Circassia Announces FDA Approval of Duaklir for Maintenance Treatment of Chronic Obstructive Pulmonary Disease

Oxford, UK – 1 April 2019: 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.

The Duaklir® approval is based on a broad clinical database, including data from three phase III studies, ACLIFORM, AUGMENT and AMPLIFY. The label also includes clinical data from the phase IV ASCENT study, which shows aclidinium therapy is effective at reducing COPD exacerbations.  As a result, Duaklir® is the only twice-daily LAMA / LABA in the United States with COPD exacerbation data included in its prescribing information.

Steve Harris, Circassia’s Chief Executive, said: “We are delighted with the FDA approval of Duaklir®, which we believe will provide a valuable treatment option for the significant number of patients with COPD in the United States. The addition of Duaklir® to our portfolio further strengthens our range of marketed respiratory products and we look forward to launching it in the US in the coming months alongside our aclidinium monotherapy, Tudorza®, as part of the significant LAMA / LABA market that is predicted to grow rapidly over the coming years.” 

Michael Asmus, Circassia’s Vice President, US Medical Affairs, said: “With guidelines recommending combined LAMA and LABA therapy for a number of COPD patient groups, we believe Duaklir® will make an important contribution to the treatment of this debilitating disease. Dukalir®’s approval is based on a broad clinical database, including data demonstrating a reduction in the risk of COPD exacerbations driven by its aclidinium component, and we look forward to making this new therapeutic option available to patients across the United States.” 

AstraZeneca partnership
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