0QNA Basilea Pharmaceutica Ag

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 severe bacterial and fungal infections, announced today that sales of the antifungal Cresemba^® (isavuconazole) by its license partner Pfizer in Europe exceeded the threshold that triggered a milestone payment of USD 25 million to Basilea.

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

The license 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 inside and outside of Europe. According to the latest available market data, total global in-market sales of Cresemba amounted to USD 489 million in the 12 months between April 2023 and March 2024, a 24 percent growth year-on-year.¹

About isavuconazole (Cresemba^®)

Isavuconazole is an intravenous (i.v.) and oral azole antifungal, commercialized under the trade name Cresemba^®. Basilea has entered into several license and distribution agreements for isavuconazole covering approximately 115 countries. In the 27 European Union member states, as well as in Iceland, Liechtenstein and Norway, isavuconazole is approved for patients aged from 1 year of age and older for the treatment of invasive aspergillosis and for the treatment of mucormycosis in patients for whom amphotericin B is inappropriate.² Isavuconazole is also approved in the United States (US) and several additional countries in Europe and beyond, including the U.K., 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 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:

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

References

1. IQVIA Analytics Link, March 2024. In-market sales reported as moving annual total (MAT) in US dollar.
2. European Public Assessment Report (EPAR) Cresemba, not yet updated to reflect recent extension to pediatric patients: https://www.ema.europa.eu/en/medicines/human/EPAR/cresemba [Accessed: September 6, 2024]
3. The registration status and approved indications may vary from country to country.
   

Attachment

• Press release (PDF)

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