Basilea announces Zevtera® (ceftobiprole) marketing authorization in Brazil

Basel/Allschwil, Switzerland, July 12, 2022

Basilea Pharmaceutica Ltd (SIX: BSLN), a commercial-stage biopharmaceutical company, announced today that its distribution partner for Latin America, Knight Therapeutics Inc. (“Knight”, TSX: GUD), has received a marketing authorization from the Agência Nacional de Vigilância Sanitária (Anvisa) in Brazil for the broad-spectrum, anti-MRSA (methicillin-resistant Staphylococcus aureus) antibiotic Zevtera^® (ceftobiprole). Zevtera is indicated for the treatment of adult patients with community-acquired pneumonia (CAP) and adult patients with hospital-acquired pneumonia (HAP), excluding ventilator-associated pneumonia (VAP).

David Veitch, Basilea’s Chief Executive Officer, stated: “We are very pleased with the approval of Zevtera in Brazil. We look forward to working with Knight to make Zevtera available to patients in Brazil. Knight has a strong local presence in Brazil, with a track record of successfully launching anti-infective brands in the country.”

The grant of the marketing authorization triggered a milestone payment from Knight to Basilea.

About Zevtera (ceftobiprole)

Ceftobiprole medocaril, the prodrug of the active moiety ceftobiprole, is a cephalosporin antibiotic for intravenous administration, with rapid bactericidal activity against a wide range of Gram-positive and Gram-negative bacteria. This includes methicillin-susceptible and methicillin-resistant Staphylococcus aureus (MSSA, MRSA) and susceptible Pseudomonas spp.¹ The brand is currently approved and marketed as Zevtera and Mabelio in a number of countries in Europe and beyond. Basilea has entered into license and distribution agreements in Europe, Eurasian countries, Latin America, China, Canada, Israel, and the Middle East and North Africa (MENA) regions.

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 bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of severe bacterial infections. In addition, we have several preclinical anti-infective assets 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 press release can be downloaded from www.basilea.com.

References

1. Summary of Product Characteristics (SmPC) Zevtera: https://www.medicines.org.uk/emc/product/9164/smpc
   [Accessed: July 11, 2022]

Attachment

• Press release (PDF)