Therapeutic focus - recent antibiotic setbacks disappointing for already slow field

Research into new antibiotics after years of neglect is certainly on the rise, and last week’s anti-infective’s advisory committee meeting at the FDA which reviewed three late-stage candidates indicates how the field is high up on the agenda of both regulators and drug companies.

However, consensus data from EvaluatePharma shows that despite the renewed push over the last couple of years, there is zero growth forecast for anti-bacterial products as a whole, between 2007 and 2014 (see tables below). With analysts still adjusting their estimates following negative reviews of two of the products reviewed by the FDA’s experts last week, and the big delay announced yesterday for what looked to be the most promising new antibiotic on the scene, Basilea and Johnson & Johnson’s, Zeftera, even zero growth could be optimistic.

WW Anti-infectives Sales (2007-14) ($m)
  2007 2014 CAGR
           Penicillins  476  397  (3%)
           Cephalosporins  2,712  2,681  (0%)
           Quinolones  4,329  2,811  (6%)
           Macrolides  1,550  938  (7%)
           Other antibiotics  7,269  9,774  4%
Anti-bacterials 15,814 15,771 (0%)
      Anti-virals  18,989  28,322  6%
      Vaccines  18,402  38,301  11%
           Anti-parasitics  39  171  24%
           Anti-fungals  3,314  4,693  5%
           Sera & gammaglobulins  3,584  7,315  11%
           Other systemic anti-infectives  3,620  3,487  (1%)
 Total Systemic Anti-infectives 63,762 98,061 6%

The table below shows anti-bacterials which analysts believe have the most potential, and which have only just been recently launched or are not yet approved. The events of the last couple of weeks, however, means three of the top four are likely to see significant downgrades.

After yesterday’s approvable letter, Zeftera is now unlikely to reach the market before the end of 2010 in the US, although sales look likely to commence in Europe next year. (Basilea plunges on second antibiotic delay, November 26, 2008) Negative votes from the FDA advisory committee for both Targanta’s oritavancin and Arpida’s Iclaprim mean forecasts for those drugs are likely to plunge, if not disappear for now. (Arpida pays for solo strategy as FDA voices serious iclaprim concerns, November 19, 2008and Event - Targanta and Theravance face short wait for final FDA decisions, November 20, 2008)

New anti-infectives forecast to grow the market
Rank Product Company Pharmacological Class 2014 sales ($m) Phase (Current)
 1 Zeftera Johnson & Johnson Cephalosporin  984  Approved
 2 Cayston Gilead Sciences Monobactam  261  Phase III
 3 Oritavancin Targanta Therapeutics Glycopeptide  255  Filed
 4 Iclaprim Arpida Dihydrofolate reductase inhibitor  228  Filed
 5 TMC207 Johnson & Johnson Diarylquinoline (DARQ)  205  Phase II
 6 Tobramycin inhalation powder Novartis Aminoglycoside  190  Phase III
 7 PPI-0903 Forest Laboratories Cephalosporin  170  Phase III
 8 Telavancin Astellas Pharma Glycopeptide  170  Filed
 9 Zeven/Exulett Pfizer Glycopeptide  159  Phase III
 10 Difimicin (OPT-80) Optimer Pharmaceuticals Bacterial RNA polymerase inhibitor  151  Phase III

Of the others in the list, Gilead’s Cayston is for a very specific infection that Cystic Fibrosis patients often sufferer, J&J’s TMC207 is for TB, and tobramycin inhalation powder is also for cystic fibrosis. Which means little significant new growth, at least in the next few years, looks likely from the late stage pipeline across the industry.

The following table of antibiotics already on the market shows the top ten growing strongly over the next seven years, illustrating the demand that exists in the market. As for which antibiotics are forecast to be the biggest sellers in 2014, two of the fastest growing also top that list, Pfizer’s Zyvox followed by Cubicin.

Fastest growing antibiotics already on the market Annual sales ($m)    
Rank Product Company Pharmacological Class  2007  2014  CAGR  Phase (Current)
 1 Doribax Johnson & Johnson Carbapenem  2  493  120% Marketed
 2 Finibax Shionogi Carbapenem  22  97  24% Marketed
 3 Tygacil Wyeth Glycylcycline  138  585  23% Marketed
 4 Cubicin Novartis/Cubist Lipopeptide  313  1,127  20% Marketed
 5 Avelox Shionogi Quinolone  17  38  12% Marketed
 6 Invanz Merck & Co Carbapenem  190  359  10% Marketed
 7 Factive Oscient Pharmaceuticals Quinolone  20  33  8% Marketed
 8 Azitrox Zentiva Macrolide  14  23  8% Marketed
 9 Alfasid Actavis Penicillin & beta-lactamase inhibitor  16  27  7% Marketed
 10 Zyvox Pfizer Oxazolidinone  944  1,558  7% Marketed

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