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Novexel and Forest Laboratories Announce License Agreement for NXL 104, a Novel Broad-Spectrum Beta Lactamase Inhibitor

Tuesday, January 22, 2008 General News
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PARIS and NEW YORK, Jan. 22 Novexel, S.A. andForest Laboratories Holdings Limited, a wholly owned subsidiary of ForestLaboratories, Inc. (NYSE: FRX), today announced that they have entered into anagreement for the development, manufacture and commercialization of Novexel'snovel intravenous beta lactamase inhibitor, NXL 104 in combination withForest's ceftaroline. NXL 104 is designed to be co-administered with selectantibiotics to enhance their spectrum of activity. Under the terms of thelicense, Forest will receive the exclusive rights to administer NXL 104 withceftaroline as a combination product in North America. Ceftaroline is anovel, bactericidal injectable broad spectrum cephalosporin being developed asa therapeutic agent for the treatment of gram-positive pathogens includingmethicillin resistant staphylococcus aureus (MRSA), and multi-drug resistantstreptococcus pneumoniae (MDRSP), as well as common gram-negative organisms.Ceftaroline is being studied as a monotherapy in phase III clinical trials forcomplicated skin and skin structure infections and community acquiredpneumonia. Forest intends to initiate Phase I studies of the ceftaroline/NXL104 combination in the next fiscal year. Forest will also receive a firstnegotiation right in North America to an additional NXL 104 combination withceftazidime, a cephalosporin antibiotic having a different spectrum ofactivity compared to ceftaroline. This combination is currently being studiedin phase I clinical trials conducted by Novexel.
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NXL 104 inhibits bacterial enzymes called beta-lactamases that break downbeta-lactam antibiotics (in particular Penicillins and Cephalosporins). Beta-lactamase inhibition represents a mechanism for counteracting resistance andenhancing broad-spectrum activity of beta-lactam antibiotics. A compositionof matter patent which claims NXL 104 would provide protection for theceftaroline/NXL 104 combination product until 2022, subject to possible patentterm extension.
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Under the terms of the agreement, Forest will pay Novexel an upfrontlicense payment of euro 75 million. Forest will fund development andcommercialization of the ceftaroline/NXL 104 combination. Additionalmilestone payments to Novexel if the combination product is successfullydeveloped could total euro 75 million. Following the product's regulatorymarketing approval, Forest will pay Novexel a low double digit royalty onproduct sales throughout North America.

Iain Buchanan, Chief Executive Officer of Novexel said "Novexel is verypleased to conclude this transaction with Forest Laboratories which willcombine the potent beta lactamase inhibition of NXL 104 with the antibacterialspectrum of ceftaroline. We look forward to working with our partner toensure the successful development of this compelling product. In addition,the significant funding which Novexel will receive under this agreement willenable the company to devote the appropriate resources to the parallel andindependent Phase II development of NXL 104 in combination with ceftazidime.

Howard Solomon, Chairman and Chief Executive Officer of Forest, said, "Webelieve this collaboration with Novexel, resulting in combining ceftarolinewith NXL 104, will significantly advance the continuous effort to protectpatients against infectious pathogens. NXL 104 is the latest developmentagainst the most widely used defense that these pathogens utilize as the basisfor their resistance to antibiotics. By increasing the already significantspectrum of activity of ceftaroline, including MRSA, with the addition of thebeta lactamase inhibitor NXL 104, we will have achieved the premier, broad-spectrum antibiotic presently available.

We look forward to collaborating with the accomplished scientists atNovexel in the further development of ceftaroline/NXL 104 and other advanc
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