COLUMBIA LABS' ADVANTAGE-24 NONOXYNOL-9 SPERMICIDE SLATED TO BE INTRODUCED in the U.S. in the second half of 1993, the company projects. Advantage-24 combines the formula of the company's Replens vaginal moisturizer with the spermicide nonoxynol-9. Columbia Labs does not yet have a marketing partner for the product. Speaking at an investor conference sponsored by Furman Selz in New York on April 21, Columbia Labs President William Bologna reported that, in clinical trials, Advantage-24 gel has a contraceptive efficacy rate "in excess of 95%." Bologna also suggested that Advantage-24's 1.5 g dosage level is effective for a longer period of time than other spermicidal gels on the market. Although Columbia Labs plans to initially market Advantage-24 in the U.S. as a spermicide, the company is looking at the product overseas as an agent used to prevent sexually transmitted diseases, Bologna said. The company is conducting clinical trials for the STD prevention indication in Europe, Bologna noted. Columbia would like to submit an NDA for the claim in the U.S. during the first quarter of 1994 once clinical trials have been completed. European submissions for the STD indication are planned for this year. The first round of efficacy trials for STD prevention involving seven centers in Europe has recently been completed, Bologna said. He told the investor group that the product "reduced transmission [of chlamydia] by at least 60%." Columbia Labs also is monitoring Advantage 24's ability to inhibit transmission of HIV, gonorrhea and syphilis. The company said it intends to test a total of 600 to 700 women in 12 different test centers. Columbia Labs' vaginal moisturizer Replens is currently being marketed by Warner-Lambert in the U.S. and Canada. "We had a slow but disappointing start with Warner Lambert," Bologna told analysts. He added that the company expected "to see some of the benefits in obvious success with consumers in the next few quarters." Replens is marketed to menopausal women and breast cancer patients whose drop in estrogen levels causes vaginal dryness. Vaginal moisturizers, such as Replens and Schering-Plough's Gyne-Moistrin, have not been included in FDA's OTC ingredient review. The company indicated that it would like to see the category included in a monograph. Also, Columbia is looking at expanding Replens labeling to include an anti-bacterial claim based on the product's ability to reduce vaginal pH. In clinical studies, Replens was able to reduce mean pH of study participants to 4.1. "Bacteria cannot thrive in an environment where the pH is below 4.7," Bologna explained to the conference. He reported that results of several trials will be presented at an international menopause congress in Stockholm on June 28. Replens currently is available in 10 European countries as well as in the U.S. The product will be launched in Germany and Japan in the next six months. In addition, since the product is marketed in a number of countries as an H&BA, Columbia said it has filed drug registrations "in more than 20 countries" in Europe, Africa and Asia as well as Australia and New Zealand. Another product in Columbia's U.S. pipeline is a Replens line extension, the vaginal moisturizer Feminesse, which contains the same formula as Replens. Feminesse will be marketed to younger women and promoted for the relief of vaginosis symptoms, namely vaginal discharge and odor. Feminesse is now sold only in the U.K.; Columbia does not yet have a marketing partner for the product in the U.S. The company said it intends to piggyback supplemental filings for Feminiesse onto pending Replens submissions in certain markets in the hopes of accelerating the approval process.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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