Basilea reports marketing authorization of antifungal Cresemba® in Brazil

Basel, Switzerland, October 29, 2019 – Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that its partner Grupo Biotoscana S.L. (“GBT”), received the regulatory approval and marketing authorization for the antifungal Cresemba® (isavuconazole) in Brazil. GBT is Basilea’s distribution partner for Cresemba and the antibiotic Zevtera® (ceftobiprole) in Latin America.

David Veitch, Basilea's Chief Executive Officer, said: “We are very pleased with the approval of Cresemba in Brazil, which is commercially the most important market for the brand in Latin America. We are looking forward to GBT launching Cresemba in Brazil, adding yet another market towards our goal of doubling the number of countries in which Cresemba is launched to 40 by the end of 2019. The market potential in these new countries and the continued growth in markets where the brand has been launched earlier, give us continued confidence in the long-term growth potential for Cresemba."

For the 12-month period of July 2018 to June 2019, total "in-market" sales of Cresemba amounted to approximately 180 million U.S. dollars (more than 35 percent growth year-on-year).1

David Veitch commented: "It is very reassuring to see the continued strong Cresemba "in-market" sales growth for all regions where the drug is currently launched. This confirms that Cresemba is addressing a high unmet medical need. Aspergillosis and mucormycosis have a devastating effect, adding to the impact of the underlying condition in patients with cancer, diabetes or undergoing transplantations."

About Cresemba (isavuconazole)

Isavuconazole is an intravenous (i.v.) and oral azole antifungal, commercialized under the trade name Cresemba. Cresemba is approved in Brazil for patients 18 years of age and older for the treatment of invasive aspergillosis and mucormycosis.2 Cresemba is approved in 46 countries altogether and currently marketed in 38 countries, including the United States, most EU member states and several additional countries in and outside of Europe. Cresemba was reviewed under the recently introduced orphan drug legislation in Brazil and has U.S. and European orphan drug designation 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 (MENA) region, Canada, Russia, Turkey and Israel.3

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 anti-infectives. 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    IQVIA, June 2019. In-market sales reported as moving annual total (MAT) in U.S. Dollar corrected for currency fluctuations.

2    Brazilian Health Regulatory Agency (ANVISA), October 2019

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

Attachments

• Press release (PDF)