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Nycomed Announces FDA Filing for Daxas(R) in COPD
Date:7/20/2009

In May 2009, Nycomed also completed the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMEA) for Daxas as a once-daily oral treatment for patients with symptomatic COPD. The filing is currently under regulatory review.

Hakan Bjorklund, Chief Executive Officer of Nycomed, said: "With its novel mode of action, Daxas represents an important new approach to the management of COPD -- a disease which is predicted to become the third leading cause of death worldwide by 2030. The FDA filing, which follows the submission of Daxas to the EMEA in May, is another important step for Daxas in the key US market. Discussions with potential US commercialisation partners are now well advanced."

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 three 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 )

About Daxas

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 relate
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SOURCE Nycomed
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