Summary
With the recent setbacks to Almirall’s clidinium bromide – it is not now scheduled to re-enter the regulatory fray until late 2011/early 2012 - the way has opened up for the PDE4 inhibitor Daxas (roflumilast) to be the next big thing in COPD. If it can only overcome the final, regulatory hurdles, it stands a good chance of becoming a substantial blockbuster. Daxas may not turn out to be the greatest thing since sliced bread for this indication – but then it doesn’t need to be. COPD is a common respiratory disease with a much greater level of unmet need than exists in the more familiar asthma indication. Only one dedicated drug, Spiriva (tiotropium) from Boehringer Ingelheim/Pfizer, has really made it in COPD so far, with recently announced sales of $2.7 billion in 2008.
Analysis
Nycomed has understandably gone ahead first with a European submission – patent life remaining there is limited, with the Daxas patent scheduled to expire there in 2014.
But with the longer protection in the US from market exclusivity, which doesn’t commence until a product is on the market, this is where the lion’s share of the potential for Daxas exists – an interesting prospect which potential US partners are evidently now mulling over.
And once Daxas is safely launched, with the asthma market providing the model, fixed combinations of Daxas for COPD could in the longer term provide a very big upside.
