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Novexel's NXL104/ceftazidime Combination Commences Phase II Clinical Trial in Hospital Patients With Complicated Urinary Tract Infections
Date:11/12/2008

tion of antibiotic therapy for each patient should be 7 to 14 days. The results of this study are expected in late 2009.

In completed Phase I studies in healthy subjects NXL104/ceftazidime was generally well tolerated and the pharmacokinetics of the two components were well matched. Additional studies in special populations are ongoing.

Iain Buchanan, Novexel's CEO, said, "We continue to believe that this novel combination, which is based around our novel beta-lactamase inhibitor, NXL104, has the potential to play an important role in confronting the increasing problem of hospital infections caused by resistant Gram negative bacteria. The start of our first Phase II study with NXL104 in combination with ceftazidime is an important milestone for the company."

Under an independent development program, Forest Laboratories (NYSE : FRX) will combine NXL104 in a treatment regimen with Forest's ceftaroline, a novel, bactericidal injectable broad spectrum cephalosporin being developed as a therapeutic agent for the treatment of gram-positive pathogens including methicillin resistant staphylococcus aureus (MRSA), and multi-drug resistant streptococcus pneumoniae (MDRSP), as well as common gram-negative organisms. Ceftaroline is being studied as a monotherapy in Phase III clinical trials by Forest. In January 2008, Novexel granted Forest a license to develop, manufacture and commercialise NXL104, only in combination with ceftaroline, in North America.

Novexel retains worldwide rights on the NXL104/ceftazidime combination.

About NXL104

NXL104 is a novel injectable non beta lactam, beta-lactamase inhibitor, which is being developed to address the increasing problem of microbial resistance to beta lactam antibiotics (penicillins, cephalosporins, carbopenems) mediated by beta-lactamase enzymes. NXL104 is a significant advance, as it is able to inhibit a broader range of beta-lactamases than currently marketed beta-lactam inhibitors. Its s
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SOURCE Novexel
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