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Basilea Initiates Next Phase 1 Multiple Ascending Dose Study With Antibiotic Bal30072 Active Against Multidrug-Resistant Gram-Negative Bacteria

BASEL, SWITZERLAND -- (Marketwire) -- 11/22/12 -- Basilea Pharmaceutica AG / Basilea initiates next phase 1 multiple ascending dose study with antibiotic BAL30072 active against multidrug-resistant Gram-negative bacteria. Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement.

Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that it has initiated the next planned pharmacokinetic phase 1 healthy volunteer study in its clinical development program for BAL30072, Basilea's new investigational antibiotic with activity against multidrug-resistant Gram- negative bacteria.

Gram-negative pathogens account for approximately half of all hospital- acquired bacterial infections. Many Gram-negative pathogens have acquired the ability to produce enzymes that destroy beta-lactam antibiotics, which have been the mainstay of antibiotic therapy for several decades. Multidrug-resistant bacteria for which there are few or no therapeutic options available are being encountered with increasing frequency and are associated with increased mortality, prolonged hospital stays and higher healthcare costs.

BAL30072 is a novel injectable sulfactam antibiotic that in in-vitro and in-vivo models demonstrated potent bactericidal activity against a broad range of clinically relevant multidrug-resistant Gram-negative pathogens such as Pseudomonas or Acinetobacter species. BAL30072 overcomes several mechanisms of bacterial resistance. In particular, it is not easily destroyed by bacterial enzymes such as extended-spectrum beta-lactamases (ESBLs), carbapenemases or the New Delhi metallo-beta-lactamase 1 (NDM-1), which cause resistance to many marketed antibiotics.

Prof. Achim Kaufhold, Chief Medical Officer of Basilea, stated: "Due to its potent antimicrobial activity BAL30072 has the potential to play an essential role in the therapy of serious and life-threatening infections caused by Gram-negative bacteria for which currently only limited therapeutic options exist. We are now expanding our phase 1 clinical program for this promising drug candidate to optimize dosing regimens in preparation for phase 2 clinical studies."

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.

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

Press release (PDF): http://hugin.info/134390/R/1659937/537459.pdf

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(ii) they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Basilea Pharmaceutica AG via Thomson Reuters ONE [HUG#1659937]

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