FDA calls for additional Ph III study for Basilea's ceftobiprole

Swiss drugmaker Basilea Pharmaceutica (SIX: BSLN) saw its shares drop as much as 12% yesterday, after it revealed that the US Food and Drug Administration would require additional Phase III clinical data before it could approve the firm’s ceftobiprole, intended for the treatment of pneumonia, in light of new regulatory requirements for pneumonia in the USA.

The FDA confirmed that the current ceftobiprole studies should be complemented with prospective data in community and hospital-acquired pneumonia in accordance with its new guidelines. Basilea does not currently intend to initiate new Phase III trials for ceftobiprole without a partner for the USA.

Ronald Scott, Basilea's chief executive, stated: "We are currently focused on preparing the launch of ceftobiprole for the treatment of community and hospital-acquired pneumonia in Europe with a pharmaceutical distributor or contract sales organization. We anticipate that ceftobiprole will be available in the first key European markets in the second half of this year."