Novartis acquires global marketing rights for new drug from Paratek

Swiss pharmaceutical company Novartis AG said yesterday that it has gained exclusive worldwide marketing rights to an experimental antibiotic to treat infections caused by drug-resistant bacteria from privately held Paratek Pharmaceuticals.
 
Basel-based Novartis, formed through the merger of Ciba-Geigy and Sandoz in 1996, said that it has gained exclusive worldwide rights to market an experimental antibiotic PTK 0796 from Paratek Pharmaceuticals, a privately held company based in Boston, Massachusetts.
 
PTK 0796 is 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).
 
Novartis did not disclose the payments, but said that it will make an upfront payment to Paratek in return for the exclusive rights to commercialize PTK 0796 worldwide.
 
According to the US media, the deal for Paratek was worth up to $485 million in milestones and fees combined.

Both companies will share responsibility and costs for developing PTK 0796. Paratek will be eligible to receive future milestone payments, and will also receive a royalty on net sales of PTK 0796 around the world.
 
Novartis, which had $41.46 revenue in 2008 said, because PTK 0796 may be given as a once-daily 30-minute IV infusion or daily oral tablet, patients need not stay in hospital for treatment, thereby saving on hospitalisation costs.
 
''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, said Novartis.
 
The advantage PTK 0796 will have over other drugs in the same category is that one dose can be administered a day, while drugs like Pfizer's Zyvox has to be administered twice a day.
 
"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, CEO 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.
 
Novartis, which claims to have invested approximately $7.2 billion in R&D activities throughout the group, had filed a court case in a Chennai court against the state of India in 2006 seeking to prohibit the country from developing generic drugs based on its patents.
 
The case was filed against the state of India, since the country's law refuses to recognise a patent for an existing medicine if there is a modified formula resulting in a re-patent of the drug.

But the Chennai court ruled against Novartis in August  2007 as the court said that the Swiss pharmaceutical company was trying to limit competition to its own patented medicines, which was posing a threat to poor people, who can not afford to pay the high cost of medicines for life threatening diseases like cancer, HIV and  AIDS, diabetes and other diseases.

The high court also said that it had no jurisdiction on whether Indian Patent law complied with  WTO patent guidelines.

Novartis decided not to appeal the ruling since over half a million people wrote to the CEO of Novartis during the course of the trial expressing their opposition to the case.