In October 2019, Rigel entered into exclusive commercialization license agreements with Medison Pharma to commercialize fostamatinib disodium hexahydrate (fostamatinib) in all potential indications in Canada and Israel.
In November 2020, Rigel received approval from Health Canada for its new drug submission (NDS) for fostamatinib for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to other treatments. The brand name for the product in Canada is TAVALISSE® and it is the first and only spleen tyrosine kinase (SYK) inhibitor approved in Canada for this indication.
Rigel received an upfront payment of $5 million, which includes an advanced royalty payment, with the potential for approximately $35 million in regulatory and commercial milestones. In addition, the company will receive royalty payments beginning at 30% of net sales after credit for the advanced royalty payment is fulfilled.
Development of fostamatinib in Canada and Israel:
- Medison is planning the Canadian product launch for TAVALISSE in January 2021
- A new drug application (NDA) has been submitted in Israel for fostamatinib for the treatment of ITP in adult patients, response expected from Ministry of Health in Q2 2021