Almirall and Kyorin announce a licensing agreement in Japan with aclidinium bromide
This second licensing agreement with aclidinium bromide further extends the global reach of the product
- It is estimated that about 8.6% of Japanese people aged 40 or over suffer from COPD
Barcelona, February 24, 2011.- Almirall, S.A. (ALM.MC) and Kyorin Pharmaceutical Co., Ltd. (TSE; 4569) today announced that they have entered into an agreement providing Kyorin exclusive rights to develop and commercialize aclidinium bromide in Japan for the treatment of COPD (Chronic Obstructive Pulmonary Disease).
Under the terms of the agreement Kyorin will pay to Almirall a downpayment and potential development and sales milestones equivalent of up to € 38 mill in total.
Kyorin will assume responsibility for development, regulatory approval and commercialization of aclidinium bromide in Japan. The agreement also includes escalating royalties based on the sales performance.
"We are very pleased to initiate this collaboration with Kyorin, a very well established pharmaceutical company in Japan with good experience in respiratory. This second licensing agreement with aclidinium represents a step further in extending the global reach of the product and maximizing its value potential. This agreement is also a milestone in our mission to offer society innovative medicines to fulfil unmet medical needs", said Jorge Gallardo, Chairman and Chief Executive Officer of Almirall.
Keiji Hirai, President and Chief Executive Officer of Kyorin said "We are very pleased to partner with Almirall having a strong network in the respiratory field worldwide. Kyorin has been focusing its marketing activities on respiratory, ear-nose-throat and urology. We believe that this transaction with aclidinium will strengthen Kyorin's development pipelines as well as its presence in respiratory".
About aclidinium bromide and the Genuair® inhaler Aclidinium bromide is a novel, long-acting inhaled anticholinergic bronchodilator which has a long residence time at the M3 receptors and a shorter residence time at the M2 receptors. Aclidinium is rapidly hydrolyzed in human plasma to two major inactive metabolites. Forest Laboratories, Inc. licensed US rights for aclidinium from Almirall, while Almirall maintains rights for the rest of the world. The companies are jointly involved in the development of the compound which showed positive results from the ATTAIN phase III study that confirm clinically significant bronchodilation and improvement of symptoms in COPD patients treated with aclidinium bromide twice daily (BID). Regulatory filings in Europe and USA for aclidinium bromide monotherapy are planned for mid 2011.
Aclidinium bromide is administered to patients using a novel, investigational, state-of-the-art multidose dry powder inhaler (MDPI), Genuair®. The Genuair® inhaler was designed with a feedback system, which through a 'colored control window' and an audible click helps confirm that the patient has inhaled correctly. It contains multiple doses of aclidinium, includes a visible dose-level indicator and also incorporates safety features such as an anti-double-dosing mechanism and an end-of-dose lock-out system to prevent use of an empty inhaler. Genuair® is a registered trademark owned by Almirall, S.A.
About COPD The World Health Organization (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. It is estimated that about 8.6% of Japan people aged 40 or over suffer from COPD.
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.
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), rheumatoid arthritis, multiple sclerosis, 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 Kyorin Kyorin Pharmaceutical is a core company of the Kyorin Group, which focuses on the drug discovery business with the aim to provide people in the world with innovative breakthrough drugs, along with actively acquiring the licensing products for the enhancement of its development pipelines.
Kyorin's in-house research is concentrated on respiratory, urology and infection. Kyorin enhances the relationship with healthcare professionals by well understanding their needs and responding to them more quickly through focusing its marketing resources on respiratory, ear-nose-throat and urology.
For more information, visit www.kyorin-pharm.co.jp/en/.
More information: Ketchum Pleon Sonia San Segundo / Victorino Ballestero sonia.sansegundo@ketchumpleon.com Tel.:34 91 788 32 00
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