Nycomed's Daxas(R) Shows Encouraging Preliminary Results in Phase III CO...(ments and COPD symptoms as well as safet...)

Date:10/28/2008

ments and COPD symptoms as well as safety and tolerability. Daxas (500 microgram roflumilast) was administered orally once daily for up to 52 weeks. The randomised, double-blind, placebo-controlled studies were conducted in a number of territories, including the US, Europe, Canada, Australia, Russia, India and South Africa. Both HERMES and AURA met their primary endpoints. Further analysis, including of the secondary endpoints, is ongoing.

Two further Phase III studies, EOS and HELIOS, recruited more than 1,500 patients to evaluate the efficacy of Daxas when used concomitantly with standard bronchodilator treatments for COPD, ie, tiotropium or salmeterol. Both are multicentre, double-blind, randomised, parallel group studies in patients with moderate or severe COPD. The primary endpoints were a mean change in pre-bronchodilator FEV1 from baseline during the treatment period. Both EOS and HELIOS confirmed the efficacy of Daxas when used with standard bronchodilator treatments.

About Nycomed

Nycomed is a privately owned pharmaceutical company that provides medicines for hospitals, specialists and general practitioners, as well as over-the-counter medicines in selected markets.

The company is active in a range of therapeutic areas, focusing on gastroenterology, respiratory, inflammation, pain management, osteoporosis and surgical management. New products are sourced both from its own research and from business partners.

Based in Europe, Nycomed is present in over 50 countries worldwide with increasing emphasis on fast-growing markets.

The combined group employs 12,000 people. In 2007, it had annual sales of euro 3.5 billion and an adjusted EBITDA of euro 1.2 billion.

For more information visit http://www.nycomed.com

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SOURCE Nycomed Copyright©2008 PR Newswire. All rights reserved

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