Data from Columbia Laboratories' Study for the Prevention of Preterm Birth to be Presented at the Society for Maternal-Fetal Medicine (SMFM) 2009 Annual Meeting
LIVINGSTON, N.J.--(BUSINESS WIRE)--Jan 29, 2009 - Columbia Laboratories, Inc. (Nasdaq: CBRX) today announced that the PREGNANT Study, Columbia's ongoing study to prevent preterm birth in pregnant women with a short cervical length, will be discussed at a scientific session of the SMFM Annual Meeting held in San Diego, California, January 26 - 31, 2009. In addition, further analysis of Columbia's first study in the prevention of preterm birth in women with a history of preterm birth will be presented during the course of the meeting. Investigators for both studies are scheduled to present three posters based on published abstracts.
Dr. Jason Baxter of Thomas Jefferson University Hospital, Philadelphia, will present and discuss the ongoing PREGNANT Study protocol in women with a short cervix in mid-pregnancy. Dr. John O'Brien of Central Baptist Hospital, Lexington, KY, is the sponsor of the three posters. The additional analyses presented in the posters underscore the safety profile of the use of the vaginal progesterone gel and establish that aspects of obstetrical history other than a history of preterm birth do not form the basis for identifying responders to progesterone. As previously presented the responders to progesterone appear to be the patients with objective measurements in the current pregnancy such as short cervical length.
The poster titles are: “Does Progesterone Supplementation Alter the Relative Frequency of Spontaneous or Indicated Preterm Birth?”; “Do Elements of the Obstetrical History Provide a Possible Indication for Progesterone Supplementation?” and “Natural Progesterone Administration and the Risk of Medical Complications of Pregnancy: Secondary Analysis from a Multinational, Randomized, Double Blind, Placebo-Controlled Trial.” The abstracts were published in the 2008 December issue supplement of the American Journal of Obstetrics and Gynecology.
“The publication of these findings strengthens our commitment to studying the benefits of administering vaginal progesterone for the prevention of preterm birth in women with a short cervix,” stated Robert S. Mills, Columbia's president and chief executive officer. “Currently there are no FDA-approved treatments available to prevent preterm birth, a serious unmet medical need. We believe PROCHIEVE® 8%, if approved for this new indication, will be an important drug in the fight against preterm delivery in women with a short cervix. Our ongoing PREGNANT (PROCHIEVE Extending GestatioN A New Therapy) Study is the largest clinical trial being conducted to determine whether natural progesterone delivered vaginally can prevent preterm birth in women with a short cervix at mid-pregnancy and improve infant outcomes.”
About Short Cervix
Women who have a cervical length of 3.0 centimeters or less when measured by transvaginal ultrasound in 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 in mid-pregnancy.
About PROCHIEVE ® 8%
PROCHIEVE® 8% (progesterone gel) is a bioadhesive product that utilizes Columbia's proprietary Bioadhesive Delivery System (BDS) to deliver natural progesterone vaginally in a convenient and patient-friendly, pre-filled, tampon-like applicator. By using a non-immunogenic (hypo-allergenic) bioadhesive polymer designed to adhere to the vaginal tissue, PROCHIEVE® 8% promotes controlled and sustained absorption of progesterone and minimizes leakage, a side effect commonly seen with vaginal suppositories. As a result, the product does not restrict normal activities.
PROCHIEVE® 8% contains 90 mg of natural progesterone. It is FDA-approved for progesterone supplementation or replacement as part of an Assisted Reproductive Technology (ART) treatment for infertile women with progesterone deficiency and for the treatment of secondary amenorrhea, and is safe for use during pregnancy.
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 www.prochieve8.com.
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 markets CRINONE® 8% (progesterone gel) and PROCHIEVE® 8% (progesterone gel) in the United States for progesterone supplementation as part of an Assisted Reproductive Technology treatment for infertile women with progesterone deficiency. The Company also markets STRIANT® (testosterone buccal system) for the treatment of hypogonadism in men. The Company's partners market CRINONE® 8%, STRIANT®, and three other products to additional U.S. and foreign markets. The Company's research and development programs include the PREGNANT (PROCHIEVE® Extending GestatioN A New Therapy) Study of PROCHIEVE® 8% to reduce the risk of preterm birth in women with a short cervix at mid-pregnancy and a vaginal lidocaine product to prevent and treat dysmenorrhea. For more information, please visit www.columbialabs.com.
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, and clinical research programs, which statements are indicated by the words “will,” “plan,” “expect,” “estimate,” “should,” “show,” and similar expressions. Such forward-looking statements involve 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® 8% (progesterone gel), PROCHIEVE® 8% (progesterone gel), and STRIANT® (testosterone buccal system) in the U.S.; the timely and successful development of new products, including vaginal lidocaine for dysmenorrhea, and new indications for current products, including PROCHIEVE® 8% to reduce the risk of preterm birth in women with a short cervix in mid-pregnancy; the timely and successful completion of clinical studies, including the ongoing Phase III PREGNANT (PROCHIEVE® Extending GestatioN A New Therapy) Study of PROCHIEVE® 8% in short cervix patients; success in obtaining acceptance and approval of new products and new indications for current products by the FDA and international regulatory agencies; 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.
PROCHIEVE®, CRINONE® and STRIANT® are registered trademarks of Columbia Laboratories, Inc.
Contact: Columbia Laboratories, Inc.
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Posted: January 2009