- Both 12-month pivotal studies in patients with symptomatic Chronic Obstructive Pulmonary Disease (COPD) meet primary endpoints
- Data show reductions in moderate and severe exacerbations requiring medical intervention
- Application for marketing authorisation in EU and US expected in 2009
- Partnering process for commercialisation in the US to be initiated
ZURICH, Switzerland, Oct. 28 /PRNewswire/ -- Nycomed today announced encouraging results from a preliminary analysis of four Phase III trials of Daxas(R) (roflumilast) in the treatment of symptomatic COPD. Two pivotal 12-month studies met their primary endpoints, showing effects on exacerbation rates and pulmonary function (FEV1). Furthermore, two supporting six-month studies confirmed the efficacy of Daxas when used with standard bronchodilator treatments. Further analysis including the secondary endpoints is ongoing and full data from all four studies are expected to be published during 2009. In light of the initial data analysis, Nycomed expects to file for European and US marketing authorisation next year. The company will also initiate the process of identifying a partner to commercialise Daxas in the United States.
Commenting on today's announcement, Hakan Bjorklund, Chief Executive Officer of Nycomed, said: "We are extremely encouraged by the positive results from our preliminary analysis of four phase III trials involving more than 4,500 patients. We believe Daxas has the potential to make a significant contribution to COPD management and will therefore be a great addition to Nycomed's product portfolio."
Anders Ullman, Executive Vice President R&D, added: "COPD has a very
high morbidity and mortality. Epidemiological data suggest that it is
growing at a significant rate all around the world. Daxas is well placed to
be the only anti-inflammatory product that specifically targets the
inflammatory processes, which appear to play an important role in COPD.
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