Basilea reports presentation of isavuconazole and ceftobiprole data at European Congress of Clinical Microbiology and Infectious Diseases (ECCMID)
(Thomson Reuters ONE) -
Basilea Pharmaceutica AG /
Basilea reports presentation of isavuconazole and ceftobiprole data at European
Congress 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 announcement.
* Post-hoc analysis on clinical response of ceftobiprole in staphylococcal
bacteremia
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 presented.
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 -resistant Staphylococcus 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 visit www.eccmid.org.
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.(1) The 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-resistant
Staphylococcus aureus (MRSA) and susceptible Pseudomonas spp.(2) Ceftobiprole 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).(2) It 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
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 Corporate Communications & Investor Relations |
| +41 61 606 1102 |
| media_relations(at)basilea.com |
| investor_relations(at)basilea.com |
+----------------------------------------------------+
This press release can be downloaded from www.basilea.com.
References
1 European Public Assessment Report (EPAR) for CRESEMBA:
http://www.ema.europa.eu
[Accessed: April 12, 2016]
2 UK Summary of Product Characteristics (SPC) for Zevtera:
http://www.mhra.gov.uk/
[Accessed: April 12, 2016]
Press release (PDF):
http://hugin.info/134390/R/2003843/739757.pdf
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Basilea Pharmaceutica AG via GlobeNewswire
[HUG#2003843]
Unternehmensinformation / Kurzprofil:
Datum: 15.04.2016 - 07:15 Uhr
Sprache: Deutsch
News-ID 464236
Anzahl Zeichen: 13396
contact information:
Town:
Basel
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 317 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Basilea reports presentation of isavuconazole and ceftobiprole data at European Congress of Clinical Microbiology and Infectious Diseases (ECCMID)"
steht unter der journalistisch-redaktionellen Verantwortung von
Basilea Pharmaceutica AG (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
