May 2, 2011 / 9:16 PM / 9 years ago

UPDATE 1-Vivus to submit Qnexa application as limited indication, shares up

* Says decided goals of Qnexa study with FDA

* Plans to resubmit Qnexa marketing approval in Q4 as lmtd indication

* Q1 loss per shr $0.12 vs est $0.15

* Shares up 6 pct after-market (Follows alerts)

May 2 (Reuters) - 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 bearing potential.

Vivus also narrowed its quarterly loss and beat market estimates, as it reduced research and development spending on its drugs.

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 Kakkrakandy)

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below