AstraZeneca in Respiratory Disease PactBy
AstraZeneca has entered a strategic collaboration with Circassia Pharmaceuticals, an Oxford, UK-headquartered respiratory biopharmaceutical company, for the development and commercialization of Tudorza (aclidinium bromide) and Duaklir (aclidinium bromide), in the US. Tudorza and Duaklir are inhaled respiratory medicines for treating chronic obstructive pulmonary disease (COPD). Tudorza was approved and launched in the US in 2012. Duaklir, a registered trademark in certain European countries, is expected to be submitted for US regulatory review in 2018.
Under the collaboration, 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 and will complete ongoing development activities as well as continue to manufacture and supply both medicines.
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 agreement, AstraZeneca will receive $50 million in ordinary shares in Circassia. Circassia will also pay $100 million at the earlier of approval of Duaklir in the US or 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 product 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.
Tudorza and Duaklir are presented as a dry powder for inhalation and are delivered via a breath-actuated multi-dose dry powder inhaler, Pressair. The Pressair device is marketed in some countries under the trade name Genuair. Tudorza has been approved and marketed in the US since 2012. Duaklir is approved and marketed in the European Union and a number of additional rest of the world countries, and is subject to two ongoing clinical trials to support a planned regulatory submission to the US Food and Drug Administration.