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Basilea Pharmaceutica AG: Basilea reports presentation of isavuconazole and ceftobiprole data at European Congress of Clinical Microbiology and Infectious Disea

Basilea Pharmaceutica AG / Basilea reports presentation of isavuconazole and
ceftobiprole data at EuropeanCongress of Clinical Microbiology and Infectious
Diseases (ECCMID) . Processed and transmitted by NASDAQ OMX Corporate
Solutions.The issuer is solely responsible for the content of this
* Post-hoc analysis on clinical response of ceftobiprole in staphylococcal

Basel, Switzerland, April 15, 2016

- Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that a broad range of
posters and oral presentations with scientific data on the antifungal
isavuconazole (CRESEMBA®) and the antibiotic ceftobiprole (Zevtera®) were
presented at the European Congress of Clinical Microbiology and Infectious
Diseases (ECCMID). At the conference, which was held in Amsterdam, the
Netherlands, starting on April 9, 2016, the company hosted symposia on new
perspectives in the management of nosocomial pneumonia and current challenges
and recent developments for the treatment of invasive mold infections.

The data presented on isavuconazole included further analyses from the
isavuconazole SECURE phase 3 study in invasive aspergillosis and the results
of the ACTIVE phase 3 study in invasive candidiasis. In addition, in-vitro
data on the activity of isavuconazole against a variety of fungal pathogens,
including isolates with reduced susceptibility to other azoles, were

For ceftobiprole, the presentations included data from a post-hoc analysis of
patients with staphylococcal bacteremia from four double-blind, randomized,
phase 3 studies in complicated skin or pulmonary infections. The data
demonstrated that clinical responses with ceftobiprole were similar to those
for standard-of-care comparators, with a trend towards lower 30-day all-cause
mortality with ceftobiprole. Bloodstream infections caused by
Methicillin-susceptible and -resistantStaphylococcus aureus
are a potentially life-threatening complication of staphylococcal infections
in other sites of the body.

| Isavuconazole posters and presentations at ECCMID 2016 |
| * Pharmacodynamics of isavuconazole in experimental invasive pulmonary |
| aspergillosis: a virtuous cycle between bench and bedside - L. Kovanda, R. |
| Petraitiene, V. Petraitis, T. J. Walsh, A. Desai, P. Bonate, W. W. Hope; |
| ePoster EP0006 |
| * Efficacy and safety outcomes in patients with probable or proven versus |
| possible invasive mould disease from the phase 3 secure study, evaluating |
| isavuconazole versus voriconazole for the primary treatment of invasive |
| fungal disease caused by Aspergillus spp. or other filamentous fungi - J. |
| Maertens, D. Selleslag, W. Heinz, R. Herbrecht, G. Rahav, M. Giladi, M. |
| Aoun, O. A. Cornely, N. Azie, A. Kaufhold, M. Engelhardt, M. Saulay, A. |
| Ullmann; ePoster EP0010 |
| * In vitro activity of isavuconazole against Candida and Aspergillus - M. C. |
| Arendrup, R. H. Jensen, K. Astvad; Oral presentation O227 |
| * Isavuconazole versus caspofungin in the treatment of candidaemia and other |
| invasive Candida infections: the ACTIVE trial - B.-J. Kullberg, G. |
| Thompson, P. Pappas, J. Vazquez, C. Viscoli, L. Ostrosky-Zeichner, C. |
| Rotstein, J. Sobel, R. Herbrecht, G. Rahav, E. Van Wijngaerden, J. De |
| Waele, S. Jaruratanasirikul, P. Chetchotisakd, L. Kovanda, C. Lademacher, |
| M. Lee, M. Engelhardt; Oral presentation O423 |
| * Intra-subject variability and exposure-response relationship of |
| isavuconazole in the phase 3 SECURE study in patients with invasive mould |
| disease caused by Aspergillus spp. and other filamentous fungi - T. Kaindl, |
| M. Engelhardt, R. Townsend, A. Desai, L. Kovanda, M. Saulay, A. H. |
| Schmitt-Hoffmann; Oral presentation O424 |
| * Population pharmacokinetics of isavuconazole in patients with invasive |
| Candida infections (IC) and combined analysis of patients with IC or |
| invasive aspergillosis - A. Desai, L. Kovanda, C. Lademacher, R. W. |
| Townsend, S. Mujais, P. L. Bonate; Poster P1572 |
| * In vitro activity of isavuconazole against azole-resistant environmental |
| Aspergillus fumigatus isolates, cryptic Candida strains and emerging yeasts |
| - P. Le Pape, B. Ariza, C. Loge, R. Lavergne, F. Morio, C. Picot, S. |
| Valderrama, C. Alvarez; Poster P1584 |

| Ceftobiprole posters and presentations at ECCMID 2016 |
| * EUCAST zone diameter breakpoints and quality control criteria for |
| ceftobiprole 5 mcg - E. Matuschek, J. Åhman, A. Santerre Henriksen, G. |
| Kahlmeter; Poster P0825 |
| * A pooled analysis of clinical cure and mortality with ceftobiprole |
| medocaril versus comparators in staphylococcal bacteraemia in complicated |
| skin infections, and community- and hospital acquired pneumonia - J. Rello, |
| G. Rahav, T. Scheeren, M. Saulay, M. Engelhardt, T. Welte; Oral |
| presentation O318 |
| * Pharmacokinetics and pharmacodynamics of ceftobiprole in adults who are |
| severely obese - A. Schmitt-Hoffmann, M. Engelhardt, J. Spickermann, M. |
| Jones, A. Kaufhold; Poster P1250 |
| * Bone penetration of the new-generation cephalosporin ceftobiprole in |
| patients following hip replacement surgery - A.-H. Schmitt-Hoffmann, M. |
| Engelhard, J. Spickermann, M. Jones, A. Kaufhold; Poster P1251 |
| * Pharmacokinetics of ceftobiprole in paediatric patients - J. Blumer, A.-H. |
| Schmitt-Hoffmann, M. Engelhardt, J. Spickermann, M. Jones, A. Kaufhold; |
| Poster P1252 |
| * Ceftobiprole resistance in Danish MRSA - A. Larsen, A. Petersen, F. Hansen, |
| A. Santerre Henriksen, R. Skov; Poster P1343 |
| * Comparison of MRSA susceptibility to ceftobiprole as determined by either |
| Etest or microdilution methods - L. Galia, G. Cornaglia, A. Mazzariol; |
| Poster P1345 |
For further information please

About CRESEMBA® (isavuconazole)

Isavuconazole is an intravenous and oral azole antifungal and the active agent
of the prodrug isavuconazonium sulfate. The drug was co-developed with
Basilea's license partner Astellas Pharma Inc. Astellas commercializes
isavuconazole in the U.S. and Basilea holds full rights in markets outside
the United States. Isavuconazole was approved in March 2015 by the United
States Food and Drug Administration (FDA) for the use for patients 18 years
of age and older in the treatment of invasive aspergillosis and invasive
mucormycosis, and was launched in the U.S. by Astellas in April 2015.
Isavuconazole is marketed under the trade name CRESEMBA®. The European
Commission granted isavuconazole marketing authorization in October 2015 for
the treatment of adult patients with invasive aspergillosis and for the
treatment of adult patients with mucormycosis for whom amphotericin B is
inappropriate.1The European marketing authorization is valid in all 28
European Union member states, as well as in Iceland, Liechtenstein and
Norway. Basilea has launched CRESEMBA in the UK and Germany, and launches in
additional European countries are planned throughout 2016. Isavuconazole has
orphan drug designation for the treatment of invasive aspergillosis and
mucormycosis in Europe and the U.S. Outside the United States and the EU,
isavuconazole is currently an investigational product and not approved for
commercial use.

About Zevtera® (ceftobiprole)

Zevtera®(ceftobiprole medocaril) is a broad-spectrum antibiotic for
intravenous administration with bactericidal activity against certain
Gram-positive and Gram-negative bacteria, including
methicillin-resistantStaphylococcus aureus
(MRSA) and susceptiblePseudomonas
spp.2Ceftobiprole is approved for sale in 13 European countries and Canada for
the treatment of adult patients with community-acquired pneumonia and
hospital-acquired pneumonia (excluding ventilator-associated pneumonia).2It
has been launched in Germany, France, Italy, the United Kingdom and Austria.
Ceftobiprole received Qualified Infectious Disease Product (QIDP) designation
from the U.S. Food and Drug Administration for the potential treatment of
community-acquired bacterial pneumonia and acute bacterial skin and skin
structure infections. Ceftobiprole is not approved in the United States.

About Basilea

Basilea Pharmaceutica Ltd. is a biopharmaceutical company developing products
that address increasing resistance and non-response to current treatment
options in the therapeutic areas of bacterial infections, fungal infections
and cancer. The company uses the integrated research, development and
commercial operations of its subsidiary Basilea Pharmaceutica International
Ltd. to discover, develop and commercialize innovative pharmaceutical
products to meet the medical needs of patients with serious and potentially
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


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 Corporate Communications&Investor Relations |
|+41 61 606 1102 |
| |
| |
| |
This press release can be downloaded


1 European Public Assessment Report (EPAR) for

[Accessed: April 12, 2016]

2 UK Summary of Product Characteristics (SPC) for

[Accessed: April 12, 2016]

Press release (PDF)


This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Basilea Pharmaceutica AG via Globenewswire


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