Columbia Laboratories Comments on UNAIDS Condemnation of Nonoxynol-9 -N9- Products, Including Advantage-S, as Microbicides is Premature and Results From a Faultily Designed and Administered Study

Columbia Laboratories Comments on UNAIDS Condemnation of Nonoxynol-9 -N9- Products, Including Advantage-S, as Microbicides is Premature and Results From a Faultily Designed and Administered Study

Business Wire - July 12, 2000

MIAMI--(BUSINESS WIRE)--July 12, 2000--Columbia Laboratories (AMEX:COB) today commented in response to a press release issued by UNAIDS that Advantage-S is a sustained and controlled release formulation containing 52.5 MG of N9 per dose initially designed to be used once daily. WHO/UNAIDS conducted and published a study demonstrating it was safe to use at that dose (AIDS 1998, 12:433-437). Subsequently, a safety trial was conducted by UNAIDS administering the product four times per day in female sex workers and it again was judged to be safe. In the UNAIDS Phase III clinical trial no upper limit was put on dosing. In fact, the protocol encouraged women to use the product after each act of intercourse, which ranged from 0-20 per day. Women who used the product per-protocol may have used 10 or even 20 doses in a day. At this dose, previous studies have shown that N9 causes local lesions and is probably unsuitable as a microbicide. Advantage-S was designed to avoid this problem and by not limiting the dose to that which was tested and shown to be safe, the study encouraged women to dose themselves to a toxic level.

"Before UNAIDS condemns N9 per se or Advantage-S, careful analysis of the data should be conducted to see if there is a correlation between the dose administered and the increased risk of transmission of HIV," commented William J. Bologna, Chairman and CEO of Columbia Laboratories, Inc.

"The maximum tolerated dose that was studied in this population was four times per day. Under no circumstances should this dose have been exceeded. Despite this the investigators allowed and even encouraged women to dose themselves to known toxic levels. The most disturbing aspect of this study is that the statistical design was two tailed. This means that it was anticipated from previous studies that a toxic dose of N9 could be reached and thus, when a difference was seen in the interim analysis, the Drug Safety Monitoring Board (DSMB) was obliged to ensure that it was the active group and not the placebo that had a lower incidence of transmission. Their failure to do so is unpardonable and unethical. UNAIDS and the DSMB they appointed may have been grossly negligent in the manner in which they designed and monitored this study."

Columbia Laboratories, Inc. today called for the appointment of a team of outside experts to be given unfettered access to all the data from this study and to report their independent findings to the public at large. It is the Company's belief that this is the only manner in which the women who are the victims of this epidemic can be appropriately served.

Columbia Laboratories, Inc. is a U.S.-based international pharmaceutical company dedicated to research and development of women's health care products, including those intended to treat infertility, dysmenorrhea, endometriosis, 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. 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, 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, including the Company's Annual Report on Form 10-K for the year ended December 31, 1999.

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CONTACT: Columbia Laboratories, Inc., New York James Apostolakis, Vice Chairman & President 212/588-1900 or David Weinberg, Chief Financial Officer 305/933-6089 (Miami) or In-Site Communications, Inc., New York Lisa Carlton-Wilson, Investor Relations/Media Relations 212/759-3929
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