Basilea receives USD 10 million milestone payment related to approval of antifungal Cresemba® (isavuconazole) in China

• Chinese National Medical Products Administration (NMPA) granted Drug Approval License for Cresemba in China to Basilea’s license partner Pfizer

Ad hoc announcement pursuant to Art. 53 LR

Basel, Switzerland, December 21, 2021

Basilea Pharmaceutica Ltd. (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with infectious diseases and cancer, announced today that its license partner, Pfizer Inc. (NYSE: PFE, “Pfizer”), has received a Drug Approval License from the National Medical Products Administration (NMPA) in China, for the oral formulation of its antifungal Cresemba® (isavuconazole). With this authorization, oral Cresemba is now approved in China for the treatment of adult patients with invasive mucormycosis. The granting of the Drug Approval License triggered a milestone payment of USD 10 million from Pfizer to Basilea. The intravenous formulation for the treatment of invasive mucormycosis is currently being reviewed under a separate marketing authorization application.

In October 2020, Pfizer also submitted marketing authorization applications for oral and intravenous Cresemba for the treatment of invasive aspergillosis. These applications are under regulatory review by the Center for Drug Evaluation at the NMPA.

David Veitch, Basilea’s CEO said: “We congratulate our partner Pfizer on the approval of Cresemba for the treatment of adult patients with invasive mucormycosis in China. Invasive fungal infections, such as mucormycosis, can pose a serious threat to patients if left untreated. With this approval, patients in China who are suffering from mucormycosis will now have access to a treatment that can help to address their unmet needs. China is a very important commercial market for Cresemba, accounting for approximately 20 percent of global sales for newer antifungals.”

The license agreement between Basilea and Pfizer covers Europe (excluding the Nordic countries), Russia, Turkey and Israel, as well as China (including Hong Kong and Macao) and sixteen countries in the Asia Pacific region. In addition to receiving mid-teen royalties on sales, Basilea remains eligible for further milestone payments of up to approximately USD 600 million under the agreement with Pfizer.

Cresemba has been approved in more than 60 countries to date and is currently marketed in 55 countries, including the United States, most EU member states and additional countries inside and outside of Europe. In the twelve-month period between July 2020 and June 2021, total "in-market" sales of Cresemba amounted to USD 285 million, a 24 percent growth year-on-year.1

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 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 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 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 cancer and infectious diseases. 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 a number of preclinical assets in both cancer and infectious diseases 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 ad hoc announcement can be downloaded from www.basilea.com.

References

1. IQVIA, June 2021. In-market sales reported as moving annual total (MAT) in U.S. dollar.
2. European Public Assessment Report (EPAR) Cresemba: www.ema.europa.eu [Accessed: December 20, 2021]
3. The registration status and approved indications may vary from country to country.

Attachment

• Press release (PDF)