Eklira® Genuair® by Almirall available in Spain for the treatment of COPD

• The new medicine comes from Almirall's R&D in the respiratory area
• It combines the efficacy of aclidinium with the innovative technology of the Genuair® device, which has demonstrated be easier to use compared to other inhalers, an advantage for patients[1]
• COPD in Spain affects 10%[2]of the population and is the fifth leading cause of death, even higher than car accidents [3]

Madrid, 31 January 2013, Almirall, S.A. has started the commercialisation of Eklira® Genuair® in Spain. This is a bronchodilator medicine from its own research for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults. The active ingredient is aclidinium; a new inhaled and long-acting muscarinic antagonist, (LAMA), which is delivered through Genuair®,an innovative and patient friendly device.

According to Dr Pilar de Lucas, President of the SEPAR (Spanish Society for Pneumology and Thoracic Surgery): "Bronchodilators are fundamental for the treatment of COPD. Aclidinium, the most recently available bronchodilator, has proven to be an effective medicine that delivered in an easy to use device, importantly, reduces the patient's symptoms not only during the day but also at night".

The treatment combines the efficacy of aclidinium in improving lung function[4]and day, nighttime and early morning symptoms of COPD[5],[6],7and in reducing exacerbations[7], with the innovative technology of a novel dry powder multi-dose inhaler (MDPI), which comes preloaded and ready to use. Its technology, convenience and ease of use mean a greater correct inhalations[8]and showed patient preference compared to other inhalers1. "Compliance of treatment is higher when there are no significant side effects and when the device is easy to use", adds Dr. de Lucas.

Efficacy studies show that aclidinium provides significant bronchodilation improvement, as well as symptom control from the first dose and throughout the day. Patients showed approximately 30% reduction of moderate to severe exacerbations and a clinically relevant improvement of breathing difficulties[9]and in patient's specific health status[10].

"The launch of Eklira in Spain, which is a therapeutic innovation for the treatment of COPD,   proves Almiralll's commitment to patients and to boosting R&D in Spain. Almirall represents 3% of the total pharmaceutical R&D investment in Spain becoming the 3rd leading company to invest most in R&D in all sectors", states Enrique Domínguez, Managing Director of Almirall in Spain.

Patient convenience and safety

In Spain COPD affects10% of the population and is the fifth-leading cause of death, even higher than car accidents. "The main symptom of COPD is dyspnea, or breathing difficulties, a sensation that in its early stages is manifested during exercise or heavy activities but as the disease progresses, it also appears with lighter activities such as getting dressed, showering, shaving, etc. This means that it interferes with daily regular activities and this is why it has such a negative effect on patient's quality of life", adds Dr. de Lucas.

LAMAs are the cornerstone in treating COPD and are recommended for all patient groups. Aclidinium is the first and only LAMA delivered through Almirall's new dry powder, multi-dose inhaler, which stands apart from traditional dry powder inhalers for its easy delivery system consisting of just two steps: press and inhale. This is why it is so easy to use. It comes preloaded for 30 days, aiding patient compliance.

It also incorporates important safety devices 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.

COPD

COPD is a disease characterized by persistent airflow limitation that makes it hard to breatheand that worsens over time.  It is also commonly known as chronic bronchitis or emphysema, a pair of commonly co-existing diseases of the lungs in which the airways become narrowed. COPD affect the ability to breath and is a progressive disease that is quite often fatal. Daily activities and exercise can become more difficult as the disease worsens.  

A lung function test known as spirometry is needed to determine COPD. Treatment is established according to the stage of the disease (mild, moderate, severe or very severe) and the patient's symptoms.

Aclidinium

Aclidinium is the most recent compound of Almirall's respiratory franchise.   It is expected that the range of Almirall products in respiratory will cover the main options in monontherapy and in combination, offering a wide range of treatments in the Genuair® inhaler. In Europe, Almirall has already launched aclidinium – apart from in Spain- in Germany, the United Kingdom, Denmark, Iceland and Norway.  Since December last year it has also been marketed in the United States by our partner Forest Laboratories.In Japan the product is under development in partnership with Kyorin and in Korea with Daewoong.

In Europe Almirall holds the exclusive marketing rights to the product in the United Kingdom, the Netherlands and the Nordic Countries.   Menarini will have joint marketing rights in the rest of the EU member states and Russia, Turkey and other CEI countries under the trade name Bretaris® Genuair®, while Almirall will market the product in Europe under the trade name Eklira® Genuair®. Almirall holds the rights for the rest of the world.

Eklira^®Genuair^®and Bretaris® Genuair ® are trademarks the property of Almirall, S.A.

For more information about Eklira® Genuair® go to the product's SmPC: http://www.ema.europa.eu/docs/es_ES/document_library/EPAR_-_Product_Information/human/002211/WC5001…

Almirall

Almirall is a pharmaceutical company committed to innovate through valuable medicines. Headquartered in Barcelona, Spain, it researches, develops, manufactures and commercialises its own R&D and licensed drugs with the aim of improving people's health and wellbeing now and to future generations. Almirall medicines, focused on respiratory, dermatology, gastrointestinal and pain, are currently in over 70 countries while the company has direct presence in Europe, Mexico and Canada through 13 affiliates.

For more information, visit: www.almirall.com

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