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2015-04-24

Basilea Pharmaceutica AG: Basilea reports isavuconazole and ceftobiprole data to be presented at ECCMID

Basilea Pharmaceutica AG / Basilea reports isavuconazole and ceftobiprole data
to be presented at ECCMID. Processed and transmitted by NASDAQ OMX Corporate
Solutions. The issuer is solely responsible for the content of this
announcement.
Basel, Switzerland, April 24, 2015

- Basilea Pharmaceutica Ltd. (SIX: BSLN) reported today that a broad range of
scientific data will be presented on the antifungal isavuconazole and the
antibiotic ceftobiprole at the European Congress of Clinical Microbiology and
Infectious Diseases (ECCMID) held in Copenhagen, Denmark, from 25 - 28 April
2015.

The presentations at ECCMID will include more detailed analyses of the
isavuconazole data from two phase 3 clinical trials in adult patients with
invasive fungal infections: SECURE, a randomized, double-blind,
active-control study of adult patients with invasive aspergillosis, and
VITAL, an open-label non-comparative study of isavuconazole in adult patients
with invasive aspergillosis and renal impairment or in patients with invasive
fungal disease caused by other fungi, including those causing mucormycosis.

Additionally, posters and oral presentations will feature ceftobiprole, such
as data on the activity spectrum of ceftobiprole against current clinical
pathogens causing respiratory tract infections and its activity in community-
and hospital-acquired pneumonia (CAP and HAP), including early- and
late-onset HAP. In addition, pharmacokinetics, safety and tolerability of
high-dose ceftobiprole in the intensive care setting are being presented.

HAP is one of the most common infectious diseases acquired in hospitals,
affecting 0.5-1.7% of hospitalized patients.1It is caused by a wide spectrum
of Gram-positive bacteria such asStaphylococcus aureus
, particularly methicillin-resistant strains (MRSA), and Gram-negative
bacteria. In MRSA pneumonia treatment failure rates are high and have been
attributed to inadequate antibiotic therapy.2

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| Isavuconazole posters at ECCMID 2015 |
| * Safety and outcomes in invasive aspergillosis patients with renal vs. no |
| renal impairment treated with isavuconazole: experience from the SECURE |
| (randomized) and VITAL trials - K. M. Mullane M. Aoun, B. Franks, N. Azie, |
| S. Mujais, A. Kaufhold, J. Maertens,; ePoster EV0932, ePoster viewing, |
| Saturday, April 25, 2015, ePoster area |
| * Exposure response analysis of isavuconazole in patients with disease caused |
| by Aspergillus species or other filamentous fungi - A. Desai, L. Kovanda, |
| W. Hope, J. Mouton, D. Andes, D. Kowalski, R. Townsend, P. L. Bonate; |
| poster P0217, paper poster session I, Saturday, April 25, 2015, |
| 15:30-16:30, poster area |
| * Safety and outcomes in obese patients with invasive fungal disease treated |
| with isavuconazole in the phase 3 randomised double-blind SECURE trial - D. |
| Goff, D. Andes, W. W. Hope, N. Azie, F. Shi, L. Kim, L. Kovanda, A.-H. |
| Schmitt-Hoffmann, T. Gumbo; poster P0233, paper poster session I, Saturday, |
| April 25, 2015, 15:30-16:30, poster area |
| * An open-label phase 3 study of isavuconazole (VITAL): focus on patients |
| with mixed fungal infections - G. Rahav, I. Oren, K. M. Mullane, R. Maher, |
| M. Lee, B. Zeiher, A.-H. Schmitt-Hoffmann, M. Giladi; poster P0230, paper |
| poster session I, Saturday, April 25, 2015, 15:30-16:30, poster area |
| * Drug interaction profiles of isavuconazole, voriconazole and posaconazole |
| with immunosuppressants metabolized by CYP4503A4 (CYP3A4) - R. Townsend, A. |
| Desai, N. Azie, M. Jones, M. Engelhardt, A.-H. Schmitt-Hoffmann; poster |
| P0216, paper poster session I, Saturday, April 25, 2015, 15:30-16:30, |
| poster area |
| * Clinical outcomes by minimum inhibitory concentrations of baseline |
| Aspergillus pathogens from isavuconazole phase 3 SECURE and VITAL studies - |
| W. Hope, M. Ghannoum, L. Kovanda, M. Jones, A. Kaufhold, M. Engelhardt, A. |
| Santerre-Henriksen; ePoster EP016, ePoster session, Saturday, April 25, |
| 16:06-16:12, ePoster area 3 |
| * A comparison of the safety profiles of isavuconazole vs voriconazole in the |
| phase 3 SECURE study in patients with invasive mould infections - A. J. |
| Ullmann, D. Selleslag, W. J. Heinz, R. Herbrecht, G. Rahav, M. Giladi, M. |
| Aoun, O. A. Cornely, N. Azie, A. Kaufhold, M. Engelhardt, J. Maertens; |
| ePoster EP018, ePoster session, Saturday, April 25, 16:18-16:24, ePoster |
| area 3 |
| * Impact of dose fractionation on the in vivo efficacy of isavuconazole in a |
| murine model of Aspergillus fumigatus infection - S. Seyedmousavi, R. J. M. |
| Brüggemann, J. F. Meis, W. J. G. Melchers, P. E. Verweij, J. W. Mouton; |
| poster P0219, paper poster session I, Saturday, April 25, 2015, |
| 15:30-16:30, poster area |
| * Successful treatment of contaminated epidural steroid associated fungal |
| meningitis with isavuconazole - N. Everson, J. Smith, D. Garner; poster |
| P0231, paper poster session I, Saturday, April 25, 2015, 15:30-16:30, |
| poster area |
| * Efficacy of isavuconazole against wild-type and Cyp51 mutant isolates of |
| Aspergillus fumigatus in a mouse infection model - S. Seyedmousavi, R. J. |
| M. Brüggemann, J. F. Meis, W. J. G. Melchers, P. E. Verweij, J. W. Mouton; |
| poster P1286; paper poster session VI, , Tuesday, April 28, 2015, |
| 12:30-13:30, poster area |
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| Ceftobiprole posters and presentations at ECCMID 2015 |
| * Susceptibility of ceftobiprole and comparators against Staphylococcus |
| aureus from hospital-acquired respiratory-tract infections in the UK and |
| Ireland: 2011-12&2012-13 - I. Morrissey, S. Hawser, R. Reynolds, M. Jones, |
| A. Santerre-Henriksen; ePoster EV0228, ePoster viewing, Saturday, April 25, |
| 2015, ePoster area |
| * In vitro activity of ceftobiprole against clinical isolates collected from |
| blood and respiratory specimen of hospitalized patients: results of the PEG |
| study - M. Kresken, B. Körber-Irrgang, D. Hafner; poster P0831, paper |
| poster session IV, Monday, April 27, 2015, 12:30-13:30, poster area |
| * Clinical cure and mortality outcomes with ceftobiprole medocaril versus |
| ceftazidime plus linezolid in patients with early versus late onset |
| hospital-acquired pneumonia - T. Scheeren, T. Welte, G. Capellier, M. |
| Saulay, M. Engelhardt; oral presentation O194, Monday, April 27, 2015, |
| 16:36-16:48, hall J |
| * Pharmacokinetics, safety and tolerability of high-dose ceftobiprole |
| medocaril administered as prolonged infusion in intensive-care-unit (ICU) |
| patients - A. Torres, M. Sanchez-Garcia, I. Demeyer, M. Saulay, A.-H. |
| Schmitt-Hoffmann, M. Engelhardt, M. S. Park; oral presentation O199, |
| Monday, April 27, 2015, 17:36-17:48, hall J |
| * Comparison of ceftobiprole susceptibility testing using broth microdilution |
| and gradient strip (Etest®) - I. Morrissey, S. Hawser, R. Janes, M. Jones, |
| A. Santerre-Henriksen; poster P1247, paper poster session VI, Tuesday, |
| April 28, 2015, 12:30-13:30, poster area |
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| BAL30072 posters at ECCMID 2015 |
| * Activity of BAL30072 and BAL30072 / meropenem (1:1) combination against |
| recent clinical isolates of Klebsiella pneumoniae from urinary tract |
| infections - I. Morrissey, S. Magnet, S. P. Hawser, A. Santerre-Henriksen; |
| ePoster EV0202, ePoster viewing, Saturday, April 25, 2015, ePoster area |
| * Efficacy of BAL30072 in murine lung infection models of multi-resistant |
| Gram-negative bacteria - A. Sattar, S. Vaddi, P. Thommes, J. Teague, A. |
| Santerre-Henriksen, M. Jones, A.-H. Schmitt-Hoffmann, P. A. Warn; ePoster |
| EP153, ePoster session, Monday, April 27, 2015, 13:30-13:36, ePoster area 5 |
| |
| * Efficacy of BAL30072 in combination with meropenem in murine thigh |
| infection models of multi-resistant Gram-negative bacteria - P. Thommes, A. |
| Sattar, E. Burgess, G. Parker, L. J. Payne, A. Santerre-Henriksen, M. |
| Jones, A.-H. Schmitt-Hoffmann, P. A. Warn; poster P1380, paper poster |
| session VI, Tuesday, April 28, 12:30-13:30, poster area |
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For further information please visitwww.eccmid.org.

About isavuconazole

Isavuconazole is an azole antifungal and the active agent of the prodrug
isavuconazonium sulfate (U.S. trade name CRESEMBA®). Isavuconazole is being
co-developed with Astellas Pharma Inc.

Isavuconazole was approved in March 2015 by the U.S. Food and Drug
Administration (FDA) for patients 18 years of age and older for the treatment
of invasive aspergillosis and invasive mucormycosis. These are
life-threatening fungal infections predominantly occurring in
immunocompromised patients. Basilea's partner Astellas will market the drug
as CRESEMBA®.

A European Marketing Authorization Application for these indications,
submitted by Basilea, is currently under review by the European Medicines
Agency. Outside the U.S., isavuconazole is an investigational product and
currently not approved for commercial use.

The following Important Safety Information for CRESEMBA®(isavuconazonium
sulfate) is applicable only to the product approved in the United States:

CRESEMBA®is contraindicated in persons with known hypersensitivity to
isavuconazole.

Coadministration of strong CYP3A4 inhibitors, such as ketoconazole or
high-dose ritonavir (400 mg every 12 hours), with CRESEMBA®is contraindicated
because strong CYP3A4 ...

Författare Hugin

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