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Advances in the Treatment of Serious Systemic Fungal Infections--An Update

Decision Resources, Inc, March 2005, Pages: 17

Opportunistic fungal infections are a major problem in immunocompromised patients. In recent years, the number of patients with severe immunosuppression has risen dramatically as a result of advances in the treatment of HIV/AIDS, cancer, and other conditions. Many strains of fungi are developing resistance to current drugs, especially fluconazole. As this public health problem reaches a crisis, the available drugs (polyenes, azoles, pyrimidines, and the emerging echinocandins) have become inadequate to meet the task. Only a few antifungals have received approval in the United States, and these agents have notable limitations, including narrow spectrum of activity, toxicity (side effects), and emerging fungal resistance. The significant market opportunity for antifungal drugs has attracted many pharmaceutical and biopharmaceutical companies to become involved in R&D.

This report gives an overview of opportunistic and endemic fungal pathogens, current therapies, and emerging strategies that aim to treat this growing patient population.

Business Implications
- Many different types of fungi can cause serious systemic infections in humans, and opportunistic fungal infections are now recognized as a major problem in immunocompromised patients. In recent years, the number of patients with severe immunosuppression has increased dramatically as a result of advances in the life-prolonging treatment of patients with HIV/AIDS, cancer, and other conditions.

- The first antifungal drug to be approved in the United States, amphotericin B, received FDA approval in 1958. Despite its toxicity problems, amphotericin B is still widely used to treat fungal infections, and new formulations are in development. Overall, the antifungal therapeutic market has been stagnating since the introduction of caspofungin (Mercks Cancidas) and voriconazole (Pfizers Vfend), both of which were approved in the United States in 2001.

- New azoles and echinocandins are in late-stage development, and many companies have novel antifungals in early stages of development that are based on a wide variety of approaches. Additional research is ongoing to identify novel targets for the treatment of fungal infections.

- Other factors are changing the antifungals market. The expiration of the patent for Pfizer’s Diflucan (fluconazole) and the emergence of generic versions will have an immediate impact on the competitive landscape. Other influential trends include the growing use of prophylactic and empirical antifungal therapy, and a widening interest in the potential for combination therapy. We anticipate significant changes in the antifungal therapy market over the next few years.



Introduction
Overview of Common Opportunistic and Endemic Fungal Pathogens
Current Therapies for Systemic Fungal Infections
Select Emerging Antifungal Therapies and Strategies
Prospects for Antifungal Therapies
Table 1. Select Fungi That Can Cause Serious Systemic Fungal Infections
Table 2. Select Antifungal Drugs for the Treatment of Systemic Fungal Infections
Table 3. Select Companies with Antifungals in Clinical Development
Table 4. Select Companies with Antifungals in Preclinical Development
Table 5. Estimated Worldwide Sales of Antifungal Products, 2003 and 2008 (millions of U.S. dollars)



- Ace BioSciences and Genmab
- Biodelivery Sciences International
- Diversa
- Ecopia BioSciences
- Elitra Pharmaceuticals
- Entomed
- Enzonb/Zeneus Pharma
- Fujisawaa
- Genelabs Technologies
- Helix BioMedix
- Immtech International
- Inhibitex
- InterMune Pharmaceuticals
- Janssen Pharmaceutica
- Janssen Pharmaceutica
- Merck & Co.
- MycoLogics
- Paratek Pharmaceuticals
- Pfizer
- Pfizer
- Schering-Plough
- Valeant Pharmaceuticals
- Vicuron Pharmaceuticals

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