Nycomed files Daxas with FDA, potential partners lined up

Nycomed, rumoured to be planning a bid for Solvay’s pharmaceuticals division, has filed its lung disease drug Daxas with regulators in the USA.

The Zurich-based company has submitted a New Drug Application with the US Food and Drug Administration for Daxas (roflumilast) as a once-daily oral treatment for patients with symptomatic chronic obstructive pulmonary disease. The filing is based on results from four Phase III trials, two of which showed positive effects on exacerbation rates and pulmonary function.

Nycomed added that two supporting six-month studies also confirmed the efficacy of Daxas when used with standard bronchodilator treatments. Chief executive Hakan Bjorklund noted that “discussions with potential US commercialisation partners are now well advanced", adding that “with its novel mode of action, Daxas represents an important new approach to the management of COPD”.

Daxas, a phosphodiesterase 4 enzyme inhibitor was filed with the European Medicines Agency in May. If approved, the drug would compete with Boehringer Ingelheim/Pfizer’s Spiriva (tiotropium), GlaxoSmithKline's Advair/Seretide (salmeterol and fluticasone) and AstraZeneca’s Symbicort (budesonide/formoterol).

According to World Health Organisation, 80 million people have moderate to severe COPD worldwide and more than three million people died from the disease in 2005. The WHO predicts that total deaths from COPD could increase by more than 30% in the next 10 years, “unless urgent action is taken to reduce the underlying risk factors, especially smoking”, Nycomed noted.