Press Release: Strong sales growth for Cresemba and Zevtera trigger further milestone payments to Basilea

Allschwil, Switzerland, January 28, 2025

Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, reported today that the sales in 2024 of the antifungal Cresemba(R) (isavuconazole) and the antibiotic Zevtera(R) (ceftobiprole) exceeded thresholds triggering sales milestone payments from distribution partners to Basilea, in the total amount of approximately CHF 2.2 million.

For Cresemba, this comprises a milestone payment for sales in Canada, by AVIR Pharma Inc, as well as the first sales milestone payment for the Middle East and North Africa (MENA) region, by Hikma Pharmaceuticals LLC. For Zevtera, this reflects a milestone payment in Europe, by Advanz Pharma.

David Veitch, Chief Executive Officer, said: "We are very pleased with the commercial progress of our two commercialized brands in Canada, the MENA region and Europe. Their continued growth confirms that Cresemba and Zevtera are serving significant medical needs around the world."

Basilea's commercial partnerships cover well over 100 countries worldwide. By year-end 2024, Cresemba was marketed in more than 70 countries while Zevtera was marketed in 20 countries. According to the latest available market data, total global in-market sales of Cresemba in the twelve-month period between October 2023 and September 2024 amounted to USD 533 million, a 20 percent growth year-on-year, making it the largest branded antifungal for invasive fungal infections worldwide.(1)

About Cresemba(R) (isavuconazole)

Isavuconazole is an intravenous (i.v.) and oral azole antifungal, commercialized under the trade name Cresemba(R). In Canada, Cresemba is approved for use in adults and pediatrics from 1 year up to 18 years for the treatment of invasive aspergillosis and invasive mucormycosis.(2) In countries of the MENA region, it is indicated in adults for the treatment of invasive aspergillosis and for the treatment of mucormycosis in patients for whom amphotericin B is inappropriate. Isavuconazole is also approved in the United States (US),(3) the EU(4) and several additional countries in Europe and beyond, including Japan and China.(5)

About Zevtera(R) (ceftobiprole medocaril sodium)

Ceftobiprole, the active moiety of the prodrug ceftobiprole medocaril, is an advanced generation cephalosporin antibiotic for intravenous administration, with rapid bactericidal activity against a wide range of Gram-positive bacteria, such as Staphylococcus aureus, including methicillin-resistant strains (MRSA), and Gram-negative bacteria.(6) In several countries in Europe, the brand is approved as Zevtera(R) and Mabelio(R) for the treatment of adult patients with hospital-acquired bacterial pneumonia (HABP), excluding ventilator-associated bacterial pneumonia (VABP), and for the treatment of community-acquired bacterial pneumonia (CABP).(6) Zevtera is also approved in the United States(7) (, ) (8), China and several other countries.(5)

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.

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

References

1. IQVIA Analytics Link, September 2024. In-market sales reported as moving

annual total (MAT) in US dollar.

2. Health Canada, Cresemba(R) (isavuconazole) Product Monograph:

https://pdf.hres.ca/dpd_pm/00077745.PDF [Accessed: January 27, 2025]

3. Full US prescribing information:

https://www.astellas.us/docs/cresemba.pdf [Accessed: January 27, 2025]

4. European Public Assessment Report (EPAR):

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

January 27, 2025]

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

country.

6. Summary of Product Characteristics (SmPC) Zevtera:

https://www.medicines.org.uk/emc/product/9164/smpc [Accessed: January 27,

2025]

7. Full US prescribing information:

https://www.basilea.com/ZEVTERA_US_prescribing_information_46b9y4wk

8. Basilea's ceftobiprole phase 3 program is funded in part with federal

funds from the US Department of Health and Human Services (HHS);

Administration for Strategic Preparedness and Response (ASPR); Biomedical

Advanced Research and Development Authority (BARDA), under contract

number HHSO100201600002C. Basilea has been awarded approximately USD 111

million, or approximately 75 percent of the costs related to the

Staphylococcus aureus bacteremia (SAB) and acute bacterial skin and skin

structure infections (ABSSSI) phase 3 studies, regulatory activities and

non-clinical work.

Attachment

-- Press release (PDF)

https://ml-eu.globenewswire.com/Resource/Download/ac33b4b4-0c55-45d4-8904-1f46e2494e2f

(END) Dow Jones Newswires

January 28, 2025 01:15 ET (06:15 GMT)