DATAMONITOR PRESS RELEASE
29th March 2004
US product launches and key patent expiries will present tough challenges for RTI
(Respiratory tract infections) players
 
Respiratory tract infections (RTIs), including pneumonia, tonsillitis and bronchitishave led to a total 174,000 deaths in Europe and 3.8 million worldwide, accounting for 6% and 1.3% of the global and European disease burden (World Health Report, 2003). It is, therefore, no surprise that such infections account for the largest portion of community-based antibacterial prescriptions (e.g. 36% of EU5 prescriptions – MIDAS Medical Data, IMS Health, September 2003). However, according to independent market analyst, Datamonitor (DTM.L), events over the next 2 years will have a significant threat to the maintenance of community antibacterial revenues from RTIs, and companies must be prepared with effective life-cycle management (LCM) and positioning strategies.
 
Aventis’ Ketek and Genome Therapeutic’s Factive threaten existing RTI players
Two novel antibacterials, namely Aventis’s Ketek (telithromycin) and Genome Therapeutic’s Factive (gemifloxacin), are due to be launched in the US in 2004. Both of these products will carry an indication for the treatment of RTIs and as the US contributes almost 50% to antibacterial sales, represent a significant threat to existing players. However, both products are also linked to safety concerns – Factive through class effects such as QT prolongation, and Ketek through reports in France that a myasthenia gravia sufferer died and others suffered potentially life-threatening side-effects after taking it. It remains unclear how such products will be positioned and whether physicians will welcome them as the new gold standard for RTI’s.

Patent expiries mean generic equivalents will affect competing brands
In addition, the US patent expiries of leading RTI therapies are also coming up in 2005, notably Pfizer’s Zithromax (azithromycin) and Abbott’s Biaxin (clarithromycin). The expected rapid influx of generic equivalents will not only affect the competing brands, but all RTI therapies, who will
face stiff competition from cheaper, equally efficacious treatments. The impact of patent expiry on blockbuster antibacterial sales was clearly highlighted by the US Augmentin (GlaxoSmithKline’s amoxicillin-clavulanate)’s 52% fall in sales between 2002 and 2003 (year ending June, MIDAS Sales Data, IMS Health, September 2003), the period in which the final US patent expired. 

However, despite the increased availability of generic amoxicillin-clavulanate products, Zithromax’s sales continued to increase (17% growth June 2002- June 2003; MIDAS Sales Data, IMS Health, September 2003).   This reflects Zithromax’s patent expiry spells bad news for the sector

Zithromax’s convenient once-a-day dosage (Augmentin requires 2 tablets per day) and its widespread brand awareness among both physicians and patients. However, these forthcoming patent expiries, particularly that of Zithromax, are likely to spell bad news for the sector as a whole.

Zithromax represents the Gold standard in many indications, with its leading efficacy, dosing and tolerability. When cheaper equivalents become
available, it is hard to envisage where azithromycin competitors will find a niche.

(13/4/04)