Basilea reports launch of antibiotic Zevtera (ceftobiprole) in Canada by Avir Pharma

Basel, Switzerland, April 09, 2018 - Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that its partner Avir Pharma Inc. ("Avir Pharma") has launched Basilea's hospital antibiotic Zevtera^® (ceftobiprole) in Canada.

David Veitch, Chief Commercial Officer, said: "We are very pleased with the launch of Zevtera in Canada. We look forward to Zevtera being available to patients in Canada as a new treatment option."

Zevtera is approved in Canada for the treatment of adult patients with hospital-acquired pneumonia (HAP), excluding ventilator-associated pneumonia (VAP), and for the treatment of community-acquired pneumonia (CAP).¹

Basilea entered into a distribution and license agreement for Zevtera and the antifungal Cresemba^® (isavuconazole) with Avir Pharma in June 2017. Basilea supplies Avir Pharma with products at a transfer price and is eligible to receive further regulatory and sales milestone payments.

About Zevtera^® (ceftobiprole)

Ceftobiprole is a cephalosporin antibiotic for intravenous administration with rapid bactericidal activity against a wide range of Gram-positive and Gram-negative bacteria, including methicillin-susceptible and resistant Staphylococcus aureus (MSSA, MRSA) and susceptible Pseudomonas spp.² Ceftobiprole is approved for the treatment of adult patients with community-acquired pneumonia (CAP) and hospital-acquired pneumonia (HAP), excluding ventilator-associated pneumonia (VAP).^{1, 2} It is marketed in major European countries, Argentina and Canada. Basilea has entered into license and distribution agreements for the brand in Europe, Latin America, China, Canada, Israel, and the Middle East and North Africa (MENA) region. Ceftobiprole is currently in a phase 3 clinical program for registration in the U.S.

About hospital-acquired and community-acquired pneumonia

Hospital-acquired pneumonia (HAP) is one of the most common hospital-acquired infections and has been shown to have among the highest mortality rates of all hospital-acquired infections.³ Methicillin-resistant Staphylococcus aureus (MRSA) is one of the most frequent causes of hospital-acquired pneumonia.⁴ Community-acquired pneumonia (CAP) is a common condition with up to 60% of the patients requiring hospital admission and intravenous antibiotics.⁵ Prompt empiric intervention with an appropriate broad-spectrum antibiotic treatment is considered a best medical practice. The increasing incidence of bacteria resistant to many established antibiotics is a major concern.

About Basilea

Basilea Pharmaceutica Ltd. is a commercial stage biopharmaceutical company developing products that address the medical challenge of increasing resistance and non-response to current treatment options in the therapeutic areas of bacterial infections, fungal infections and cancer. 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 concerning Basilea Pharmaceutica Ltd. and its business. 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.

For further information, please contact:

This press release can be downloaded from www.basilea.com.

References

1. Zevtera (ceftobiprole medocaril) Product Monograph. Blainville (QC): Avir Pharma Inc., October 30, 2017
2. U.K. Summary of Product Characteristics (SPC) Zevtera: http://www.mhra.gov.uk/ [Accessed: April 06, 2018]
3. C. Rotstein et al. Clinical practice guidelines for hospital-acquired pneumonia and ventilator-associated pneumonia in adults. Canadian Journal of Infectious Diseases & Medical Microbiology 2008 (19), 19-53
4. R. N. Jones. Microbial etiologies of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. Clinical Infectious Diseases 2010 (51), S81-S87
5. W. I. Sligl et al. Severe community-acquired pneumonia. Critical Care Clinics 2013 (29), 563-601

Attachment

• Press release (PDF).pdf