Kronos Longevity Research Institute -KLRI- Changes Protocol for HRT Study

Business Wire,  August 16, 2004  

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LIVINGSTON, N.J. -- Revised KLRI Study Will Not Include Prochieve(R) 4% (progesterone gel); Prochieve 4% (progesterone gel) Selected for Second Study in HRT by Third Party Investigators

Columbia Laboratories, Inc. (Nasdaq:CBRX) announced today that the Kronos Longevity Research Institute (KLRI) and the principal investigators have revised the protocol of the Kronos Early Estrogen Prevention Study (KEEPS). The KEEPS protocol initially required a low dose of natural progesterone, by a non-oral route, in all study patients who had not undergone a hysterectomy and were receiving active estrogens. KLRI recently decided this study will now use an oral progestin that is currently approved for hormone therapy in perimenopausal women due to FDA requirements for collecting biopsy data under the initial study protocol.

Fred Wilkinson, Chairman, President and Chief Executive Officer of Columbia Laboratories, commented, "While we are disappointed by KLRI's decision to substitute another product for the bioidentical, micronized progesterone delivered by Prochieve 4%, we understand that the protocol change was in direct response to FDA's requirement for endometrial biopsies, which was not factored into the initial KEEPS design and budget."

"A second study evaluating HRT in a similar patient population with planned endometrial biopsies recently committed to using Prochieve 4% for the prevention of endometrial hyperplasia. This is a smaller scale study, of a shorter duration than KEEPS, which makes it possible to generate data sooner to accomplish our goal of securing expanded labeling for Prochieve 4% with the FDA. The lead investigators are awaiting final funding for this study and we look forward to disclosing additional details on this study before it begins," concluded Wilkinson.

About Prochieve 4%

Prochieve 4% (progesterone gel) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of secondary amenorrhea. Prochieve 4% utilizes Columbia Laboratories' proprietary Bioadhesive Delivery System to deliver micronized progesterone vaginally in a convenient and easy-to-use pre-filled, tampon-like applicator. Using a bioadhesive polymer designed to adhere to vaginal tissue, Prochieve 4% 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 4% contains 45 mg of natural progesterone. The most common side effects of Prochieve 4% when used in combination with estrogen include cramps, fatigue, depression, emotional lability, sleep disorder, and headache. Prochieve 4% 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.

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. Columbia markets Striant(R) (testosterone buccal system) for 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. The Company has developed a buccal delivery system for peptides. Columbia's products primarily utilize the company's Bioadhesive Delivery System (BDS) technology. 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 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. Such risks and uncertainties include, but are not limited to: the ability of third party investigators to secure funding for the aforementioned HRT clinical study; timely and successful completion of clinical studies; the acceptance and approval by the U.S. Food and Drug Administration of a label extension for Prochieve 4%; challenges and costs inherent in product marketing; 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.