Basilea to file application for marketing authorization of ceftobiprole for the treatment of pneumonia | Reuters.
Basilea Pharmaceutica Ltd. (SIX:BSLN) today announced that it will apply in the second half of 2012 for approval of its antibiotic ceftobiprole in Europe. In addition, reporting of topline data for the alitretinoin U.S. phase III study for chronic refractory hand eczema will occur in the first quarter of this year. Basilea thus has the potential for two regulatory submissions in 2012. Basilea has completed investigator site audits of two international double-blind randomized controlled phase III studies of ceftobiprole for the treatment of severe community-acquired and hospital-acquired pneumonia. The audits included 26 investigator sites, covering more than one third of patients of both trials. On the basis of these audits and following health authority feedback on potential filing strategies, Basilea has decided to apply in the second half of 2012 for the approval of ceftobiprole in Europe for pneumonia treated in the hospital setting.
