Phase III drug superior to Spiriva, says Novartis
pharmafile | May 21, 2009 | News story | Research and Development, Sales and Marketing |Â Â COPD, NovaritsÂ
Novartis says its COPD treatment has shown significant benefits over two established rivals, and could form the cornerstone of a successful new pipeline for the company.
The phase III treatment QAB149 showed improved lung function in patients in up to one year of treatment compared to Spiriva (marketed by Boehringer-Ingelheim and Pfizer) and also Foradil – Novartis' own treatment that it has just handed over to Schering Plough.
The new treatment could reach the market as early as 2010, and could become a blockbuster if it can prove further superiority to current market-leading drugs.
Novartis' global head of development Trevor Mundel said: "Novartis is committed to developing a range of therapies for patients with respiratory diseases such as COPD. QAB149 could become the foundation of a portfolio of medicines that aims to improve peoples' respiratory health."
Chronic obstructive pulmonary disease (COPD) is a chronic obstruction of the airways caused primarily by smoking, and is the world's fourth most common cause of death. It progresses slowly and eventually leads to a largely irreversible loss of lung function.
COPD is currently incurable, and existing treatments focus on improving airflow with the use of long-acting bronchodilators.
Initial results from three phase III trials showed QAB149 could deliver clinically relevant lung function improvements within five minutes of the first dose, lasting for 24 hours in patients, and revealed a good safety profile. It also showed improvements over Foradil and Spiriva at significant periods and doses, though further study results will be released later this year.
QAB149 is currently being review by regulators in Europe and the US. If approved, Novartis says it could become the foundation of its portfolio of products, including fixed-dose combinations, designed to address unmet needs in respiratory care.
Foradil
The new phase III data has come just as Novartis has renegotiated its collaboration with Schering-Plough, and handed its exclusive worldwide rights to develop and commercialise its product Foradil.
In return, Novartis has taken rights to develop a fixed-dose combination of Schering-Plough's Asmanex – a maintenance treatment for asthma with its potential rising star QAB149.
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