Servier has terminated its 2017 collaboration agreement with CTI BioPharma but could still take the rights to Pixuvri following an upcoming regulatory decision. The action comes seven months after the B-cell non-Hodgkin lymphoma drug failed a key clinical trial.
Cytotoxic aza-anthracenedione Pixuvri came to market in the European Union via the conditional approval pathway in 2012. At that stage, the Committee for Medicinal Products for Human Use felt the lack of data on Pixuvri in patients who had previously received MabThera prohibited a standard approval. The committee tasked CTI with providing additional clinical data and seeking full approval.
Servier licensed the rights to Pixuvri in some markets in 2014 and expanded the agreement to cover all ex-U.S. territories in 2017. Yet, the confirmatory trial requested by European authorities dragged on well beyond the 2015 deadline originally targeted by CTI.
Data from the requested study belatedly dropped last year but showed Pixuvri had failed to improve progression-free survival. That left CTI and Servier facing the prospect of losing the rolling conditional approval that has permitted the sale of Pixuvri since 2012, and never getting the chance to expand use of the drug beyond its original indication.
Servier has responded to the setback by terminating the 2017 agreement that gave it ex-U.S. rights to Pixuvri. The French pharma will pay CTI €620,000 ($707,000) in relation to the termination, with up to €200,000 more to follow if the transition drags on beyond the end of March.
The transition period will end once the European Medicines Agency makes a decision about whether to approve Pixuvri. Until then, CTI will remain responsible for ex-U.S. pharmacovigilance activities, filing a marketing authorization application and the wind down of the failed clinical trial.
If EMA approves Pixuvri, Servier will pay CTI €2 million and assume responsibility for the drug globally. If EMA rejects Pixuvri, Servier will choose whether to pay €2 million and assume responsibility for the drug or work with CTI to withdraw the drug from the market.
Editor's note: This story has been updated to clarify Servier's ongoing link to Pixuvri.