Circassia Pharmaceuticals notified AstraZeneca that it will exercise its option to acquire the full US commercial rights to the Tudorza aclidinium DPI, the company said. Circassia acquired US rights to Tudorza and to Duaklir aclidinium/formoterol DPI in March 2017 in a deal that included 50/50 profit sharing with AstraZeneca.
Completion of the option exercise, which is expected to occur on December 31, 2018, will trigger a $5 million payment to AstraZeneca. A deferred option payment of $20 million will be due on FDA approval of Duaklir, at which time another $100 million payment is due under the original deal.
The FDA accepted the NDA for Duaklir in August 2018, with a PDUFA date set for March 31, 2019, along with an sNDA that would add COPD exacerbation reductions and cardiovascular safety data to the Tudorza prescribing information. AstraZeneca will transfer the product license for Tudorza to Circassia following completion of the FDA’s review of the sNDA.
Circassia CEO Steve Harris stated, “Exercising our option for the full US commercial rights to Tudorza represents a strategic opportunity for Circassia. We will have significantly more control of the product’s commercialization strategy, and with prescription levels continuing to stabilise, we now have a robust foundation from which to grow the product. We plan to build on our learnings of the past 18 months and are launching a dedicated COPD sales force alongside a focused Niox team, which we believe will improve promotion of our existing products and provide a platform for the launch of Duaklir, once approved. With both the Tudorza option exercise and Duaklir regulatory review process anticipated to complete in the coming months, we look forward to 2019 with significant optimism.”
Read the Circassia Pharmaceuticals press release.
