Product Details
Identified using Sosei’s proprietary search technologies, NVA237 is a long acting bronchodilator for the treatment of chronic obstructive pulmonary disease (More about COPD).
NVA237 is the anti-muscarinic agent glycopyrronium bromide which is currently registered for intravenous use during surgery. Sosei recognised its potential as a bronchodilator through research which confirmed NVA237 has a high affinity for M1 and M3 muscarinic receptor sub-types responsible for cholinergic bronchoconstriction and mucus secretion in the lung.
Clinical trials conducted by Sosei using a commercially available dry-powder inhaler device demonstrated that single doses of NVA237 produced a significant improvement in bronchodilation that was maintained for at least 32 hours after dosing and had a low systemic bioavailability. After multiple dosing, NVA237 provided sustained 24 hour bronchodilation and was well tolerated at all doses over a 28 day treatment period. In addition, the inclusion of an open-label tiotropium group in this study provided data to suggest that onset of action may be more rapid with NVA237 than with therapeutic doses of tiotropium.
Worldwide, exclusive rights to NVA237 were granted to Novartis in April 2005. Novartis are responsible for the further development and commercialisation of this and also the combination product QVA149.
In October 2008 Novartis announced results of a Phase II dose ranging study in the new proprietary Novartis device and a 28 day safety study in the USA under an IND regulatory authorisation. Data from these two studies showed that NVA237 demonstrated sustained 24-hour bronchodilation with efficacy comparable to tiotropium and potentially faster onset of action, and was well tolerated with a good overall safety profile and no clinically relevant cardiovascular findings.
Novartis commenced Phase III trial of NVA237 in June 2009.
In addition, Novartis expect to file an NDA submission for NVA237 in 2011.
About COPD
COPD is a chronic obstruction of the airways which in the developed world is caused primarily by smoking. Symptoms include chronic bronchitis and/or emphysema which slowly progress and eventually lead to a largely irreversible loss of lung function. COPD is currently the fourth most common cause of death in the USA and by 2030 is predicted to become the third most common cause of death and the fourth most important disability causing illness. Around three-quarters of patients with advanced COPD are unable to perform normal everyday activities.
The airway obstruction in COPD is largely fixed but is partially reversible by bronchodilator (or other) therapy. In particular, inhaled anti-muscarinic drugs such as ipratropium bromide (Atrovent® and tiotropium bromide (Spiriva®) have been shown to be beneficial in treating the symptoms of COPD.
Market Overview
COPD is a large and fast expanding market which is estimated to be worth around $6 billion (2007) and is expected to double by 2011 as a result of better recognition of the disease and improved treatment options. In particular recent growth has been driven by Spiriva® which recorded sales of $2.77 billion in 2008.
