Switzerland's Nycomed says it has the late-stage data needed to make a solid case to regulators for its lung disease drug Daxas. And now it's touting the data to partners who might be interested in snagging the U.S. commercialization rights.
Researchers for the company say that four pivotal trials have produced positive data on Daxas for symptomatic COPD. Both 12-month trials met their primary endpoint and two supporting six-month studies confirmed efficacy when combined with a standard bronchodilator therapy. The company will use that data in filings planned next year for Europe and the U.S.
"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," said Anders Ullman, EVP R&D. "With final data from these four studies expected during 2009, we look forward to the next steps in the development of Daxas."
Analysts say the drug is a likely competitor to Glaxo's Advair and Spiriva.
- read the report from PharmaTimes
- view the Nycomed release