Novartis gains rights to oral broad-spectrum MRSA antibiotic

Swiss drugmaker Novartis has gained exclusive worldwide rights to PTK 0796, a once-daily broad-spectrum antibiotic that can be given by intravenously or orally to treat a wide variety of infections including methicillin-resistant Staphylococcus aureus (MRSA) and multi-drug resistant Streptococcus pneumoniae (MDRSP).

Under the agreement with Paratek Pharmaceuticals, a privately held company based in Boston, Massachusetts, the companies will share responsibility for developing PTK 0796. Novartis will make an undisclosed upfront payment to Paratek. Paratek will be eligible to receive future milestone payments, and will also receive a royalty on net sales of PTK 0796 around the world.

A Phase III study is already under way in complicated skin infections, and clinical trials are planned in a number of other potential indications.

PTK 0796 could offer patients a convenient way to continue antibiotic treatment after they have been discharged from hospital. It could be used as a single agent against a range of bacteria, unlike other antibiotics that may have to be used in combination.

"PTK 0796 is being developed to address the growing problem of bacterial resistance to currently available antibiotics," said Joe Jimenez, chief executive of the pharmaceuticals division of Novartis. "It will potentially benefit patients by offering a flexible and highly effective approach to the treatment of a number of critical infections."

The in-licensing of PTK 0796 represents a further expansion of the Novartis infectious diseases portfolio following the acquisition of Protez Pharmaceuticals in June 2008. This transaction included US and EU rights to PTZ601 (razupenem), which is currently in Phase II development as the first injectable broad-spectrum antibiotic in the carbapenem class to cover MRSA.

The Novartis portfolio of medicines for hospital-based infections also includes Cubicin (daptomycin), marketed in the EU and other countries for treating complicated skin and soft tissue infections. Cubicin is the first of a new class of antibiotics called cyclic lipopeptides.