Quarterly report pursuant to Section 13 or 15(d)

Subsequent Events

v3.19.3
Subsequent Events
9 Months Ended
Sep. 30, 2019
Subsequent Events  
Subsequent Events

14.Subsequent Events

 

In October 2019, we entered into exclusive commercialization license agreements with Medison Pharma to commercialize fostamatinib in all potential indications in Canada and Israel and we received an upfront payment of $5 million, which included an advanced royalty payment.

 

In October 2019, we announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA, has adopted a positive trend vote on the Marketing Authorization Application (MAA). The indication for the positive trend vote is for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments. The CHMP intends to hold a final vote on their recommendation at their November meeting. Pending a formal positive CHMP opinion, the European Commission, which has the authority to approve medicines for use in Europe, would be expected to render their decision approximately 60 days after the opinion is received. Such an approval could enable a product launch in initial European markets in early 2020. Under our agreement with Grifols, we will receive a $20.0 million payment from Grifols upon approval from the EMA for fostamatinib in chronic ITP.