Strong sales performance of Cresemba® (isavuconazole) in Europe leads to USD 25 million milestone payment to Basilea | 06.09.24

Ad hoc announcement pursuant to Art. 53 LR

Allschwil, Switzerland, September 6, 2024

Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with serious bacterial and fungal infections, today announced that sales of its antifungal agent Cresemba^® (isavuconazole) by its licensing partner Pfizer in Europe crossed the threshold triggering a $25 million milestone payment to Basilea.

David Veitch, Chief Executive Officer of Basilea, said: “We are very pleased with Cresemba’s continued recognition for meeting the critical medical needs of patients with life-threatening invasive fungal infections, and its strong sales performance in Europe, which has resulted in this milestone payment. We have already announced several sales milestone payments in Asia Pacific and China this year. The number of sales milestone payments activated this year reflects Cresemba’s continued success and continued growth around the world.”

The licensing agreement between Basilea and Pfizer for Cresemba covers Europe (excluding the Nordic countries), as well as 16 countries in the Asia-Pacific region and China.

Cresemba is approved and marketed in more than 70 countries, including the United States, most EU member states, and additional countries within and outside Europe. According to the latest available market data, total global in-market sales of Cresemba were USD 489 million in the 12 months between April 2023 and March 2024, a growth of 24 percent year-over-year.¹

About isavuconazole (Cresemba^®)

Isavuconazole is an intravenous (IV) and oral azole antifungal agent marketed under the trade name Cresemba^®. Basilea has entered into several license 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 1 year of age and older for the treatment of invasive aspergillosis and for the treatment of mucormycosis in patients in whom amphotericin B is not appropriate.² Isavuconazole is also approved in the United States (US) and several other countries in Europe and beyond, including the United Kingdom, China and Japan.³ It has orphan drug designation in the US, Europe and Australia for its approved indications.

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 medicines to address the needs of patients suffering from serious 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). Visit basilea.com.

Disclaimer

This communication contains, expressly or implicitly, certain forward-looking statements, such as “believe”, “assume”, “expect”, “predict”, “project”, “may”, “could”, “will” or similar expressions with respect to 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 may 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 the date hereof and undertakes no obligation to update any forward-looking statements contained herein, whether as a result of new information, future events or otherwise.

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

References

1. IQVIA Analytics Link, March 2024. Market sales are reported as a rolling annual total (MAT) in US dollars.
2. European Public Assessment Report (EPAR) Cresemba, not yet updated to reflect the recent extension to paediatric patients: https://www.ema.europa.eu/en/medicines/human/EPAR/cresemba (accessed 6 September 2024)
3. Registration status and approved indications may vary by country.