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UPDATE 1-Columbia Labs shares up after data suggests new finding

Thu Apr 26, 2007 9:46am EDT

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(Recasts; adds CEO comments, details, share movement)

Regulatory News

April 26 (Reuters) - Shares of Columbia Laboratories Inc. (CBRX.O) jumped 23 percent on Thursday after it said another look at late-stage trial data suggested its progesterone gel may delay cervical shortening, a condition that may increase the risk of preterm birth.

In February, Columbia said it was dropping development of the gel, Prochieve, after a late-stage trial failed to meet its goal of reducing the rate of preterm birth in women with a previous preterm birth earlier than 35 weeks gestation.

The effect on cervical length was not the primary focus of the trial, the company said.

Chief Executive Officer Robert Mills said, "We are excited to share these unexpected findings, which may support the further development of Prochieve to prevent preterm birth in women with a short cervix."

The company is planning to meet with the U.S. Food and Drug Administration to explore the potential clinical and regulatory path for Prochieve to prevent preterm birth, Mills added.

Prochieve is already approved as part of a reproductive treatment for infertile women with progesterone deficiency and for secondary amenorrhea, the stoppage of menstruation in a woman who has previously experienced normal menses.

Shares of the company were trading at $2.88 in early morning trade on the Nasdaq. (Reporting by Supantha Mukherjee, Pratish Narayanan in Bangalore)



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