AstraZeneca has announced an agreement with Circassia Pharmaceuticals for development and commercialization of the Tudorza and Duaklir dry powder inhalers in the US.
AstraZeneca will receive $50 million in Circassia ordinary shares and $100 million on approval of Duaklir in the US or June 30, 2019, whichever comes first. Circassia will have the option to acquire full commercial rights to Tudorza in the US for $80 million.
Circassia will market the Tudorza Pressair aclidinium bromide DPI, which was approved in the US in 2012 and, if approved, the Duaklir aclidinium/formoterol DPI. Duaklir Genuair was approved in Europe in 2014. AstraZeneca says that an NDA for Duaklir is expected to be submitted to the FDA in 2018.
US profits from Tudorza will be split equally between the two companies and Circassia will pay tiered percentage royalties on any sales of Duaklir in the future. Circassia will also pay up to $62.5 million in development costs for both DPIs.
Circassia CEO Steve Harris commented, “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, as well as our existing NIOX products, transforming Circassia into a world-class respiratory business.”
AstraZeneca Executive VP, Global Product & Portfolio Strategy Mark Mallon stated, “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 programs. Circassia will be an important strategic partner for AstraZeneca in the US and we look forward to working closely together.”
AstraZeneca acquired US and Canadian rights to Tudorza and Duaklir from Actavis in 2015. Circassia acquired DPI developer Prosonix in 2015.
Read the AstraZeneca press release.
