UPDATE: Vivus Reports Robust Data From Weight-Loss Drug
September 09 2009 - 9:59AM
Dow Jones News
Vivus Inc. (VVUS) said its Qnexa experimental weight-loss drug
showed strong results in two large-stage studies, setting the
company up to file for market approval in the potential
multibillion-dollar market.
The trials, which included about 3,750 patients studied over 56
weeks, sent Vivus shares up 59% as the data exceeded all of the
Food and Drug Administration's requirements for obesity treatments
and had a clean side-effect profile. Vivus will use the data, along
with a positive trial reported in March, to file for marketing
approval by year-end and seek a partnership to sell the drug in
late-2010 at the earliest.
"We will immediately begin discussions with global
pharmaceutical companies," Leland Wilson, chief executive of Vivus,
said on a conference call.
Shares of Vivus hit their highest levels in more than 10 years,
recently up $4.07 to $10.98.
Obesity is an enormous market with few widely used treatments on
the market. JMP securities recently projected Qnexa's annual sales
would hit $1.5 billion by 2015.
The news from Vivus is also pushing up VVUS's competitors in the
race to bring a new therapy to market: Arena Pharmaceuticals Inc.
(ARNA) is up 5% to $4.83, and Orexigen Therapeutics Inc. (OREX) is
up 4% to $8.49.
Although comparing the results of different clinical trials is
difficult, J.P. Morgan analyst Cory Kasimov noted that Vivus's data
compares "quite favorably" to its competitors.
"[The data] exceeded our already high expectations and
significantly differentiated Qnexa from the competition," Kasimov
wrote in a note to clients.
Under FDA guidelines for clinical trials of obesity treatments,
one of two goals must be met. A trial must show that at least 35%
of the drug group lost at least 5% of body weight, but that group
must be double the percentage of patients with similar weight loss
on the placebo. Alternatively, a study can show that patients had
an average weight loss that was at least five percentage points
higher than the placebo group's loss.
Unlike its competitors, Vivus met both requirements, a strong
result, and did so in both trials. The Equip study showed an
average weight loss 14.7%, or 37 pounds, and the Conquer study
showed a loss of 13.2% of body weight, or 30 pounds.
Qnexa is a combination of phentermine and topiramate, sold as
Topamax by Johnson & Johnson (JNJ).
Although the dosages used in Qnexa are significantly lower than
the approved uses of its components, observers have been watching
for side effects as Topiramate's label includes warnings about
psychiatric side effects including suicidal behavior.
Patients in both trials were regularly monitored for suicide
risk, with more than 38,000 assessments, but there was no signal
found at all, the company said.
The most commonly reported side effects in both trials were dry
mouth, tingling, constipation, altered taste and insomnia. There
was no pattern of serious adverse events in patients using the
drug.
The company highlighted that more people completed the study in
the drug treatment arms, than those taking a placebo, a
demonstration of its lack of side effects.
The studies also showed improvements in such risk measures as
blood pressure, lipid levels and type 2 diabetes.
Vivus is in a three-way race with Arena and Orexigen to develop
a new obesity treatment. Orexigen reported the successful outcome
of three major Phase III trials of its drug Contrave in July,
sending its stock up more than 50%.
Arena is planning to disclose results of a late-stage trial of
lorcaserin by the end of the month. In March, it reported the
success of an earlier trial, but results disappointed some on Wall
Street as the average patient lost 5.8% of body weight, or 12.7
pounds, compared to 2.2%, or 4.7 pounds, for the placebo group over
12 months.
The potential side effects of obesity drugs have made large
pharma companies cautious because of past disasters like the former
Wyeth (WYE) drugs, part of the notorious fen-phen combination,
which were linked to heart-valve damage and led to billions in
lawsuit settlements.
-Thomas Gryta; Dow Jones Newswires; 212-416-2169;
thomas.gryta@dowjones.com