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Columbia Labs Plummets on Negative FDA Review

WASHINGTON (AP) ? Shares of Columbia Laboratories plummeted more than 50 percent Tuesday after federal drug reviewers said the company's hormone-based gel appears to be ineffective for preventing premature birth.

Shares of the Livingston, N.J.-based company fell $1.30, or 54 percent, to close at $1.10.

The Food and Drug Administration said in an online review that Columbia Labs' drug failed to show a significant reduction in preterm birth among U.S. women tested in the company's trial. The company has submitted the progesterone-based gel, called Prochieve, as a treatment to reduce instances of non-full-term births by women with abnormally short cervixes. The company estimates the problem affects 10 to 12 percent of all pregnancies in the U.S.

On Friday, the FDA will ask a panel of outside experts to vote on the effectiveness and safety of the drug. The FDA is not required to follow the group's advice, though it often does. The FDA will make its final decision on the drug later this year.

Columbia is co-developing Prochieve with generic and specialty drugmaker Watson Pharmaceuticals Inc. Watson's shares ended down $4.23, or 7 percent, at $57.98.

 

Posted: January 2012


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