French group Novexel, a spin-off of Sanofi-Aventis, and the USA’s Forest Laboratories have paired up under a deal to develop, manufacture and commercialise a combination of the former’s NXL 104 and the latter’s antibiotic ceftaroline.

NXL 104, the first in a new class of inhibitors of beta lactamases, is designed to boost the spectrum of activity of certain antibiotics and, under the terms of the license, Forest gains exclusive rights to use of the agent with ceftaroline as a combination product in North America.

Ceftaroline is a novel, bactericidal injectable broad-spectrum cephalosporin, which Forest is developing for the treatment of gram-positive pathogens such as the notorious superbug MRSA), as well as common gram-negative organisms.

The drug is currently in Phase III testing for complicated skin and skin structure infections and community-acquired pneumonia, and the US drugmaker says it plans to kick off Phase I studies of the ceftaroline/NXL 104 combination in the next fiscal year.

Deal worth at least 150m euros
In return for its rights, Forest has agreed to pay Novexel an upfront license payment of 75 million euros and fund development and commercialisation of the combination. If the product makes it to market, Novexel could also receive additional milestone payments of a further 75 million euros and a low double-digit royalty on product sales throughout North America.

Forest also gets first dibs in North America to an additional combination of NXL 104 with ceftazidime, a cephalosporin antibiotic with a different spectrum of activity than ceftaroline, currently being studied in Phase I clinical trials. And sccording to Iain Buchanan, the Paris-based group’s chief executive, the “significant funding” the company stands to receive from its deal with Forest will enable it to push this combination into Phase II development.