AstraZeneca has struck a $95 million (€86 million) deal to buy a FDA priority review voucher from Swedish Orphan Biovitrum (Sobi). The purchase comes as AstraZeneca enters a 12-month period in which it plans to file for approval of about 10 assets.
Using the voucher, AstraZeneca will be able to shave four months off the FDA regulatory review of one drug, enabling it to race through the process in six months. AstraZeneca is yet to disclose which drug it will use the voucher on, but its anticipated filing schedule for the coming 12 months features some candidates.
Over that period, AstraZeneca plans to file for approval of therapies including renal anemia drug roxadustat, which is racing rival assets from Akebia Therapeutics and GlaxoSmithKline to market, and add coronary artery disease to the list of Brilinta indications. Given the size of the anemia market and level of competition, roxadustat is a drug AstraZeneca may want to get past the FDA as fast as possible.
AstraZeneca is also targeting 2019 filings for approval of trastuzumab deruxtecan in breast cancer, Calquence in chronic lymphocytic leukemia and selumetinib in neurofibromatosis type 1, but those applications already stand to get a speedy review at the FDA under the breakthrough status program.
For Sobi, the deal provides a near-instant partial return on the $518 million it paid to acquire FNγ inhibitor emapalumab and associated assets from NovImmune in June. Sobi licensed the global rights to emapalumab in 2018, after NovImmune filed for approval, but that deal left it without the priority review voucher the FDA awarded upon authorizing the drug later in the year. Sobi then returned to NovImmune to acquire the priority review voucher and other assets.
The $95 million Sobi will receive from the sale of the voucher is in line with recent deals involving other companies. In November, Eli Lilly bought a voucher from Siga Technologies for a little less, $80 million, but in March Biohaven Pharmaceutical paid a little more, $105 million, for another voucher.
Those figures are a far cry from the highs hit in the brief boom period for vouchers. While the first voucher sold for $67 million, the value of the assets quickly spiraled, culminating in AbbVie paying $350 million for one.