Positive results for three late-stage drugs
Novartis raised a challenge to its competitors in the chronic obstructive pulmonary disease (COPD) sector at the European Respiratory Society meeting this week, reporting late-stage results from all three of its drug development programmes.
The Swiss pharma major reported phase III data on long-acting beta agonist (LABA) Onbrez/Arcapta (indacaterol maleate) and long-acting muscarinic antagonist (LAMA) Seebri (glycopyrronium bromide), as well as QVA149, a fixed-dose combination of both drugs.
Novartis is planning to file QVA149 for approval by the end of the year, with analysts predicting sales of $3bn to $5bn at peak, while Onbrez is already on the market in the US and EU and Seebri has been submitted in the EU and Japan.
Three studies in the IGNITE programme of QVA149 showed that the LABA/LAMA combination was superior to competitors on various measures of lung function and clinical outcome, said the firm.
The ILLUMINATE study found that QVA149 was superior to GlaxoSmithKline's multibillion-dollar blockbuster Advair/Seretide (salmeterol/fluticasone) in maintaining forced expiratory volume (FEV) - a measure of lung function - as well as COPD symptoms such as shortness of breath.
SHINE compared QVA149 to glycopyrronium bromide or indacaterol maleate given as monotherapies - as well as Pfizer/Boehringer Ingelheim's muscarinic antagonist Spiriva (tiotropium) - and also came down in favour of Novartis' drug on FEV and COPD symptoms, as well as a quality-of-life scale.
Thirdly, the ENLIGHTEN trial looked at long-term exposure to QVA149 and showed the drug was safe and tolerable over a year's treatment.
Novartis also presented results from two trials of Seebri - GLOW1 and GLOW2 - which showed that the LAMA increased lung function and improved patient outcomes compared to placebo, and a pooled analysis (INERGIZE) of phase III/IV data on Onbrez which indicated the drug was superior to Spiriva in improving shortness of breath.
The portfolio of COPD drugs is trying to grab a slice of a combined asthma/COPD market estimated to reach $47bn by 2017, according to BCC Research.
QVA149, Onbrez and Seebri will be jostling for position with GSK's Advair follow-up Relvar/Breo (vilanterol plus fluticasone furoate) - which has already been filed in the EU and US - along with LABA/LAMA combination vilanterol and umeclidinium bromide, which is being developed by GSK and partner Theravance.
Some analysts have suggested that QVA149 will also see stiff competition from Boehringer's olodaterol/tiotropium LABA/LAMA combination, which is due to reach the market in 2013, as well as generic versions of Advair now that it has started losing patent protection.