Almirall reveals leading edge inhaler for new COPD drug aclidinium bromide
SummarySpanish pharmaceutical company Almirall has unveiled a state-of-the-art new dry-powder inhaler in which it plans to market its lead pipeline compound aclidinium bromide for chronic obstructive pulmonary disease (COPD). The device, developed by specialist inhaler company Sofotec, acquired by Almirall in 2006, is set to become the gold standard in inhaler design, claims the company, and will aid patient compliance with anticholinergic medication.
Almirall’s Director of Pharmaceutical Development Dr Carsten Niederlaender said the inhalation device will appeal to patients and healthcare professionals because it is small, compact, portable, preloaded and extremely easy to use unlike some of the currently available inhalers for COPD medications. Patients merely have to remove the cap, press the dose-release button and inhale. It should therefore improve patient adherence. The device, which comes preloaded with 30 doses, has a window that changes from red to green when a dose has been effectively delivered and which registers an audible click, providing patients with feedback and reassurance. A dose indicator flags up a red signal to warn patients when the inhaler is close to empty and the device locks out when its 30-day supply is exhausted to prevent patients inhaling inert dry-powder residue. The new inhaler is one of very few that ticks all the boxes for complying with international regulatory requirements, said Dr Niederlaender.
Aclidinium bromide, which will be sold in the new inhaler, is currently in phase III trials which have recruited 1600 COPD patients from 23 countries worldwide and for which key data will be disclosed at next year’s American Thoracic society meeting. The drug – a long-acting anti muscarinic agent being co-developed with Forest Laboratories in the US - will itself break new ground, according to Almirall. “We think it will be a star. It is a jewel in our crown,” said Global Research and Development (R&D) Medical Director Dr Gozalo de Miguet in Barcelona this week. A phase II trial presented at the 2007 European Respiratory Society meeting showed a single dose achieves significant, rapid and long-lasting bronchodilation with an onset of action at around 15 minutes and improved lung function for up to 32 hours. It acts like already-available anticholinergic agents tiotropium and ipratropium, as a bronchodilator, but in vitro research shows it has a faster onset than tiotropium, longer duration of action than ipratropium, and a good ratio of M3/M2 selectivity. Because it is rapidly hydrolysed in plasma it is much less likely to cause side effects than the other antimuscarinics, he explained.
Almirall is pursuing a three-line strategy for aclidinium bromide. It is being developed initially as a once-daily monotherapy for first-line maintenance therapy in COPD and will be filed with regulators for this indication in 2009. It is also in phase II trials in a fixed-dose combination with the long-acting beta agonist formoterol. This is expected to be filed in 2011. Additionally, it is at a preclinical development stage as a fixed-dose combination with an inhaled corticosteroid which could be ready to file in 2012.
COPD is a progressive disease in which patients progress to an increasing number of treatments in combination, pointed out Executive Director R&D Dr Per Olof Andersson. Currently, however, there is no combination treatment inhaler available for COPD that includes an antimuscarinic therapy
Almirall, which was floated on the Spanish stock exchange in June 2007 and is now rapidly expanding, has a 40-year R&D history in pharmaceuticals and has several drugs for other conditions in its pipeline. These include asthma, psoriasis and other skin conditions, rheumatoid arthritis and multiple sclerosis. Executive Director R&D Dr Per Olof Andersson said Almirall’s expertise in its core areas of research – inflammatory disorders, psoriasis, multiple sclerosis, rheumatoid arthritis and asthma/COPD – was on a par with larger Pharma companies operating in the same clinical areas. COPD has been its main focus but Almirall has a strong pipeline of promising compounds for treatment of other inflammatory diseases besides COPD, he added.
COPD is currently the fourth biggest killer in Europe with mortality continuing to rise at a time when mortality from cardiovascular diseases is declining. It affects from 4-10 per cent of adults (men and women) and causes between 200,000 and 300,000 deaths in Europe annually. The condition is strongly linked to cigarette smoking which is expected to account for 8.3 million deaths per year.
Almirall had sales of €590 million in the first nine months of 2007 and has increased its R&D spend this year by almost 30 per cent to €78.3 million.
Olwen Glynn Owen