Tudorza received Food and Drug Administration (FDA) approval in July 2012, while Duaklir, which has been approved in the European Union, will likely be submitted to FDA regulatory review in 2018 after the completion of two ongoing clinical trials.
Both drugs are inhaled as a dry powder and delivered via a breath-actuated multi-dose dry powder inhaler called Pressair. This device is commercialized in some countries under the trade name Genuair.
According to an agreement announced March 17 between the two British companies, Circassia has U.S. rights to Duaklir and will also promote Tudorza in the United States. AstraZeneca will complete ongoing development actions, and produce and supply the two drugs.
Both companies will share the U.S. profits from Tudorza equally, and Circassia will pay royalties on potential future U.S. sales of Duaklir. Circassia will also contribute up to $62.5 million to develop both drugs.
“Tudorza and Duaklir are important components of AstraZeneca’s respiratory franchise globally, and this collaboration will support their commercialisation in the U.S. for the benefit of the millions of COPD patients,” Mark Mallon, AstraZenca’s executive vice president for global product and portfolio strategy, said in a press release. “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 U.S. and we look forward to working closely together.”
Added CEO Steve Harris of Circassia: “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 U.S. sales force to promote Tudorza as our priority, as well as our existing NIOX products, transforming Circassia into a world-class respiratory business.”
COPD is characterized by a persistent cough that reflects the damage occurring to the air sacks of the lungs. In COPD, the lungs lose their ability to repair this damage on their own, leading to the loss of healthy alveolar tissue.