Contents:

I Report overview and regulatory considerations The structure of the report is presented in this section along with additional resources that the reader may find useful. The regulatory approval process is reviewed including the basic steps required for new drug applications and for generic drugs. The approval process remains the gateway to the market and this critical test for any new product must be accomplished. II Physiology of bacterial and fungal disease The mechanisms of bacterial pathogenesis and currently used antibacterial strategies are described. The cell wall structures, often targets for the development of antibiotics, are reviewed for gram-positive and gram-negative bacteria. Colonization of host surfaces, the essential beginnings of the infection process, is discussed. Progression of infection, tissue invasion and tropism are examined along with the resulting disease process. This section reviews how bacterial infections are currently treated including the following strategies: Inhibition of cell-wall synthesis Inhibition of protein synthesis Interfering with bacterial metabolism Alteration of cell-wall permeability The review of physiology sets the stage for an examination of the mechanisms of bacterial resistance in all major antibacterial classes. Pharmacokinetic considerations of absorption, distribution, metabolism and excretion are presented as well as the principles of antibiotic therapy. The spectrum of antibacterial therapy along with potential adverse reactions is presented. Finally, mycology fundamentals and various systemic and topical antifungal therapies and potential adverse reactions are reviewed. III Strategies and technologies for developing new antibacterial and antifungal agents Antibiotic resistance is increasingly driving changes in the pharmaceutical market. Having become a developmentally dormant segment for at least 20 years, the rush to catch up is accelerated by the danger of resistance. With more than two dozen microbe genomes now elucidated, new strategies can be identified. Some of these novel approaches to treating and preventing infection may circumvent the barrier of resistance altogether. Certain technology strategies may offer broad treatment capabilities while others will focus on specific, difficult to treat infections. This section discusses issues such as: Emerging infectious diseases - highlighting the dramatic increases in specific resistant organisms Currently successful technology strategies and how these may be modified and expanded for improved clinical outcomes Examination of new classes of antibiotics, particularly those with a near-term potential market impact Review of the mechanisms of resistance and how these can be exploited to develop new technology strategies The section also includes a discussion of the factors forcing emergence of both resistance and new diseases. A summary of the new technologies under development by companies targeting antibacterial and antifungal opportunities is presented. IV Market overview and forecasts by therapeutic category The antibacterial and antifungal segments are subject to the larger forces that impact the entire pharmaceutical industry. The trends affecting the pharmaceutical market overall that will continue to operate for the pharmaceutical market as a whole and the antibacterial/antifungal market segment specifically are discussed. How increasing competition in certain antibacterial and antifungal may transform certain segments is discussed. The continuing impact of generics is analyzed and specific market segments are reviewed for both antibacterial and antifungals. This section presents sales forecasts of market segments by antibacterial and antifungal drug class. The underlying reasons for growth in each segment are discussed. Antibacterial classes include: Penicillins ß-lactamase inhibitors Cephalosporins Macrolides Quinolones General: broad and medium spectrum V Company Profiles The boom in genomic information is evidenced by the increased number of strategic alliances in the antibacterials and antifungals segment. Additionally, numerous companies have entered the market armed with a new understanding of the infectious process and technology born out of genomics, bioinformatics, and proteomics. Both major pharmaceutical companies and upcoming biotechnology companies are presented in this section. Comprehensive review of the leading companies developing antibacterial and antifungal drugs and discovery technologies Company alliances and deal structures Products on the market and in clinical trials Direct links to company Web sites (CD-ROM report version)

Companies Mentioned

Abbott Laboratories Alpharma Alza AM-Pharma American Home Products Antex Biologics Aronex AstraZeneca Aventis Bayer AG BioDelivery Sciences Bristol-Myers Squibb British Biotech Chiron Cubist Pharmaceuticals Daiichi Pharmaceuticals Dainippon Pharmaceutical Eli Lilly Faulding Fujisawa Ganeden Biotech Genome Therapeutics Gilead Sciences GlaxoSmithKline Hoffmann-La Roche Ibis Therapeutics Johnson & Johnson Kyowa Hakko Kogyo Mieji Seiki Kaisha SP Merck Microcide Pharmaceuticals Micrologix Biotech Millennium Pharmaceuticals Mycota Biosciences Mylan NewBiotics Novartis Novavax Pfizer Phage Therapeutics Pharmacia Phytera Sankyo Schering Plough SIGA Technologies StressGen Taisho Pharmaceutical The Liposome Company Tularik Unimed Versicor Xoma