Encouraging results support further development of Almirall's long-acting beta-agonist (LABA)

Monday, 23 February 2009

Further to the results of prior studies published last year, Almirall, the international pharmaceutical company based in Spain, announced new Phase II multi-dose study results demonstrating that its novel once-daily, inhaled, long-acting beta-agonist (LABA) -LAS100977-, for the treatment of bronchoconstriction in asthmatic patients, shows fast-acting and 24-hour efficacy, as well as a good safety and tolerability profile in patients during multiple dose administrations.

The development of a once daily fixed-dose combination of LAS100977 with a corticosteroid in the Genuair® inhaler is ongoing.

"We are encouraged by these latest results, and we believe that the combination of LAS100977 with an already identified corticosteroid has the potential to become a best in class respiratory treatment." says Per Olof Andersson, R&D Executive Director of Almirall. "We look forward to announcing a partnership for the development and commercialization of this novel drug in 2009."

Almirall is committed to research and develop innovative drugs within the respiratory field where there are still considerable unmet medical needs. LAS 100977 along with aclidinium bromide, a long acting muscarinic antagonist, are the most advanced drugs within Almirallâs respiratory product pipeline.

Almirall has already started discussions with potential partners towards development and commercialization collaborations on LAS100977.

About the study
The multi-dose, placebo-controlled, three-period cross-over study, included 20 stable asthmatic patients. All patients were on stable doses of an inhaled corticosteroid. Patients were randomised to receive once daily inhaled treatment with one of three doses of LAS100977 or placebo for 7 days, using a capsule inhaler. Measurements of efficacy (FEV1, FVC, PEF and FEF25-75)* and safety (adverse events, vital signs, ECGs) were taken at scheduled time points over 24 hours, on the first (Day 1) and last day (Day 7).

LAS 100977 demonstrated 24 hour bronchodilation and sustained efficacy during multiple dose administrations with no significant increase in cardiovascular adverse events. These results reaffirm the findings of previous studies which demonstrated that Almirall investigational compound is potent and selective with a good tolerance and safety profile.

Over a 24 hour period, the drug showed a sustained statistically and clinically significant effect with the three doses tested from Day 1 to Day 7 and provided an onset of action five minutes after the first administration. Trough and Peak FEV1 were significantly superior to placebo at all doses tested both day 1 and day 7.

LAS100977
Almirall investigational compound LAS100977 is a novel once daily LABA, demonstrating fast-acting and long-lasting (24-hour) efficacy with a good safety and tolerability profile in patients with stable asthma after multiple dosing. COPD studies are planned.

The Genuair® inhaler
LAS100977 will be developed using Genuair®, a novel, state-of-the-art, multi-dose dry powder inhaler (MDPI). Genuair® was designed with a Click and Colour feedback system which, through a 'coloured control window' and an audible click, indicates that the patient has inhaled correctly. The Genuair® inhaler incorporates significant safety features such as a visible dose indicator, an anti-double dosing mechanism and an end-of-dose lock-out system to prevent use of an empty inhaler.

About Asthma
Asthma is a chronic disease characterised by recurrent attacks of breathlessness and wheezing, which vary in severity and frequency from person to person. In affected individuals, symptoms may occur several times in a day or week, and for some people become worse during physical activity or at night.

The World Health Organization (WHO) estimates that 300 million people suffer from asthma and 255,000 people died of asthma in 2005. It is an under-diagnosed and under-treated disease that creates a substantial burden to individuals and families and possibly restricting individuals' activities for a lifetime.

About Almirall
Almirall is an international pharmaceutical company committed to innovation and health. Headquartered in Barcelona, Spain, Almirall researches, develops, manufactures and commercialises its R&D and licensed drugs with the aim of improving people's health and wellbeing. The therapeutic areas on which Almirall focuses its research resources are related to the treatment of asthma, COPD (Chronic Obstructive Pulmonary Disease), rheumatoid arthritis, multiple sclerosis, psoriasis and dermatology.

Almirall's products are currently present in over 70 countries worldwide and it has a direct presence in Europe and Latin America through 11 affiliates. For further information please visit the website at: www.almirall.com.