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Columbia Laboratories Reports Preliminary Findings from the Ongoing,Data Analysis of the Phase III Clinical Study of PROCHIEVE 8%,(progesterone gel) to Prevent Preterm Birth

LIVINGSTON, N.J.--(BUSINESS WIRE)--Apr 26, 2007 - Columbia Laboratories, Inc. (NASDAQ: CBRX) today announced that preliminary results from the ongoing data analysis of the recently-completed randomized, placebo-controlled, double-blind Phase III clinical trial of PROCHIEVE(R) 8% (progesterone gel) for the prevention of preterm birth in women with a previous preterm birth earlier than 35 weeks gestation has revealed a possible effect of PROCHIEVE 8% in delaying cervical shortening. A short cervix (equal to or less than 3.0 centimeters as measured by ultrasound in mid-pregnancy) is a known indicator of increased risk for preterm birth; as the rate of cervical shortening increases during pregnancy, the risk of a preterm birth increases.

Although an effect on cervical length was not the primary focus of this trial, per the study protocol cervical length measurements were performed on all women at baseline and at 28 weeks gestation. Data from the study show a delay in cervical shortening in patients treated with PROCHIEVE 8%, and suggest a correlation between the cervical length data, progesterone administration, and both a reduction in the likelihood of preterm birth and an improvement in infant outcomes.

"We are excited to share these unexpected findings, which may support the further development of PROCHIEVE 8% to prevent preterm birth in women with a short cervix. It is estimated that of the 4 million pregnancies each year in the United States, 10 to 30 percent of pregnant women have a cervical length of 2.5 to 3.0 centimeters, in mid-pregnancy. This includes many women with first-time pregnancies, the group that suffers the largest number of premature babies each year," said Robert S. Mills, president and chief executive officer of Columbia Laboratories. "We are planning to meet with the FDA in the coming months to explore the potential clinical and regulatory path for PROCHIEVE 8% to prevent preterm bir
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