Vivus Says Weight Detriment With Tablet Unprecedented

GAITHERSBURG, Maryland (Reuters) – Vivus Inc, anticipating to win capitulation to sell the initial new medication diet drug in some-more than a decade, told U.S. healing advisers on Thursday its weight-loss tablet gives patients a protected choice for shedding pounds and mending their health.

Vivus is seeking Food and Drug Administration await to sell its drug, Qnexa, to adults to use once a day to slim down. But initial it contingency infer its tablet avoids side goods which have sidelined prior products.

The stakes are outrageous for Vivus and its investors, who have pushed the batch up some-more than 130 percent in the past year, drawn by the intensity for outrageous sales to millions of overweight Americans.

FDA's advisory row will import Vivus' interpretation prior to determining after on Thursday either to behind the drug. The FDA will import the advisers' opinion prior to creation a last decision.

Investors are additionally examination the row assembly for clues on the capitulation intensity for two opposition drug from Arena Pharmaceuticals Inc and Orexigen Therapeutics Inc, whose shares have additionally soared.

Arena shares were up some-more than 30 percent in early afternoon trade on the Nasdaq, whilst Orexigen was up 7 percent.

FDA staff mostly await the efficacy of Qnexa, the initial of 3 intensity new diet drug up for examination this year. But they are endangered about its outcome on fetuses, mental illness and heart rate. Memory detriment and alternative cognitive problems and physique poison changes are additionally vicious issues.

That assessment, expelled progressing this week, was cheered by investors who sent Vivus shares up scarcely 20 percent, betting the reserve issues were not vicious sufficient to keep Qnexa from pharmacy shelves. Trade in the shares was halted on Thursday sunrise forward of the FDA advisers' decision.

"The reserve risk compared with Qnexa are well known ... we did not comply any surprises," pronounced Vivus expert Neil Gesundheit, adding many patients saw at slightest 10 percent weight detriment when receiving the tablet along with a softened diet and some-more exercise.

Those who took the top sip for a year and did not give up over side goods mislaid a median of 15 percent of their physique weight, or rounded off 35-40 pounds, Gesundheit told panelists.

"These levels of weight detriment are unprecedented," he said.

If approved, Qnexa would suggest a intensity fat-fighting jump-start to the some-more than two-thirds of Americans who are overweight -- and would progress a scarcely 20-year-old biotech association which has not had a U.S. product authorized given 1996.

Last year, medication and over-the-counter diet drug took in usually $381.5 million, according to IMS Health.

If Qnexa gets the FDA's immature light, which figure could soar. Analysts guess it could see $689 million in sales by 2014, according to accord foresee interpretation from Thomson Reuters.

Current weight-loss drug have not gained many traction, as many usually trim a few pounds, but lift vicious or upsetting side goods such as heart risks or gas.

"It's transparent which we need new healing therapies to conduct the widespread of obesity," pronounced Louis Aronne, a Weill-Cornell Healing College highbrow who spoke on interest of Vivus.

Weight can be managed with diet and practice and operation is additionally an option.

'FOCUS ON SAFETY'

"In general, the FDA is in agreement with the association with apply oneself to the weight-loss goods of the drug," pronounced Eric Coleman, emissary executive of the FDA multiplication which oversees metabolic drugs. "The concentration is essentially on safety."

Qnexa's intensity to means inborn defects in unborn babies is a sold concern, generally given women of kid temperament age are the pill's aim customer.

So far, analysts have remained assured about Vivus' capability to strike reserve hurdles.

"The vicious cause in seeking at the interpretation is the huge good which (Qnexa) provides," pronounced Ira Detriment of Washington Analysis Corp, who follows the FDA for monetary clients. "The risks are not insurmountable. They can be managed."

Qnexa attempts to urge on the barbarous "fen-phen" diet drug. It combines one of fen-phen's mixture -- the ardour suppressant phentermine -- with the anti-seizure drug topiramate. Fen-phen's alternative ingredient, fenfluramine, was cold in 1997 when vicious heart valve problems emerged.

Patients receiving Qnexa saw in between 3 percent and 9 percent weight detriment over placebo, depending on how many of the drug they took, FDA staff said. Patients additionally saw softened red red blood vigour and softened fats and sugarine levels in the blood.

At slightest one panelist, University of California Los Angeles healing highbrow Sanjay Kaul, pronounced he longed for to have certain the probable risks did not shroud pounds lost.

Current diet pills embody Abbott Laboratories' Meridia, which carries multiform heart-related risks, and Roche Holding AG's Xenical, which causes liver problems and rash bowel movements.

"Imagine what a drug can do which doesn't have side goods and removes some-more weight," pronounced Leerink Swann researcher Steve Yoo.

(Additional stating by Susan Kelly in Chicago; modifying by Bernard Orr, John Wallace and Andre Grenon)

Related Video

For new drugs, see healthlifeandstuff.com - An research of what competence occur with the drug Qnexa from Vivus as it goes up for an FDA examination panel

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