Summary
The level of unmet need in COPD, a very common respiratory disease, is high. Consequently, provided a new drug is registrable it does not have to have outstanding qualities to become a substantial success. Nycomed’s Daxas has recently been submitted for registration for COPD in the US and Europe. If registered, this novel drug will be the first member of its class to reach the market.
Analysis
Nycomed recently signaled the presentation of detailed clinical results on Daxas in mid-September at the European Respiratory Society Congress in Vienna. However, the data from four trials has just been published in two articles in the Lancet (August 29th edition). The studies demonstrate that Daxas improves lung function and reduced exacerbations in patients with moderate to severe COPD. One of the Lancet articles concluded that Daxas “could become an important treatment” in such patients.
The results also show that Daxas gives additional benefit to patients already on other types of COPD treatment. Also the side-effects profile in these trials looks reasonable.
To have these results published now in such a prestigious journal must be a fillip to Nycomed in gaining international regulatory approvals. With the help in the US of Nycomed’s recently appointed US partner Forest, Daxas ought to be capable of achieving more than basic blockbuster status as a plain product. And once registration has been achieved, a variety of options for potentially much more valuable fixed combinations of Daxas with other classes of COPD drugs can then be seriously considered.
John Ansell consults with leading institutions through GLG
Analyses are solely the work of the authors and have not been edited or endorsed by GLG.
