Community-Acquired Pneumonia: In a Crowded Generics-Dominated Market, Room for New Agents Still Exists

In the large respiratory tract infection (RTI) market, community acquired pneumonia (CAP) is one of the more favorable indications for antibiotic developers. CAP can be a gateway indication to the large outpatient RTI market as well as an indication with a sizable inpatient population. Shifting patterns in antibiotic resistance have resulted in the widespread use of broad-spectrum agents and will continue to drive the uptake of novel therapies. Nevertheless, CAP remains a difficult market to penetrate because it is highly mature, competitive, and composed of many safe and effective generic therapies. Thus, emerging therapies vying to enter this market must offer considerable improvements over current treatments on those end points and drug attributes that matter most to physicians--achieving this could mean the difference between lackluster sales and commercial success.

The main goal in the treatment of CAP is clinical success. What are the key primary and secondary clinical trial end points with which new therapies are evaluated? How do primary care physicians weight specific efficacy end points and other drug attributes in their prescribing decisions for CAP?

Levofloxacin (Johnson & Johnson’s Levaquin, Sanofi-Aventis’s Tavanic, Daiichi Sankyo’s Cravit) is the 2006 major-market sales leader for CAP. Will levofloxacin maintain its status as the market-leading agent through 2016? How will levofloxacin and other current therapies fare against emerging therapies? Will emerging therapies offer improvements in the efficacy end points and drug attributes that are most influential in physician prescribing decisions? If so, which drugs will suffer the most from entry of these new agents?

Based on its clinical profile, moxifloxacin is the 2006 clinical gold standard in our drug comparator model and will remain so through 2016 because of its superior clinical profile over the current and emerging therapies evaluated in this study. On what clinical attributes is moxifloxacin most differentiated from its competitors? What are the weaknesses of this therapy upon which emerging therapies can capitalize? Which emerging therapies, if any, pose the great threat to moxifloxacin as well as the other key current therapies?

Key drug development opportunity tested in our target product profiles for community-acquired pneumonia: An antibiotic with targeted activity against respiratory pathogens that does not affect bowel flora for the treatment of community-acquired pneumonia.

- Levofloxacin (Johnson & Johnson’s Levaquin, Sanofi-Aventis’s Tavanic, Daiichi Sankyo’s Cravit)

- Clarithromycin (Abbott’s Biaxin/Biaxin XL/Klacid, Taisho Toyama’s Clarith, generics)

- Amoxicillin/clavulanate (GlaxoSmithKline’s Augmentin/Augmentin ES/Augmentin XR, generics)

Community-Acquired Pneumonia: In a Crowded Generics-Dominated Market, Room for New Agents Still Exists is a DecisionBase 2008 study from Decision Resources. DecisionBase 2008 combines market forecasts with clinical and commercial end points to assess market share projections in 35 indications. These outputs are driven by quantitative and qualitative primary research. DecisionBase 2008 provides detailed market share, patient share, and price-per-day projections for emerging drugs in development. The market share projections are based on prescriber surveys that compare physicians’ expectations of a potential target product profile with an emerging product profile of the leading drugs in development.