Australia's CSL unveiled Phase III trial results for hemophilia B candidate rIX-FP that met the primary endpoint and separately noted it bought exclusive rights to commercialize flu treatment, Rapivab, from BioCryst Pharmaceuticals last week. The note highlighted the growing reach of the biopharma in a core blood products business and in vaccines following its purchase of a Novartis ($NVS) unit last year.
The candidate is under review by the U.S. FDA for approval, the company said, as well as the European Medicines Agency.
The trial data from the CSL Behring unit was presented at the International Society of Thrombosis and Haemostasis Congress in Toronto, CSL said in a release that noted no patients developed inhibitors to Factor IX.
In the case of Rapivab, the single-dose intravenous treatment for acute uncomplicated flu was developed under contract with the U.S. government as part of pandemic preparedness efforts, the company said.
It was approved for use in the U.S. in December 2014 and is licensed in Japan and South Korea.
Another CSL unit, bioCSL, which specializes in flu prevention globally, will obtain exclusive worldwide commercial rights, except Japan, Korea, Taiwan and Israel.
BioCryst will retain responsibility for pandemic stockpiling in the U.S., while bioCSL will have exclusive rights to pursue pandemic stockpiling outside the U.S. BioCryst will receive an upfront payment of $33.7 million and may receive up to $12 million in additional payments related to the successful achievement of certain regulatory milestones, the company said. BioCryst will also receive tiered royalties based on net sales thresholds and proceeds from stockpiling purchases outside the U.S.
- here is the release