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The Qnexa Question

Qnexa
Source: vivus.com
Qnexa

Some analysts had been telling clients recently that they thought Vivus' diet drug Qnexa could take the lead in the three-contestant race to get the next prescription diet pill on the market. But they didn't think it would take such a commanding lead.

This morning the biopharma company announcedthat some patients on Qnexa lost as much as 37 pounds or 14.7 percent of their body weight over 13 months. Plus, they had the added benefit of lower blood sugar levels, lower blood pressure and lower triglycerides.

As I suggested in my exclusive interview with Vivus CEO Leland Wilson it almost sounds too good to be true.

Before I go any further, when people hear results like that their first question is always, "When can I get it?"

Most analysts think the FDA could approve Qnexa by the end of next year.

These are the kind of results that, no doubt, will lead the mainstream media to refer to Qnexa as a "miracle pill" or "wonder drug."

But weight loss ain't gonna come in a pill.

Experts say you have to eat less, exercise more and, yes, maybe take a medication...or more than one. But, frankly, you can't expect to sit on your butt and have the pounds to magically melt away. There's also surgery, which my sister recently opted for. I spoke with her over the weekend, by the way, and she told me she's lost about 40 pounds, so far, but is still adjusting her eating habits to accommodate her much smaller and more restrictive digestive system.

One of the country's leading obesity doctors, Louis Aronne, says Qnexa may offer the biggest amount of weight loss sans surgery.

But every drug has side effects.

Qnexa is made up of two old drugs. One is what some refer to as the good half of the infamous Fen-Phen. In other words, the half that didn't cause the heart trouble that doomed that diet craze and cost Wyeth billions of dollars.

And the other ingredient is Johnson & Johnson's Topamax for migraines and epileptic seizures, which also has a history of side effects. You can bet the FDA will scrutinize the safety of Qnexa. But on a conference call this morning a Vivus official said the only apparent serious side effects he believes could be related to the drug in the two large studies were two patients with kidney stones and one with gallstones.

Arena Pharmaceuticals and Orexigen are also in the final stage of developing a diet pill, but their weight loss data don't come close to Vivus'. Wall Street likes to pick a winner and today it looks like it could be VVUS. But Dr. Aronne and others say the obesity market is so big, the need so great and individual patient responses are so different that there will be ample room on the market for all of them.

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However, if Vivus can win FDA approval and overcome any lingering public stigma or taint associated with even half of the name Fen-Phen, Qnexa just might be the next cocktail party-talk, diet pill sensation.

(Correction: An earlier version of this story reported that some of the patients had experienced 'higher' triglycerides. Actually the patients reportedly experienced 'lower' triglycerides. We have corrected the error.)

Questions? Comments? Pharma@cnbc.com and follow me on Twitter at mhuckman

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