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.
In September 2011, Novartis announced the results from Phase III studies (GLOW 1 and GLOW 3) at the European Respiratory Society congress. Data from these two studies showed that NVA237 provides superior bronchodilation and increases exercise endurance relative to placebo. Additional data from these studies show that NVA237 significantly prolonged time to first moderate to severe COPD exacerbation and reduced associated hospitalization compared to placebo.
Based on the positive results from these studies Novartis submitted NVA237 for approval in Europe in September, and in Japan in November 2011.
In addition, Novartis have stated that they intend to launch NVA237 in 2012.
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. Worldwide, COPD is estimated to affect a total of 210 million people and is projected to become the third leading cause of death by 2020.
Market Overview
COPD is a large and fast expanding market which is estimated to be worth around $9 billion (2008) and is expected to reach $11 billion by 2014 as a result of better recognition of the disease and improved treatment options.
