Duaklir® launch planned H2 2019
Duaklir® to join Tudorza® in Circassia’s portfolio of US COPD products
Circassia Pharmaceuticals plc (‘Circassia’ or ‘the Company’; LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, today announces the US Food and Drug Administration (FDA) has approved Duaklir® for the maintenance treatment of chronic obstructive pulmonary disease (COPD). Duaklir® is a fixed-dose combination of the long-acting muscarinic antagonist (LAMA) aclidinium bromide (400 mcg) and long-acting beta-agonist (LABA) formoterol fumarate (12 mcg) administered twice-daily via the breath-actuated inhaler Pressair®. Circassia is on track to launch Duaklir® in the United States in the second half of 2019 via its dedicated COPD sales force.
In 2017, Circassia and AstraZeneca established a collaboration for the commercialisation of Tudorza® and Duaklir® in the United States. At the end of 2018, Circassia exercised its option over Tudorza® and the Company now has the full US commercial rights to both products. Under the companies’ agreement, a contingent option fee of $20 million becomes due to AstraZeneca within 30 days of the FDA approval of Duaklir®, and final deferred consideration of $100 million is due by 30 June 2019. The Company is in discussions with third-party finance providers to satisfy all or part of these payments. If this financing is not forthcoming, Circassia plans to use a loan facility provided by AstraZeneca under the companies’ agreement to satisfy the outstanding amount.
Duaklir® and Tudorza® are registered trademarks of Almirall S.A.
Pressair® is a registered trade mark of the AstraZeneca group of companies