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Columbia Laboratories Advances Clinical Development of Lidocaine Candidate
Vaginally-administered Lidocaine Under Development to Prevent and Treat Dysmenorrhea
LIVINGSTON, NJ — November 7, 2006 — Columbia Laboratories (NASDAQ: CBRX) initiated a 42-patient clinical study of its vaginally-administered lidocaine candidate, which the Company is developing to prevent and treat dysmenorrhea. This study will evaluate blood levels obtained by Columbia’s vaginally-administered lidocaine formulation at each of three dose strengths over multiple doses.
“Our lidocaine candidate has shown impressive results in prior clinical studies,” said Robert S. Mills, president and chief executive officer of Columbia Laboratories. “With the current study, we hope to confirm that blood levels achieved by the highest dose strength over four doses are consistent with those predicted by the prior single-dose pharmacokinetic study. If this study is successful, we will then initiate a crossover Phase II/III trial with our lidocaine candidate. Not only will this Phase II/III trial be smaller and quicker than our previously planned Phase II trial, it may be acceptable as a Phase III trial, all compelling reasons why we selected this clinical pathway, and in line with our goal of speeding the path to market for our lidocaine product.”
The 42-patient cohort will be randomly divided into three groups, corresponding to the three different dose strengths of the lidocaine product candidate to be evaluated. These healthy volunteers will receive a lidocaine product candidate at one of those dose strengths on each of four consecutive days, the expected commercial dosing regime.
About Dysmenorrhea
Dysmenorrhea is characterized by recurrent uterine cramping and pain before and during menses. It affects 50% of menstruating women, and accounts for 600 million lost work hours and approximately $2 billion in lost productivity annually. Current treatments address the pain but not the underlying problem. Columbia’s hypothesis is that administering lidocaine vaginally, using its proprietary bioadhesive delivery system (BDS) technology, can minimize or prevent the severe cramping that results in the debilitating pain of dysmenorrhea.
About Columbia Laboratories
Columbia Laboratories, Inc. is a U.S.-based international pharmaceutical company dedicated to the development and commercialization of reproductive healthcare and endocrinology products that use its novel BDS technology. 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. The Company recently completed enrollment in a large-scale pivotal Phase III study to evaluate the possible utility of PROCHIEVE 8% in the prevention of recurrent preterm birth. This randomized, double-blind, placebo-controlled trial is the largest preterm prevention trial ever undertaken, and involves 669 patients at more than 60 centers globally. The Company’s additional research and development programs include a vaginally-administered 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: 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 as further described in the Company’s annual report on Form 10-K; 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 and clinical studies for our vaginally-administered lidocaine product candidate; 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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