11.12.2023 07:14:50

Press Release: Basilea announces that FDA -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 Ltd, Allschwil

Hegenheimermattweg 167b

4123 Allschwil

Switzerland

Phone +41 61 606 1102

E-mail media_relations@basilea.com

investor_relations@basilea.com

This press release can be downloaded from www.basilea.com.

References

1. ClinicalTrials.gov identifier: NCT03816176A. C. Arrieta, H. Segers, J. D.

Deville et al. Safety and Outcomes of Isavuconazonium Sulfate for the

Treatment of Invasive Aspergillosis or Invasive Mucormycosis in Pediatric

Patients. IDWeek 2023, Abstract #1124

2. ClinicalTrials.gov identifier: NCT03241550A. C. Arrieta, M. Neely, J. C.

Day, et al. Tolerability, and Population Pharmacokinetics of Intravenous

and Oral Isavuconazonium Sulfate in Pediatric Patients. Antimicrobial

Agents and Chemotherapy 2021;65(8):e0029021

3. IQVIA Analytics Link, June 2023. In-market sales reported as moving

annual total (MAT) in US dollar.

4. European Public Assessment Report (EPAR) Cresemba:

https://www.ema.europa.eu/en/medicines/human/EPAR/cresemba

https://www.ema.europa.eu/en/medicines/human/EPAR/cresemba [Accessed:

December 10, 2023]

5. The registration status and approved indications may vary from country to

country.

6. J. Cadena, G. R. Thompson 3rd, T. F..Patterson. Aspergillosis:

Epidemiology, Diagnosis, and Treatment. Infectious Disease Clinics of

North America 2021 (35), 415-434

7. 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

8. Z. D. Pana E. Roilides, A. Warris et al. Epidemiology of Invasive Fungal

Disease in Children. Journal of the Pediatric Infectious Diseases Society

2017 (6), suppl. 1, S3-S11

Attachment

-- Press release (PDF)

https://ml-eu.globenewswire.com/Resource/Download/09ae6cff-f7a4-4291-8757-65734f5257ab

(END) Dow Jones Newswires

December 11, 2023 01:15 ET (06:15 GMT)

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