Companies will jointly develop broad-spectrum oral and IV anti-infective for hospital-acquired infections.
Novartis negotiated exclusive worldwide commercialization rights to Paratek Pharmaceuticals’ Phase III broad-spectrum antibiotic, PTK 0796. The companies will share responsibilities for its continued development.
Novartis will pay Paratek an up-front fee and future milestone payments in addition to royalties on global net sales. A Phase III trial with PTK 0796 is already under way against complicated skin and skin structure infections, and clinical trials are planned in a range of other indications.
PTK -796 is an aminomethycycline in development both as a once-daily oral tablet and an IV infusion for treating a range of infections including MRSA and multi-drug resistant Streptococcus pneumonia.
Commenting on the agreement, Novartis pharmaceuticals division CEO, Joe Jimenez, says that PTK 0796 represents an important addition to the company’s growing portfolio of antibiotics. In June 2008, Novartis’ acquisition of Protez Pharmaceuticals gave it North American and European rights to the the injectable antibiotic PTZ601 (razupenem). Novartis claims this drug, currently in Phase II development, could represent the first injectable broad-spectrum carbapenem antibiotic suitable for treating MRSA. The company doesn’t project filing for approval of PTZ601 before 2012.
Novartis already has its foot in the door of the hospital-based infections market, through the marketing of Cubist Pharmaceuticals’ cyclic lipopeptide, Cubicin®, in the EU and other countries. Cubicin is an IV antibiotic, which Cubist first launched in the U.S. in November 2003. The drug is indicated for the treatment of skin and skin structure infections caused by S. aureus and certain other Gram-positive bacteria as well as for S. aureus-related bloodstream infections including right-sided infective endocarditis caused by methicillin-susceptible and methicillin-resistant isolates.
Cubist derives the majority of its revenues from sales of Cubicin and projects that the drug could achieve peak sales of over $1 billion in the U.S. alone. Net revenues from worldwide sales of Cubicin reached $422.1 million in calendar 2008 compared with $290.4 million in 2007. During last year’s fourth quarter, U.S. sales of the drug reached $120 million, with global sales topping $131 million.