Columbia Laboratories Completes Enrollment in Pivotal Phase III Study
of Prochieve 8% to Prevent Preterm Birth
LIVINGSTON, NJ— August 1, 2006—Columbia Laboratories, Inc. (NASDAQ: CBRX) today announced it has completed enrollment in its randomized, double-blind, placebo-controlled Phase III study of Prochieve® 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® 8% to safely, effectively and tolerably prevent preterm birth in pregnant women who are predisposed to this problem. Prochieve® 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® 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®
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® 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® 8%, if approved for this new indication, will be an important drug in the fight against preterm delivery,” concluded Mills.
About Prochieve® 8%
Prochieve®
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®
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 U.S.-based international pharmaceutical
company dedicated to the development and commercialization of women's health
care and endocrinology products. Columbia markets Prochieve®
8% (progesterone gel) for progesterone supplementation as part of an 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®
(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® 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®
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®
8% (progesterone gel), Prochieve®
4% (progesterone gel), and Striant®
(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®
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®
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®
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®, Crinone® and Striant® are registered trademarks of Columbia Laboratories, Inc.
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