Basilea Pharmaceutica Ltd. 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.
CEO Dr. Anthony Man commented: "Ceftobiprole is a unique antibiotic that has the potential to provide broad antibacterial coverage in the treatment of patients with severe and life-threatening pneumonia.
Based on independent site audits and the robustness of the trial data we plan to file an application for marketing approval for severe pneumonia treated in the hospital setting. We target filing in Europe in the second half of 2012. We will finalize our filing plans for the U.S. upon additional discussions with the FDA." All patients of the alitretinoin U.S. phase III HANDEL study have completed the blinded six-month follow-up period after end of treatment. The company is preparing the database lock and subsequent unblinding of data. The U.S. program includes comprehensive safety assessments such as bone mineral density measurements, audiological, ophthalmological and psychiatric assessments. Following detailed analyses of this study, Basilea plans to discuss with the FDA the design of a risk evaluation and mitigation strategies (REMS) program to support a potential New Drug Application (NDA) filing.
Dr. Man stated: "We expect topline data from this comprehensive study in the first quarter. We plan to file by the end of 2012 after bone mineral density data is available at mid-year and we have had a subsequent pre-NDA meeting with the FDA."