Basilea reports clinical phase 3 study start with antibiotic ceftobiprole in skin infections under BARDA contract - Seite 2

Basilea's phase 3 ceftobiprole program is being conducted under a contract with the U.S. Biomedical Advanced Research and Development Authority (BARDA) which provides funding of up to USD 108 million.

About ceftobiprole

Ceftobiprole is a cephalosporin antibiotic for intravenous administration with rapid bactericidal activity against a wide range of Gram-positive and Gram-negative bacteria, including methicillin-susceptible and resistant Staphylococcus aureus (MSSA, MRSA) and susceptible Pseudomonas spp.¹ Ceftobiprole is currently approved for sale in major European countries and several non-European countries for the treatment of adult patients with community-acquired pneumonia (CAP) and hospital-acquired pneumonia (HAP), excluding ventilator-associated pneumonia (VAP).¹ It is marketed in major European countries. Basilea has entered into license and distribution agreements for the drug in Europe, Latin America, China, Canada, Israel, and the Middle East and North Africa (MENA) region. Ceftobiprole has Qualified Infectious Disease Product (QIDP) status in the U.S. for the potential treatment of ABSSSI, Staphylococcus aureus bacteremia (SAB) and CAP, providing priority review and an extension of market exclusivity in the U.S. to ten years after approval. Basilea's clinical phase 3 program aims at the regulatory approval of ceftobiprole in the United States. It includes two cross-supportive phase 3 studies and receives funding from the Biomedical Advanced Research and Development Authority (BARDA), the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, under contract number HHSO100201600002C. Subject to the successful outcomes of these studies, there may an option to apply for label extensions in Europe and other regions. Ceftobiprole is not currently approved for commercial sale in the U.S.

About Basilea

Basilea Pharmaceutica Ltd. is a commercial stage biopharmaceutical company developing products that address the medical challenge of increasing resistance and non-response to current treatment options in the therapeutic areas of bacterial infections, fungal infections and cancer. The company is committed to discovering, developing and commercializing innovative pharmaceutical products to meet the medical needs of patients with serious and life-threatening conditions. Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland and listed on the SIX Swiss Exchange (SIX: BSLN). Additional information can be found at Basilea's website www.basilea.com.