(BW) Nonoxynol-9 Products Discussed At FDA Advisory Committee Meeting, Including Columbia Laboratories' Advantage 24

(BW) Nonoxynol-9 Products Discussed At FDA Advisory Committee Meeting, Including Columbia Laboratories' Advantage 24

BUSINESS WIRE - 44 Montgomery St, 39th Floor, San Francisco, CA 94104; Tel: (415) 986-4422; FAX: (415) 788-5335 - Monday November 25 8:27 AM EDT

MIAMI--(BUSINESS WIRE)--Nov. 25, 1996-- -- Advantage 24 Effectiveness Studies Ongoing In International Phase III Clinicals Utilizing Design Recommended By FDA Committees -- Columbia Laboratories Inc today reported that at a meeting of the U.S. Food and Drug Administration's Nonprescription Drugs, Reproductive Health Drugs, Anti-Infective Drugs and Antiviral Drugs advisory committees held last week, safety data on Advantage 24(TM) was presented which showed that in testing by the United Nations Global program on HIV/AIDS (UNAIDS) and the National Institutes of Health (NIH), Advantage 24, unlike many other nonoxynol-9 products tested by UNAIDS and NIH, is safe even when administered four times a day.

Because of its favorable safety profile, Advantage 24 was the only product that UNAIDS selected for testing to determine its effectiveness against the spread of sexually transmitted diseases (STDs). Therefore, in May 1996, Columbia Laboratories and UNAIDS announced the initiation of an international Phase III clinical study of Advantage 24 for the prevention of the heterosexual transmission of the human immunodeficiency virus (HIV) and STDs in approximately 2,000 women. Additionally, the NIH is performing similar testing in Africa.

Advantage 24, which utilizes Columbia Laboratories' patented bioadhesive delivery system to deliver nonoxynol-9, is currently marketed in the U.S. by Lake Pharmaceuticals, Inc. and in Canada by Roberts Pharmaceuticals, as a long-lasting, vaginally-delivered spermicide, pursuant to strategic alliance agreements with Columbia Laboratories.

Columbia Laboratories Inc. is a U.S.-based international pharmaceutical company, dedicated to the development of women's prescription and over-the-counter products, including those which help prevent sexually transmitted diseases. Columbia's products primarily utilize the company's patented bioadhesive delivery technology.

CONTACT: Columbia Laboratories Inc., Miami Margaret J. Roell, Chief Financial Officer 305/860-1692

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