Novartis' COPD drug clears phase III trial

Novartis' chronic obstructive pulmonary disease (COPD) drug NVA237 has shown significant improvements in symptoms and lung function after a full year's treatment in a phase III study.

The GLOW 2 trial is one of three studies carried out by Novartis to support registration of NVA237 (glycopyrronium bromide), which was submitted for approval in the EU last year under the Seebri brand name. It is scheduled for filing in the US in 2014.

In the latest study, long-acting muscarinic agonist (LAMA) NVA237 given once a day proved superior to placebo and similar to Pfizer/Boehringer Ingelheim's rival LAMA Spiriva (tiotropium) in increasing lung function, improving COPD symptoms and reducing exacerbations of the disease.

The results indicated that NVA237 had a rapid onset of action after the first dose, typically within five minutes, achieved 24-hour bronchodilation and was well-tolerated.

The drug is one of a portfolio of COPD treatments under development at the Swiss pharma company as it mounts an offensive on a market currently dominated by GlaxoSmithKline's Advair (fluticasone plus salmeterol), an $8bn blockbuster which will start to lose patent protection in Europe next year.

The others are long-acting beta agonist Onbrez/Arcapta (indacaterol maleatel), which is already available in the US and Japan, and QVA149 which combines the active ingredients in NVA237 and Onbrez into one formulation.

The latter product could be the first COPD drug to combine a long-acting beta agonist (LABA) with a long-acting muscarinic antagonist (LAMA) in a once-daily formulation, a profile which has led to predictions of annual peak sales between $3bn and $5bn.

The prospects for both NVA237 and QVA149 remain unclear in the US however, as the FDA requested additional clinical data on both drugs last year.

"The results of GLOW2 demonstrate that NVA237 could be the second innovative product in our COPD portfolio," commented Tim Wright, head of development at Novartis Pharmaceuticals.

- Meanwhile, GlaxoSmithKline says it has completed its acquisition of a 26.7 per cent share in Theravance, its partner for the development of a stable of COPD drugs.

These include LABA and corticosteroid combination Relovair (vilanterol plus fluticasone), an Advair follow-up which is scheduled for filing in the US and Europe in the coming weeks.

The two companies also have a LAMA/LABA combination in phase III testing and a bifunctional muscarinic antagonist and beta agonist (MABA) molecule in phase II.