Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 32 n° 302

Duaklir will be available in the United States

Posted by fidest press agency su giovedì, 24 ottobre 2019

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. 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.

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