Basilea Announces Portfolio Updates: Cresemba and Zevtera Achieve Key Milestones, Pipeline Progresses
核心洞察
Cresemba's market presence expanded to over 70 countries, achieving USD 533 million in global sales, marking a 20% year-over-year growth and solidifying its position as a leading antifungal.
Zevtera gained FDA approval for SAB, ABSSSI (搜索), and CABP (搜索), with Innoviva Specialty Therapeutics (搜索) (IST) announced as the US commercialization partner, targeting a mid-2025 launch.
Basilea (搜索) secured significant non-dilutive funding from BARDA and CARB-X to advance novel antifungals and antibacterials, including fosmanogepix and BAL2420, currently in Phase 3 and preclinical stages.
Basilea (搜索) Pharmaceutica Ltd. reported significant advancements in its R&D portfolio, highlighted by the commercial success of Cresemba and Zevtera, and the progression of its clinical and preclinical pipeline. The company also secured substantial funding to support the development of novel anti-infectives.
Cresemba: Expanded Indications and Market Growth
Cresemba (isavuconazole) saw its indications expanded to include pediatric patients for the treatment of invasive aspergillosis (搜索) and mucormycosis (搜索), following approvals by both the European Commission and the US FDA. This expansion not only broadens the patient population eligible for Cresemba but also extends its market exclusivity in the EU until October 2027 and in the US until September 2027. The drug is now marketed in over 70 countries, including the US, most EU member states, China, and Japan. Global in-market sales reached USD 533 million between October 2023 and September 2024, representing a 20% year-over-year growth, making it the largest branded antifungal for invasive fungal infections worldwide.
Zevtera: US Approval and Commercialization
Zevtera (ceftobiprole) received US FDA approval in April for Staphylococcus aureus bacteremia (搜索) (SAB), acute bacterial skin and skin structure infections (ABSSSI (搜索)), and community-acquired bacterial pneumonia (CABP (搜索)). In September, Zevtera was approved for New-Technology Add-On Payment (NTAP) in the US, providing hospitals with additional reimbursement. Innoviva Specialty Therapeutics (搜索) (IST) was announced as the commercialization partner for the US market, with a launch expected in mid-2025. Additionally, ceftobiprole has been included in China's National Reimbursement Drug List (NRDL), making it eligible for reimbursement under the national basic medical insurance program from 2025.
Advancing the Clinical and Preclinical Pipeline
Basilea (搜索) secured up to USD 268 million in non-dilutive funding from the Biomedical Advanced Research and Development Authority (BARDA) over 12 years for the development of novel antifungals and antibacterials. An initial commitment of USD 29 million supports the development of fosmanogepix and BAL2062. A Phase 3 study with fosmanogepix in adult patients with candidemia (搜索) and/or invasive candidiasis (搜索) has commenced, with a second Phase 3 study in invasive mold infections expected to start soon. Furthermore, the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) awarded USD 7.3 million for the LptA (搜索) inhibitor antibiotic, BAL2420, which is being developed for severe infections caused by Gram-negative bacteria. A first-in-human clinical study is expected to start mid-2026. Preclinical evaluations for tonabacase and BAL2062 are also progressing, with potential clinical studies planned.