Yesterday, Novartis (NVS) released encouraging data on its investigational respiratory drug QAB149 which is being developed for the treatment of patients suffering from chronic obstructive pulmonary disease (COPD). The drug, to be used once daily, improved lung function and significantly reduced breathlessness in a late stage trial compared to Pfizer’s (PFE) Spiriva (tiotropium), a treatment currently used.

The data were presented this week at the European Respiratory Society (ERS) 2009 Annual Congress in Vienna. QAB149 is currently under regulatory review in the European Union, the US and several other countries for the treatment of COPD.

The trial carried out for both 12 weeks and 26 weeks showed better results with QAB149 compared to Spiriva. Apart from improving lung function and reducing breathlessness, patients on QAB149 recorded greater than 20% increase in days, when no ‘relief’ medication or therapies were required to treat severe breathlessness, compared to patients treated with Spiriva. Additionally, the drug showed good overall safety and tolerability profile for all evaluated doses. The most common adverse reactions included nasopharyngitis, cough, upper respiratory tract infection, and headache which become less frequent on continuation of the treatment.

At present, Spiriva, jointly marketed by Pfizer and Boehringer Ingelheim, is the most commonly used treatment option available for COPD. The disease is commonly caused by cigarette smoke or any other harmful fumes resulting in persistent obstruction of airflow in the lungs causing breathlessness. Per company estimates, about 210 million people are affected worldwide.

The positive outcome of the trial could fetch the drug approval from US and European Union regulatory authorities. QAB149 could record robust sales on approval and would compete with GlaxoSmithKline’s (GSK) Advair (with sales of £4.1 billion in 2008) in the COPD market.
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