Novartis’ COPD contender cleared in EU
pharmafile | December 4, 2009 | News story | Sales and Marketing |Â Â COPD, Novartis, respÂ
Novartis has been given a green light in the European Union to sell its Onbrez respiratory drug, allowing the firm to tap into a multibillion dollar market for chronic obstructive pulmonary disease (COPD) treatments.
The Onbrez Breezhaler is a once-daily bronchodilator treatment based on indacaterol maleate (formerly known as QAB149) and is the first new inhaled treatment for COPD to reach the EU in seven years, said the Swiss drugmaker.
The firm says it is the only licensed treatment that combines a rapid onset (four to five minutes) with full 24-hour bronchodilation.
Onbrez is also under regulatory review in the US, but suffered a setback last month when a Food and Drug Administration (FDA) advisory committee asked for more information on the dosing of the drug.
COPD has become a highly lucrative market for the pharmaceutical industry because of the huge numbers of patients afflicted with the disease. Around 82 million Europeans have the condition and it is the third-leading cause of death worldwide.
Overall, the market is estimated at around $9 billion a year, with GlaxoSmithKline currently leading the field with its combination steroid and bronchodilator Advair/Seretide (fluticasone and salmeterol) product, with sales of £4.1 billion in 2008, split between asthma and COPD.
AstraZeneca sells a similar combination product for COPD – Symbicort (budesonide and formoterol) – with sales of around $2 billion last year also split between asthma and COPD.
Meanwhile, Pfizer and Boehringer Ingelheim’s Spiriva (tiotropium bromide) achieved sales of more than 2 billion euros in 2008.
Analysts believe the Onbrez Breezhaler product has lesser sales potential – in the order of a few hundred million dollars a year – but could easily become a blockbuster with sales of more than $1 billion when follow-up combination products based on indacaterol reach the market.
Earlier this year Novartis reported the results of phase III comparative studies in which it claimed Onbrez had shown superior benefits on lung function in COPD patients compared to Spiriva and Foradil (formoterol), a bronchodilator formerly developed by Novartis but now in Merck & Co’s hands.
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