Qnexa new weight-loss drug

 Vivus Diet Drug Trims 5% of Fat in Race for Approval (Update1)

According to Bloomberg Vivus Inc. said its experimental weight-loss drug Qnexa helped patients lose enough weight in studies to allow the biotechnology company to seek U.S. approval to sell the treatment this year.

Two 56-week studies counted patients on Qnexa who lost at least 5 percent of their weight, compared with how many on a placebo pill did the same. In one study, 67 percent of people taking the drug achieved that goal, compared with 17 percent on placebo. In the other trial, it was 70 percent, compared with 21 percent. The company’s shares rose as much as 74 percent in early New York trading.

Vivus is racing Orexigen Therapeutics Inc. Arena Pharmaceuticals Inc., both of San Diego, to introduce a new diet drug in the U.S., a market that might be worth $10 billion annually for a safe therapy that helps patients lose 10 percent of their weight in a year, said Needham & Co. analyst Mark Monane. Global obesity levels, linked to rising rates of diabetes and heart disease, will swell 75 percent to 700 million people by 2015, according to the World Health Organization.

“Obesity is one of the last true, broad-based consumer markets where you can get significant revenue,” , said Michael King, a New York-based analyst for Merriman Curhan Ford & Co., in an Aug. 20 telephone interview. Qnexa may generate global sales of $3 billion by 2016, he said.

Shares of Mountain View, California-based Vivus rose to as high as $12 in early Nasdaq Stock Market composite trading after the stock closed yesterday at $6.91. The shares traded at $11.30 at 7:25 a.m.

Final Stage

The Vivus studies reported today are the final stage of clinical trials generally required to seek U.S. regulatory clearance.

Patients who finished both studies followed a low-calorie diet and lost an average of 6 pounds after a year with a placebo. In one of the two studies, called Equip, people on the highest dose of Qnexa lost an average of 18 pounds when they completed the trial. In the second study, called Conquer, average weight loss on the higher dose of Qnexa was 30 pounds.

Qnexa combines a generic form of the appetite suppressant phentermine, a commonly prescribed obesity drug that was an ingredient in the recalled diet pill known as fen-phen, with the anticonvulsant drug topiramate, the generic form of Johnson & Johnson’s Co.’s Topamax, which is used to treat epilepsy and migraine headaches.

Greater Effect

While each of the ingredients in Qnexa have some weight- loss impact, the combination of the two “has a greater effect than either of the individual components,” King said.

Vivus plans to seek a partner — most likely a large pharmaceutical company — to market the drug if the study meets its goals, Chief Financial Officer Timothy Morris said in an Aug. 4 interview.

“The ideal target would be a global partner to make it easier to have a coordinated effort,’” Morris said.

In July, Orexigen said three studies found that at least twice as many patients lost 5 percent or more of their body weight on Contrave, compared with those who got a placebo, or dummy pill. The drug showed about a 5 percent difference in the mean weight loss of patients compared with those on a placebo.

Contrave is a combination of bupropion, a drug used for smoking-cessation and depression, and naltrexone, which is used to reduce cravings in opiate addicts and alcoholics. Orexigen said it plans to seek U.S. permission to sell the drug in the first half of 2010.

First to Seek

Arena Pharmaceuticals may be the first of the three companies to ask U.S. regulators to approve its obesity treatment, lorcaserin, when it files “late this year,” Chief Executive Officer Jack Lief told analysts during an Aug. 3 conference call. The company expects to release in September the results of the second of two pivotal, late-stage studies of lorcaserin that will be used to seek approval of the drug.

Lorcaserin is similar to, but chemically different from, fenfluramine, an ingredient in Wyeth’s combination diet-drug known as fen-phen, which was taken off the market in 1997 after being linked to heart and lung problems. Studies so far have demonstrated the Arena drug is well-tolerated by patients and shows no evidence of the heart-valve damage seen in fen-phen users, the company said.

Experimental data released by Arena in June showed lorcaserin met one of two benchmarks required by the U.S. Food and Drug Administration to show a drug’s effectiveness. The treatment helped 48 percent of patients — or more than twice the comparable placebo result — lose more than 5 percent of their total body weight, the study found.

Weight Loss

The average weight loss after one year for lorcaserin was 3.6 percent more than that of patients on a placebo. The results failed to meet a second FDA standard that an obesity drug has at least a 5 percentage point difference in weight loss between the drug and a placebo.

About 32 percent of Americans adults are obese, according to data from the Centers for Disease Control and Prevention in Atlanta. Medical spending for obesity was $147 billion in 2008, an 87 percent increase over the past decade, according to a government study published July 27 in the journal Health Affairs.

Paris-based drugmaker Sanofi-Aventis SA withdrew its weight loss drug Acomplia from the market in Europe last year after it was rejected by the U.S. Food and Drug Administration over reports of increased psychiatric disorders. New York-based Pfizer Inc. and Merck & Co. of Whitehouse Station, New Jersey halted development of similar drugs.

Amylin Pharmaceuticals Inc., of San Diego, is working on a drug that combines pramlintide, the active ingredient in its diabetes drug Symlin, with leptin, a hormone tied to hunger.

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