Basilea Secures USD 268 Million Agreement with BARDA to Develop Novel Antifungal and Antibacterial Treatments

Basilea Secures USD 268 Million Agreement with BARDA to Develop Novel Antifungal and Antibacterial Treatments

(IN BRIEF) Basilea Pharmaceutica has entered into a multi-year agreement with the Biomedical Advanced Research and Development Authority (BARDA) to support the development of novel antifungal and antibacterial treatments. The agreement provides an initial USD 29 million, with the potential for up to USD 268 million in funding over 12 years if key milestones are met. This partnership will aid in advancing Basilea’s antifungal drugs, fosmanogepix and BAL2062. As a result, Basilea has increased its financial guidance for 2024, expecting higher revenue and net profit.

(PRESS RELEASE) ALLSCHWIL, 19-Sep-2024 — /EuropaWire/ — Basilea Pharmaceutica Ltd, a biopharmaceutical company based in Allschwil, Switzerland, has secured a significant partnership with the Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services. This new multi-year Other Transaction Agreement (OTA) will provide an initial USD 29 million to support the development of Basilea’s pioneering antifungal treatments, fosmanogepix and BAL2062. The total potential funding could reach up to USD 268 million over the next 12 years, contingent on meeting various developmental milestones.

David Veitch, Basilea’s Chief Executive Officer, highlighted the longstanding collaboration with BARDA, which began in 2013. He said, “This extended partnership strengthens our ability to develop urgently needed antifungals and antibacterials and reinforces our strategy to become a leading company in anti-infectives.”

The agreement offers flexible options for advancing or discontinuing drug candidates based on performance and need, allowing for efficient resource management and cost-saving measures for both BARDA and Basilea.

As a result of this new funding, Basilea has revised its financial guidance for 2024, reflecting an increase in expected revenue and net profit. The company anticipates total revenue to rise to CHF 203 million for FY 2024, up from the previously estimated CHF 196 million, and expects a net profit of CHF 60 million. BARDA reimbursements will be reported under other revenue, while development costs will continue to be recorded under research and development expenses.

This partnership marks a significant step forward in the development of innovative treatments for severe bacterial and fungal infections, reinforcing Basilea’s commitment to addressing unmet medical needs.

About fosmanogepix
Fosmanogepix is a clinical-stage broad-spectrum antifungal. It has a novel mechanism of action and its active moiety has shown activity against common species of Candida and Aspergillus, including multi-drug-resistant strains, such as Candida auris and Candida glabrata, as well as rare difficult-to-treat molds including Fusarium spp., Scedosporium spp., and some fungi from the Mucorales order.1 Fosmanogepix is available in intravenous and oral formulations and has been evaluated for efficacy and safety in a phase 1 / phase 2 program, including three openlabel phase 2 studies for the treatment of Candidemia, including Candida auris, and invasive mold infections.1, 2, 3, 4 Basilea will initiate shortly a double-blind non-inferiority phase 3 study in invasive yeast infections. 5 Fosmanogepix has received Fast Track and Orphan Drug designations from the US Food and Drug Administration for seven separate indications, and is designated as a Qualified Infectious Disease Product (QIDP) for the treatment of four indications

About BAL2062
BAL2062 is a first-in-class antifungal, derived from a natural product, and has demonstrated fungicidal activity against clinically important molds such as Aspergillus spp., including azoleresistant strains.6 Safety and tolerability have been demonstrated in a previously completed phase 1 study with single and multiple ascending intravenous (i.v.) doses.7 The drug candidate has Qualified Infectious Disease Product (QIDP), Orphan Drug and Fast Track designation from the US Food & Drug Administration (FDA) for invasive aspergillosis.

About invasive mold infections
Invasive aspergillosis and invasive infections with rare molds (e.g., Fusarium spp., Scedosporium spp., and Mucorales fungi) are life-threatening infections that predominantly affect immunocompromised patients, including patients with hematologic malignancies (blood cancer), transplant patients, or patients with other immunodeficiency disorders. These infections are associated with high morbidity and mortality.8, 9

About invasive candidiasis
Invasive candidiasis, including deep-seated tissue candidiasis and candidemia, is an increasingly important nosocomial infection, especially in patients hospitalized in intensive care units. Candida species are ranked as the fourth main cause of bloodstream infections in hospitals in the US.10 The prognosis of invasive candidiasis remains difficult, with a reported mortality rate for invasive candidiasis as high as 40%, even when patients receive antifungal therapy.11

About Basilea
Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com.

Disclaimer
This communication expressly or implicitly contains certain forward-looking statements, such as “believe”, “assume”, “expect”, “forecast”, “project”, “may”, “could”, “might”, “will” or similar expressions concerning Basilea Pharmaceutica Ltd, Allschwil and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd, Allschwil to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd, Allschwil is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

This ad hoc announcement can be downloaded from www.basilea.com.

References
1. K. J. Shaw, A. S. Ibrahim. Fosmanogepix:A Review of the First-in-Class Broad Spectrum Agent for the Treatment of Invasive Fungal Infections. Journal of Fungi (Basel) 2020 (6), 239
2. M. R. Hodges, E. Ople, P. Wedel et al. Safety and Pharmacokinetics of Intravenous and Oral Fosmanogepix, a First-in-Class Antifungal Agent, in Healthy Volunteers. Antimicrobial Agents and Chemotherapy 2023 (67), e01623-22
3. J. A. Vazquez, P. G. Pappas, K. Boffard et al. Clinical Efficacy and Safety of a Novel Antifungal, Fosmanogepix, in Patients with Candidemia Caused by Candida auris: Results from a Phase 2 Trial. Antimicrobial Agents and Chemotherapy2023 (67), e01419-22
4. P. G. Pappas, J. A. Vazquez, I. Oren et al. Clinical safety and efficacy of novel antifungal, fosmanogepix, for the treatment of candidaemia: results from a Phase 2 trial. Journal of Antimicrobial Chemotherapy 2023 (78), 2471-2480
5. ClinicalTrials.gov identifier NCT05421858
6. K. J. Shaw. GR-2397: Review of the Novel Siderophore-like Antifungal Agent for the Treatment of Invasive Aspergillosis. Journal of Fungi (Basel) 2022 (8), 909
7. ClinicalTrials.gov identifier NCT02956499: M. P. Mammen, D. Armas, F. H. Hughes et al. First-in-Human Phase 1 Study To Assess Safety, Tolerability, and Pharmacokinetics of a Novel Antifungal Drug, VL-2397, in Healthy Adults. Antimicrobial Agents and Chemotherapy 2019 (63), e00969-19
8. J. Cadena, G. R. Thompson 3rd, T. F..Patterson. Aspergillosis: Epidemiology, Diagnosis, and Treatment. Infectious Disease Clinics of North America 2021 (35), 415-434
9. M. Slavin, S. van Hal, T. C. Sorrell et al. Invasive infections due to filamentous fungi other than Aspergillus: epidemiology and determinants of mortality. Clinical Microbiology and Infection 2015 (21), 490.e1-490.e10
10. Candidemia (Blood Infection) and Other Candida Infections. 2019 Factsheet by the American Thoracic Society: https://www.thoracic.org/patients/patient-resources/resources/candidemia.pdf (Accessed: September 18, 2024)
11. B. J. Kullberg, M. C. Arendrup. Invasive Candidiasis. The New England Journal of Medicine 2015 (373), 1445-1456

Media Contact:

Peer Nils Schröder, PhD
Head of Corporate Communications & Investor Relations
Basilea Pharmaceutica International Ltd
Phone: +41 61 606 1102
E-mail: media_relations@basilea.com
investor_relations@basilea.com

SOURCE: Basilea Pharmaceutica Ltd