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Columbia Laboratories Completes Lidocaine Vaginal Gel Pharmacokinetics Study; Phase II Study Planned

Posted on: Thursday, 8 September 2005, 09:00 CDT

Columbia Laboratories, Inc. (NASDAQ:CBRX) today announced the successful completion of its lidocaine vaginal gel pharmacokinetics study. Lidocaine vaginal gel is under development by the Company for the prevention and treatment of dysmenorrhea and pelvic pain. The study results will determine the appropriate doses for the Phase II study now scheduled to start in the fourth quarter of 2005.

The completed pharmacokinetics study was designed to evaluate both the blood levels obtained by, as well as the relative safety from, 3 doses of lidocaine formulated with Columbia's patented bioadhesive vaginal gel. Positive clinical outcomes of one of those doses in a pilot study of the Company's lidocaine vaginal gel were published in the April 2005 supplement to Obstetrics & Gynecology, the Journal of the American College of Obstetricians and Gynecologists (ACOG).

"We are pleased to report that a single vaginal dose of lidocaine in our bioadhesive gel formulation is associated with blood levels for each of 3 doses studied that are well within an accepted range. In addition, the pharmacokinetic profile produced by our unique formulations supports a single daily dose," stated Fred Wilkinson, Columbia's president and chief executive officer. "The results of our work provide the foundation for moving forward with a once-a-day dosing regimen in dysmenorrheic patients. The positive clinical effects seen in our pilot study coupled with the relatively low blood levels in this pharmacokinetic study reflect the First Uterine Pass Effect(TM) response specifically provided by our patented technology."

About Dysmenorrhea

Dysmenorrhea is characterized by recurrent uterine cramping and pain during, and sometimes just before, a woman's monthly period. Symptoms usually last two to three days. This condition affects nearly one in six women worldwide, and is the leading cause of workplace and school absences.

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 8% in the prevention of preterm birth and 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 Company's clinical research programs, 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. 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:, timely and successful completion of clinical studies, positive results from subsequent lidocaine vaginal gel trials, the timely and successful development of products; success in obtaining acceptance and approval of new products and 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 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 First Uterine Pass Effect(TM) is a trademark of Columbia Laboratories, Inc.

Source: Business Wire

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