PathoGenesis Nears First NDA Filing

PathoGenesis has reported the results of two Phase III trials with TOBI(tobramycin), which show that the inhaled antibiotic can improve lung function in people with cystic fibrosis and chronic lung infections caused by Pseudomonas aeruginosa.

On the strength of these data, PathoGenesis plans to file a New Drug Application for TOBI in the second quarter of this year, the first product to reach this level of development at the company. The product will not address a vary large market, but is important to PathoGenesis as it builds a franchise in anti-infectives, in advance of its other, potentially more lucrative projects, including TOBI for tuberculosis, and two other novel TB compounds.

The company has conducted two Phase III studies, including a total of 468 patients at 69 CF centers in the USA. Treatment with TOBI or matched placebo was given on an intermittent basis (four weeks on therapy, and then four weeks off), over six months. The treatment was additive to any supportive therapy which might be required over the study period.