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.
Iain Buchanan, chief executive officer of Novexel said "Novexel is very pleased to conclude this transaction with Forest Laboratories which will combine the potent beta lactamase inhibition of NXL104 with the antibacterial spectrum of ceftaroline. We look forward to working with our partner to ensure the successful development of this compelling product. In addition, 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 NXL104 in combination with ceftazidime.
Howard Solomon, chairman and chief executive officer of Forest, said, "We believe this collaboration with Novexel, resulting in combining ceftaroline with NXL104, will significantly advance the continuous effort to protect patients against infectious pathogens. NXL104 is the latest development against the most widely used defense that these pathogens utilize as the basis for their resistance to antibiotics. By increasing the already significant spectrum of activity of ceftaroline, including MRSA, with the addition of the beta lactamase inhibitor NXL104, we will have achieved the premier, broad-spectrum antibiotic presently available. We look forward to collaborating with the accomplished scientists at Novexel in the further development of ceftaroline/NXL104 and other advances in the infectious disease area."
Novexel is a pharmaceutical company that researches and develops novel class anti-infectives for the treatment of severe and difficult to treat bacterial and fungal infections. The company has an extensive portfolio of antibacterial and anti-fungal compounds, R&D programmes and intellectual property.
Forest Laboratories is a US-based pharmaceutical company dedicated to identifying, developing and delivering products that make a positive difference in peoples' lives.