Basilea receives CHF 5 million milestone payment related to marketing authorization of antifungal Cresemba® in Russia

Basel, Switzerland, June 22, 2020

Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that it has received a CHF 5 million milestone payment from its license partner Pfizer Inc. (NYSE: PFE, “Pfizer”). The milestone was triggered by the granting of the marketing authorization for the antifungal Cresemba® (isavuconazole) in the Russian Federation.

David Veitch, Chief Executive Officer, said: “We are very pleased that physicians in Russia will soon be able to prescribe Cresemba for their patients with invasive mold infections. This approval is an important milestone in the global commercial roll-out of the brand, as Russia is one of the commercially most important markets outside of China, the EU and the U.S.”

In Russia, oral Cresemba is approved in adults for the treatment of invasive aspergillosis and the treatment of mucormycosis in adult patients for whom amphotericin B is inappropriate.1 The intravenous formulation is currently being reviewed under a separate marketing authorization application.

In June 2017, Basilea entered into a licensing agreement with Pfizer for isavuconazole in Europe (excluding the Nordics), Russia, Turkey and Israel. The agreement was extended in November 2017 to China, including Hong Kong and Macao, and sixteen countries in the Asia-Pacific region. Under the agreement with Pfizer, Basilea is still eligible for regulatory and sales milestone payments of approximately USD 630 million, in addition to receiving mid-teen royalties on in-market sales of Cresemba.

Cresemba is currently marketed in more than 40 countries, including the United States, most EU member states and several additional countries inside and outside of Europe. For the full-year 2019, total "in-market" sales of Cresemba amounted to approximately 200 million U.S. dollars, which is a more than 30 percent growth year-on-year.2

About Cresemba (isavuconazole)

Isavuconazole is an intravenous (i.v.) and oral azole antifungal, commercialized under the trade name Cresemba. 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.3 This is also the approved indication for Cresemba in Russia. Cresemba is also approved in the United States and several additional countries in Europe and beyond.4 It has orphan drug designation in the U.S., Europe and Australia for its approved indications. 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.

About Basilea

Basilea Pharmaceutica Ltd. is a commercial-stage biopharmaceutical company, focused on the development of products that address the medical challenges in the therapeutic areas of oncology and infectious diseases. With two commercialized drugs, the company is committed to discovering, developing and commercializing innovative pharmaceutical products to meet the medical needs of patients with serious and life-threatening conditions. Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland and listed on the SIX Swiss Exchange (SIX: BSLN). Additional information can be found at Basilea's website www.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. Ministry of Health of the Russian Federation, June 2020
2. IQVIA, December 2019. In-market sales reported as moving annual total (MAT) in U.S. Dollar corrected for currency fluctuations.
3. European Public Assessment Report (EPAR) Cresemba: www.ema.europa.eu [Accessed: June 21, 2020]
4. The registration status and approved indications may vary from country to country.

Attachment

• Press release (PDF)