Swiss biopharma company Basilea has launched its new cephalosporin antibiotic Zevtera in the UK, the latest market in its European roll-out for the drug.
Zevtera (ceftobiprole medocaril) is being introduced as a first-line treatment for severe bacterial respiratory infections and is the only antibiotic approved as a single-agent therapy for community-acquired pneumonia (CAP) and hospital-acquired pneumonia (HAP).
It is a broad-spectrum antibiotic and can be used to treat infections caused both Gram- positive and Gram-negative bacteria, including methicillin-resistant Staphylococcus aureus (MRSA) and Pseudomonas species.
Treatment failure rates in pneumonia, especially pneumonia caused by MRSA are still high and have been attributed in part to inadequate initial antibiotic therapy.
The launch comes as antibiotic resistance and the pressing need for new drug candidates has become a hot topic with the UK government, with the Cabinet Office warning in April that infections resistant to current drugs are expected to “increase markedly over the next 20 years.”
The ongoing UK Review on Antimicrobial Resistance (AMR) recently called on the drug industry to do more to fund research into novel antimicrobials and proposed a bounty for new drugs reaching the market. The report suggested that by 2050 the global cost of antibiotics resistance will be up to $100trn and account for 10 million extra deaths a year.
Zevtera – which is known as Mabelio in some markets – debuted in Germany towards the end of last year and has also rolling out in other EU markets, including France and Italy where pricing negotiations concluded a few months ago.
The launch of Zevtera in Europe is being supported by Quintiles’ commercial services unit under the terms of a deal signed by the two companies last July. Quintiles is providing a dedicated sales force as well as market access and medical science liaison (MSL) personnel to support the roll-out.
Basilea notes that once a new antibiotic becomes available hospitals test the drug against pathogens prevalent in their area before deciding to include it in their treatment protocols, and sales tend to grow slowly as this process plays out.
The company is also seeking regulatory approvals and partnerships to help bring the new antibiotic to markets outside the EU, but suffered a setback in the US recently when the FDA said it would need additional phase III data for approval.
The Swiss company has said it does not intend to start those trials without the help of a commercial partner for the US market, and is also seeking partners for other territories including Australia, South America and Asia.