New drugs in the pipeline that pose the first real competitive threats to blockbuster respiratory products Spiriva and Advair will receive close scrutiny at the European Respiratory Society conference over the coming week.
Novartis, its generics arm Sandoz and partner Vectura will present detailed phase III data on NVA237, a novel muscarinic antagonist that will vie for a slice of Spiriva’s $4bn market, as well as providing the first look at a generic version of GlaxoSmithKline’s Advair. Glaxo, meanwhile, is also set to reveal new data on some of its follow-on respiratory products, meaning the meeting should yield some interesting insights into some potentially important respiratory drugs.
Novartis is presenting data from two studies from the pivotal Glow programme it has run with NVA237 – the drug is due to be filed with regulators before the end of the year.
Glow 1 was run in 800 patients with moderate-to-severe chronic obstructive pulmonary disease, testing NVA237, generically known as glycopyrrolate, against placebo. Back in April the Swiss company said the primary endpoint of the trial was met, with the active agent demonstrating superior bronchodilation to placebo at 12 weeks; this will be the first look at the detailed results (Vectura breathing easier following COPD data, April 19, 2011).
Abstracts have already been released and some analysts reckon the improvement in lung function – an 108ml increase in FEV1 at week 12 - will be considered clinically meaningful by doctors. Others, however, have commented that this result is lower than the drug achieved in phase II studies, and could be considered modest compared to Spiriva, which achieved 140ml at week 13 in phase III trials.
Analysts have mentioned FEV1 improvement ranging from 90ml to 120ml, as the level NVA237 needed to achieve to compete with Spiriva.
Differentiating and copying
Importantly, however, the drug met secondary endpoints in the study; measures included reduction in exacerbations and speed of onset of action, and these could still provide important differentiation. A second smaller study due to be presented as a late breaking abstract, Glow 3, looked at exercise endurance.
With full results of another important trial which contained a Spiriva arm, Glow 2, not due for presentation until 2012, the picture of the drug’s efficacy will not be fully painted at ERS. But a closer look at the data – as well as physicians’ initial reaction - will be sought to help gauge the drug’s chance of competing against entrenched Spiriva.
NAV237 was licensed by Novartis from UK respiratory company Vectura, which also has a lot riding on another product likely to attract attention, VR315. A copycat version of Advair, the Swiss company’s generics arm Sandoz extended its regional marketing rights to the product last month (Event - EU approval could follow deal flurry for Vectura's Advair generic, August 8, 2011).
Although the timing of European approval is now uncertain after the filing was removed from the Finnish medicine regulator’s website last week, the conference provides the first look at clinical data that has been kept under wraps until now. Now branded Forspiro, studies will be presented encompassing almost 800 asthmatic patients; the abstracts point to similar lung function improvements to Advair with similar side effects. They also mention that patients preferred the Forspiro inhaler – Vectura’s Gyrohaler – to Advair’s Diskus device.
In the pipeline
This first glimpse at the competition Advair is likely to face will be closely scrutinised, by financial analysts as well as Glaxo. However, the UK pharma giant has an extensive pipeline of respiratory agents in development and will be presenting data on a number of these, including Relovair, dubbed “son of Advair”, and the first look at mid-stage data from its most advanced Spiriva competitor.
Only incremental phase II data on Relovair will be released at ERS – important phase III results in COPD and asthma are due early next year – meaning muscarinic antagonist GSK573719 is likely to attract more attention.
The drug has already moved into pivotal studies as both a monotherapy and in combination with a long acting bronchodilator vilanterol – a component of Relovair – so this data will provide an interesting insight into the drug’s potential.
Abstracts suggest strong efficacy, but also a high proportion of adverse events, and greater detail will be of interest.
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