Switzerland-headquartered Nycomed has presented encouraging preliminary results from two late-stage trials of Daxas, the firm’s investigational compound for chronic obstructive pulmonary disease.

Nycomed said that two pivotal 12-month Phase III studies of Daxas (roflumilast) met their primary endpoints, showing effects on exacerbation rates and pulmonary function (FEV1). Also, two supporting six-month studies confirmed the efficacy of the drug when used with standard bronchodilator treatments.

The Zurich-based firm said that full data from all four studies are expected to be published during 2009. It expects to file for European and US marketing authorisation next year and will “initiate the process” of identifying a partner to commercialise Daxas in the USA.

Daxas is an orally administered phosphodiesterase 4 enzyme inhibitor, targeting cells and mediators in the body believed to be important in the COPD disease process. The firm says that if approved, Daxas, a once-a-day tablet, will be the first drug in its class and the first oral anti-inflammatory treatment for COPD patients.

Hakan Bjorklund, Nycomed’s chief executive, noting that the four Phase III trials involve more than 4,500 patients, will be “a great addition” to the firm’s product portfolio." If Daxas gets the go-ahead, it would compete with the likes of Boehringer Ingelheim and Pfizer’s Spiriva (tiotropium) and GlaxoSmithKline’s combination drug Advair/Seretide (salmeterol and fluticasone). AstraZeneca is hoping to get US approval soon for its asthma combo Symbicort (budesonide/formoterol) as a treatment for COPD.