Nycomed Holding its Breath

Following the May expiry of European patents protecting its biggest-selling drug, Nycomed is hoping COPD compound Daxas roflumilast will help fill part of the revenue gap. If approved, the nonsteroidal phosphodiesterase-4 inhibitor would be the first innovative COPD treatment to reach the market in 30 years and potentially the first disease-modifying drug ever approved for the disease.

However, proving the latter will take three-to-five year mortality trials that the company and partner Forest Laboratories Inc. haven't yet designed. In the meantime, Nycomed hopes that improved safety and efficacy will drive use of Daxas, which could both replace steroids in later-stage patients with chronic obstructive pulmonary disease and potentially be used earlier in the course of disease than steroids.

An NDA for Daxas is under FDA review. While a PDUFA date hasn't been announced, the companies are hoping to receive approval in 2010. Nycomed expects a decision next year from EMEA on its MAA.

"COPD therapy has seen very little innovation over the years and what this compound does is provide a new perspective on how to tackle the disease," Klaus Rabe, professor of medicine at Leiden University Medical Center, told BioCentury.

Rabe was a lead investigator in one of the four Phase III trials of Daxas published in The Lancet in August and presented at the CHEST meeting early this month.

Based on those data, clinicians contacted by BioCentury said the drug's ability to improve lung function and reduce exacerbations shows exciting potential. But since all the studies so far have tested Daxas as an add-on to bronchodilators, the physicians said more work needs to be done if it is going to compete with current treatments. This would include trials comparing Daxas head to head with marketed drugs, as well as long-term studies to determine the compound's effect

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