Navigation Links
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 th in this patient population. We also aim to publish the data from the recently completed trial in a series of manuscripts later this year and in early 2008."


PROCHIEVE(R) 8% (progesterone gel) is FDA-approved for progesterone supplementation or replacement as part of Assisted Reproductive Technology (ART) treatment for infertile women with progesterone deficiency and for the treatment of secondary amenorrhea. Several trials showing these benefits have been published. PROCHIEVE 8% is safe for use during pregnancy, and has been safely used by tens of thousands of women globally to help sustain pregnancy at the early stages for ten years.

The most common side effects of PROCHIEVE 8% include breast enlargement, constipation, somnolence, nausea, headache, and perineal pain. 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.

For more information, please visit

About Columbia Laboratories

Columbia Laboratories, Inc. is a U.S.-based international pharmaceutical company dedicated to the development and commercialization of women's healthcare and endocrinology products that use its novel bioadhesive drug delivery technology. Columbia markets CRINONE(R) 8% (progesterone gel) and PROCHIEVE(R) 8% (progesterone gel) in the United States for progesterone supplementation as part of Assisted Reproductive Technology treatment for infertile women with progesterone deficiency, and PROCHIEVE 4% (progesterone gel) for the treatment of secondary amenorrhea. The Company also markets STRIANT(R) (testosterone buccal system) for the treatment of hypogonadism in men. For more information, please visit

Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: This press release contains forward-looking statements about Columbia Laboratories, Inc.'s expectations regarding the Company's strategic direction, prospects and future results, which statements are indicated by the words "will," "plan," "expect" and similar expressions. Such forward-looking statements are subject to certain risks and uncertainties; actual results may differ materially from those projected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. Factors that might cause future results to differ include, but are not limited to, the following: the successful marketing of CRINONE(R) 8% (progesterone gel), PROCHIEVE(R) 8%(progesterone gel), PROCHIEVE 4% (progesterone gel), and STRIANT(R) (testosterone buccal tablet) in the U.S.; the timely and successful development of new products, including the clinical and regulatory path for possible development of PROCHIEVE 8% for the prevention of preterm birth; the timely and successful completion of clinical studies; the impact of competitive products and pricing; competitive economic and regulatory factors in the pharmaceutical and healthcare industry; general economic conditions; and other risks and uncertainties that may be detailed, from time-to-time, in Columbia's reports filed with the Securities and Exchange Commission. Columbia Laboratories undertakes no obligation to publicly update any forward-looking statements.

CRINONE(R), PROCHIEVE(R) and STRIANT(R) are registered trademarks of Columbia Laboratories, Inc.


Columbia Laboratories, Inc.
James A. Meer, 973-486-8860
Senior Vice President, CFO & Treasurer
Rx Communications, LLC
Melody A. Carey, 917-322-2571


Related medicine technology :

1. Columbia Laboratories Reports Positive Results from Multi-dose Pharmacokinetic Study of Vaginally-administered Lidocaine
2. Prolexys Pharmaceuticals and Columbia University Researchers Publish Study on Anti-Tumor Properties of a Selective Small Molecule Anti-Tumor Agent With Novel Mechanism of Action
3. Northfield Laboratories Reports Results of Pivotal Phase III Trauma Study
4. Forest Laboratories, Inc. and Cypress Bioscience, Inc. Announce Positive Results of Phase III Study for Milnacipran as a Treatment for Fibromyalgia Syndrome
5. Northfield Laboratories Investor Update
6. Corgenix Reports New Clinical Data Correlating AtherOx Technology With Vascular Disease
7. Cobalis Reports Phase III Trial Results for PreHistin in Seasonal Allergic Rhinitis
8. Cosmo Pharmaceuticals Reports Positive Preliminary Phase II/III Data with Rifamycin MMX in Infectious Diarrhea
9. Cytos Biotechnology Reports Results from Phase IIa Study with CYT003-QbG10 in Patients Suffering from Atopic Dermatitis
10. Cytokinetics Reports Additional Clinical Trials Data for Ispinesib
11. The European Myeloma Platform Reports New Survival data for Revlimid Presented at the International Myeloma Workshop in Greece
Post Your Comments:
(Date:11/30/2015)... Elbit Imaging Ltd. (TASE, NASDAQ: ... that it was informed by InSightec Ltd. ("InSightec"), that the ... approved its Exablate Neuro system to treat movement, pain ... --> Insightec,s Exablate Neuro platform is transforming medicine ... technologies: Focused Ultrasound, which is used to lesion the ...
(Date:11/29/2015)... 29, 2015   Royal Philips  (NYSE: PHG, AEX: ... at the 2015 Radiological Society of North America Annual ... Place in Chicago . Visitors to ... company,s broad portfolio of integrated Diagnostic Imaging, Clinical Informatics, ... clinical performance, improve workflow and create a superior patient ...
(Date:11/29/2015)... , Nov. 29, 2015 CIVCO Medical ... technology at the Radiological Society of ... Chicago November 29 – December ... designed to offer customers unrivaled versatility, enhanced user ... --> ...
Breaking Medicine Technology:
(Date:11/30/2015)... ... November 30, 2015 , ... It’s inevitable that everyone will ... close friend, or animal pass away, death lives among us. It is your perspective, ... from a family of 11 children, author T Sky understands that she may see ...
(Date:11/30/2015)... ... November 30, 2015 , ... Vasont Systems, a ... Universal Integrator (VUI) extension unites with Syncro Soft’s latest software update, oXygen XML ... continuous process with the latest release of oXygen® XML editor and the Vasont® ...
(Date:11/30/2015)... ... 2015 , ... GKhair & Tibolli team members and artists were excited and ... November 8th and 9th at the Puerto Rico Convention Center, San Juan Puerto Rico. ... top of the line fashion journalists. The San Juan Beauty Show carries immense credibility ...
(Date:11/30/2015)... CHICAGO, IL November 30, 2015 (PRWEB) , ... ... ... SpeechCheck and Winscribe are pleased to announce their strategic partnership at ... speech recognition consultants, SpeechCheck, Inc., and Winscribe, global providers of cutting-edge dictation ...
(Date:11/30/2015)... ... November 30, 2015 , ... CTI Group ... which empower organizations through communication analytics, announced today that their Proteus® VoIP QMS ... their service quality. , Proteus® VoIP QMS (Quality Management System) does ...
Breaking Medicine News(10 mins):