Basilea reports the launch of antifungal Cresemba® (isavuconazole) in Taiwan, triggering the second milestone payment related to Asia-Pacific

Basel, Switzerland, July 15, 2020

Basilea Pharmaceutica Ltd. (SIX: BSLN) reported today that its license partner, Pfizer Inc. (NYSE: PFE, “Pfizer”), has launched the antifungal Cresemba^® (isavuconazole) in Taiwan. The launch triggered the second milestone payment (USD 0.5 million) related to the Asia-Pacific territory from Pfizer to Basilea.

David Veitch, Chief Executive Officer, said: “We are very pleased with the launch of Cresemba in Taiwan, which triggers the second launch milestone payment related to the Asia-Pacific region and follows the launch in Australia earlier this year. We are glad we can now bring Cresemba to patients in Taiwan and we are looking forward to our partner Pfizer making Cresemba more broadly available in the region, for the benefit of patients suffering from invasive mold infections."

In Taiwan, 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

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 45 countries, including the United States, most EU member states and several additional countries inside and outside of Europe. For the twelve months to the end of the first quarter 2020, total "in-market" sales of Cresemba amounted to USD 220 million, 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 label in Taiwan. 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. Taiwan Food & Drug Administration (TFDA), January 2020
2. IQVIA, March 2020. In-market sales reported as moving annual total (MAT) in U.S. Dollar corrected for currency fluctuations.
3. European Public Assessment Report (EPAR) Cresemba: http://www.ema.europa.eu [Accessed: July 14, 2020]
4. The registration status and approved indications may vary from country to country.

Attachment

• Press release (PDF)