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Novexel's NXL104/ceftazidime Combination Commences Second Phase II Clinical Trial in Hospital Patients With Complicated Intra-Abdominal Infections (cIAIs)
Date:3/3/2009

he total duration of antibiotic therapy for each patient should be 5 to 14 days. The results of this study are expected in early 2010.

This second Phase II trial in cIAIs, follows a Phase II clinical trial of NXL104/cetazidime in hospitalized patients with complicated urinary tracts infections (cUTIs). This study which began in November is due to complete 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, "The start of this second Phase II study demonstrates Novexel's commitment to developing NXL104 in combination with ceftazidime in a broad range of indications where resistant Gram negative bacteria are present or are suspected. NXL104 has the ability to inhibit the activity of a broader range of clinically important beta-lactamases than currently marketed beta-lactam inhibitors and we believe that this combination product could provide an important new treatment option in the hospital."

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. Ceftaroline is 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.


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