Circassia Receives FDA Boost for COPD Drugs in the US

UK biotech Circassia has experienced a significant turnaround with two favorable decisions from the FDA regarding its COPD drugs, Tudorza and Duaklir. This development is part of Circassia's broader strategy to rebuild its business following a series of unsuccessful allergy drug trials earlier in the decade.

Tudorza (aclidinium bromide), a long-acting muscarinic agonist (LAMA), was already launched in the US and received FDA approval in 2012. Duaklir, which combines aclidinium with a long-acting beta agonist, formoterol fumarate, has recently been approved by the FDA. This approval follows AstraZeneca's agreement to complete ongoing clinical research, contributing up to $62.5 million towards development activities.

Circassia now holds full US commercial rights to both products, having exercised an option over Tudorza at the end of 2018. However, the FDA's approval of Duaklir triggers financial obligations from Circassia to AstraZeneca, including a $20 million contingent option fee due within 30 days of approval and a final deferred consideration of $100 million by 30 June 2019. Circassia is exploring third-party financing options to meet these payments, with a backup plan to utilize a loan facility provided by AstraZeneca if necessary.

The drugs will enter a highly competitive market, facing generic competitors to GlaxoSmithKline’s Advair and more modern LAMA+LABA combination drugs like GSK’s Anoro Ellipta. In a separate decision, the FDA allowed Circassia to add data from the phase 4 ASCENT trial to Tudorza’s label, showing COPD exacerbations and no increase in major cardiovascular events compared with placebo. This makes Tudorza the only product in its class with such data on the label, enhancing its marketability against rival LAMA monotherapies in the US.

This series of events underscores Circassia's efforts to pivot its business strategy and capitalize on its respiratory drug portfolio, amidst financial challenges and a competitive landscape.