Ad hoc announcement pursuant to Art. 53 LR

Allschwil, Switzerland, August 27, 2024

Basilea Pharmaceutica AG, Allschwil (SIX: BSLN), a biopharmaceutical company focused on the needs of patients with severe bacterial and fungal infections, today announced that the European Commission (EC) has expanded the indications for the antifungal Cresemba.^® (isavuconazole) for pediatric patients and an extension of market exclusivity for an additional two years, which triggered a milestone payment of CHF 10 million from Basilea’s licensing partner Pfizer Inc.

Dr. Marc Engelhardt, Chief Medical Officer of Basilea, said: “We are very pleased with the European Commission’s decision to approve Cresemba for use in children suffering from invasive aspergillosis or mucormycosis. These serious fungal infections mainly affect children suffering from hematological malignancies or immunodeficiency diseases. There is a high unmet medical need for new antifungal treatment options for children. We are pleased that this vulnerable patient group in Europe will now have access to Cresemba.”

The approval is based on the results of two clinical trials in children, including an open-label, non-comparative, multicenter Phase 2 study to evaluate the safety, efficacy and pharmacokinetics of Cresemba for the treatment of invasive aspergillosis and invasive mucormycosis in children aged 1 to 17 years.^{1, 2}

In addition to the approval, the European Commission granted Cresemba a pediatric exclusivity, which extends the period of market exclusivity for Cresemba in the European Union by an additional two years until October 2027.

About isavuconazole (Cresemba^®)

Isavuconazole is an intravenous (IV) and oral azole antifungal sold under the trade name Cresemba.^®Basilea has entered into several licensing and distribution agreements for isavuconazole covering approximately 115 countries. In the 27 Member States of the European Union, as well as in Iceland, Liechtenstein and Norway, isavuconazole is approved for patients aged one year and older for the treatment of invasive aspergillosis and for the treatment of mucormycosis in patients who are not suitable for amphotericin B.³ Isavuconazole is also approved in the United States (US) and several other countries in Europe and beyond, including the United Kingdom, China, and Japan.⁴ For the approved indications, it is considered an orphan drug in the USA, Europe and Australia.

About Basilea

Basilea is a biopharmaceutical company founded in 2000 and headquartered in Switzerland. Our goal is to discover, develop and commercialize innovative medicines for 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-infectives in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com.

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Disclaimer

This communication explicitly or implicitly contains certain forward-looking statements such as “believe”, “anticipate”, “expect”, “forecast”, “project”, “may”, “could”, “potential”, “will” or similar expressions concerning Basilea Pharmaceutica Ltd., Allschwil and its business activities, including with respect to the progress, timing and completion of research and development and clinical trials for product candidates. Such statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd., Allschwil to differ materially from those expressed or implied by such forward-looking statements. This communication is dated today. Basilea Pharmaceutica Ltd., Allschwil assumes no obligation to update any forward-looking statements as a result of new information, future events or otherwise.

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

References

1. ClinicalTrials.gov identifier: NCT03816176
   AC Arrieta, H Segers, JD Deville et al. Safety and outcomes of isavuconazonium sulfate for the treatment of invasive aspergillosis or invasive mucormycosis in pediatric patients. IDWeek 2023, Abstract No. 1124

2. ClinicalTrials.gov identifier: NCT03241550
   AC Arrieta, M. Neely, JC Day, et al. Tolerability and population pharmacokinetics of intravenous and oral isavuconazonium sulfate in pediatric patients. Antimicrobials and Chemotherapy 2021;65(8):e0029021

3. Basilea has received the European Commission’s decision. The European Public Assessment Report (EPAR) for Cresemba has not yet been updated to reflect the extension to pediatric patients: https://www.ema.europa.eu/en/medicines/human/EPAR/cresemba (accessed August 26, 2024)

4. Registration status and approved indications may vary from country to country.

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