Basilea reports positive results from first clinical phase I study with its novel antibiotic BAL30072

The double-blind randomized clinical phase I study investigated the safety, tolerability and pharmacokinetics of single ascending doses of BAL30072 in healthy volunteers. BAL30072 was safe and well tolerated at all dose levels. It displayed dose-proportional plasma levels as well as linear pharmacokinetic properties. Detailed study results will be presented at upcoming scientific conferences.

"We are delighted with the good safety and tolerability of BAL30072 demonstrated in this first study in man, which is in line with our preclinical observations," said Dr. Anthony Man, CEO of Basilea Pharmaceutica Ltd. "These results support the potential of BAL30072 as a new treatment option for severe and life-threatening infections caused by multidrug-resistant Gram-negative bacteria, where currently very limited therapeutic options exist. We are committed to addressing the significant medical challenge arising from the rapid global spread of new emerging Gram-negative superbugs and we will be further advancing the phase I program with this promising drug this year."

Clinically important multidrug-resistant Gram-negative pathogens such as Pseudomonas aeruginosa, Acinetobacter spp., Klebsiella spp. and Enterobacter spp. are associated with prolonged hospital stays, higher healthcare costs and increased mortality. These pathogens may cause serious and life-threatening infections such as sepsis, severe lung or complicated urinary tract infections. In a recent study which involved thousands of patients in intensive care units around the world, Gram-negative pathogens were found in about 60 percent of patients tested positive on bacterial infections.

About BAL30072
BAL30072 is a novel siderophore (iron-binding) sulfactam antibiotic with a unique mode of action, conferring potent bactericidal activity against a broad range of multidrug- resistant Gram-negative pathogens such as Pseudomonas aeruginosa or Acinetobacter spp., as demonstrated in in vitro and in vivo models. BAL30072 is stable towards many types of bacterial beta-lactamase enzymes which inactivate most of the currently marketed beta- lactam anti­biotics. This stability covers many of the extended-spectrum beta-lactamases (ESBLs) as well as carbapenemases and metallo-beta-lactamases such as New Delhi metallo- beta-lactamase 1 (NDM-1). A clinical phase I multiple-ascending-dose study with BAL30072 is anticipated to start in the second half of 2011.

Contact
Peer Nils Schröder, Ph.D. Head Public Relations & Corporate Communications +41 61 606 1102 media_relations@basilea.com