Novartis’ (NVS) respiratory ambitions are comfortably on track. In the wake of the first significant presentation of pivotal data on NVA237 and an earlier-than-expected European filing, the COPD therapy is confirmed as the biggest threat on the horizon for Boehringher Ingelheim’s bumper blockbuster Spiriva.
With a quick onset of action and an impressive impact on exacerbations – spells of intense worsening of symptoms that carry a substantial mortality risk for very ill patients – the drug has a good chance of reaching the market, analysts believe. Other new entrants in the class are on their way, but NVA237 is shaping up to be a robust competitor.
Glowing data
Over the last few days Novartis has unveiled a suite of data at the European Respiratory Society meeting, the first detailed look at phase III data on the drug (Preview - ERS to provide peek at potential respiratory blockbusters, September 21, 2011). Generically called glycopyrrolate and licensed from Vectura, shares in the small British respiratory specialist climbed 3.5% today to 89.25p on news of a $5m milestone payment, banked on the European filing.
Results from the 800-patient Glow 1 study highlighted the attributes of NVA237 that Novartis is likely to emphasise in its attempts to win approval and, ultimately, market share.
Firstly a swift onset of action - the drug induced a significant and clinically meaningful improvement in lung function compared to placebo five minutes after the first dose, maintained for 24 hours. Dyspnea or breathlessness was significantly improved over the 26 weeks of the study, while quality of life measures improved and the use of rescue medication reduced.
Importantly, the drug was also safe and well tolerated, in particular in terms of dry mouth. This is suffered by anything from 15% to 20% of Spiriva patients, but less than 3% of patients in the Glow 1 study.
Exacerbating effects
In Glow 3, which was presented as a late-breaking abstract at the conference Tuesday, the drug significantly improved the time patients could endure exercise, by 21% at day 21; endurance was boosted by 10% on day one.
Perhaps the most eye catching data presented was on exacerbations. Reducing these events is an increasingly important target of therapy and on this measure NVA237 scored impressively.
In the Glow 1 study, use of the drug significantly prolonged the time to a patient’s first exacerbation, reducing the risk by 31%, and the time to the first event requiring hospitalisation; the study failed to show a statistically significant reduction in the rate of exacerbations, over placebo.
Still, the study was only conducted over 26 weeks, and 80% of the patients had not experienced an exacerbation within the year before entering the trial, analysts at Citi noted Tuesday, saying that the magnitude and the significance of the benefit represents “an upside surprise”.
Continuing comparisons
Spiriva has also been proven to reduce exacerbations and is indicated to do so on its prescribing label. Comparing across trials is fraught with caveats but the Glow 1 data suggests NVA237 could be at least as effective as the £4bn blockbuster on this measure – the longer Glow 2 study, which was conducted over one year and has an open label Spiriva arm, will allow a more insightful comparison.
Data are due next year and this trial remains an important test for NVA237, considering the improvement in lung function seen so far has not completely blown Spiriva out of the water. The 108ml increase in FEV1 at week 12 is considered clinically meaningful but Spiriva achieved 140ml at week 13 in one of its phase III trials.
Comparable improvements in lung function would be manageable for Novartis, if NVA237 can continue to point to superiority on measures such as exacerbations and tolerability.
