Basilea Pharmaceutica - Zevtera path to US approval open
On 28 June 2022, Basilea announced positive top-line results from the Phase III ERADICATE study, investigating the use of its drug-resistant antibacterial agent, Zevtera (ceftobiprole) in the treatment of Staphylococcus aureus bacteraemia (SAB). In combination with the 2019 Phase III TARGET study in acute bacterial skin and skin structure infections (ABSSSI), the results complete the data package for Basilea to seek FDA approval for Zevtera in both indications. Management expects to file a new drug application (NDA) with the FDA around year-end 2022. Due to higher pricing, wider reimbursement and a higher incidence of MRSA infections, we continue to view the US market as a considerable commercial opportunity for Zevtera. We value Basilea at CHF886.7m or CHF74.9/share (versus CHF847.7m or CHF71.6/share previously).Basilea Pharmaceutica is an integrated biopharmaceutical company engaged in the discovery, development and commercialization of pharmaceutical products for the treatment of bacterial infections, fungal infections, oncology and skin diseases. Co. focuses on antibiotics and antifungals as well as oncology and dermatology drugs. Co.'s portfolio spans from innovative early-stage through clinical late-stage drug candidates to a marketed product. In the context of its international commercialization organization, Co. has subsidiaries in Denmark, France, Germany, Italy, Spain and the United Kingdom.
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