FDA Fast Track Designation for Water-Soluble Antifungal

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May 2, 2006, 12:35AM

(PZ) FDA Fast Track Designation for Basilea's Novel Broad-Spectrum

Water-Soluble Antifungal BAL8557

© 2006 PRIMEZONE

BASEL, Switzerland, May 2, 2006 (PRIMEZONE) -- Basilea Pharmaceutica Ltd.

(SWX:BSLN) announced today that it received fast track designation from the U.S.

Food and Drug Administration (FDA) for its novel broad-spectrum antifungal.

Fast track designation is intended to expedite the availability of treatments

that address unmet medical needs for serious and life-threatening diseases.

Invasive fungal infections are a major cause of morbidity and mortality in

patients with weakened immune systems. The overall rate of invasive fungal

infections in these patients is approximately 25% and mortality ranges from 50 -

100%. The number of drugs available to treat severe infections caused by

invasive fungi such as zygomyces is limited.

BAL8557's extended antifungal spectrum covers most yeasts and molds including

fluconazole resistant candida strains, aspergillus and zygomyces that cause

serious infections in patients with a weakened immune system. BAL8557 is

water-soluble and can be given by injection or orally. It is highly

bio-available and can be administered in convenient once-daily or once-weekly

dosing

regimens. BAL8557 also has potentially less drug-drug interactions than a

number

of other drugs in current use.

" We have a broad product development strategy for invasive yeast and mold

infections. We also recognize that patients with such infections and impaired

renal function have limited treatment options because many existing drugs can

further impair kidney function. In contrast, our injectable form of BAL8557 is

a water-based formulation without additives known to damage kidney function.

BAL8557 is designated as a fast track product because it can provide

potential benefit for the treatment of invasive fungal infections in patients

with

moderate to severe renal impairment. BAL8557 is our second late stage hospital

anti-infective drug with fast track status, highlighting our commitment as a

leading anti-infectives company to develop drugs for high medical need " ,

commented Dr. Man, Basilea's CEO.

In September last year Basilea reported positive phase II results on BAL8557

in the treatment of esophageal candidiasis. The safety profile of BAL8557 in

those patients was observed to be similar to that of fluconazole. Pivotal

phase III trials in invasive fungal infections are scheduled to start in the

second half of 2006.

Dr. Rienk Pypstra, Chief Development Officer indicated, " With this fast track

designation, the FDA has signaled that BAL8557 has the potential to fulfill

a significant therapeutic need. We will therefore integrate the needs of

patients with renal impairment into our phase III program. We are pleased that

this designation will allow us to accelerate the development of BAL8557 to

bring this promising drug to patients with invasive fungal infections as early

as

possible. "

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 infection 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, dosing flexibility as well as the development of resistance.

About BAL8557

BAL8557, Basilea's novel broad-spectrum antifungal agent, is an

investigational drug in development for the treatment of severe invasive fungal

infections. Unlike other azoles, 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. BAL8557 phase III trials are

currently in preparation.

About Basilea

Basilea Pharmaceutica Ltd. (BSLN) is a biopharmaceutical company

headquartered in Basel, Switzerland, and listed on the SWX Swiss Exchange.

Basilea was

founded in October 2000 to discover, develop and bring innovative medicines to

the market. The company's fully integrated research and development

operations are currently focused on new anti-bacterial and anti-fungal agents to

fight drug resistance as well as on dermatology drugs.

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.

The 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/1048111/172631.pdf

CONTACT: Basilea Pharmaceutica Ltd.

Investor Relations

Dr. Barbara Zink

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