AstraZeneca has entered into a strategic collaboration with Circassia Pharmaceuticals plc, a respiratory biopharmaceutical company, for the development and commercialization of Tudorza and Duaklir in the U.S.
Tudorzaand Duaklir are inhaled respiratory medicines for the treatment of chronic obstructive pulmonary disease (COPD). COPD is often associated with the effects of smoking.
Tudorza was approved and launched in the US in 2012. Duaklir is expected to be submitted for US regulatory review in 2018.
Under the terms of the agreement, Circassia will lead the promotion of Tudorza in the US and has been granted an option to gain the full commercial rights in the future. Circassia has also been granted the rights to Duaklir in the US. AstraZeneca will receive a minority equity stake in Circassia. AstraZeneca will complete ongoing development activities and continue to manufacture and supply both medicines.
This collaboration gives AZ a stake in a company with plans to strengthen its respiratory presence in the U.S.
Mark Mallon, Executive Vice President, Global Product & Portfolio Strategy at AstraZeneca, said: “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.”
Steve Harris, CEO of Circassia, said: “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.”
The agreement is expected to complete in the second quarter of 2017, subject to approval by shareholders of Circassia and customary closing conditions.
Under the terms of the agreement, AstraZeneca will receive $50 million in shares in Circassia. Circassia will also pay $100 million with the approval of Duaklir in the U.S., or on June 30, 2019. Should Circassia decide to exercise the option to sub-license the commercial rights to Tudorza in the US, Circassia will pay up to a further $80 million.
The two companies will share US profits from Tudorza equally. AstraZeneca will continue to book US sales of Tudorza until Circassia’s potential exercise of the option. Circassia will pay AstraZeneca tiered percentage royalties on potential future US sales of Duaklir. In addition, Circassia will contribute up to $62.5 million towards the development activities for the medicines.
The agreement does not impact AstraZeneca’s financial guidance for 2017.
AstraZeneca has about 1,500 employees in Delaware.