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Columbia Laboratories Completes Enrollment in Pivotal Phase III Study of Prochieve 8% to Prevent Preterm Birth

Posted on: Tuesday, 1 August 2006, 09:00 CDT

Columbia Laboratories, Inc. (NASDAQ: CBRX) today announced it has completed enrollment in its randomized, double-blind, placebo-controlled Phase III study of Prochieve(R) 8% (progesterone gel) for a new indication, the prevention of preterm birth. This large-scale global trial involves over 600 patients at more than 60 centers throughout the United States, Europe, South America, Asia and South Africa. It is designed to assess the ability of Prochieve(R) 8% to safely, effectively and tolerably prevent preterm birth in pregnant women who are predisposed to this problem. Prochieve(R) 8% is currently FDA-approved and commercially available to treat infertility and secondary amenorrhea.

"We are very pleased to have completed enrollment for the Prochieve(R) preterm study two months ahead of our stated guidance," said Robert S. Mills, Columbia's president and chief executive officer. "This achievement resulted from an intense, sustained joint effort by Columbia's clinical team and the study coordinators and participating physicians. We eagerly await the advancement of our last patient's pregnancy, which should reach the 37 week gestation mark in December 2006, and are simultaneously developing our strategies to launch and market Prochieve(R) 8% for this possible new indication. We look forward to announcing initial results from this study in late first quarter or early second quarter 2007. Assuming positive results, we will compile and submit the dossier for a label indication with the FDA in mid-2007.

"Our commitment to Prochieve(R) 8% for the prevention of preterm delivery is strong and unwavering. This natural progesterone product has a proven safety record in pregnant women and can be easily self-administered at home. We believe Prochieve(R) 8%, if approved for this new indication, will be an important drug in the fight against preterm delivery," concluded Mills.

About Prochieve(R) 8%

Prochieve(R) 8% (progesterone gel) is a bioadhesive product that utilizes Columbia Laboratories' proprietary Bioadhesive Delivery System (BDS) to deliver natural progesterone vaginally in a convenient and easy-to-use, pre-filled, tampon-like applicator. By using a non-immunogenic (hypo-allergenic) bioadhesive polymer designed to adhere to the vaginal tissue, Prochieve(R) 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(R) 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(R) 8% include breast enlargement, constipation, somnolence, nausea, headache, and perineal pain. Prochieve(R) 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 U.S.-based international pharmaceutical company dedicated to the development and commercialization of women's health care and endocrinology products. Columbia markets 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. The Company also markets Striant(R) (testosterone buccal system) for the treatment of hypogonadism in men. Columbia's products and product candidates utilize the Company's bioadhesive drug delivery technology, which is able to deliver a broad range of compounds, including peptides, across many of the body's mucosal surfaces to address numerous therapeutic areas. The Company is investigating the potential utility of Prochieve(R) 8% (progesterone gel) to prevent preterm birth and is developing a vaginally-administered lidocaine product to treat dysmenorrhea and pelvic pain. For more information, please visit www.columbialabs.com.

Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: Except for historical information contained herein, certain statements of Columbia Laboratories, Inc.'s expectations made in this press release, including those regarding the timing and potential results of the Company's Prochieve(R) preterm clinical research program, constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such forward-looking statements involve certain risks and uncertainties. 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 Prochieve(R) 8% (progesterone gel), Prochieve(R) 4% (progesterone gel), and Striant(R) (testosterone buccal tablet) in the U.S.; whether Prochieve is dispensed to patients of physicians on Serono's target list of fertility specialists at a rate of less than 10% the amount of Crinone(R) dispensed to those patients; the timing and size of orders for out-licensed products from our marketing partners; the timely and successful completion of clinical studies, including the Prochieve(R) 8% study for preventing preterm birth; success in obtaining acceptance and approval of new products and indications for current products by the FDA and international regulatory agencies, including acceptance and approval of an indication for preventing preterm delivery for Prochieve(R) 8% from the FDA; the timely and successful development of products; 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(R), Crinone(R) and Striant(R) are registered trademarks of Columbia Laboratories, Inc.

Source: Business Wire

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