Bioavailability Systems - Redefining the Curve

History

BAS was founded in 1996 by James W. Harris, PhD and Robert A. Baugher as a limited liability company incorporated in Maryland. The company's goal was to pursue the identification and commercialization of active anti- First Pass Effect components in grapefruit. In 1997 Dr. Harris successfully isolated compounds from grapefruit demonstrated to be highly active through in-vitro tests as human CYP 3A inhibitors. The compounds are complex molecules containing an unusual spiro-ortho-ester (SOE) substructure. The structure of the SOE class of inhibitors was elucidated in May 1997 and the first of a series of patents was filed.

In 1998 and 1999 human clinical trials were conducted under dietary supplement protocols on the co-administration of a refined grapefruit extract with the HIV protease inhibitor saquinavir in healthy volunteers. These trials established proof of concept for the enhancement of the oral bioavailability of saquinavir with the observation of an average 40-fold increase of the blood concentration of saquinavir. The improvement in oral bioavailability was much higher than could be reasonably expected by drug delivery formulation technologies prevalent in the pharmaceutical industry. An investigation of synthetic chemical methods was commissioned that resulted in the first synthesis of these compounds. This success provided additional intellectual property related to methods of synthesis and manufacture.

BAS is now pursuing development of SOEs as pharmaceutical products in a number of applications in association with approved pharmaceuticals where oral bioavailability boosting will provide therapeutic and pharmacoeconomic benefit. A lead drug candidate has been selected. Initial clinical studies are scheduled for 2007.

Management

Simon F. Sellers, PhD, CEO and COO
Dr. Sellers has extensive management experience in the pharmaceutical chemical industry and commercial contacts with both the emerging and established pharmaceutical sectors. He has experience with chemical technology and business development, the licensing in and out of novel technology, as an R&D Director, as a sales and marketing team manager, and in the design and negotiation of supply contracts to the pharmaceutical industry. Previous roles have included Vice President & General Manager of Great Lakes Fine Chemicals and Vice President of Sales & Marketing for Catalytica Pharmaceuticals. Dr. Sellers earned his PhD in organic chemistry from the University of Birmingham, UK in 1979 and a MBA from the University of Florida, 1996.

James W. Harris, PhD, Founder and Chief Scientific Officer
Dr. Harris is a co-founder of BAS and the sole inventor of all BAS patents except the synthetic chemistry series. In 1996, Dr. Harris left the FDA in order to found Bioavailability Systems with Mr. Baugher, a lifelong friend and former employer. From 1991 to 1996, Dr. Harris worked for the FDA, Center for Drug Evaluation and Research, ultimately becoming a key member in clinical pharmacology research. During that time he published papers on the elucidation of the metabolism of Taxol™ by CYP 3A and the isolation of the principal Taxol™ metabolite. He became aware of the literature on the grapefruit effect and was sufficiently fascinated to seek a means of participating in the commercialization of the effect. Dr. Harris earned an MS and a PhD in Toxicology from the University of Rochester School of Medicine and Dentistry in 1989 and 1991 respectively, and a BS in Chemistry from Vanderbilt University in 1987.

Robert A. Baugher, Founder, Chairman of the Board and Managing Partner
Mr. Baugher has been the sole investor in BAS and is the majority shareholder. He has thirty years of business experience in a variety of retail, advertising, hotel industry and real estate development settings. Mr. Baugher served as a Director of the Prime Bank of Titusville, Florida from 1989 to 1998. In 1994, the Governor of Florida appointed him to the Florida International Trade and Commerce Committee. He earned a BA in Economics/Management from the University of South Florida in 1972.

C. Craig Tisher, MD, Chairman of the Medical Advisory Board
Dr. Tisher is an eminent nephrologist and Dean of the College of Medicine at the University of Florida. He is the Chairman of the BAS Medical Advisory Board and is in the process of recruiting three additional members with a strong level of transplant and clinical expertise. He holds the Folke H. Peterson Distinguished Professorship at the University of Florida. He is also the Director of the University of Florida Center for Clinical Trials Research. He was Chief, Division of Nephrology, Hypertension and Transplantation at the University of Florida from 1980 to 1997. Previously Dr. Tisher held positions at Duke University School of Medicine, Walter Reed Army Institute of Research and Washington University School of Medicine, St Louis. He was President of the American Society of Nephrology from 1990 to 91 and served as Editor of the Journal of the American Society of Nephrology from 1996 to 2001. Dean Tisher earned his MD from the Washington University School of Medicine in 1961. He is the author or co-author of more than two hundred articles, reviews and editorials.

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