Bactericidal antibiotic with activity against MRSA for treatment of cSSSIs would earn 25% patient share: Report

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that a therapy's effect on overall clinical success is the attribute that most influences surveyed infectious disease specialists' prescribing decisions in the treatment of complicated skin and skin structure infections (cSSSIs). Clinical data and the opinions of interviewed thought leaders indicate that current and emerging therapies have no advantage over the combination of piperacillin/tazobactam (Pfizer's Zosyn/Tazocin, generics) plus vancomycin (multiple generics) on this attribute.

The new report entitled Complicated Skin and Skin Structure Infections: Recent FDA Nonapprovals Leave Untapped Opportunity for Emerging Broad-Spectrum MRSA Agents finds that an oral, bactericidal antibiotic with activity against methicillin-resistant Staphylococcus aureus (MRSA) for the treatment of cSSSIs would earn a 25 percent patient share in cSSSIs in both the United States and Europe, according to surveyed infectious disease specialists.  

The report also finds that, based on available data and expert opinion, Pfizer's Zyvox will retain Decision Resources' proprietary clinical gold standard for cSSSIs through 2018. In 2009, Zyvox earned gold standard status owing to its efficacy against MRSA and vancomycin-resistant enterococci (VRE), and its safety, tolerability and delivery. While some therapies in development for cSSSIs hold promise, most have efficacy, safety and tolerability, and/or delivery features that are similar to Zyvox – a feature that highlights the challenges new therapies face to differentiate themselves from successful current therapies. Although no therapy in development for cSSSIs is expected to displace Zyvox as the clinical gold standard, Forest/Astra Zeneca/Takeda's ceftaroline is positioned to be a notable competitor in the market, following its expected launch for cSSSIs in 2011 in the U.S. and Europe.

"Ceftaroline is poised to be the first marketed cephalosporin with activity against MRSA. Its potent MRSA activity combined with its efficacy in cSSSIs, a favorable safety and tolerability profile, and high physician enthusiasm for MRSA cephalosporins puts ceftaroline at the top of the list of emerging therapies for cSSSIs," said Decision Resources Therapeutic Area Director Danielle Drayton, Ph.D. "However, the most immediate barrier to the drug's market access is its  successful navigation of the U.S. regulatory process in the wake of several unsuccessful predecessors over the last several years."