Novartis Signs Agreement With Paratek For PTK 0796

Novartis has gained exclusive worldwide rights to market PTK 0796 as the potential first once-daily broad-spectrum antibiotic that can be given by intravenous (IV) infusion or oral tablet.

PTK 0796 is indicated for the treatment of 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).

As per the agreement with Paratek Pharmaceuticals (Paratek ), both the companies will share responsibility for developing PTK 0796. A phase III study is already under way in complicated skin and skin structure infections (cSSSI), and clinical trials are planned in a number of other potential indications.

Moreover, the agreement states that Novartis will make an upfront payment to Paratek in return for the exclusive rights to commercialise PTK 0796 worldwide. Both the 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.

The company claims that PTK 0796, given as a once-daily 30-minute IV infusion or daily oral tablet, could offer patients a convenient way to continue antibiotic treatment after they have been discharged from hospital.

While commenting on the drug the company also said that it could be used as a single agent against a range of bacteria, unlike other antibiotics which may have to be used in combination.

In addition, PTK 0796 has shown activity against multi-drug resistant bacteria such as MRSA, vancomycin-resistant enterococci (VRE) and Gram-negatives producing ESBL (extended-spectrum beta-lactamase).

Clinical studies involving a total of more than 500 patients have shown that PTK 0796 has a favorable safety and tolerability profile. A phase II study in cSSSI found that clinical success rates among evaluable patients were 98% for PTK 0796 and 93% for linezolid (Zyvox).

Joe Jimenez, CEO of the Novartis Pharmaceuticals Division, said: “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,” “It will potentially benefit patients by offering a flexible and highly effective approach to the treatment of a number of critical infections.”