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Almirall licenses Aclidinium to Daewoong in Korea

  • Korea is the third territorial licensing agreement for Aclidinium. Previous partnerships have been established in the US and Japan  
  • It is estimated that around 13% of the Korean population aged 40 or over suffers from Chronic Obstructive Pulmonary Disease (COPD)[1]  
  • Aclidinium, a new therapeutic option, is awaiting regulatory feedback in the US and Europe

Barcelona and Seoul, 13 February 2012.-Almirall and Daewoong announce an agreement by which Almirall grants Daewoong the exclusive rights for Aclidinium in Korea for the treatment of COPD. Daewoong will be responsible for development, regulatory approval and marketing of Aclidinium in Korea. Financial details of the agreement have not been disclosed. With this third licence-out agreement, Almirall extends the global reach of its research respiratory compound, which is already covered in the US and Japan. "We are very pleased to initiate this collaboration with Daewoong, an experienced pharmaceutical company in the Korean market and with whom Almirall has formed a long-standing relationship. COPD is a disease that affects 13% of the Korean population and is not always diagnosed and treated adequately.   We are glad to share the same commitment as Daewoongto enhance people's health", says Eduardo Sanchiz, Chief Executive Officer of Almirall. Dr. Jongwook Lee, Chief Executive Officer of Daewoong Pharmaceuticals, states that "Disease awareness in COPD is steadily rising in Korea and this will lead to a remarkable growth of the COPD market with an advance in the diagnosis and treatment rate. Daewoong is very pleased to extend our strong relationship with Almirall and having a novel product like Aclidinium will enable us to offer more beneficial treatment and improve patient the quality of life." Aclidinium, a new therapeutic option from Almirall's respiratory R&D, was filed for registration in the US and Europe in 2011. Regulatory feedback is expected in 2012.

About aclidinium and the Genuair® inhaler Aclidinium bromide is a novel, long-acting inhaled muscarinic antagonist -sometimes referred to as an anticholinergic-, which has a long residence time at M3 receptors and a shorter residence time at M2 receptors, and which is designed to be rapidly broken down in plasma, leading to high topical efficacy but low propensity for systemic anticholinergic effects. When given by inhalation, Aclidinium leads to bronchodilation by inhibiting airway smooth muscle contraction. Aclidinium bromide is rapidly hydrolyzed in human plasma to two major inactive metabolites. Almirall has licensed-out Aclidinium bromide to Forest for USA and Kyorin for Japan. Almirall and Forest are jointly involved in the development of the compound. Aclidinium bromide was administered to patients in the trials using a novel, state-of-the-art, user-friendly multidose dry powder inhaler (MDPI), Genuair®. This inhaler 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 the dose correctly. It also 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 COPD 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. The most common symptoms of COPD are breathlessness (an increased effort to breathe), heaviness or a ‘need for air', excessive mucus, and a chronic cough. Some people feel they are gasping for breath. These symptoms get worse when exercising, in case of a respiratory infection or during an exacerbation – periods of time when there is a sudden increase in symptoms and the disease is worse. COPD affects the ability to breathe and is a progressive disease, which means that COPD gets worse over time. Daily activities may become more difficult as the disease worsens. There are significant unmet needs in the treatment of COPD and new therapies may be of value.

About Almirall Almirall is an international pharmaceutical company based on innovation and committed to health. 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. Almirall focuses its research resources on therapeutic areas related to the treatment of asthma, COPD (Chronic Obstructive Pulmonary Disease), gastrointestinal disorders, psoriasis and other dermatological conditions. Almirall's products are currently present in over 70 countries while it has direct presence in Europe and Latin America through 12 affiliates. For further information please visit the website at: www.almirall.com

About Daewoong Daewoong is a leading Korean pharmaceutical company with a turnover of nearly $700 million U.S. in 2010 and is ranked first in the South Korean pharmaceutical market in terms of requested reimbursement totals, according to Health Insurance Review Agency (HIRA). In particular, Daewoong Pharmaceutical Co. Ltd. has made numerous successful partnerships with multinational pharmaceutical companies launching number of blockbuster products on the Korean market. Daewoong has expanded global business operations throughout Asia and is currently developing strategies for the global market. Daewoong's products are currently present in over 13 countries while it has direct presence in Asia through 6 branches. For further information please visit the website at: www.daewoong.co.kr

More information: Ketchum Pleon  Sonia San Segundo sonia.sansegundo@ketchumpleon.com Tel.:34 91 788 32 00


[1]Prevalence of Chronic Obstructive Pulmonary Disease in Korea: The fourth Korean National Health and Nutrition Examination Survey, 2008

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