Emerging Antibacterial Agents

Pharmacor -- January 2007

  Introduction:

The late-stage antibacterial pipeline is not keeping up with the increasing need for novel agents targeting drug-resistant bacteria. The maturity, high competition, and increased genericization of the antibiotic market have prompted many major pharmaceutical companies to reduce or eliminate antibacterial discovery and development programs. Meanwhile, the emergence of drug resistance among bacteria has significantly eroded the efficacy of current antibiotics. Infections caused by drug-resistant bacteria are associated with increased morbidity, mortality, and health care costs. In this report, we examine the early- to late-stage antibacterial pipeline to assess future prospects and identify potential winners and losers. The late-stage pipeline is skewed toward products targeting the crowded market of resistant gram-positive infections, but the true commercial opportunity may lie in novel classes in earlier stages of development.

  Questions Answered in This Report:

The antibacterial pipeline is dotted with more than 20 agents from novel drug classes. What novel strategies and bacterial targets are pharmaceutical companies exploring? What are the strengths and weaknesses of these approaches? Which novel classes will likely be the most successful? Against which drugs will they compete?

The variety and steadily increasing incidence of problematic drug-resistant bacteria demand new, powerful antibiotics. Which drug-resistant bacteria are fueling the unmet medical need in the community and hospital settings? Will the antibacterial pipeline deliver new agents to treat these pathogens? What do physicians view as the most critical drug resistance trends over the next ten years?

Vancomycin is the most widely used antibiotic in the treatment of hospital-acquired infections caused by suspected resistant gram-positive pathogens such as methicillin-resistant Staphylococcus aureus (MRSA). How will emerging anti-MRSA agents fare against vancomycin? Which of these agents is generating the most excitement among thought leaders? Given that vancomycin is available generically and is therefore inexpensive, will any of the emerging anti-MRSA antibiotics unseat vancomycin as the patient-share leader?

The patent expiries of several blockbuster antibiotics (e.g., azithromycin [Pfizer’s Zithromax], clarithromycin [Abbott’s Biaxin], levofloxacin [Johnson & Johnson’s Levaquin]) will greatly affect future market potential in the community sector. Do any of the emerging antibacterial agents hold enough commercial promise to fill the void left by the generic erosion of leading products?

  Scope:

Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.

Primary research: 44 country-specific interviews with experts in antibacterial drug development and treatment.

Number of emerging therapies covered in this report: Phase II: 12 drugs; Phase III: 14 drugs; preregistration: 1 drug. Coverage of 46 preclinical and Phase I products.

Pipeline analysis: By phase of development, class, novelty of mechanism, targeted market sectors, and type of company.

Market forecast features: Using a top-down model, we forecast drug sales (by country and by class) of the antibacterial market and estimate peak-year major-market sales of emerging agents.