Circassia has issued a notice of option exercise to AstraZeneca related to US commercial rights of Tudorza. The company intends to complete the option exercise by the end of this month.
At present, Circassia is distributing Tudorza in the US as part of a profit share agreement signed in April 2017.
As per terms of the deal, AstraZeneca will secure $5m after the completion of the option exercise.
AstraZeneca will also receive a deferred deferred Tudorza option payment of $20m after securing approval for Duaklir (aclidinium / formoterol), as well as deferred consideration of $100m.
The deal provides Circassia with US commercial rights to Duaklir, which is currently under review by the US Food and Drug Administration (FDA). It is expected to secure approval by the end of March next year.
Both firms will conclude a plan for the support services such as pharmacovigilance, regulatory and sales order processing. AstraZeneca will continue services until the option exercise is completed.
Circassia will hold responsibility for Tudorza’s promotion, while AstraZeneca will continue the manufacturing of Tudorza.
AstraZeneca, which is the Tudorza licence holder in the US, has submitted a supplemental NDA based on clinical data from the Ascent study in the product’s label.
Tudorza product license will be transferred to Circassia, following completion of review by the FDA.
Circassia Pharmaceuticals CEO Steve Harris said: “We will have significantly more control of the product’s commercialisation strategy, and with prescription levels continuing to stabilise, we now have a robust foundation from which to grow the product.
“We plan to build on our learnings of the past 18 months and are launching a dedicated COPD sales force alongside a focused NIOX team, which we believe will improve promotion of our existing products and provide a platform for the launch of Duaklir, once approved.”
Circassia is a specialty pharmaceutical business, which markets Niox asthma management products in the US, the UK, and Germany.