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Basilea reports launch of antibiotic Zevtera (ceftobiprole) in Saudi Arabia by Hikma Pharmaceuticals LLC
[May 15, 2018]

Basilea reports launch of antibiotic Zevtera (ceftobiprole) in Saudi Arabia by Hikma Pharmaceuticals LLC


Basel, Switzerland, May 15, 2018 - Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that its partner Hikma Pharmaceuticals LLC has launched Basilea's hospital antibiotic Zevtera® (ceftobiprole) in Saudi Arabia.

Adesh Kaul, Chief Corporate Development Officer, said: "We are very pleased with the launch of Zevtera in Saudi Arabia. This is the first launch by our partner Hikma, a leading pharmaceutical company in the Middle East and North Africa region. Infections with bacteria resistant to established antibiotics remain a major health care concern across this region. Following the market entry in Saudi Arabia we are therefore looking forward to Hikma expanding the availability of Zevtera to further countries in the Middle East and North Africa."

Zevtera is approved in Saudi Arabia 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).

Basilea entered into a distribution and license agreement for Zevtera with Hikma in 2015 and for the antifungal Cresemba® (isavuconazole) in 2016.

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.1 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 It is marketed in major European countries, Argentina, Canada and Saudi Arabia. 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.2 Methicillin-resistant Staphylococcus aureus (MRSA) is one of the most frequent causes of hospital-acquired pneumonia.3 There is an increasing burden of antibiotic resistance, including MRSA, in countries of the Middle East and North Africa region.4,5 Community-acquired pneumonia (CAP) is a common condition with up to 60% of the patients requiring hospital admission and intravenous antibiotics.6 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. 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 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:

Peer Nils Schröder, PhD
Head of Corporate Communications & Investor Relations
+41 61 606 1102
media_relations@basilea.com
investor_relations@basilea.com

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

References

1   U.K. Summary of Product Characteristics (SPC) Zevtera: http://www.mhra.gov.uk/
[Accessed: May 14, 2018]

2   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

3   R. N. Jones. Microbial etiologies of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. Clinical Infectious Diseases 2010 (51), S81-S87

4   H. M. Zowawi. Antimicrobial resistance in Saudi Arabia. An urgent call for an immediate action. Saudi Medical Journal 2016 (37), 935-940

5   A. Shibl et al. Infectious diseases in the Arabian Peninsula and Egypt. Clinical Microbiology and Infection 2012 (18), 1068-1080

6   W. I. Sligl et al. Severe community-acquired pneumonia. Critical Care Clinics 2013 (29), 563-601

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