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The company intends to submit the results at the annual meeting of the North American Menopause Society, NAMS in Nashville, to be held from Ocober11-14, 2006. Bio-E-Gel a fast-drying gel formulation of estradiol, the same estrogen produced naturally in women, was developed to be absorbed through the skin after topical application on the upper arm. In the study, Bio-E-Gel was administered using a metered dose applicator that delivers 0.

87 g of gel per actuation, thereby allowing for precise titration from dose to dose, the company noted. The Lincolnshire, Illinois-based Pharma Company said the Bio-E-Gel transfer study was conducted in accordance with U.S.

Food Drug Administration guidance. In the study, women applied Bio-E-Gel to their upper arm, and then had five minutes of vigorous arm-to-arm contact with their male partners at the application site either two hours or eight hours after application. Blood levels of estradiol measured in the men over a 48-hour period showed no change in Estradiol levels in the men after skin contact indicating that Bio-E-Gel is not transferred by vigorous skin-to-skin contact, the company noted.

In another part of this same study, the amount of Bio-E-Gel remaining on a woman's arm was measured two hours and eight hours after application. Results showed only a small fraction, 4.6 percent and 7.

8 percent of the applied dose remaining on the application site two hours and eight hours after application, respectively. In the final part of the study, when the application site was washed with soap and water eight hours after application of Bio-E-Gel the small fraction of estradiol remaining on the arm was further reduced to about 1 percent of the original dose. The company indicated that NDA for Bio-E-Gel currently is undergoing FDA review and includes data from the pivotal Phase III clinical trial of Bio-E-Gel and data from three additional clinical trials; a transfer study, a sunscreen study and a pharmacokinetic study.

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