Good news25 Sep 2009 18:44
LONDON, Sept 25 (Reuters) - A new once-daily Novartis drug for treating 'smoker's lung', or COPD, has been recommended for approval in Europe, the European Medicines Agency said on Friday.
The green light is a boost for the Swiss drugmaker's ambitions in respiratory medicine, a field currently dominated by GlaxoSmithKline, AstraZeneca and Pfizer .
QAB149, or indacaterol, is the first once-daily bronchodilator treatment for adult patients with chronic obstructive pulmonary disease (COPD). When approved, the drug and its inhaler device, Concept-1, will be known as Onbrez Breezhaler.
'On approval, our plans are for QAB149 to form the foundation of a new portfolio of potential products designed to improve patients' respiratory health,' said Trevor Mundel, head of development at Novartis.
The European Commission generally follows the recommendations of the London-based medicines agency and delivers its final decision within three months.
Novartis will initially sell QAB149 as a monotherapy. But industry analysts believe unlocking the medicine's full sales potential -- which some have put at $3-5 billion a year -- will depend on combining QAB149 with other treatments.
Novartis is studying combinations with NVA237, a new drug it is developing with Vectura, and with Schering-Plough's inhaled steroid mometasone.
Those combinations may not reach the market until around 2013, analysts estimate.