Columbia Laboratories Announces Submissions for Mutual Recognition Procedure in European Union for Striant SR.

LIVINGSTON, N.J. -- Columbia Laboratories, Inc. (NASDAQ: CBRX) has made submissions for the Mutual Recognition Procedure (MRP) in the European Union (EU) for Striant(TM) SR 30 mg Mucoadhesive Buccal Tablets for testosterone replacement therapy in men with primary or secondary hypogonadism. Striant SR, marketed in the US as Striant(R) (testosterone buccal system), offers a safe, effective and convenient option in testosterone replacement therapy for men suffering from a deficiency or absence of testosterone associated with hypogonadism.

The United Kingdom was the Reference Member State for the MRP, with approval in this first market achieved in February 2004; Striant SR has since been launched in that market by Ardana Bioscience, Ltd. Marketing Authorization licenses for additional EU countries are expected to be granted over the next twelve months beginning in late 2004.

"This marks another significant milestone for Striant and Columbia, and will pave the way for expanding the commercial availability of Striant beyond the US and U.K., where it is currently available," noted Fred Wilkinson, Chairman, President and Chief Executive Officer of Columbia Laboratories. "We believe the many benefits afforded by Columbia's novel delivery mechanism for Striant will position Striant as a highly effective competitor in the global market, and we are pleased to have completed the MRP submissions within our stated timeframe. In addition to Striant's ability to deliver steady-state testosterone levels in the blood well within the physiologic range, without titration, the product has a highly favorable safety profile and no transference issues."

Columbia will receive milestone payments totaling $1.35 million upon receipt of marketing approval in major European countries under the Company's 2002 license and supply agreement with Ardana Bioscience, Ltd. and 2003 license and supply agreement with Mipharm S.p.A. Ardana holds the license to market Striant SR in 18 countries within the EU, including the U.K. Mipharm will market, distribute and sell Striant SR in Italy. Columbia will also recognize revenues from the sale of Striant SR to these marketing partners following approval in each country, and will receive milestone payments totaling $2.8 million upon the achievement of certain cumulative net sales by its partners.

Filing for the MRP for Striant SR was based on clinical data generated from two clinical trials. A 12-week multicenter, open-label, single arm trial was conducted in the US to evaluate the efficacy, safety and tolerability of Striant in 98 hypogonadal men. Of the 82 patients who completed the trial, 86.6 percent had an average testosterone concentration within the physiologic (normal) range at the end of 12 weeks. Striant was also evaluated in a seven-day, randomized, multicenter, open-label European parallel trial in which 57 patients were treated with either Striant or Androderm, a testosterone replacement patch. At the conclusion of this trial, 97 percent of Striant patients had an average testosterone concentration within the physiologic (normal) range, compared to 56 percent in the Androderm group. The novel buccal delivery was well-accepted by patients in these clinical studies.

About Hypogonadism

Hypogonadism (low testosterone) can be caused by conditions associated with the testes, pituitary gland or hypothalamus gland, or by a genetic disorder. Signs and symptoms of hypogonadism can include decreased libido (sexual desire), erectile dysfunction (ED), fatigue, depression, reduced muscle mass, and osteoporosis. Testosterone replacement therapy helps to provide and maintain normal levels of testosterone.

About Striant SR

Prior to the introduction of Striant SR, patients with hypogonadism have been treated with transdermal patches, topical gels, injectable formulations of testosterone, or surgically-inserted testosterone implants. Striant SR utilizes Columbia's proprietary Bioadhesive Delivery System (BDS), including its patented progressive hydration buccal technology to deliver testosterone via the buccal cavity twice daily. This buccal delivery platform which may also be used to deliver other previously approved and marketed drugs that cannot be ingested. The controlled- and sustained-release buccal testosterone product (which has the appearance of a small monoconvex tablet) acts by rapidly adhering to the buccal mucosa, the small, natural depression in the mouth where the gum meets the upper lip above the incisor teeth. As it is exposed to saliva, the product softens into a gel-like form, which remains comfortably in place over each 12-hour dosing period. The product delivers testosterone through the buccal mucosa, where it is absorbed into the bloodstream and delivered directly into the superior vena cava (major blood vessel), bypassing the gastrointestinal system and liver. Striant SR is able to produce circulating testosterone concentrations in hypogonadal males that approximate physiologic levels seen in healthy young men. Because Striant SR is available in a single strength, no dose titration is required.

On June 19, 2003, the US Food and Drug Administration (FDA) approved Striant(R) (testosterone buccal system) mucoadhesive (CIII), the first-ever transbuccal (gum surface) treatment for testosterone replacement therapy in men for conditions associated with a deficiency or absence of endogenous testosterone, including hypogonadism. The U.K Medicines and Healthcare Products Regulatory Agency (MHRA) approved Striant(TM) SR 30 mg Mucoadhesive Buccal Tablets for testosterone replacement therapy in men with primary or secondary hypogonadism on February 27, 2004.

Important Safety Information

In the US pivotal trial involving 98 patients, the most frequent adverse events that occurred with an incidence of one percent or greater which were possibly, probably, or definitely related to the use of Striant were: gum or mouth irritation (9.2%), bitter taste (4.1%), gum pain (3.1%), gum tenderness (3.1%), headache (3.1%), gum edema (2.0%), and taste perversion (2.0%). A total of 16 patients reported 19 gum-related adverse events. Of these, 10 patients (10.2%) reported 12 events of mild intensity, 4 patients (4.1%) reported 5 events of moderate intensity, and 2 patients (2.0%) reported 2 events of severe intensity. Four patients (4.1%) discontinued treatment with Striant due to gum or mouth-related adverse events including 2 with severe gum irritation, 1 with mouth irritation, and 1 with "bad taste in mouth." The majority of the gum-related adverse events were transient and resolved within 1 to 14 days. Patients should be advised to regularly inspect the gum region where they apply Striant and report any abnormality to their health care professional.

Striant is not indicated for women and must not be used in women. Testosterone supplements may cause fetal harm. Striant should not be used in patients with known hypersensitivity to any of its ingredients including testosterone USP that is chemically synthesized from soy.

Androgens are contraindicated in men with carcinoma of the breast or known carcinoma of the prostate. Edema with or without congestive heart failure may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease. In addition to discontinuation of the drug, diuretic therapy may be required. Gynecomastia frequently develops and occasionally persists in patients being treated with androgens for hypogonadism. The treatment of hypogonadal men with testosterone esters may potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung diseases. Geriatric patients treated with androgens may be at an increased risk for the development of prostatic hyperplasia and prostatic carcinoma. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and therefore, insulin requirements.

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. The Company is developing 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 the 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, among other things, success in obtaining approval of Striant (TM) SR in European countries through the Mutual Recognition Process, the successful marketing of Striant(R) and Striant(TM) SR; the impact of competitive products and pricing; the timely and successful development of products; timely and successful completion of clinical studies; success in obtaining acceptance and approval of new products by the FDA and international regulatory agencies; and 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.

Striant is a registered trademark and Striant SR is a trademark of Columbia Laboratories, Inc.

Androderm is a registered trademark of Watson Pharmaceuticals.