Basilea Pharmaceutica - Zevtera crosses key US regulatory hurdle
Basilea has announced the FDA approval of its second lead asset, Zevtera (ceftobiprole), for the treatment of severe bacterial infections (three indications), marking a major commercial win. The US is the most commercially lucrative market for Zevtera, accounting for 85–90% of its total market potential. Zevtera is already approved in several countries (including in Europe) and the FDA nod is based on three Phase III studies (including the ERADICATE and TARGET studies with R&D partly funded by the BARDA). Note that the drug holds the Qualified Infectious Disease Product (QIDP) designation, which will provide up to 10-years of market exclusivity following approval. As we await more details on the US commercial partner (expected by mid-2024), we upgrade our US probability of success (PoS) to 100%, bumping our valuation to CHF1,008.6m or CHF84.0/share (from CHF80.7/share).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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