New Inhalation Device with Aclidinium Bromide may offer advantages to COPD Patients

The Spanish pharmaceutical company Almirall is developing a novel treatment for chronic obstructive pulmonary disease (COPD) to be administered by a revolutionary new type of inhaler. Company spokesmen said this week Almirall believes the new treatment aclidinium bromide has potential not only to improve on other medications of its type in relieving symptoms faster and for longer with fewer side effects, but that it will be the easiest bronchodilator to administer. The company claims the new drug will be delivered in the easiest-to-use and most failsafe dry-powder inhaler device available to date.

Speaking in Barcelona Almirall's Global Research and Development (R&D) Medical Director Dr. Gozalo de Miguet said: "We think aclidinium bromide will be a real star - a jewel in our crown". The drug, a long-acting antimuscarinic for COPD, is currently in phase III trials for which data will be presented in 2008 at the American Thoracic Society's annual meeting. Earlier this year, data from a phase IIa study presented at the European Respiratory Society meeting showed a single dose of aclidinium bromide provides a rapid and long-acting bronchodilatory effect, significantly improving lung function over 24 hours. The onset of the bronchodilator effect was evident within 15 minutes, peaked at 1 to 2 hours, and persisted for up to 32 hours at some doses.

Dr. de Miguet said the drug, an anticholinergic which targets M3 receptors in the airway, has strong selectivity for the M3 receptor compared to the M2 receptor and dissociates very slowly from it. This results in a sustained bronchodilator effect that improves measures of lung function such as the FEV1 (forced expiratory volume in 1 second). However, the drug is rapidly cleared from plasma and is therefore unlikely to have any noticeable systemic effects. This suggests it will prove superior to other anticholinergic drugs currently available with regard to side effects and patients' willingness to adhere to recommended prescribing schedules. "No patients have withdrawn from clinical trials on account of side effects," he noted. In the test tube, aclidinium bromide demonstrates comparable anticholinergic action to other antimuscarinic drugs, tiotropium and ipratropium, but acts faster than tiotropium and works for longer than ipratropium, he added. Two parallel phase III trials ACCLAIM/COPD have recruited 1600 patients and will reveal next year how well the drug performs clinically.

Almirall's Director of Pharmaceutical Development Dr. Carsten Niederlaender said the inhalation device used to deliver aclidinium bromide is "the new gold standard" in inhalers, surpassing the previous gold standard Turbohaler because it enables patients to confirm that a dose has been delivered to the lungs when they inhale. The device has a window that changes from red to green when a dose has been effectively delivered and which registers an audible click. A faint taste lingers to further confirm dose delivery. A dose indicator warns patients when only 10 doses remain and the device locks out when its 30-day supply is exhausted to prevent patients continuing to inhale dry-powder residue that lacks active medication. The new inhaler developed by Sofitec, a specialist inhaler company acquired by Almirall in 2006, ticks all the boxes for complying with international regulatory requirements, said Dr. Niederlander. "This is a state-of-the-art inhaler where ease of use was foremost in the design considerations."

Almirall's Executive Director of R&D Dr. Per Olof Andersson said the company hopes to file aclidinium bromide with international regulators in 2009. Almirall has an agreement with Forrest Laboratories in the US to develop and market the product for the US market. The drug is also being developed in a fixed-dose combination with the long-acting beta agonist formoterol and in combination with an as-yet-undisclosed inhaled corticosteroid. Currently these are in phase II and preclinical development stages respectively with filing anticipated in 2011 and 2012.

Dr. 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. "We have a strong pipeline in promising compounds for treatment of other inflammatory diseases besides COPD," he added.

Almirall is a rapidly-growing company which floated in June 2007 on the Spanish stock market. The company's medicines are marketed in over 80 countries producing sales of €590.3 in the first 9 months of 2007 reflecting 17.7 per cent growth. Since its floatation Almirall has already announced two acquisitions - Hermal, in Germany, specializing in dermatology products, and a portfolio of 8 drugs from Shire plc. The company says it is committed to strengthening its international presence and expanding the R&D and commercialization of its own products.

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