Novartis to pay up to $485 million for Paratek's IV antibiotic

Swiss drug major Novartis has gained exclusive worldwide rights from USA-based Paratek Pharmaceuticals to market PTK 0796, potentially the first once-daily broad-spectrum antibiotic that can be given by intravenous (IV) infusion or oral tablet to treat a wide variety of life-threatening infections, including those caused by highly resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and multi-drug resistant Streptococcus pneumoniae (MDRSP).

Under the terms of the agreement, Novartis and Paratek will share responsibility and costs for worldwide development of PTK 0796, while Novartis will have the exclusive right to commercialize PTK 0796 on a worldwide basis. Paratek will be eligible to receive up to $485 million in payments, which include up-front and future milestone payments, and will also receive a royalty on net  sales of PTK 0796 around the world.

Other market players

The successful development of the drug - which is seen as having blockbuster potential - should boost Novartis' Immunology and Infectious Disease segment, say analysts at Zacks Equity Research. The company has another drug, Cubicin (daptomycin) for the treatment of bacterial infections. There are many players targeting bacterial infections market, the analysts note, pointing in particular to ViroPharma's Vancocin (vancomycin), Pfizer's Zyvox (linezolid) and Wyeth's Tygacil (tigecycline). The drug will also have to fight off competition from pipeline candidates such as Johnson & Johnson's and Forest Laboratories' ceftaroline.

A Phase III study of PTK 0796 is already under way in complicated skin and skin structure infections (cSSSI), and clinical trials are planned in a number of other potential indications.

Because PTK 0796 may be given as a once-daily 30-minute IV infusion or daily oral tablet, it could offer patients a convenient way to continue antibiotic treatment after they have been discharged from hospital. Its broad spectrum of activity means it could be used as a single agent against a range of bacteria, unlike other antibiotics which may have to be used in combination.

"As the first in a new class of antibiotics, PTK 0796 is being developed to address the growing problem of bacterial resistance to currently available antibiotics," said Joe Jimenez, chief executive of the Novartis Pharmaceuticals Division. "It will potentially benefit patients by offering a flexible and highly effective approach to the treatment of a number of critical infections, and should form an important addition to our growing portfolio of antibiotic medicines," he added.

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. The Protez transaction covered the North American and European rights to PTZ601 (razupenem), 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 includes Cubicin, marketed by Novartis in the European Union and other countries for treating complicated skin and soft tissue infections (cSSTI), right-sided infective endocarditis (RIE) due to Staphylococcus aureus (S. aureus), and S. aureus bacteremia (SAB) when associated with RIE or cSSTI. Cubicin is the first of a new class of antibiotics called cyclic lipopeptides.