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2014-05-13

Basilea Pharmaceutica AG: Basilea presents new data on its antibiotics pipeline at ECCMID

Basilea Pharmaceutica AG / Basilea presents new data on its antibiotics
pipeline at ECCMID. Processed and transmitted by NASDAQ OMX Corporate
Solutions. The issuer is solely responsible for the content of this
announcement.
* Ceftobiprole phase 3 pneumonia data show rapid antibacterial effect
* BAL30072 synergy demonstrated with carbapenems

Basel, Switzerland, May 13, 2014

- Basilea Pharmaceutica Ltd. (SIX: BSLN) reported today that new data on its
antibiotics ceftobiprole and BAL30072 were presented this week at the
European Congress of Clinical Microbiology and Infectious Diseases (ECCMID)
in Barcelona, Spain.

Basilea's broad-spectrum intravenous cephalosporin antibiotic ceftobiprole
recently gained regulatory authorization in twelve European countries for the
treatment of hospital-acquired pneumonia (HAP, excluding
ventilator-associated pneumonia - VAP) and community-acquired pneumonia
(CAP). Phase 3 data analyses were presented that demonstrated more rapid
clinical responses in HAP and CAP patients treated with ceftobiprole than
with the comparator regimen.

Ronald Scott, Basilea's Chief Executive Officer, commented: "The early
clinical benefit data presented at ECCMID substantiate the potential
important role of ceftobiprole in the treatment of patients with pneumonia in
the hospital. Following the recent regulatory authorization of ceftobiprole,
Basilea is focusing on market access and making ceftobiprole available to
patients and physicians."

Results of apost-hoc
analysis of phase 3 data including 571 HAP patients randomized on ceftobiprole
or ceftazidime/linezolid were presented orally. The results show higher early
clinical improvement rates at day 4 for ceftobiprole than for the comparator
regimen, particularly in patients infected with
methicillin-resistantStaphylococcus aureus
(MRSA) prior to initiation of therapy. (Oral presentation O151)

Regarding CAP, a poster presentation of apost-hoc
analysis of data from the 638-patient phase 3 study showed that, for high-risk
patients hospitalized with CAP, the early clinical response rates at day 3
and the clinical cure rates at the test-of-cure visit were numerically higher
for ceftobiprole than for the comparator regimen. (Poster eP431)

Further presented data demonstrated thein-vitro
potency of ceftobiprole against over 4,000 contemporary clinically relevant
Gram-positive bacteria, including methicillin-susceptible and
methicillin-resistantStaphylococcus aureus
and streptococci isolated from 17 European countries and Israel. (Poster
eP187)

In addition, data of a study with pathogens isolated in 2013 from European and
Israeli patients hospitalized with pneumonia showed ceftobiprole's potent
broad-spectrumin-vitro
activity against MRSA, penicillin-resistant/ceftriaxone
non-susceptibleStreptococcus pneumoniae
, Enterobacteriacea andPseudomonas aeruginosa
. (Poster eP188)

In-vitro
data on Basilea's investigational anti-Gram-negative antibiotic BAL30072,
currently in phase 1 clinical development, were also presented, demonstrating
synergy between BAL30072 and antibiotics from the carbapenem class against
recent clinical isolates of difficult-to-treat Gram-negative bacteria,
including those carrying the resistance-conferring NDM-1 metallo
beta-lactamase gene. (Posters P0296 and P0297)

---------------------------------------------------------------------------------
|Ceftobiprole posters/presentations at ECCMID 2014 |
| * Early clinical improvement and clinical cure in a randomised controlled |
| phase 3 study of ceftobiprole versus ceftazidime/linezolid in patients with |
| hospital-acquired pneumonia - T. Scheeren, A. Rodriguez, X. Zhou, M. |
| Saulay, M. Engelhardt; Oral presentation O151 |
| * Early clinical response in a randomised controlled phase 3 study of |
| ceftobiprole versus ceftriaxone with or without linezolid in patients with |
| community-acquired pneumonia requiring hospitalisation - T. Welte, G. |
| Herrera, Y.-C. Chuang, A. Demange, M. Engelhardt; Poster eP431 |
| * Antimicrobial activity of ceftobiprole tested against staphylococci and |
| streptococci from European countries and Israel (2013) - R. K. Flamm, D. J. |
| Farrell, J. M. Streit, H. S. Sader, R. N. Jones; Poster eP187 |
| * Ceftobiprole activity tested against bacterial isolates from hospitalized |
| patients with pneumonia in European hospitals and Israel (2013) - R. K. |
| Flamm, D. J. Farrell, J. M. Streit, H. S. Sader, R. N. Jones; Poster eP188 |
---------------------------------------------------------------------------------

---------------------------------------------------------------------------------
|BAL30072 posters at ECCMID 2014 |
| * Activity of BAL30072 alone and in combination with carbapenems against |
| Gram-negative bacteria - I. Morrissey, C. Siegmund, E. Genet, M. Neri, S. |
| Hawser, M. Jones, M. Page, A. Santerre Henriksen; Poster P0296 |
| * Determination of the effect of blaNDM-1 gene copy number on the activity of |
| BAL30072 alone and in combination with meropenem against clinical NDM-1 |
| positive bacteria - L. Jones; M. G. P. Page, M. E. Jones, T. R. Walsh; |
| Poster P0297 |
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For further information please visitwww.eccmid.org

About Ceftobiprole

Ceftobiprole (ceftobiprole medocaril) is a broad-spectrum intravenous
antibiotic from the cephalosporin class for the potential first-line
treatment of severe bacterial infections. It has recently gained regulatory
authorization from twelve European states through the Decentralized procedure
for the treatment of hospital-acquired pneumonia (HAP, excluding
ventilator-associated pneumonia, VAP) and community-acquired pneumonia (CAP)
in patients 18 years of age and older, and is currently under regulatory
review in Switzerland. Ceftobiprole demonstrated broad-spectrumin-vitro
bactericidal activity against Gram-positive bacteria including
methicillin-resistant and vancomycin-resistantStaphylococcus aureus
(MRSA, VRSA) and penicillin- and ceftriaxone-resistantStreptococcus pneumoniae
(PRSP, CRSP) as well as Gram-negative pathogens including strains of
Enterobacteriaceae andPseudomonas
.

Safety information

As with all beta-lactam antibacterial agents, serious and occasionally fatal
hypersensitivity (anaphylactic) reactions have been reported. In case of
severe hypersensitivity reactions, treatment with ceftobiprole must be
discontinued immediately and adequate emergency measures must be initiated.
Before beginning treatment, it should be established whether the patient has
a history of severe hypersensitivity reactions to ceftobiprole, to other
cephalosporins or to any other type of beta-lactam agent. Caution should be
used if ceftobiprole is given to patients with a history of non-severe
hypersensitivity to other beta-lactam agents.

The most common adverse reactions occurring in>=3% of patients treated with
were nausea, vomiting, diarrhoea, infusion site reactions, hypersensitivity
(including urticaria, pruritic rash and drug hypersensitivity) and dysgeusia.

The use of ceftobiprole may result in overgrowth of non-susceptible organisms,
including fungi. Appropriate measures should be taken if evidence of
super-infection occurs during therapy.

Seizures have been associated with the use of ceftobiprole. Seizures occurred
most commonly in patients with pre-existing central nervous system
(CNS)/seizure disorders during treatment with ceftobiprole. Therefore caution
is advised when treating these patients.

Clostridium difficile
-associated diarrhoea has been reported with use of ceftobiprole and may range
in severity from mild to life-threatening. This diagnosis should be
considered in patients with diarrhoea during or subsequent to the
administration of ceftobiprole. Discontinuation of therapy with ceftobiprole
and the administration of specific treatment forC. difficile
should be considered. Medicinal products that inhibit peristalsis should not
be given.

Ceftobiprole has not been shown to be effective in the treatment of patients
with VAP. Ceftobiprole should not be initiated in patients with VAP. It is
recommended that in patients with HAP who subsequently require ventilation,
ceftobiprole should be used with caution.

See full prescribing information for ceftobiprole (UK Summary of Product
Characteristics):http://www.mhra.gov.uk/Safetyinformation/Medicinesinformation/SPCandPILs....
htm?subsName=CEFTOBIPROLE MEDOCARIL SODIUM&pageID=SecondLevel

About BAL30072

BAL30072 is an intravenous monosulfactam antibiotic in phase 1 clinical
development with bactericidal activity against infections by
multidrug-resistant Gram-negative bacteria. The investigational drug
demonstratedin-vitro
andin-vivo
coverage of Gram-negative pathogens including multidrug-resistantAcinetobacter
baumannii and Pseudomonas aeruginosa
and has robust activity against strains that produce antibiotic-inactivating
enzymes such as metallo-beta-lactamases. BAL30072 has shown synergistic or
additive activity with antibiotics from the carbapenem class. Basilea entered
a contract with U.S. BARDA, who may provide development funding for BAL30072
of up to USD 89 million.

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:

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