AstraZeneca today raised its game in the respiratory market with the publication of data showing its asthma drug Symbicort (budesonide/formoterol) can be used to both maintain and relieve symptoms of the condition, cutting both the rate of severe exacerbations and hospitalisations. This is the first study to spotlight the benefits of as-needed Symbicort in this setting.
SMILE was a year-long trial across 20 countries and involving almost 3,400 asthma patients aged over 12 who were given the combined corticosteroid/long-acting beta agonist as maintenance therapy plus relief medications in the shape of Symbicort, formoterol alone or Brethine (terbutaline). Results showed the rate of severe exacerbations was 37, 29, and 19 per 100 patients/year with as-needed terbutaline, formoterol and Symbicort, and there were also significant improvements in secondary endpoints, including hospitalisation, mild exacerbation days, night-time awakenings and lung function, for AstraZeneca's combined therapy.
AstraZeneca is trying to propel the drug's earnings potential to better compete with GlaxoSmithKline's Seretide/Advair (fluticasone and salmeterol), a multi-billion-dollar offering which recently saw a label change after being linked to an increase in asthma-related deaths. Symbicort advanced 25% to $308 million during the second quarter of the year; impressive, but not a patch on Advair's sales over the same period, which rose 12% to £822 million ($1.5 billion).
Datamonitor has said that the value of the combination asthma market in the five major European markets was $1.8 billion in 2004, with Symbicort holding a 27% market share. This could increase to 38% by 2008, with sales of over $1.2 billion, with the benefit of the new labeling, it added. AstraZeneca originally filed for approval of this so-called SMART (Symbicort Maintenance and Reliever Therapy) treatment back in 2003, but withdrew the application a year later following discussions during Europe's mutual recognition procedure. It is currently being reviewed by the European Medicines Agency, and many anticipate the new label could be approved by the end of the year.
The new dosing approach will allow patients to increase the dose of Symbicort (budesonide and formoterol) when their asthma is bad, helping them relieve symptoms more effectively and reducing the severity of attacks. But AstraZeneca will need to watch its heels as drugmakers rush to be the first to develop once-daily products to combat asthma. Novartis, for example, recently inked a deal with Schering-Plough to develop a once-a-day product combining Schering-Plough's inhaled steroid Asmanex (mometasone furoate) with a novel beta agonist, indacaterol (QAB149), developed by Novartis.
The worldwide respiratory market for therapies to treat asthma and COPD was estimated at approximately $15 billion in 2005 and is expected to grow to $22 billion by 2015, according to IMS.
The data are published in this week's issue of The Lancet.
