Basilea Pharmaceutica Ltd (SIX: BSLN), a commercial-stage biopharmaceutical company, announced today that the sales of the antifungal Cresemba^® (isavuconazole) by its license partner Pfizer Inc. (NYSE: PFE, “Pfizer”) in the Asia Pacific region, exceeded the threshold triggering the first sales milestone payment for this region of USD 1.25 million.

David Veitch, Basilea’s Chief Executive Officer, stated: “We are very pleased with the commercial progress of Cresemba, which has now triggered the first sales milestone payment from Pfizer for the Asia Pacific region. The continued growth in the established markets in the US and Europe and the increasing contributions from new regions, such as Asia Pacific, confirm that Cresemba is serving a high medical need around the world.”

The license agreement between Basilea and Pfizer for Cresemba covers Europe (excluding the Nordic countries) as well as countries in the Asia Pacific region and China. Under the agreement with Pfizer, Basilea is eligible for additional regulatory and sales milestone payments of up to around CHF 550 million, in addition to receiving mid-teen royalties on sales.

Cresemba is approved in 68 countries to date and is currently marketed in 57 countries, including the United States, most EU member states and additional countries inside and outside of Europe. In the twelve months between January and December 2021, total global in-market sales of Cresemba amounted to USD 324 million, a 28 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 the United States, Europe, China, Japan, Latin America, Asia-Pacific, the Middle East and North Africa region, Canada, Russia, Turkey and Israel. In the 27 European Union member states, as well as in Iceland, Liechtenstein, Norway and the U.K., isavuconazole is approved for the treatment of adult patients with invasive aspergillosis and for the treatment of adult patients with mucormycosis for whom amphotericin B is inappropriate.² In China, the oral formulation is approved for the treatment of adult patients with invasive aspergillosis and invasive mucormycosis. Isavuconazole is also approved in the United States and several additional countries in Europe and beyond.³ It has orphan drug designation in the U.S., Europe and Australia for its approved indications.

About invasive aspergillosis and invasive mucormycosis

Invasive aspergillosis and invasive mucormycosis are life-threatening mold infections that predominantly affect immunocompromised patients, such as patients with hematologic malignancies (blood cancer). Both infections are associated with high morbidity and mortality.

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 bacterial and fungal infections and cancer. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of severe bacterial infections. We are conducting clinical studies with two targeted drug candidates for the treatment of a range of cancers and have several preclinical assets in both anti-infectives and cancer 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 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. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd 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.

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

References

1. IQVIA, December 2021. In-market sales reported as moving annual total (MAT) in U.S. dollar.
2. European Public Assessment Report (EPAR) Cresemba: http://www.ema.europa.eu [Accessed: June 16, 2022]
3. The registration status and approved indications may vary from country to country.