April 20, 2018

Basilea reports presentations of isavuconazole and ceftobiprole data at European Congress of Clinical Microbiology and Infectious Diseases (ECCMID)

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Basel, Switzerland, April 20, 2018 - Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that a broad range of posters and presentations on the antifungal isavuconazole (Cresemba®) and the antibiotic ceftobiprole (Zevtera®) will be presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), which will be held in Madrid, Spain, from April 21 to 24, 2018.

The details for the presentations are as follows:

Isavuconazole at ECCMID 2018

Saturday, 21 April 2018 - 15:30 - 16:30 CEST, Paper Poster Arena
  • Visual and spectrophotometric MICs setting of azoles and amphotericin B against Aspergillus fumigatus complex are comparable using EUCAST 9.3.1 methodology - L. J. Marcos-Zambrano, S. Lopez, L. Martin, X. García-Fernández, A. Gómez, E. Bouza Santiago, P. Munoz, P. Escribano, J. Guinea Ortega; Poster P0169
  • Antifungal susceptibility to azoles of clinical invasive Spanish Aspergillus fumigatus complex isolates: no sign of resistance at present - L. J. Marcos-Zambrano, S. Lopez, L. Martin, X. García-Fernández, A. Gómez, M. del Carmen Martinez Jimenez, E. Bouza Santiago, P. Munoz, P. Escribano, J. Guinea Ortega; Poster P0170
  • Comparison of the MICs obtained by Etest and EUCAST methods for amphotericin B, itraconazole, posaconazole, voriconazole and isavuconazole against clinical isolates of Aspergillus fumigatus - J. Guitard, L. Verdurme, Y. Senghor, M. E. Bougnoux, A. Fekkar, F. Botterel, E. Dannaoui, C. Hennequin; Poster P0175
  • Isavuconazole MICs distribution of 20 yeast species involved in human invasive infections - M. Desnos-Ollivier, A. Boullié, O. Lortholary, F. Dromer; Poster P0296
  • In vitro pharmacodynamics of isavuconazole, voriconazole, and posaconazole against agents of aspergillosis, mucormycosis, phaeohyphomycosis, fusariosis, and scedosporiosis. - R. Lewis, N. Beyda, N. Albert, D. P. Kontoyiannis; Poster P0297
  • Real life use of isavuconazole - F. Vuotto, B.  Hennart, S. Loridant, F. Loeuillet, M. C. Chopin, B. Sendid, S. Alfandari, K. Faure ; Poster P0298
  • The cost of treating invasive mould disease with isavuconazole compared with liposomal amphotericin B followed by posaconazole in France - E. Bagshaw, B. Salaun, M. Blackney, J. Posthumus, D. Kuessner; Poster P0303
  • Resistance screening of commonly used antimycotics in rare yeast - A. Pérez Hansen, C. Lass-Flörl, M. Lackner; Poster P0306
  • Isavuconazole shortens the QTc interval - S. Mellinghoff, M. Bassetti, D. Dörfel, S. Hagel, N. Lehners, A. Plis, E. Schalk, A. Vena, O. A. Cornely; Poster P0308A


Isavuconazole at ECCMID 2018  (continued)

Saturday, 21 April 2018 - 15:30 - 16:30 CEST, Paper Poster Arena

  • Antifungal susceptibility of Spanish Candida auris isolates determined by Etest and Sensititre YeastOne - A. Ruiz, M. Fernandez, E. Canton, M. Garrido Jareño, P. Ramirez, J. L. López-Hontangas, J. P. Garcia; Poster 0312
  • Septic metastatic complications after Candida auris candidaemia in the first Spanish outbreak setting - M. Tasias, E. Calabuig, M. Montero, F. Blanes, J. Fernandez, A. Ruiz, I. Castro, A. Aleixandre, J. Mollar, J. Pemán, M. Slavert;
    Poster P0315
Sunday, 22 April 2018 - 13:30 - 14:30 CEST, Paper Poster Arena

  • Evaluation of gradient strip for antifungal susceptibility testing of isavuconazole and comparators against Mucorales - P. Vidal, E. Dannaoui; Poster P1243
Monday, 23 April 2018 - 14:30 - 15:30 CEST, ePoster Arena 1

  • Identification of an isavuconazole dosing regimen for children aged 2-17 years - A. Desai, W. Hope, M. Neely, C. Lademacher, L. Kovanda; ePoster, oral pres. O0795
Tuesday, 24 April 2018; 14:30 - 15:00 CEST, Hall G
  • Pro/con debate: Isavuconazole (not amphotericin B) as primary treatment for mucormycosis - O. A. Cornely; Symposium S1070 / Amphotericin B (not isavuconazole) as primary treatment for mucormycosis - F. Lanternier; Symposium S1071


Ceftobiprole at ECCMID 2018

Saturday, 21 April to Tuesday, 24 April 2018, ePoster terminals

  • Activity of ceftobiprole and comparators against a collection of teicoplanin- and/or linezolid-resistant coagulase-negative staphylococci isolated from bloodstream infections - M. Coppi, A. Antonelli, G. Baldi, L. Mosconi, A. Santerre Henriksen, F. Arena, T. Giani, G. M.  Rossolini; ePoster E0003
  • Activity of ceftobiprole and comparators against European respiratory tract isolates of MSSA and MRSA from 2016 - I. Morrissey, S. De Angelis, S. Magnet, S. Hawser, A. Santerre-Henriksen; ePoster E0006
Saturday, 21 April 2018; 15:30 - 16:30 CEST, Paper Poster Arena

  • Ceftobiprole versus vancomycin in treatment of methicillin-resistant Staphylococcus aureus (MRSA) meningitis in an experimental rabbit model - S. Mermer, E. Bolat, T. Turhan, S. Aydemir, H. Sipahi, O. R. Sipahi; Poster P0263
Monday, 23 April 2018; 13:30 - 14:30 CEST, Paper Poster Arena
  • In vitro susceptibility testing of cerufoxime, cefixime, cefpodoxime, cefotaxime, ceftaroline, ceftobiprole, linezolid and tedizolid against isolates of Nocardia by using the E-test method - E. Bergeron, F. Vautrin, T.  Durand, F.  Laurent, V. Rodriguez-Nava; Poster P1841
  • In vitro activity of tedizolid, dalbavancin and ceftobiprole against Clostridium difficile - D. Binyamin, O. Nitzan, M. Azrad, Z. Hamo, O. Koren, A. Peretz; P1844


Ceftobiprole at ECCMID 2018 (continued)

Tuesday, 24 April 2018; 12:30 - 13:30 CEST, Paper Poster Arena
  • In vivo assessment of ceftobiprole versus daptomycin in a murine model of Staphylococcus aureus bacteremia: antimicrobial activity and impact on host inflammatory response - L. Bouard, J. Caillon, V. Le Mabecque, E. Thomas, K. Asehnoune, C. Jacqueline; Poster P2025
  • Epidemiology and ceftobiprole susceptibility of European Enterobacteriaceae and Gram-positive clinical isolates from different infection sources collected in 2016 - S. Hawser, S. De Angelis, S. Magnet, I. Morrissey, A. Santerre-Henriksen; Poster P2441
  • Bactericidal and synergistic activity of ceftobiprole combined with different antibiotics against selected Gram-positive isolates - F. Campanile, D. Bongiorno, C. Pulitano, S. Stefani; Poster P2498

For further information please visit www.eccmid.org.

About isavuconazole (Cresemba®)

Isavuconazole is an intravenous (i.v.) and oral azole antifungal, commercialized under the trade name Cresemba. 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. Cresemba is approved in the United States for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis.1 In the 28 European Union member states, as well as in Iceland, Liechtenstein and Norway, Cresemba 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.2 In Switzerland, Cresemba is approved for the treatment of adult patients with invasive aspergillosis and for the treatment of mucormycosis in adult patients who are resistant to or intolerant of amphotericin B and in adult patients with moderate to severe renal impairment.3 Isavuconazole has U.S. and European orphan drug designation for its approved indications. Outside the U.S. and Europe, the drug is currently not approved for commercial use.

About ceftobiprole (Zevtera®)

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.4 Ceftobiprole is approved for the treatment of adult patients with community-acquired pneumonia (CAP) and hospital-acquired pneumonia (HAP), excluding ventilator-associated pneumonia (VAP).4 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 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   Cresemba US prescribing information [Accessed: April 19, 2018]
2   European Public Assessment Report (EPAR) Cresemba: www.ema.europa.eu [Accessed: April 19, 2018]
3   Full indication in: Swissmedic-approved information for healthcare professionals as of August 2017
4   U.K. Summary of Product Characteristics (SPC) Zevtera: www.mhra.gov.uk [Accessed: April 19, 2018]