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

Basel, Switzerland, February 27, 2020 – Basilea Pharmaceutica Ltd. BSLN reported today that its license partner Pfizer Inc. PFE "Pfizer"))) has launched the antifungal Cresemba^® (isavuconazole) in Australia. The launch triggered the first 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 Australia, which marks an important milestone in the roll-out of Cresemba for the Asia-Pacific region. Our aim is to expand the global availability of Cresemba for the benefit of patients suffering from invasive mold infections. By increasing the number of new country launches, in addition to increasing numbers of patients being treated in already launched countries, this forms the basis for us maintaining the strong growth momentum of our brands and achieving our goal of increasing our "non-deferred" revenues related to Cresemba and our antibiotic Zevtera by 12% to 27% to CHF 77-87 million in 2020."

In Australia, 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 agreements with Pfizer, Basilea is still eligible for regulatory and sales milestone payments of approximately USD 635 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 12-month period ending September 2019, total "in-market" sales of Cresemba amounted to approximately 190 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 the same label as in Australia. Cresemba is also approved in the United States and several additional countries in Europe and beyond.⁴ It has orphan drug designation in Australia, the U.S. and Europe 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 invasive aspergillosis and mucormycosis

Invasive mold infections often affect immunocompromised patients, such as patients with cancer and after transplantation. They are mainly caused by airborne Aspergillus species and invasive aspergillosis is often fatal. However, Mucormycetes, which can be found for example in soil, have emerged as the second most frequent group of molds causing invasive infections. Over 50% of patients with mucormycosis die from this infection, so its mortality rate is particularly high. Today there are only limited available treatment options for invasive mold infections.

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 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   Australian Government, Department of Health, Therapeutic Goods Administration, May 2019

2   IQVIA, September 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: http://www.ema.europa.eu
[Accessed: February 26, 2020]

4   The registration status and approved indications may vary from country to country.  

Attachment

• Press release (PDF)