AstraZeneca and Circassia are partnering to develop and commercialize two inhaled respiratory treatments for chronic obstructive pulmonary disease (COPD) in the United States, Tudorza (aclidinium bromide) and Duaklir (aclidinium bromide).
Tudorza was approved by the U.S. Food and Drug Administration (FDA) in 2012, and its marketing began that year. Duaklir is marketed in the European Union and a number of other countries. It is expected to be submitted for U.S. regulatory review in 2018.
The partners expect to finalize their deal in the second quarter of 2017. Under it, AstraZeneca will continue to manufacture and market Tudorza and Duaklir in exchange for a minority stake in Circassia.
Profits from Tudorza will be shared equally. Circassia will promote the therapy in the United States, with the option of obtaining full commercial rights to it. The company will also have the U.S. rights to Duaklir.
AstraZeneca will receive an initial $50 million in shares, and $100 million more if the FDA approves Duaklir.
Both Duaklir and Tudorza were formulated as a dry powder for inhalation. They are delivered by a multi-dose dry powder inhaler called the Pressair, marketed in some countries as Genuair.
Duaklir is being evaluated in two clinical trials supporting AstraZeneca’s quest for FDA approval. One is the Phase 3 AMPLIFY trial (NCT02796677), the other the Phase 4 ASCENT COPD trial (NCT01966107).
“Tudorza and Duaklir are important components of AstraZeneca’s respiratory franchise globally, and this collaboration will support their commercialization in the US for the benefit of the millions of COPD patients. It also further sharpens our focus on Symbicort, Bevespi Aerosphere, benralizumab and other respiratory development programmes. Circassia will be an important strategic partner for AstraZeneca in the US and we look forward to working closely together,” Mark Mallon, AstraZeneca’s executive vice president of global product and portfolio strategy, said in a press release.
Steve Harris, the chief executive of Circassia, added: “This proposed transaction is an ideal fit with Circassia’s strategy and respiratory focus. It represents a transformational opportunity for the company. As part of the long-term strategic collaboration with AstraZeneca, we will immediately double our US sales force to promote Tudorza as our priority.”