Nycomed's Daxas(R) Shows Encouraging Preliminary Results in Phase III CO...(th final data from these four studies ex...)

COPD remains a significant area of unmet medical need. It is a progressive and irreversible lung disease resulting in difficulty in breathing. The disease is characterised by severe episodes of worsening, called exacerbations. According to World Health Organization (WHO) estimates, 80 million people have moderate to severe COPD worldwide. More than 3 million people died of COPD in 2005, which corresponds to 5% of all deaths globally. 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.

(see http://www.who.int/respiratory/copd/burden/en/index.html)

Nycomed's Daxas is an orally administered phosphodiesterase 4 (PDE4) enzyme inhibitor, targeting cells and mediators in the body believed to be important in the COPD disease process. Daxas is expected to act on the underlying mechanism of COPD and related inflammatory diseases. It could significantly improve the way these conditions are managed, reducing exacerbations requiring medical intervention, including hospitalisation. If approved, Daxas, a once-a-day tablet, will be the first drug in its class. It will also be the first oral anti-inflammatory treatment for COPD patients. Current treatment for COPD patients includes the use of inhaled bronchodilators and inhaled corticosteroids.

Nycomed's extensive programme for Daxas includes two international Phase III, 12-month trials, HERMES and AURA, which have recruited a total of 3,000 patients. The primary aim of both studies was to investigate the effect of Daxas on exacerbation rates and pulmonary function (FEV1) in severe and very severe COPD patients. Secondary endpoints included other lung function measure
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