Nycomed submits Daxas for COPD in Europe

Nycomed has filed its lung disease drug Daxas with regulators in Europe and is planning to make a similar submission in the USA soon.

The Switzerland-based drugmaker has submitted a marketing authorisation application to the European Medicines Agency for Daxas (roflumilast) as a once-daily oral treatment for chronic obstructive pulmonary disease. The submission is based on what Nycomed calls “encouraging results” from four Phase III trials of the phosphodiesterase 4 enzyme inhibitor which demonstrate its effectiveness on exacerbation rates and pulmonary function.

Chief executive Hakan Bjorklund said that with its novel mode of action, Daxas represents “a potentially important new approach in the management of COPD – a disease which is predicted to become the third leading cause of death worldwide by 2030”. He added that the “search for a US partner is on track”, and Nycomed will submit a regulatory filing to the Food and Drug Administration soon.

If approved, Daxas will compete with Boehringer Ingelheim/Pfizer’s Spiriva (tiotropium), GlaxoSmithKline's Advair/Seretide (salmeterol and fluticasone) and AstraZeneca’s Symbicort (budesonide/formoterol)

These are interesting times for privately-owned Nycomed which has stated in the past that it intends to go for a stock market listing as soon as it judges the conditions to be right. It is majority-owned by four private equity groups, led by Nordic Capital with a 41% stake.

In March, a report in The Wall Street Journal claimed that Nycomed has reportedly asked Goldman Sachs to explore a possible sale of the company which could bring in as much as 10 billion euros. However analysts believe the IPO is a far more likely option.