Barcelona and San Diego, May 16^th 2014: New data to be presented from the Almirall respiratory portfolio at the American Thoracic Society (ATS) Annual Congress 2014 in San Diego, USA, further demonstrates Almirall’s long-term dedication to providing new treatment options for patients with chronic obstructive pulmonary disease (COPD) and asthma.^1,2 

 Phase III data from the AUGMENT trial showing improvement in lung function will be presented at ATS 2014 for the 400/12mcg and 400/6mcg fixed-dose combinations (FDC) of aclidinium bromide, a long-acting muscarinic antagonist (LAMA), and formoterol, a well-known long-acting β2-agonist (LABA), both used in the treatment of COPD.¹

 Results from the ACLIFORM study assessing the efficacy, safety and tolerability of two doses of twice-daily (BID) aclidinium bromide/formoterol fumarate FDC(400/6mcg and 400/12mcg) in patients with moderate-to-severe COPD, will also be presented.²

 “Almirall is committed to developing innovative therapeutic solutions that will make a difference to the daily lives of millions of people with COPD worldwide,” said Dr Bertil Lindmark, Almirall’s Chief Scientific Officer. “People with COPD often experience breathlessness and poor health status so Almirall is very excited by the potential of aclidinium and formoterol in combination as a new treatment option.

In addition to the new data being presented for aclidinium bromide/formoterol fumarate, Almirall will be presenting results of a long-term study on aclidinium bromide (Tudorza™/Eklira^®), the first and only LAMA delivered by Genuair^® a novel multi-dose, breath-activated dry powder inhaler that comes pre-loaded and ready to use.³

 Efficacy, safety and tolerability data for abediterol, a novel long acting β2-adrenergic agonist for patients with persistent asthma, will also be presented, as well as poster sessions on study data for MABA and PAN-JAK inhibitor compounds.⁴

 About AUGMENT/ACLIFORM

Two pivotal Phase III studies, ACLIFORM/COPD (ACLIdinium/FORMoterol fumarate combination for Investigative use in the treatment of moderate to severe COPD) and AUGMENT/COPD (Aclidinium/formoterol FUmurate Combination for InvestiGative use in the TreatMENT of Moderate to Severe COPD) – run in 25 countries worldwide – were completed in 2013 involving ca. 3,400 patients with moderate to severe COPD.

 About aclidinium bromide

 Aclidinium is a long-acting inhaled muscarinic receptor antagonist (sometimes referred to as an anticholinergic) that has a longer residence time at M3 receptors than the M2 receptors. Inhaled aclidinium bromide acts locally in the lungs as an antagonist of the M3 receptors on airway smooth muscle and induces bronchodilation.

 Aclidinium is marketed in Europe by Almirall as Eklira^® Genuair^® and by Menarini as Bretaris^® Genuair^®. In the USA aclidinium is marketed as Tudorza™ Pressair^®by Forest Laboratories and in Canada it is marketed by Almirall Tudorza™ Genuair^®.

 About Pressair^TM/Genuair^®

Aclidinium bromide is the first and only LAMA delivered by multiple dose DPI. Findings of a recent publication suggest that poor adherence to inhaled therapies is common among patients with asthma and COPD. Pressair™/Genuair^® was designed with a double feedback system: per our instructions for use: a ‘click’ sounds when the patient is inhaling correctly and a control coloured window changes from green (ready to use) to red when the patient inhaled correctly. Moreover, the device incorporates safety features such as a visible dose indicator to show patient approximately how many doses remain, an anti-double-dosing mechanism and an end-of-dose lock-out system to prevent use of an empty inhaler.

 About aclidinium bromide/formoterol fumarate

 Aclidinium bromide/formoterol fumarate (400/12mcg and 400/6mcg) are investigational fixed dose combinations of two approved long-acting bronchodilators with different mechanisms of action and similar pharmocodynamic profiles. Aclidinium bromide is an anticholinergic or long acting muscarinic antagonist (LAMA) that produces bronchodilation by inhibiting the muscarinic M3 receptor in the airway smooth muscle. Formoterol fumarate is a long-acting beta-agonist (LABA) that stimulates the B2-receptors in the bronchial smooth muscle resulting in bronchodilation. Both aclidinium bromide (Tudorza™/Elkira^®) and formoterol fumarate are separately approved for the maintenance treatment of COPD in the United States and Europe.

 About COPD

Chronic Obstruction Pulmonary Disease (COPD), or chronic obstructive pulmonary disease, is a common, progressive, and debilitating lung disease characterized by persistent airflow limitation that makes it hard to breathe. The World Health Organization (WHO) has described COPD as a global epidemic; an estimated 64 million people have COPD worldwide. 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.⁹ WHO predicts that COPD will become the third leading cause of death worldwide by 2030.¹⁰ COPD is already the fourth leading cause of death in the U.S.¹¹

 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 chronic cough. As the condition worsens and breathlessness increases, daily activities, such as walking up a short flight of stairs or carrying a suitcase, can become very difficult. New therapies to treat this debilitating disease may be of value.

 COPD has historically been seen as a disease that affects old men, despite the fact that nowadays 44% of patients are women.

 In addition to the impact of the disease on a patient’s quality of life, COPD poses a significant financial burden to society. Among respiratory diseases, COPD is the leading cause of lost work days.

 Almirall

Almirall is a global company based in Barcelona dedicated to providing valuable medicines through its R&D, agreements and alliances. Our work covers the whole of the drug value chain. A consolidated profitable growth allows us to devote our talent and efforts in the respiratory and dermatology areas, with a focused interest in gastroenterology and pain. Our size enables us to be agile and flexible so that we can accomplish the purpose of taking our innovative products wherever they are needed.

Founded in 1943, Almirall is listed on the Spanish Stock Exchange (ticker: ALM) and it has become a source of value creation for society due to its vision and the commitment of its long-standing major shareholders. In 2013, its revenues totaled 825 million euros and, with more than 3,000 employees, it has gradually built up a trusted presence across Europe, as well as in the US, Canada and Mexico.