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ENROLLMENT COMPLETE IN COLUMBIA LABORATORIES' PHASE III STUDY OF PROCHIEVE 8% TO REDUCE PRETERM BIRTH
PREGNANT Study results expected around the end of the year LIVINGSTON, NJ — June 8, 2010 — Columbia Laboratories, Inc. (Nasdaq: CBRX) today announced it completed enrollment in the PREGNANT (PROCHIEVE Extending GestatioN A New Therapy) Study last week. This randomized, double-blind, placebo controlled Phase III clinical study is evaluating the safety and efficacy of PROCHIEVE® 8% (progesterone gel) to reduce the risk of preterm birth in women with a cervical length between 1.0 and 2.0 centimeters as measured by transvaginal ultrasound at mid-pregnancy. “We are pleased to have completed enrollment in this important clinical program,” said Frank C. Condella, Jr., Columbia’s president and chief executive officer. “All patients were enrolled at mid-pregnancy, so the last infant could be born as late as mid-November. We intend to report top line study results four to six weeks later. If data from the PREGNANT Study are positive, we expect to file an NDA for PROCHIEVE 8% in this new indication with the FDA in 2011.” The PREGNANT study enrolled 465 healthy pregnant women between the ages of 15 and 45 at more than 40 sites in 10 countries. Nearly half of the subjects were enrolled in the U.S. Subjects were randomly assigned to receive either PROCHIEVE 8% or placebo vaginal gel once daily until the earlier of 37 weeks gestation or delivery. The primary endpoint of this study is the reduction in the incidence of preterm birth at less than or equal to 32 6/7 weeks gestation vs. placebo. Secondary outcomes include improvements in infant outcomes, reductions in the frequency of neonatal morbidities, mortalities and admissions for preterm labor, and the reduction in the frequency of preterm birth at less than or equal to 27 6/7 and 34 6/7, an d less than 36 6/7, weeks gestation. Previous studies have shown that administering progesterone to women with a short cervix at mid-pregnancy can delay delivery and reduce the number of neonatal intensive care unit (“NICU") admissions and the number of days in the NICU, indicators of neonatal morbidity. One of every eight live born infants is born prematurely; short cervix is the single most important predictor of preterm birth. There are currently no products approved for the prevention of preterm birth. About Short Cervix Women who have a cervical length of 3.0 centimeters or less when measured by transvaginal ultrasound at mid-pregnancy are at increased risk for preterm birth. It is estimated that 10% and 30% of pregnant women have a cervical length of less than 2.5 and 3.0 centimeters, respectively, when measured at mid-pregnancy.
About CRINONE/PROCHIEVE CRINONE® 8% (progesterone gel) is currently used for progesterone supplementation or replacement as part of an Assisted Reproductive Technology (ART) treatment for infertile women with a progesterone deficiency. Patient preference for CRINONE 8% has been demonstrated in five clinical trials. This product is also available under the trade name PROCHIEVE®. For more information, please visit www.crinoneusa.com. The most common side effects of CRINONE 8%/ PROCHIEVE 8% include breast enlargement, constipation, somnolence, nausea, headache, and perineal pain. CRINONE 8%/ PROCHIEVE 8% is contraindicated in patients with active thrombophlebitis or thromboembolic disorders or a history of hormone associated thrombophlebitis or thromboembolic disorders, missed abortion, undiagnosed vaginal bleeding, liver dysfunction or disease, and known or suspected malignancy of the breast or genital organs. About Columbia Laboratories Columbia Laboratories, Inc. is a specialty pharmaceutical company focused on developing and commercializing products for the women’s healthcare and endocrinology markets that use its novel bioadhesive drug delivery technology. Columbia’s United States sales organization markets CRINONE® 8% (progesterone gel) in the United States for progesterone supplementation as part of an Assisted Reproductive Technology treatment for infertile women with progesterone deficiency and STRIANT® (testosterone buccal system) for the treatment of hypogonadism in men. Columbia's partners market CRINONE 8% and STRIANT to for eign markets.
On March, 3, 2010, Columbia entered into a definitive agreement to sell, subject to stockholder approval, substantially all of its progesterone related assets, including its preterm birth patents and applications, and 11.2 million shares of common stock to Watson Pharmaceuticals, Inc. (the “Watson Transaction”) for a $47 million upfront payment plus royalties of 10 to 20 percent of annual net sales of certain progesterone products. Additional payments up to $45.5 million can be earned by the successful completion of clinical development milestones in the ongoing PREGNANT Study, regulatory filings, receipt of regulatory approvals and product launches. Watson will fund the development of a second-generation vaginal progesterone product as part of a comprehensive life-cy cle management strategy. The closing of the transaction is subject to customary conditions, including approval by Columbia’s stockholders. Columbia will retain certain assets and rights to its progesterone business, including all rights necessary to perform its obligations under its agreement with Merck Serono S.A. On June 1, 2010, Columbia announced the signing of a $15 million subordinated term loan with Watson.
Columbia's press releases and other company information are available at Columbia's website at www.columbialabs.com and its investor relations website at www.cbrxir.com.
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