Novexel and Forest Laboratories Holdings, a wholly owned subsidiary of Forest Laboratories, have entered into an agreement for the development, manufacture and commercialization of Novexel's novel intravenous beta lactamase inhibitor, NXL 104 in combination with Forest's ceftaroline.
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Under the terms of the agreement, Forest will pay Novexel an upfront license payment of E75 million. Forest will fund development and commercialization of the ceftaroline/NXL 104 combination. Additional milestone payments to Novexel if the combination product is successfully developed could total E75 million. Following the product’s regulatory marketing approval, Forest will pay Novexel a low double digit royalty on product sales throughout North America.
Under the terms of the license, Forest will receive the exclusive rights to administer NXL 104 with ceftaroline as a combination product in North America.
Forest intends to initiate Phase I studies of the ceftaroline/NXL 104 combination in the fiscal 2009. Forest will also receive a first negotiation right in North America to an additional NXL 104 combination with ceftazidime, a cephalosporin antibiotic having a different spectrum of activity compared to ceftaroline. This combination is currently being studied in Phase I clinical trials conducted by Novexel.
Ceftaroline is 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.
Iain Buchanan, CEO of Novexel, said: “The significant funding which Novexel will receive under this agreement will enable the company to devote the appropriate resources to the parallel and independent Phase II development of NXL 104 in combination with ceftazidime.”
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