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Novartis on track to file COPD drug in Europe by year-end

Will also file QVA149 in Japan after positive phase III trial results

Positive results from a fifth and final phase III trial of Novartis' QVA149 have prompted the firm to plan to file the chronic obstructive pulmonary disease (COPD) drug for approval by the end of the year.

Novartis said it would submit applications for QVA149 (indacaterol fumarate and glycopyrronium bromide) in the EU and Japan following the success of the SPARK study.

QVA149 could be the first COPD drug to reach the market combining a long-acting beta agonist (LABA) with a long-acting muscarinic antagonist (LAMA) in a once-daily formulation, a competitive profile which has led analysts to predict peak sales potential of between $3bn and $5bn a year.

SPARK showed that the combination drug significantly reduced rate of moderate-to-severe exacerbations compared to monotherapy with glycopyrronium, which Novartis is also developing as a standalone product under the Seebri brand name.

In addition, QVA149 reduced overall exacerbation rates compared to glycopyrronium and open-label treatment with Pfizer/Boehringer Ingelheim's muscarinic antagonist Spiriva (tiotropium).

With five positive trials in the bag, Novartis can now press ahead with regulatory filings in Europe and Japan, although its development in the US has been hampered by an FDA request last year for additional clinical data on QVA149 and glycopyrronium delivered as a monotherapy.

QVA149 is one of a portfolio of COPD treatments under development at Novartis as it enters a category currently dominated by GlaxoSmithKline's $8bn-a-year blockbuster Seretide/Advair (salmeterol plus fluticasone propionate), which is coming to the end of its patent life in Europe, and Spiriva which together account for around two-thirds of the market.

Indacaterol has already been launched as a monotherapy in the EU and Japan as Onbrez and in the US as Arcapta, while Seebri was submitted for approval in Europe and Japan in 2011, with a US filing expected at the beginning of 2014.

At stake is a piece of a combined COPD and asthma market expected to rise from a value of $38bn last year to $47bn in 2017, according to market research firm BCC Research

Meanwhile, Novartis' rivals in the COPD sector are not standing still. GSK and partner Theravance have just completed the phase III data for their own LABA/LAMA combination based on vilanterol and umeclidinium bromide and also have Advair/Seretide follow-up Relvar/Breo (vilanterol plus fluticasone furoate) filed in the EU and US.

Also coming through the pipeline is Boehringer's olodaterol/tiotropium LABA/LAMA combination, which is due to reach the market in 2013.

30th August 2012

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