Date: 2017-03-17
Type of information: Development agreement
Compound: Tudorza® (aclidinium bromide inhalation powder) and Duaklir® (aclidinium bromide and formoterol)
Company: AstraZeneca (UK) Circassia (UK)
Therapeutic area: Lung diseases - Respiratory diseases
Type agreement: development commercialisation
Action mechanism: long-acting beta2-agonist (LABA)/ long-acting muscarinic antagonist (LAMA)/corticosteroid. Tudorza® and Duaklir® are inhaled respiratory medicines for the treatment of COPD. Tudorza® has been approved and marketed in the United States 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 FDA. Both medicines 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™ is a twice-daily inhaled long-acting muscarinic antagonist (LAMA). It produces bronchodilation by inhibiting acetylcholine’s effect on muscarinic receptors in the airway smooth muscle. Aclidinium is rapidly hydrolyzed in human plasma into two major inactive metabolites. Duaklir® is a fixed-dose combination of already-approved Eklira® (aclidinium bromide), a long-acting muscarinic-antagonist (LAMA), with the long-acting beta-agonist (LABA) formoterol. The twice-daily therapy is the only LAMA/LABA combination to show statistically significant improvement in breathlessness compared to individual therapies and is administered by the Genuair® dry powder inhaler device..
Disease: chronic obstructive pulmonary disease (COPD)
Details: * On March 17, 2017, AstraZeneca announced it has entered a strategic collaboration with Circassia Pharmaceuticals, a respiratory biopharmaceutical company, for the development and commercialisation of Tudorza® and Duaklir® in the US. These inhaled respiratory medicines are used for the treatment of chronic obstructive pulmonary disease. 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 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 Duakli®r 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.
Financial terms: 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 Ordinary Shares in Circassia, calculated by reference to the lower of the weighted average share price of Circassia over the period 20 days (i) prior to signing or (ii) prior to closing (subject to a maximum number of shares). Circassia will also pay $100 million at the earlier of approval of Duaklir® in the US or 30 June 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. As AstraZeneca will retain a significant, ongoing interest in the medicines, income will be reported as Externalisation Revenue. This includes an expected $60 million at closing, as well as any potential future royalties, deferred income and any future payment for the option to gain the US commercial rights to Tudorza®. Any potential future supply of the medicines to Circassia will be reported as Product Sales.
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