Weight Loss Blog

The first potential new prescription weight-loss pill in more than a decade works, according to FDA staff who also flagged safety concerns that Wall Street deemed benign enough to bet the drug will ultimately hit pharmacy shelves.

The review from U.S. Food and Drug Administration staff on Tuesday, contained in documents released ahead of an FDA advisory panel meeting later this week, sent drugmaker Vivus’ shares up as much as 19.7 percent.

“The topics the FDA raised are in line with what we expected,” Leerink Swann analyst Steve Yoo told Reuters. He said “the likelihood of a positive panel vote has increased, which in turn increases the likelihood of approval.”

The potential market for Vivus’ experimental Qnexa is huge. More than two-thirds of American adults are overweight or obese (http://link.reuters.com/vup37m) and other attempts at diet drugs have fizzled.

If Qnexa wins the FDA’s seal of approval, analysts estimate it could take in nearly $689 million in sales by 2014, according to consensus forecast data from Thomson Reuters. The biotech’s current market cap is $931.5 million.

Current prescription and over-the-counter weight-loss drugs took in just $381.5 million in 2009, according to IMS Health.

Vivus wants to market Qnexa for adults to use along with diet and exercise. FDA staff reviewers said Qnexa clearly helped people shed pounds but pointed to possible side-effect issues, such as the impact on heart rate, depression and pregnancy.

On Thursday, an FDA panel of outside experts will discuss the safety issues and offer advice on whether to approve Qnexa. The agency will then make the final approval decision, which Vivus expects by October 28.

FDA usually, but not always, follows the advice of its expert panelists.

Whether the FDA ultimately approves the once-a-day pill could signal how the agency plans to assess the latest crop of obesity medicines after years of failed attempts and safety woes.

The FDA decision is also a clear test of the nearly 20-year-old biotech, which has seen its stock surge ahead of what could be a major product for the company since its only other U.S. drug was approved in 1996. Rivals are also eyeing the impact of Vivus’ review on their own pending diet drugs.

Anticipation has boosted shares of the Mountain View, California-based company. It has seen its shares more than double in the past year. Shortly before the close of trading on Tuesday, Vivus stock was up $1.88 or 17.7 percent at $12.53 on the Nasdaq, off an earlier high at $12.75.

It is unclear how much further the company’s shares could rise or where they could settle after the panel votes on Thursday. Analyst estimates for fair value ranged from $9 to $20.

JPMorgan analysts, echoing others, said the FDA staff’s assessment was “far more benign than most were expecting” and therefore was likely to boost Vivus shares.

ADJUSTING NOTORIOUS ‘FEN-PHEN’

Vivus is trying to improve on the notorious “fen-phen” diet drug by combining one of its ingredients — the appetite suppressant phentermine — with the anti-seizure drug topiramate. Fen-phen’s other ingredient, fenfluramine, was pulled from the market after being linked to serious heart valve problems.

All three doses of Qnexa were “efficacious for weight loss,” FDA staff reviewers said. But they added that there are five areas of safety concerns, including the effect on pregnant women and psychiatric side effects such as depression.

Attention span, memory and language problems as well as increased heart rate in Qnexa patients are also potential safety issues, the staff said in documents posted on the FDA’s website (http://r.reuters.com/fuf37m). The potential for increased body acids was also a concern.

Analysts said they were not especially surprised or concerned about the safety issues. JPMorgan analysts downplayed the slight increase in heart rate, given the drug’s “significant improvements” of other related cardiovascular measures such as blood pressure.

But Favus Institutional Research LLC analyst Elliot Favus said the FDA’s documents were “just a laundry list of safety concerns,” adding that approval seemed unlikely.

FDA and its advisers’ action of Vivus’ drug could also signal what lies ahead for Arena Pharmaceuticals and Orexigen Therapeutics, two other obesity pill makers that have rival products up for U.S. review later this year.

Arena shares were up 11 percent, while Orexigen were up about 20 percent.

Currently available prescription diet pills include Abbott Laboratories’ Meridia, which carries warnings about high blood pressure and a risk of heart attack and stroke in some patients, and Roche Holding AG’s Xenical, which causes liver problems, uncontrolled bowel movements and gas.

Vivus’ ability to make its case to the FDA and its advisers is also a significant hurdle for the biotechnology company and its chief executive officer, Leland Wilson.

Qnexa would be the second U.S. drug for the company. Its erectile dysfunction suppository Muse won clearance in 1996 and took in $15.8 million in net U.S. revenue in 2009.

Vivus is working on another ED drug known generically as avanafil as well as other potential products for diabetes and sleep apnea.

Can Qnexa Be the Next Big Diet Pill?

Two Old Drugs Make One New Diet Pill - New Combination Pill for Weight Loss Shows Promise

Patients taking a novel diet drug that combines the stimulant phentermine with the anticonvulsant topiramate lost an average of 37 pounds over a year with significant improvement in a number of heart risk factors, according to an announcement Vivus, the developer of the drug.

In a trial known as EQUIP, which involved more than 1,200 morbidly obese patients, patients who received the drug, which has the brand name Qnexa, lost weight at every tested dose, but significant weight loss — 14.7 percent on average — occurred at the highest dose.

Results from a second trial involving 2,487 overweight and obese patients with hypertension, hyperlipidemia, or type 2 diabetes, known as CONQUER, showed an average weight loss 30 pounds with full dose of the drug combination.

When asked by ABC News and MedPage Today for a comment on the scant data reported by the drugmaker, Dr. Mitchell Roslin of Lenox Hill Hospital in New York called the results very impressive, noting that the reported weight loss approached that of the Fen-Phen combo drug that swept the diet drug market in the early 1990s.

But Fen-Phen fell as fast as it rose when the fenfluramine, which was the “Fen” in Fen-Phen, was linked to pulmonary hypertension and serious heart valve problems, which led to the drug’s withdrawal from market amid an avalanche of lawsuits.

Phentermine, a stimulant that acts as an appetite suppressant, has remained on the market, although as Roslin said, “it can increase blood pressure or make people feel jumpy.”

Dr. Carl Lavie of the Ochsner Heart and Vascular Institute in New Orleans also raised the caution flag about cardiovascular side effects of phentermine, which he said also has the potential to “cause rhythm disturbances.”

Topiramate is best known as an epilepsy drug, but Roslin said that it gained off-label traction when several published studies suggested the anticonvulsant had a beneficial “effect on binge eating and weight reduction.”

But Roslin said at least one company decided against pursuing a weight loss indication for topiramate when clinical trials found that while the drug did help people shed pounds, side-effects included drowsiness and memory problems.

“Thus the results of the combination are impressive,” Roslin said.

Lavie, agreed, noting that obesity itself is a major cardiovascular risk factor and the weight loss reported in EQUIP and CONQUER was “generally more than typically reported with other non-surgical therapies.”

But a number of questions were left unanswered by the data released by Vivus. Among these was the question: Will rebound occur when the drug is stopped?

Short-term safety looked good, Roslin said, but as long term use is needed to maintain weight loss, safety could become an issue.

Leland Wilson, president and CEO of Vivus said that based on the results from EQUIP and CONQUER trials which were “designed and executed after Special Protocol Assessments were completed by the FDA,” the company will file a New Drug Application with the FDA by the end of 2009.

Sources:
news.yahoo.com
abcnews.go.com