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

November 22, 2012 - Basel, Switzerland

Basilea Pharmaceutica AG / Basileainitiates next phase 1 multiple ascending dose study with antibioticBAL30072 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 hasinitiated the next planned pharmacokinetic phase 1 healthy volunteer studyin its clinical development program for BAL30072, Basilea's newinvestigational 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 acquiredthe ability to produce enzymes that destroy beta-lactam antibiotics, whichhave been the mainstay of antibiotic therapy for several decades.Multidrug-resistant bacteria for which there are few or no therapeuticoptions available are being encountered with increasing frequency and areassociated with increased mortality, prolonged hospital stays and higherhealthcare costs.

BAL30072 is a novel injectable sulfactam antibiotic that in in-vitro andin-vivo models demonstrated potent bactericidal activity against a broadrange of clinically relevant multidrug-resistant Gram-negative pathogenssuch as Pseudomonas or Acinetobacter species. BAL30072 overcomes severalmechanisms of bacterial resistance. In particular, it is not easilydestroyed 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 itspotent antimicrobial activity BAL30072 has the potential to play anessential role in the therapy of serious and life-threatening infectionscaused by Gram-negative bacteria for which currently only limitedtherapeutic options exist. We are now expanding our phase 1 clinicalprogram for this promising drug candidate to optimize dosing regimens inpreparation for phase 2 clinical studies."

About Basilea

Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, andlisted on the SIX Swiss Exchange (SIX: BSLN). Through the fully integratedresearch and development operations of its Swiss subsidiary BasileaPharmaceutica International Ltd. the company focuses on innovativepharmaceutical products in the therapeutic areas of bacterial infections,fungal infections and oncology, targeting the medical challenge of risingresistance and non-response to current treatment options.


This communication expressly or implicitly contains certain forward-lookingstatements concerning Basilea Pharmaceutica Ltd. and its business. Suchstatements involve certain known and unknown risks, uncertainties and otherfactors, which could cause the actual results, financial condition,performance or achievements of Basilea Pharmaceutica Ltd. to be materiallydifferent from any future results, performance or achievements expressed orimplied by such forward-looking statements. Basilea Pharmaceutica Ltd. isproviding this communication as of this date and does not undertake toupdate any forward-looking statements contained herein as a result of newinformation, future events or otherwise.

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

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