Almirall strengthens its respiratory franchise with a new generation of Chronic Obstructive Pulmonary Disease (COPD) treatment

Almirall strengthens its position in the respiratory field with a positive development progress of another New Chemical Entity (NCE). LAS190792 is a new dual long-acting Muscarinic Antagonist β2 Agonist (MABA), which combines two bronchodilator mechanisms in a single molecule for the treatment of COPD.

This new class of inhaled long-acting bronchodilators is expected to provide additional symptom relief in patients living with COPD, and to form the basis of so called triple combinations together with ICS (inhaled corticosteroids). The MABA franchise (MABA and MABA/ICS combination) offer the convenience of different mechanisms of action in one inhaler therapy, and is envisaged to become a future block buster in COPD.

“Almirall’s MABA (LAS190792) represents an exciting opportunity for the treatment of COPD and shows the strength of Almirall´s commitment to research in respiratory disease”, said Dr Bertil Lindmark, MD, PhD, and Chief Scientific Officer at Almirall.

MABA compounds offer the advantage over the two-molecule bronchodilator combinations (LABA/LAMA), in that MABA/ICS combinations can be developed with a reasonable size development programme.

In preclinical models, LAS190792 has shown to have a long duration of action and high anti-muscarinic activity combined with β2 agonism. The molecule shows very favourable drug properties and safety.

Almirall is planning to prioritize the finalization of the pre-clinical phase, aiming at starting clinical studies during first half of 2012.

LAS190792 will be developed in the Genuair^® inhaler, a novel, state-of-the-art, multi-dose dry powder inhaler. It incorporates significant safety features, including one hand dosing, visible dose indicator, an anti-double dosing mechanism and an end-of-dose lock-out system to prevent use of an empty inhaler, as well as audio feedback to confirm successful dose intake. Genuair^® is a registered trademark owned by Almirall, S.A.

After aclidinium bromide (monotherapy planned to be filed in mid 2011) and LAS100977 (LABA) + ICS (currently in phase II), this MABA is the third NCE developed by Almirall which will utilize the Genuair^® inhaler system.

About COPD

The World Health Organisation (WHO) has described COPD as a global epidemic; an estimated 210 million people have COPD worldwide and more than 3 million people died of the condition in 2005, which is equal to 5% of all deaths globally that year. Total deaths from COPD are projected to increase by more than 30% in the next 10 years without interventions to cut risks, particularly exposure to tobacco smoke.

In patients with COPD the airways in the lungs typically lose their elasticity, produce excess mucus and become thick and inflamed, limiting the passage of air. The most common symptoms of COPD are breathlessness (or a "need for air"), abnormal sputum (a mix of saliva and mucus in the airway), and a chronic cough. Daily activities, such as walking up a short flight of stairs or carrying a suitcase, can become very difficult as the condition gradually worsens. There are significant unmet needs in the treatment of COPD including limited therapeutic options to improve lung function, reduce symptoms and control exacerbations.