Drug Overview
Spectracef (cefditoren pivoxil; Vansen Pharma) is an oral semisynthetic, broad-spectrum, third-generation cephalosporin. After oral administration, the pro-drug, cefditoren pivoxil, is converted to the active drug, cefditoren, through esterase hydrolysis. The drug’s bactericidal activity stems from its ability to inhibit bacterial cell wall synthesis through binding to penicillin-binding proteins. Spectracef has demonstrated in vitro and clinical activity against a range of Gram-positive bacteria. However, its efficacy has been limited to penicillin-susceptible strains of the respiratory-relevant Streptococcus pneumonia, and the methicillin-susceptible strains of Staphylococcus aureus with no activity against the more problematic methicillin-resistant Staphylococcus aureus. It has also demonstrated efficacy against a number of Gram-negative bacteria, including the beta-lactamase-producing isolates of hemophilus influenzae, hemophilus parainfluenzae, and Moraxella catarrhalis.
Analyst Outlook
Spectracef (cefditoren pivoxil; Vansen Pharma) currently exhibits low uptake in the treatment of community-acquired pneumonia (CAP). Key opinion leaders interviewed by Datamonitor Healthcare indicated limited brand awareness for the drug. Spectracef’s commercial viability is further diminished by the availability of an authorized generic version for the drug in the US market. Datamonitor Healthcare anticipates that price competition from generic versions of older cephalosporins, as well as the launch of new generations of cephalosporins with enhanced antibacterial efficacy such as the fifth-generation Teflaro (ceftaroline fosamil; Actavis/AstraZeneca/Dainippon Sumitomo Pharma), and Zeftera (ceftobiprole medocaril; Basilea Pharmaceutica), will continue to limit Spectracef’s uptake in the treatment of CAP, and further diminish its share of this market.
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 Spectracef : Community-acquired pneumonia
LIST OF FIGURES
5 Figure 1: Spectracef – development overview
9 Figure 2: Spectracef for community-acquired pneumonia – SWOT analysis
10 Figure 3: Datamonitor Healthcare’s drug assessment summary of Spectracef in community-
acquired pneumonia
11 Figure 4: Datamonitor Healthcare’s drug assessment summary of Spectracef in community-
acquired pneumonia
LIST OF TABLES
4 Table 1: Spectracef drug profile
7 Table 2: Overview of pivotal trial data for Spectracef in community-acquired pneumonia