Basilea reports presentation of 19 posters at ICAAC on investigational anti-infectives isavuconazole, ceftobiprole, and

Basilea reports presentation of 19 posters at ICAAC on investigational
anti-infectives isavuconazole, ceftobiprole, and BAL30072

BASEL, Switzerland, Sept. 13, 2013 (GLOBE NEWSWIRE) --

Basilea Pharmaceutica Ltd. (SIX: BSLN)
announced today that 19 posters are being presented on the anti-infectives
isavuconazole, ceftobiprole, and BAL30072 at the 53rd Interscience Conference on
Antimicrobial Agents and Chemotherapy (ICAAC). The conference is taking place
from September 10 to 13, 2013 in Denver, USA.

Basilea's Chief Scientific Officer Dr. Laurenz Kellenberger commented: "Drug
resistance is a major global healthcare concern with patients facing potentially
life-threatening infections with few to no therapeutic options. The wealth of
data presented on the activity of isavuconazole, ceftobiprole, and BAL30072
against resistant pathogens further substantiates the promising profiles of
these innovative product candidates in addressing this unmet medical need. We
expect topline data from two isavuconazole phase 3 studies to be available in
the second half of 2013. In the same timeframe, we anticipate a regulatory
decision on the European Marketing Authorization Application for ceftobiprole
for the potential treatment of pneumonia in the hospital."

Presentations on isavuconazole further substantiate its broad antifungal
coverage. Isavuconazole demonstrated potent activity against global collections
of contemporary, clinically relevant pathogens causing invasive fungal disease.
Activity against invasive pulmonary aspergillosis and mucormycosis was
demonstrated in neutropenic animal models. In addition, synergistic action
between isavuconazole and micafungin was observed in-vitro against Aspergillus
spp.

A presentation showing a genotypic characterization of methicillin-resistant
Staphylococcus aureus (MRSA) strains collected during the ceftobiprole pneumonia
phase 3 studies confirmed that the isolates were representative of MRSA strains
causing nosocomial infections worldwide. Additional posters highlight the potent
synergistic activity of ceftobiprole with daptomycin in-vitro; against
vancomycin-intermediate or daptomycin-resistant MRSA isolates; and against
daptomycin-susceptible and vancomycin resistant enterococci.

Susceptibility data presented at ICAAC highlight the activity of Basilea's novel
anti-Gram-negative antibiotic BAL30072 against important potential biodefense
pathogens. In June, Basilea announced its contract with the U.S. Biomedical
Advanced Research and Development Authority (BARDA) for the development of
BAL30072.

+------------------------------------------------------------------------------+
|Posters on isavuconazole                                                      |
|                                                                              |
|Pharmacodynamics (PD) of Isavuconazole (Isav) in a Murine Invasive Pulmonary  |
|Aspergillosis (IPA) Model Against Wildtype (WT) and Cyp51 Mutants - A. Lepak, |
|K. Marchillo, J. Van Hecker, D.R. Andes; A-291                                |
|                                                                              |
|No Effect on Pharmacokinetic and Pharmacodynamic Parameters of Warfarin after |
|Coadministration with Isavuconazole - T. Yamazaki, A. Desai, H. Pearlman, D.  |
|Kowalski, C.Lademacher, R. Townsend; A-448                                   |
|                                                                              |
|Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of CYP3A4   |
|Substrate Atorvastatin in Healthy Subjects - T. Yamazaki, H. Pearlman, D.     |
|Kowalski, C. Lademacher, A.Desai, R. Townsend; A-449                         |
|                                                                              |
|Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of CYP2B6   |
|Substrate Bupropion in Healthy Subjects - A. Desai, H. Pearlman, T. Yamazaki, |
|C. Lademacher, D.Kowalski, R. Townsend; A-450                                |
|                                                                              |
|Impact of Candida species on the Isavuconazole (ISA) Pharmacodynamic (PD)     |
|Target in an in vivo Neutropenic Murine Model of Invasive Candidiasis (IC) -  |
|A. Lepak, K. Marchillo, J. Van Hecker, D. Diekema, D.R. Andes; A-451          |
|                                                                              |
|Pharmacokinetics and Efficacy of Isavuconazole for Treatment of Experimental  |
|Invasive Pulmonary Aspergillosis - R. Petraitiene, V. Petraitis, P.W. Moradi, |
|G.E. Strauss, B.T. Huertas, A.Katragkou, E. Petraityte, L.L. Kovanda, J.     |
|Smart, W.W. Hope, T.J. Walsh; M-759                                           |
|                                                                              |
|Isavuconazole Protects Immunosuppressed Mice from Rhizopus oryzae Infection - |
|G. Luo, T.Gebremariam, H. Lee, J.E. Edwards, A.S. Ibrahim; M-787             |
|                                                                              |
|In Vitro Activity of Antifungal Drugs against a Global Collection of 28       |
|Clinical and Environmental Exserohilum Species Isolates - J.F. Meis, H.       |
|Madrid, I. Breuker, F. Hagen, G.S. De Hoog, A. Chowdhary; M-1350              |
|                                                                              |
|Intra- and Interlaboratory Study of Antifungal Susceptibility Testing of      |
|Isavuconazole against Aspergillus Strains - M.A. Ghannoum, V. Chaturvedi, A.  |
|Espinel-Ingroff, A. Fothergill, R. Jones, L.Ostrosky-Zeichner, R. Rennie, T. |
|Walsh; M-1351                                                                 |
|                                                                              |
|In Vitro Interaction Between Isavuconazole and Micafungin or Amphotericin B   |
|against Medically Important Moulds - V. Petraitis, J. Meletiadis, P.W. Moradi,|
|G.E. Strauss, L.L. Kovanda, R. Petraitiene, T.J. Walsh; M-1362                |
|                                                                              |
|Isavuconazole Susceptibility in Triazole Resistant Aspergillus fumigatus - L. |
|Gregson, J. Goodwin, A. Johnson, L. McEntee, C.B. Moore, M. Richardson, W.W.  |
|Hope, S.J. Howard; M-1365                                                     |
|                                                                              |
|Activity of Isavuconazole, Amphotericin B, and Micafungin Alone and in        |
|Combination against Exserohilum rostratum - P.W. Moradi, V. Petraitis, R.     |
|Petraitiene, G.E. Strauss, D.H. Larone, Y.Zhao, A. W. Forthergill, M.        |
|Ghannoum, M. Simitsopoulou, E. Roilides, D.P. Kontoyiannis, D.S.Perlin, T. J.|
|Walsh; M-1372                                                                 |
|                                                                              |
|In Vitro Activity of Isavuconazole compared with Itraconazole, Voriconazole,  |
|and Posaconazole in azole-resistant Aspergillus fumigatus - S. Seyedmousavi,  |
|A.J. Rijs, W.J.Melchers, J.W. Mouton, P.E. Verweij; M-1377                   |
|                                                                              |
|Activity of Isavuconazole and Comparator Antifungals Tested Against           |
|Contemporary (2012) Fungal Clinical Isolates Collected Worldwide - M.         |
|Castanheira, S.A. Messer, P.R. Rhomberg, R.Dietrich, R.N. Jones, M.A.        |
|Pfaller; M-1378                                                               |
+------------------------------------------------------------------------------+



+------------------------------------------------------------------------------+
|Posters on ceftobiprole                                                       |
|                                                                              |
|%fT>MIC Predicts the Microbiological Eradication at End of Treatment with     |
|Ceftriaxon or Ceftobiprole in Patients with Community Acquired Pneumonia -    |
|A.E. Muller, N. Punt, J.W.Mouton; A-472                                      |
|                                                                              |
|Genotypic Characterization of Methicillin-resistant Staphylococcus aureus     |
|Strains Recovered from Pneumonia Clinical Trials for Ceftobiprole - R.E.      |
|Mendes, L.M. Deshpande, A.J. Costello, R.K. Flamm, R.N. Jones; C2-558         |
|                                                                              |
|Ceftobiprole (BPR) and Ampicillin (AMP) Increase Daptomycin (DAP)             |
|Susceptibility in DAP Susceptible and Resistant and Vancomycin Resistant      |
|Enterococci (VRE) - B.J. Werth, K.E.Barber, K. Tran, M.J. Rybak; E-132       |
|                                                                              |
|Activity of Ceftobiprole (BPR) Combination Regimens Against Multiple Strains  |
|of Staphylococcus aureus with Differing Resistance Phenotypes; K.E. Barber,   |
|B.J. Werth, C.E.Ireland, N.E. Stone, M.J. Rybak; E-138                       |
+------------------------------------------------------------------------------+



+------------------------------------------------------------------------------+
|Poster on BAL30072                                                            |
|                                                                              |
|In vitro Activity of BAL30072 against Biodefense Pathogens -J.R. Hershfield,  |
|L.L. Miller, S.A.Halasohoris, M.G. Page; F-1203                              |
+------------------------------------------------------------------------------+

For further information please visit www.icaac.org.

About isavuconazole

Isavuconazole is an investigational intravenous and oral broad-spectrum
antifungal, partnered with Astellas Pharma Inc., for the potential treatment of
severe invasive and life-threatening fungal infections. It is currently in phase
3 of clinical development. Isavuconazole demonstrated in-vitro and in-vivo
coverage of a broad range of yeasts (such as Candida species) and molds (such as
Aspergillus species) as well as in-vitro activity against emerging and often
fatal molds including those that cause mucormycosis. In clinical studies
isavuconazole achieved predictable drug levels in patients, supporting reliable
once-daily dosing and a switch from intravenous to oral administration.
Isavuconazole received U.S. FDA fast-track and U.S. orphan drug designation.

About ceftobiprole

Ceftobiprole is an investigational broad-spectrum intravenous antibiotic for the
potential first-line empiric treatment of severe bacterial infections. It is
currently under regulatory review in Europe for the potential treatment of
pneumonia in the hospital. Ceftobiprole has demonstrated broad-spectrum activity
against Gram-positive bacteria including methicillin-resistant and vancomycin-
resistant Staphylococcus aureus (MRSA, VRSA) and penicillin-resistant
Streptococcus pneumoniae (PRSP) as well as Gram-negative pathogens, including
Enterobacteriaceae and Pseudomonas aeruginosa.

About BAL30072

BAL30072 is an intravenous bactericidal sulfactam antibiotic against multidrug-
resistant Gram-negative bacterial infections, currently in phase 1 of clinical
development. BAL30072 demonstrated in-vitro and in-vivo coverage of Gram-
negative pathogens including multidrug-resistant Acinetobacter baumannii and
Pseudomonas aeruginosa. It has robust activity against common strains of
resistant bacteria that produce antibiotic-inactivating enzymes including
carbapenemases and metallo-beta-lactamases such as the New Delhi metallo-beta-
lactamase 1 (NDM-1). In addition, BAL30072 has shown additive or synergistic
activity with antibiotics from the carbapenem class. Basilea entered a contract
with BARDA for up to USD89million in funding for the development of BAL30072.

About Basilea

Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on
the SIX Swiss Exchange (SIX: BSLN). Through the fully integrated research and
development operations of its Swiss subsidiary Basilea Pharmaceutica
International Ltd., the company focuses on innovative pharmaceutical products in
the therapeutic areas of bacterial infections, fungal infections and oncology,
targeting the medical challenge of rising resistance and non-response to current
treatment options.

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:

+-----------------------------+--------------------------------+
| Media Relations             | Investor Relations             |
+-----------------------------+--------------------------------+
| Peer Nils Schröder, PhD     | Barbara Zink, PhD, MBA         |
| Head Public Relations &     | Head Corporate Development     |
| Corporate Communications    |                                |
| +41 61 606 1102             | +41 61 606 1233                |
| media_relations@basilea.com | investor_relations@basilea.com |
+-----------------------------+--------------------------------+

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


Press release (PDF): http://hugin.info/134390/R/1729014/577546.pdf

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