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Columbia Laboratories' Announces the Reacquisition of the U.S. Rights to Its Aids Fighting Spermicide, Advantage-S.


Business Editors

AVENTURA, Fla.--(BUSINESS WIRE)--March 20, 2000

All lawsuits are settled with Lake Consumer Products,

its former distributor

Conference Call To Be Held

Columbia Laboratories (AMEX AMEX

See: American Stock Exchange
:COB) today announced that it has reacquired all U.S. rights to Advantage-S and settled all pending litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called litigation.
 with its former distributor Lake Consumer Products for $1.2 million in cash and stock.

In 1999, there were 14.8 million women with AIDS, worldwide, and their number is growing by more than 2 million each year. The development of safe and effective microbicides capable of preventing the transmission of HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States.  (the AIDS virus AIDS virus
n.
See HIV.
) and other sexually transmitted organisms in the vagina has been Columbia's priority. We believe that Advantage-S widens the range of safe sex choices available to sexually active people and most importantly Adv. 1. most importantly - above and beyond all other consideration; "above all, you must be independent"
above all, most especially
, empowers women in the fight against AIDS. The development of a polycarbophil based bioadhesive vaginal gel permits the reduction of the dose of nonoxynol-9 (52.5mg), thereby increasing the safety margin and simultaneously increasing the efficiency of virucidal activity.

The activity of nonoxynol-9 is based on the disruption of cell membranes, of both sperm and microorganisms. Nonoxynol-9, particularly at high doses, can cause disruption of vaginal epithelial cells Epithelial cells
Cells that form a thin surface coating on the outside of a body structure.

Mentioned in: Corneal Transplantation
 that can lead to irritation. The use of the bioadhesive technology to lower the dose helps minimize this problem. This unprecedented efficacy is the result of our patented bioadhesive technology (N-9 Anti-STD: Patent No. 5,667,492, expires 10/7/14); and continuation application (no. 08/870,653, filed June 6, 1997 pending). There are corresponding patents in the rest of the world. Only the polycarbophil bioadhesive technology potentiates the action of nonoxynol-9 on STD's and at the same time minimizes the potential for irritation.

The UN Global Program on AIDS (UNAIDS UNAIDS Joint United Nations Programme on HIV/AIDS ) has been studying the safety and efficacy of Advantage-S for the past six years. UNAIDS previously published (AIDS 1998, 12:433-437) a randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
 placebo-controlled safety study of this bioadhesive vaginal gel among 534 healthy volunteers. The product was administered once a day for 14 days. Overall epithelial disruption occurred in 3.5% of the active group and 3.4% of placebo users. The conclusion of the study was that Advantage-S was safe and associated with minimal toxicity when used once daily. Based on this trial, UNAIDS selected Advantage-S as the product to be evaluated for efficacy in the prevention in the transmission of the HIV virus and other sexually transmitted diseases Sexually transmitted diseases

Infections that are acquired and transmitted by sexual contact. Although virtually any infection may be transmitted during intimate contact, the term sexually transmitted disease is restricted to conditions that are largely
.

Previous attempts to protect against HIV infection with a higher dose nonoxynol-9 products failed to show a protective effect. The investigators concluded that this might be due to the high incidence of genital mucosal lesions, because at least in theory, they could enhance transmission of HIV.

UNAIDS will complete the multi-center, randomized, placebo controlled double blind study of women at high risk of HIV infection within 90 days. The Company is optimistic that this study conducted in Africa and Asia will demonstrate that the use of the patented nonoxynol-9 bioadhesive vaginal gel, Advantage-S, results in a statistically significant reduction in the transmission of the HIV virus and other sexually transmitted diseases such as Chlamydia chlamydia (kləmĭd`ēə), genus of microorganisms that cause a variety of diseases in humans and other animals. Psittacosis, or parrot fever, caused by the species Chlamydia psittaci, .

Columbia will hold a telephone conference on Monday, March 20th at 4:00pm ET for the investment community. Individuals wishing to participate in the teleconference should call 800-633-8556 after 3:50pm ET on March 20th. From outside the United States, call 212-346-6541. Replay of the teleconference will be available from March 20th at 6:00pm until March 21st at 6:00pm by dialing 800-633-8284 from in the United States or 858-812-6440 from outside the United States and entering 14714585.

Columbia Laboratories, Inc. is a U.S.-based international pharmaceutical company, dedicated to research and development of women's health Women's Health Definition

Women's health is the effect of gender on disease and health that encompasses a broad range of biological and psychosocial issues.
 care products, including those intended to treat infertility, dysmenorrhea dysmenorrhea

Pain or cramps before or during menstruation. In primary dysmenorrhea, caused by endocrine imbalances, severity varies widely. Irritability, fatigue, backache, or nausea may also occur.
, endometriosis endometriosis (ĕn'dəmē'trē-ō`sĭs), a condition in which small pieces of the endometrium (the lining of the uterus) migrate to other places in the pelvic area. , hormonal deficiencies and the prevention of sexually transmitted diseases. Columbia's products primarily utilize the Company's patented bioadhesive delivery technology.

This press release contains statements which 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 Company and its management team. Prospective 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, the successful timely completion of the study now being concluded by the UNAIDS group, 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.
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Geographic Code:1USA
Date:Mar 20, 2000
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