* Says to resubmit Qnexa application in October
* Will not hold resubmission till Fortress study completion
* Shares up as much as 14 pct
(Adds details, stock movement)
Sept 15 Vivus Inc said the U.S. health
regulator allowed it to make an early resubmission of a new drug
application for its obesity drug Qnexa, sending the
biopharmaceutical company's shares up as much as 14 percent.
In October, the U.S. Food and Drug Administration denied
approval for the drug and asked for evidence that higher heart
rate associated with the drug does not increase the risk of
major heart problems.
Thursday's news would not only revive investors' hopes in
Qnexa, but also give a new lease of life to other obesity drug
makers -- Arena Pharmaceuticals and Orexigen
-- who faced FDA rejections last year.
While Vivus and Orexigen's drugs were thought to have
potential heart risks, Arena's drug was rejected on possible
The company, which had initially planned to resubmit the
application after completion of its Fortress study, said it
would now do so in October end.
The Fortress study analyzes the historical incidence of
birth defects in offspring of women treated with the drug
topiramate -- a component of Qnexa -- during the first trimester
Results from the Fortress study are expected in December and
validation expected in the third quarter of 2012, the company
However, results from another recent study showed that
topiramate is not a major hindrance to the development of a
fetus, the company said.
Topiramate has been used to treat seizures and migraines and
is used in Qnexa in combination with phentermine.
The company said the FDA also permitted it to seek approval
for an initial indication that includes obese men and women of
non-child bearing potential, adding that FDA's advisory
committee meeting on the drug will be held in the first quarter
Shares of Mountain View, California-based Vivus have fallen
more than 20 percent since January when the FDA delayed Qnexa's
The stock was trading up 12 percent at $9.48 on Thursday,
making it one of the top gainers on Nasdaq. Orexigen shares were
up 5 percent, while Arena was trading up 4 percent.
(Reporting by Zeba Siddiqui and Esha Dey in Bangalore; Editing
by Roshni Menon)