New Data Confirming Broad Spectrum of Basilea's Late-Stage Antifungal,

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PrimeZone (press release) - Los Angeles,CA

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New Data Confirming Broad Spectrum of Basilea's Late-Stage

Antifungal, BAL8557, Presented at the ICAAC Conference

BASEL, Switzerland, Sept. 29, 2006 (PRIMEZONE) -- Data presented at

ICAAC further support phase III development program scheduled to

start by year-end in invasive candida (yeast) and aspergillus (mold)

infections.

The positive phase II and drug-drug interaction study results

released earlier showed the potential of BAL8557 for more convenient

dosing schedules and less drug-drug interactions than a number of

antifungal drugs in current use. " Data presented at ICAAC further

support BAL8557's clinical development in severe invasive candida

and aspergillus infections. Phase III is scheduled to start by year-

end, " stated Rienk Pypstra, MD, Chief Development Officer at

Basilea. BAL8557 was recently granted fast-track designation by the

U.S. Food and Drug Administration (FDA).

At this year's Interscience Conference on Antimicrobial Agents and

Chemotherapy (ICAAC) conference in San Francisco, CA, several

posters addressed the favourable activity profile of Basilea's azole

antifungal agent BAL8557 compared to other broad-spectrum

antifungals.

Potent in vitro activity of BAL4815, the active principle of

BAL8557, was shown against Candida blood-stream isolates including

fluconazole-resistant strains (M-1589). BAL4815 showed the lowest

minimal inhibitory concentrations (MIC50 and MIC90) and therefore

the highest potency of all tested azoles in a representative

clinical sample of about 300 candida blood stream isolates.

Exophiala dermatitidis, an opportunistic pathogen known to cause

brain abscesses, was susceptible to newer azoles including BAL4815

(M-1588). Cryptococcus neoformans, a candin-resistant pathogenic

yeast also proved highly susceptible to BAL4815 (M-1587).

Quality control strains of the European Committee on Antimicrobial

Susceptibility Testing (EUCAST) were evaluated in a pilot study.

Test results of BAL4815 for yeasts and molds confirmed the good

aspergillus activity, were highly reproducible and provide for a

good basis for developing standardized susceptibility testing (M-

1571). In a new mouse model of systemic Aspergillus fumigatus

infection -- the most relevant agent of invasive aspergillosis in

man -- BAL8557 was highly effective in reducing the kidney burden in

mice with disseminated disease (A-1120).

About BAL8557

BAL8557 is a pro-drug suitable for simple intravenous administration

and its excellent oral absorption allows a convenient once daily or

even once weekly dosing, supporting patient-tailored treatment

schemes. Basilea successfully completed its key phase II trial with

both high clinical cures rates and a safety profile comparable to

gold standard therapy but with potentially a more flexible dosing

schedule. A series of clinical drug interaction studies presented at

the International Society for Human and Animal Mycology (ISHAM)

meeting earlier this year illustrated the attractive pharmacokinetic

features and the potential for less drug-drug interactions of

BAL8557. Phase III studies for the treatment of invasive candidemia

and aspergillosis including rare molds are scheduled to start by

year-end.

The Need for New Antifungal Therapies

The expansion of the immunocompromised patient population including

cancer patients with chemotherapy induced neutropenia, transplant

recipients receiving immunosuppressive therapy and HIV infected

patients has led to an increased incidence of invasive fungal

infections. In major markets alone, an estimated nine million

patients are at risk for invasive fungal infections with more than

two million patients treated.

Currently available antifungal drugs are reported to fail in more

than 50% of patients with acute invasive aspergillosis and in 20-30%

of patients with candidemia. There is a high medical need to address

the limitations of current therapies, most importantly the gaps in

the antifungal spectrum, unwanted side effects, early adequate

dosing as well as the development of resistance.

About Basilea

Basilea Pharmaceutica Ltd. (SWX:BSLN) is an independent

biopharmaceutical company headquartered in Basel, Switzerland, and

listed on the SWX Swiss Exchange. Basilea's fully integrated

research and development operations are currently focused on new

antibacterial and antifungal agents to fight drug resistance and on

the development of dermatology drugs. Basilea's products are

targeted to satisfy high medical and patient needs in the hospital

setting. The company owns a diversified product portfolio including

three products for severe medical indications in late stages of

clinical development.

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.

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

The press release can also be downloaded from the following link:

http://hugin.info/134390/R/1078418/186007.pdf

CONTACT: Basilea Pharmaceutica Ltd.

Investor Relations:

Dr. Barbara Zink

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Keywords: PHARMACEUTICALS