNA) and Orexigen Therapeutics (NASDAQ: OREX).
Arena is eagerly awaiting results from a trial of 4,000 patients this month, and is getting ready to apply for FDA approval by the end of 2009—the same time as Vivus. Orexigen is a little further behind, hoping to file its application in 2010. Both of those companies underwhelmed investors when they released the first results from their pivotal clinical trials earlier this year, although investors have bid up their shares with some more confidence as more data have been released in recent months.
All three companies are hoping to break new ground in one of the biggest potential pharmaceutical markets. About two-thirds of people in the U.S. are considered overweight or obese, largely because of the dangerous combination of a sedentary lifestyle and unhealthy diets. This has historically been a minefield for Big Pharma companies. Wyeth shelled out billions in legal settlements after the fen-phen diet drug combo was found to damage heart valves, and Sanofi-Aventis failed to win approval of another class of therapy in 2007 after regulators found rare cases of suicidal thinking among people on the drug.
Safety is critical for any obesity drug that might be taken by millions of people without an imminent life-threatening condition, so Vivus had to present a few slides to investors. There were no suicide attempts, and no indication of increased rates of suicidal thinking on the low or high doses of Qnexa, or in the placebo group, Vivus said. Depression scores improved for patients on Qnexa. Basically, there were no surprises, the company said.
There was a lot of data in the Vivus announcement, and it wasn’t made in a peer-reviewed journal or at a scientific meeting, so it’s always hard to draw absolute conclusions the way the market is doing this morning. We will see in the coming months how Arena and Orexigen—and other companies looking at the obesity market—will have to position their products now that Vivus has set what looks like a high standard. Vivus’ goal will be to get the data published in the New England Journal of Medicine, and present it at numerous medical meetings, Wilson told analysts.