* Says decided goals of Qnexa study with FDA
* Plans to resubmit Qnexa marketing approval in Q4 as lmtd
* Q1 loss per shr $0.12 vs est $0.15
* Shares up 6 pct after-market
May 2 Drugmaker Vivus Inc said it plans
to resubmit its application to market its obesity drug in the
fourth quarter as a limited indication, sending its shares up 6
percent after the bell.
The company also said it met with the Food and Drug
Administration on April 14 and agreed on the goals of a
feasibility study on Qnexa.
In January, the FDA asked Vivus to assess the feasibility of
analyzing existing databases to determine the historical
incidence of oral cleft -- commonly known as cleft lip -- in
offspring of women treated with topiramate. [ID:nN21201141]
Vivus's Qnexa combines topiramate, which has been used for
seizures and migraines, with another drug, phentermine.
The resubmission of marketing approval for Qnexa for a
limited indication would include only men and women of non-child
Vivus also narrowed its quarterly loss and beat market
estimates, as it reduced research and development spending on
Vivus reported a first-quarter net loss of $9.9 million, or
12 cents per share, compared with a net loss of $18.8 million,
or 23 cents per share, a year earlier.
Analysts on an average were expecting a loss of 15 cents per
share, according to Thomson Reuters I/B/E/S.
Shares of the Mountain View, California-based company were
trading up 6 percent at $8.25 in after-market trade on Monday.
They closed at $7.80 on Nasdaq.
(Reporting by Aniket Basu in Bangalore; Editing by Jarshad