Basilea Pharmaceutica Ltd. plans to apply European marketing authorisation for its antibiotic ceftobiprole, in the second half of 2012. In addition, reporting of topline data for the alitretinoin US 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.

Ceftobiprole is an investigational new broad-spectrum cephalosporin antibiotic for the potential first-line (empiric) treatment of severe multi-drug resistant bacterial infections. Available data demonstrate activity against a wide range of Gram-positive bacteria, including the MRSA 'superbug' as well as clinically-relevant Gram-negative bacteria such as Pseudomonas spp. and Acinetobacter spp. Ceftobiprole has been tested in a large clinical programme including two phase III studies each in the indications of pneumonia (patients hospitalized with community-acquired pneumonia and patients with hospital-acquired pneumonia) and complicated skin and skin structure infections. In total, more than 3000 patients were enrolled in these studies.

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.

Dr Anthony Man, CEO of Basilea 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 US upon additional discussions with the FDA.”

All patients of the alitretinoin US 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 US programme 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) programme 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.”

Inappropriate initial antimicrobial therapy is associated with excess mortality in patients with serious bacterial infections including severe pneumonia treated in the hospital. In order to provide appropriate initial therapy, empiric treatment should include antibiotics covering methicillin-resistant Staphylococcus aureus (MRSA) and Pseudomonas aeruginosa.

Basilea Pharmaceutica Ltd. is fully integrated research and development operations are focused on antibiotics, antifungals and oncology drugs, as well as on the development of dermatology drugs, targeting the medical challenge of resistance and non-response to current treatment options in the hospital and specialty care setting.