Novexel, the pharmaceutical company focused on the discovery and development of novel antibacterials and anti-fungals, has entered into an agreement with Forest Laboratories Holdings Limited, a wholly owned subsidiary of Forest Laboratories, Inc., for the development, manufacture and commercialization of Novexel's novel intravenous beta lactamase inhibitor, NXL104 in combination with Forest's ceftaroline. NXL104 is designed to be co-administered with select antibiotics to enhance their spectrum of activity.
Under the terms of the license, Forest will receive the exclusive rights to administer NXL104 with ceftaroline as a combination product in North America.
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. Ceftaroline is being studied as a monotherapy in Phase III clinical trials for complicated skin and skin structure infections and community acquired pneumonia. Forest intends to initiate Phase I studies of the ceftaroline/NXL104 combination in the next fiscal year.
Forest will also receive a first negotiation right in North America to an additional NXL104 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. NXL104 inhibits bacterial enzymes called beta-lactamases that break down beta-lactam antibiotics (in particular Penicillins and Cephalosporins). Beta-lactamase inhibition represents a mechanism for counteracting resistance and enhancing broad-spectrum activity of beta-lactam antibiotics. A composition of matter patent which claims NXL104 would provide protection for the ceftaroline/NXL104 combination product until 2022, subject to possible patent term extension.
Under the terms of the agreement, Forest will pay Novexel an upfront license payment of €75 million. Forest will fund development and commercialization of the ceftaroline/NXL104 combination. Additional milestone payments to Novexel if the combination product is successfully developed could total €75 million. Following the product's regulatory marketing approval, Forest will pay Novexel a low double digit royalty on product sales throughout North America.
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