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Columbia Laboratories' CEO Comments on Preterm Birth Article Published in ACOG Journal Obstetrics and Gynecology

Posted on: Monday, 31 January 2005, 09:00 CST

Columbia Laboratories, Inc. (NASDAQ: CBRX) today commented on a study underscoring the benefit of using progesterone in the prevention of preterm birth. This study, entitled "Estimated Effect of 17 Alpha-Hydroxyprogesterone Caproate on Preterm Birth in the United States," was published in the February issue of Obstetrics and Gynecology, the journal of the American College of Obstetrics and Gynecology (ACOG).

"This study emphasizes the beneficial role of progesterone in the prevention of preterm birth in at-risk women, an issue with important health, safety, and economic implications. We commend the study authors for highlighting the need for new methods of reducing the incidence of preterm birth, to which Columbia is deeply committed," said Fred Wilkinson, president and chief executive officer of Columbia Laboratories. "Through our ongoing clinical study, PROTERM(TM), we are evaluating Prochieve(R) 8%, our commercially available natural progesterone gel, in the prevention of preterm birth in at-risk women and hope to answer many of the questions raised in this article."

Authors Joann R. Petrini, PhD, MPH, National Office, March of Dimes, et al used findings from a previous study that demonstrated a 33% reduction in preterm birth with weekly deep intramuscular injections of 17 alpha-hydroxyprogesterone caproate (a synthetic progestin) initiated between 16 and 20 weeks gestation. The Petrini study applied the 33% estimated reduction to 2002 birth rates data to estimate the number of singleton births delivered to women eligible for progesterone therapy, defined as those with a history of spontaneous preterm birth and prenatal care onset within the first four months of pregnancy.

From the analysis described in their paper, study authors estimated that of the 132,933 at-risk women who sought prenatal care in the first four months of pregnancy, 29,910 women would have had recurrent preterm births in 2002. They then calculated that if these women had been treated, 9,870 spontaneous preterm births would have been prevented. Petrini et al conclude that additional research is urgently needed.

About PROTERM

PROTERM(TM) (PROgesterone gel for reducing preTERM labor and delivery) is a multi-center, randomized, double-blinded, placebo-controlled Phase III clinical study designed to assess the efficacy, safety, and tolerability of Prochieve(R) 8% (progesterone gel) in preventing preterm delivery in pregnant women who are at increased risk for preterm delivery. The study protocol defines 'at risk' patients as those with a history of a spontaneous preterm delivery or a cervical length of less than or equal to 2.5 cm (as measured by transvaginal ultrasound) with the current pregnancy. Under the study protocol, patients are treated with either Prochieve 8% or placebo for approximately seventeen weeks, or until delivery. Treatment is initiated between 18 and 22 weeks gestation. The primary endpoint of this study is time to delivery.

PROTERM is designed to enroll 626 patients, and is currently enrolling patients at 15 study sites nationwide. Please visit www.PretermDeliveryTrial.com for additional information or to see if you may be eligible to participate in this study.

About Prochieve 8%

Prochieve(R) 8% (progesterone gel) is a bioadhesive progesterone gel that is currently indicated and commercially available to treat infertility and provide pregnancy support during the first trimester, and to treat secondary amenorrhea. Prochieve 8% utilizes Columbia Laboratories' proprietary Bioadhesive Delivery System (BDS) to deliver natural progesterone vaginally via a convenient and easy-to-use pre-filled, tampon-like applicator. Using a 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 and is a safe treatment option for women of reproductive age. Please visit www.Prochieve8.com for full prescribing information.

About Columbia Laboratories

Columbia Laboratories, Inc. is a U.S.-based international pharmaceutical company dedicated to the development and commercialization of women's health care and endocrinology products, including those intended to treat infertility, dysmenorrhea, endometriosis and hormonal deficiencies and to prevent preterm birth. Columbia markets Striant(R) (testosterone buccal system) for the treatment of hypogonadism in men, Prochieve(R) 8% (progesterone gel) for progesterone supplementation as part of an Assisted Reproductive Technology treatment for infertile women with progesterone deficiency, and Prochieve(R) 4% (progesterone gel) for the treatment of secondary amenorrhea. Columbia's products and product candidates utilize the company's bioadhesive drug delivery technology. In addition to investigating the potential utility of Prochieve 8% in the prevention of preterm birth, the Company's near-term product candidates include a vaginally-administered lidocaine product to treat dysmenorrhea and pelvic pain. The Company has developed a buccal delivery system for peptides. For more information, please visit www.columbialabs.com.

This press release contains statements that constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Those statements include statements regarding the intent, belief or current expectations of Columbia Laboratories and its management team. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those projected in the forward-looking statements. Given these uncertainties, investors should not place undue reliance on these forward-looking statements. Factors that might cause future results to differ include, but are not limited to, the following: the successful marketing of Striant(R), Prochieve(R) 8% and Prochieve(R) 4% in the U.S.; the timing and size of orders from our marketing partners; the timely and successful development of products; the timely and successful completion of the PROTERM(TM) study; success in obtaining acceptance and approval of an indication for preventing preterm delivery for Prochieve 8% by the FDA; the impact of competitive products and pricing; competitive economic and regulatory factors in the pharmaceutical and health care 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.

Striant(R) and Prochieve(R) are registered trademarks and PROTERM(TM) is a trademark of Columbia Laboratories, Inc.

Source: Business Wire

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