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21-Oct-2019

Duaklir® will be available in the United States from 21st October

  • Circassia announces Duaklir® US launch at American College of Chest Physicians’ CHEST Annual Meeting 2019                   
  • Almirall receives a milestone of $100 MM coming from AstraZeneca agreement when the first commercial sale takes place
  • In 2014, Almirall entered into an agreement with AstraZeneca to transfer the rights for the development and commercialization of the Almirall respiratory franchise 

Almirall, S.A. (ALM) granted AstraZeneca (LSE, STO, NYSE: AZN) the licensed rights in the US to Duaklir®, a fixed-dose LAMA / LABA combination of the long-acting muscarinic antagonist (LAMA) aclidinium and long-acting beta-agonist (LABA) formoterol administered twice-daily via the breath-actuated, multi-dose inhaler Pressair®, in the agreement that was announced on November 3rd, 2014. Part of that agreement states that AstraZeneca will pay Almirall $100 MM when the first commercial sale takes place in the US. Duaklir® will be available in the United States from 21st October.

In April 2017, AstraZeneca entered a strategic collaboration with Circassia Pharmaceuticals plc for the development and commercialisation of Tudorza and Duaklir® in the US.

Circassia Pharmaceuticals, a specialty pharmaceutical company focused on respiratory disease, today announces the US launch of Duaklir® for the maintenance treatment of chronic obstructive pulmonary disease (COPD) at the American College of Chest Physicians’ CHEST Annual Meeting 2019, which is currently ongoing in New Orleans, LA.  

Xavier Llauradó, Regulatory Affairs Director, Almirall, stated that “the US launch of Duaklir® is good of news for many patients. The agreement with AstraZeneca has allowed us to maximize the value of our assets and this launch in the US means a big step for Almirall as it was an Almirall R&D compound”.

Duaklir® is a fixed-dose LAMA / LABA combination of the long-acting muscarinic antagonist (LAMA) aclidinium and long-acting beta-agonist (LABA) formoterol administered twice-daily via the breath-actuated, multi-dose inhaler Pressair®.  Duaklir® will be available in the United States from 21st October.

Duaklir® has been approved by the United States Food and Drug Administration (FDA) based on a broad clinical program. This includes data from three phase III studies, ACLIFORM, AUGMENT and AMPLIFY, and the phase IV ASCENT study, which shows aclidinium therapy is effective at reducing chronic obstructive pulmonary disease (COPD) exacerbations.  

About Duaklir®

Aclidinium bromide/formoterol fumarate dihydrate 400/12 μg is an approved fixed-dose LAMA/LABA combination of two long-acting bronchodilators—aclidinium bromide, a long-acting muscarinic antagonist (LAMA), and formoterol fumarate, a long-acting beta-agonist (LABA). The fixed-dose combination was approved by the European Medicines Agency (EMA) for COPD in November 2014 and was subsequently launched in the UK (January 2015), Germany and the Netherlands (February 2015), Denmark (March 2015), and in Sweden (April 2015). DUAKLIR® is available in 18 countries globally. It is now approved in Canada, as well as being approved and marketed as BRIMICA® GENUAIR® in Australia and Italy. Both aclidinium bromide and formoterol fumarate are separately approved for the maintenance treatment of COPD in Europe and the United States. Aclidinium bromide is also currently approved in 27 countries around the world, marketed under the name Tudorza®/Eklira®, including Canada, Japan and Australia.

About Tudorza®

Tudorza® (aclidinium bromide) is a long-acting muscarinic antagonist (LAMA) indicated for the long-term maintenance treatment of bronchospasm associated with COPD, including chronic bronchitis and emphysema. Tudorza® is presented as a dry powder for inhalation. Tudorza® has been approved and marketed in the US since 2012 for the treatment of bronchospasm associated with COPD. In Europe, aclidinium bromide has been approved for the maintenance treatment of COPD since 2012 and is marketed as Eklira®. 

About COPD

COPD is a progressive disease associated mainly with tobacco smoking, air pollution or occupational exposure. It can cause obstruction of airflow in the lungs resulting in extreme shortness of breath. It affects an over 329 million people worldwide and is predicted to be the third leading cause of death by 2020. COPD can be treated by improving lung function, reducing exacerbations and managing daily symptoms such as breathlessness.

About Almirall

Almirall is a leading skin-health focused global pharmaceutical company that partners with healthcare professionals, applying Science to provide medical solutions to patients and future generations. Our efforts are focused on fighting against skin health diseases and helping people feel and look their best. We support healthcare professionals by continuous improvement, bringing our innovative solutions where they are needed. 

The company, founded almost 75 years ago with headquarters in Barcelona, is listed on the Spanish Stock Exchange (ticker: ALM). Almirall has been key in value creation to society according to its commitment with to major shareholders and through its decision to help others, to understand their challenges and to use Science to provide solutions for real life. Total revenues in 2018 were 811 million euros. More than 1,800 employees are devoted to Science.

For more information, please visit almirall.com 

 

 

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Last Updated: 21-Oct-2019