Basilea Pharmaceutica Initiates Phase I Clinical Program of its Novel Antibiotic BAL30072

BASEL, SWITZERLAND--(Marketwire - November 23, 2010) -

Basilea Pharmaceutica AG /

Basilea initiates phase I clinical program of its novel antibiotic BAL30072 Processed and transmitted by Thomson Reuters.

The issuer is solely responsible for the content of this announcement.

Basel, Switzerland, November 23, 2010 - Basilea Pharmaceutica Ltd. (SWISS: BSLN) announces that the first phase I study of its innovative sulfactam antibiotic BAL30072 has been initiated. This study investigates the pharmacokinetic profile, safety and tolerability of the compound in healthy volunteers. BAL30072 has broad antimicrobial activity against multidrug-resistant Gram-negative “superbugs” that are increasingly associated with potentially life- threatening infections in hospitals around the world.

“Basilea remains focused on developing novel hospital anti-infectives targeting the medical challenge of rising drug resistance. We are delighted to see this innovative antibiotic move forward from Basilea’s own research as the third anti-infective in our clinical development pipeline,” said Dr. Anthony Man, CEO of Basilea Pharmaceutica Ltd. “BAL30072 is designed to tackle the increasing problem of antibiotic-resistance in a broad range of Gram-negative bacteria associated with a wide variety of serious and life-threatening hospital infections.”

The double-blind, randomized, placebo-controlled clinical phase I study investigates the pharmacokinetics, safety and tolerability of single ascending doses of BAL30072 in healthy male volunteers.

BAL30072 - a Trojan horse fighting resistance

BAL30072 is a novel siderophore (iron-binding) sulfactam antibiotic with a unique mode of action, conferring potent bactericidal activity against Gram- negative pathogens. The compound can act like a “Trojan horse” by exploiting natural nutrient uptake systems of pathogens to gain access to its intracellular target.

BAL30072 is stable towards many types of beta-lactamase enzymes, including many of the extended-spectrum beta-lactamases (ESBLs) and metallo-beta- lactamases, which can deactivate most of the currently marketed beta-lactam antibiotics such as cephalosporins and carbapenems. The compound demonstrates potent antibacterial in-vitro and in-vivo activity against clinically increasingly problematic multi-resistant Gram-negative bacteria such as Pseudomonas aeruginosa, Acinetobacter spp., Klebsiella spp. and Enterobacter spp. These pathogens are associated with serious and life-threatening infections, including hospital-acquired pneumonia, complicated intra-abdominal infections or complicated urinary tract infections.

About Basilea

Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on the SIX Swiss Exchange (SWISS: BSLN). Its fully integrated research and development operations are currently focused on antibiotics, antifungals and oncology drugs, as well as on the development of dermatology drugs, targeting the medical challenge of resistance and non-response to current treatment options in the hospital and specialty care setting.

Basilea is currently marketing Toctino® (alitretinoin), the only approved treatment for severe chronic hand eczema unresponsive to potent topical corticosteroids, in Denmark, France, Germany, Switzerland and the United Kingdom and has appointed distributors for Toctino® in other selected European markets, Canada and Mexico. Furthermore, a phase III clinical program on alitretinoin for the treatment of severe chronic hand eczema is ongoing in the U.S. The company has entered into a global partnership with Astellas Pharma Inc. for its phase III compound isavuconazole, a potential best-in-class azole antifungal, for the treatment of life-threatening invasive fungal infections. Full rights to ceftobiprole for the treatment of potentially life-threatening resistant bacterial infections, are being transferred back to Basilea from Cilag GmbH International, a Johnson & Johnson company.

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

[HUG#1464642]

--- End of Message ---

Basilea Pharmaceutica AG Grenzacherstrasse 487 P.O Box Basel Switzerland Listed: Freiverkehr in Börse Stuttgart, Freiverkehr in Börse Berlin, Open Market (Freiverkehr) in Frankfurter Wertpapierbörse, Freiverkehr in Bayerische Börse München; 

Press release (PDF): http://hugin.info/134390/R/1464642/403041.pdf

This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters 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 Thomson Reuters ONE