Apothecus Pharmaceutical Corp.: Government-Funded Study Shows N-9 in Film Form -- VCF Formulation -- Does Not Increase Risk of HIV Transmission in Women

Apothecus Pharmaceutical Corp.: Government-Funded Study Shows N-9 in Film Form -- VCF Formulation -- Does Not Increase Risk of HIV Transmission in Women

Business Wire - November 25, 2002

WASHINGTON--(BUSINESS WIRE)--Nov. 25, 2002--In one of the largest studies ever conducted of the spermicide nonoxynol-9 (N-9), it was demonstrated that N-9 in film form and marketed under the name of VCF(R) Vaginal Contraceptive Film(TM) does not increase the transmission of the AIDS virus.

Over one thousand women, most at high risk for transmission of AIDS, took part in the three-year, multi-million dollar study of an N-9 product in film form compared to placebo film, both used in conjunction with a condom. The study was sponsored by the National Institute for Health, the United States Agency for International Development, and the Mellon Foundation.

Results of the study, published in The New England Journal of Medicine (Roddy, RE, et al, N Engl J Med 1998: 339: 504-10), showed VCF did not increase the risk of being infected by sexually transmitted diseases (STDs) including HIV.

While VCF film is for the prevention of pregnancy and should not be used to prevent HIV or STD transmission, the study may be reassuring in light of reports on a recent study of contraceptive gels that showed that women who used N-9 in gel form had higher rates of HIV than those using a placebo (The Lancet, Vol 360, 9/28/02).

According to scientists at the company that manufactures VCF, a non-hormonal, over-the-counter contraceptive product, the differences in study outcome may be related to formulation. VCF is comprised only of purified water, glycerin, which is found in soap, and polyvinyl alcohol, a food-grade substance. Other N-9 products may contain more N-9 per dose, which may cause irritation. Or, the level of N-9 may be a factor. The dose of N-9 in VCF is 72mg. Further studies would be necessary to support these theories.

Dan Leon, president of Apothecus Pharmaceutical Corp., the maker and marketer of VCF, thinks the NIH study's finding is important to consumers everywhere.

"Because there are over three million unwanted teenage pregnancies alone occurring each year in the United States," says Mr. Leon, "we believe the results achieved by the VCF spermicide in film form is of vital importance in providing an effective, over-the-counter, non-prescription contraceptive which cannot be felt by either partner and which does not increase the transmission of the HIV virus."

Headquartered in New York, Apothecus Pharmaceutical Corp. is the world's leading manufacturer of pharmaceutical film. Apothecus manufacturers and markets the Number 1-selling vaginal contraceptive film and supplies an entire line of family planning products and other medications. For further information, contact (516) 624-8200.

CONTACT: Apothecus Pharmaceutical Corp.

Tom Leon, Chairman

Dan Leon, President

1-800-227-2393 or 516-624-8200

Frank Kappler, 415-777-4019, fkk2kpr@aol.com

SOURCE: Apothecus Pharmaceutical Corp.

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