Press Release: Basilea announces US FDA approval -2-

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.

For further information, please contact:

Peer Nils Schröder, PhD

Head of Corporate Communications & Investor Relations

Basilea Pharmaceutica International Ltd, Allschwil

Hegenheimermattweg 167b

4123 Allschwil

Switzerland

Phone +41 61 606 1102

E-mail media_relations@basilea.com

investor_relations@basilea.com

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

References

1. ERADICATE study (SAB): ClinicalTrials.gov identifier

NCT03138733T. L. Holland, S. E. Cosgrove, S. B. Doernberg et al.

Ceftobiprole for treatment of complicated Staphylococcus aureus

bacteremia. New England Journal of Medicine 2023 (389), 1390-1401; DOI:

10.1056/NEJMoa2300220

2. TARGET study (ABSSSI): ClinicalTrials.gov identifier

NCT03137173J. S. Overcash, C. Kim, R. Keech et al. Ceftobiprole compared

with vancomycin plus aztreonam in the treatment of acute bacterial skin

and skin structure infections: Results of a phase 3, randomized,

double-blind trial (TARGET). Clinical Infectious Diseases 2021 (73),

e1507-e1517

3. CABP study: ClinicalTrials.gov identifier NCT00326287S. C. Nicholson,

T. Welte, T. M. File Jr. et al. A randomised, double-blind trial

comparing ceftobiprole medocaril with ceftriaxone with or without

linezolid for the treatment of patients with community-acquired pneumonia

requiring hospitalization. International Journal of Antimicrobial Agents

2012 (39), 240-246

4. Summary of Product Characteristics (SmPC) Zevtera:

https://www.medicines.org.uk/emc/product/9164/smpc [Accessed: April 03,

2024]

5. A. P. Kourtis, K. Hatfield, J. Baggs et al. Vital signs: Epidemiology and

recent trends in methicillin-resistant and in methicillin-susceptible

Staphylococcus aureus bloodstream infections -- United States. Morbidity

and Mortality Weekly Report 2019 (68), 214-219

6. K. Hamed, M. Engelhardt, M. E. Jones et al. Ceftobiprole versus

daptomycin in Staphylococcus aureus bacteremia: a novel protocol for a

double-blind, Phase III trial. Future Microbiology 2020 (1), 35-48

7. J. Edelsberg, C. Taneja, M. Zervos et al. Trends in US hospital

admissions for skin and soft tissue infections. Emerging Infectious

Diseases 2009 (15), 1516-1518

8. J. A. Ramirez, T. L. Wiemken, P. Peyrani et al. Adults hospitalized with

pneumonia in the United States: Incidence, epidemiology, and mortality.

Clinical Infectious Diseases 2017 (65), 1807-1812

Attachment

Press release (PDF) https://www.globenewswire.com/Tracker?data=x_oD_mKqVmGOj7i_ZaNTch-MIfLfvVOloE31Anwv00zrqFeYhcB9B-hSrLpiyoLj8zw-Wcko5LlusI1H6rbkSYSAZByKHG_Hh6OATrMtN-hqfq7u6VUST6flDZeOWTncVBEEDhr50kjPOlkhuj_T6Cqcpj-sCDaqvxrHfQZvhTSDXxhGrptoAIn8IJcOFcAq

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April 04, 2024 01:15 ET (05:15 GMT)