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) ($m)|
|Sera & gammaglobulins||3,584||7,315||11%|
|Other systemic anti-infectives||3,620||3,487||(1%)|
|Total Systemic Anti-infectives||63,762||98,061||6%|
The table below shows anti-bacterials which analysts believe have the most potential, and which have only just been recently launched or are not yet approved. The events of the last couple of weeks, however, means three of the top four are likely to see significant downgrades.
After yesterday’s approvable letter, Zeftera is now unlikely to reach the market before the end of 2010 in the US, although sales look likely to commence in Europe next year. (Basilea plunges on second antibiotic delay, November 26, 2008) Negative votes from the FDA advisory committee for both Targanta’s oritavancin and Arpida’s Iclaprim mean forecasts for those drugs are likely to plunge, if not disappear for now. (Arpida pays for solo strategy as FDA voices serious iclaprim concerns, November 19, 2008and Event - Targanta and Theravance face short wait for final FDA decisions, November 20, 2008)
|New anti-infectives forecast to grow the market|
|Rank||Product||Company||Pharmacological Class||2014 sales ($m)||Phase (Current)|
|1||Zeftera||Johnson & Johnson||Cephalosporin||984||Approved|
|2||Cayston||Gilead Sciences||Monobactam||261||Phase III|
|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|
|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|
|6||Invanz||Merck & Co||Carbapenem||190||359||10%||Marketed|
|9||Alfasid||Actavis||Penicillin & beta-lactamase inhibitor||16||27||7%||Marketed|