By Cyndi Root
Basilea Pharmaceutica announced in a press release that it has engaged Quintiles, a contract research organization (CRO), to launch antibiotic Zevtera/Mabelio (ceftobiprole medocaril) in Europe. Switzerland-based Basilea has opted to unite with Quintiles to market the new broad-spectrum antibiotic in Germany in 2014 and other European markets in 2015. Quintiles will dedicate a sales force, hospital and physician liaisons, and market access personnel to the effort. Ronald Scott, CEO of Basilea, said, “We have initially opted to commercialize our products in Europe through Quintiles in order to retain flexibility and to more fully participate in the economic upside of our products. The agreement with Quintiles allows us to scale and optimize our resources during the launch of Zevtera/Mabelio on a country-by-country basis."
Basilea and Quintiles Agreement
Under the Basilea and Quintiles agreement, Quintiles will provide CRO services and assist in national pricing and reimbursement strategies in Germany. In the event of regulatory approval, Basilea will follow the Zevtera effort with another hospital product, isavuconazole. Launching both agents affords the company significant synergy, according to Mr. Scott. He says that the new agent will contribute to reducing the major threat of antibiotic resistance in Europe. The company will continue to look for opportunities to distribute its medications globally with Quintiles assistance or via licensing partnerships.
Zevtera/Mabelio are the trademark names for ceftobiprole medocaril, an intravenous preparation to treat severe bacterial infections including gram-negative bacteria and gram-positive bacteria, such as methicillin-resistant Staphylococcus aureus (MRSA). The agent is approved in 12 European countries for hospital-acquired pneumonia (HAP) and community-acquired pneumonia (CAP).
In June, Basilea announced in a press release that it had discussions with the Food and Drug Administration (FDA) regarding the new regulatory requirements for pneumonia. The FDA stated that approving ceftobiprole for pneumonia treatment would require additional Phase III studies in community and hospital-acquired pneumonia to meet the requirements of the new guidelines. Basilea is seeking a U.S. partner to commence those studies.
Isavuconazole is another antibiotic in Basilea’s portfolio that it hopes to market in tandem with Zevtera. On July 9, 2014, Basilea announced that its U.S. partner for isavuconazole development, Astellas, submitted a New Drug Application (NDA) for isavuconazole in the treatment of invasive aspergillosis and invasive mucormycosis (zygomycosis).