Forest Laboratories has started shipping its new chronic obstructive pulmonary disease (COPD) drug Tudorza Pressair to pharmacies in the US following its approval there in July.
Tudorza (aclidinium bromide) is a long-acting muscarinic antagonist (LAMA) originally developed by Spain’s Almirall and is already on the market in Germany, the UK and Denmark, where it is sold as Eklira and Bretaris Genuair.
“Tudorza is the first long-acting inhaled anticholinergic approved by the FDA for COPD in over eight years,” said Forest and Almirall in a statement.
The new drug enters a market currently dominated by Boehringer and Pfizer’s muscarinic antagonist Spiriva (tiotropium) – Tudorza’s closest rival – and GlaxoSmithKline’s long-acting beta agonist (LABA) and corticosteroid combination Seretide/Advair (salmeterol and fluticasone).
Together, Spiriva and Seretide account for two-thirds of a COPD market estimated to be worth around $9bn in the top seven pharma markets last year (the US, France, Germany, the UK, Italy, Spain and Japan) and expected to reach more than $13bn in 2021, according to market research firm Decision Resources.
As a monotherapy Tudorza is not expected to be a huge seller – Forest has predicted 2013 sales of around $30m and analysts polled by Zacks believe it could top out at around $300m a year – as its clinical profile is not hugely different to Spiriva and its twice-daily dosing is less favourable than its once-daily rival.
Forest and Almirall are also developing a combination of aclidinium with LABA formoterol which is expected to be a bigger seller as fixed-dose LABA/LAMA products are expected to be the largest COPD drug category, capturing a 33 per cent share by 2021, according to Decision Resources.
Phase III trials of the aclidinium/formoterol product are due to generate data next year. It is however likely to see stiff competition from other combination products coming through development, such as Boehringer’s olodaterol/tiotropium and Novartis’ QVA149 (glycopyrronium bromide and indacaterol maleate) which are both expected to reach the market next year. Also in late-stage testing is GSK’s umeclidinium/vilanterol prospect.
Meanwhile, the dynamics of the COPD are also expected to change dramatically with the launch of generic versions of Seretide, now that GSK’s blockbuster drug has started losing patent protection in some markets.
Tudorza is one of crop of new drugs that Forest has brought to market as it copes with generic competition to its Lexapro (escitalopram) antidepressant, which lost patent protection in the US in March and led to a 40 slump in third-quarter sales at the pharma company.