AstraZeneca has announced an exclusive worldwide licence agreement for access to the global development and commercialisation of Rigel's fostamatinib disodium, an investigational product for rheumatoid arthritis (RA) and additional indications.
Fostamatinib disodium, which has completed a comprehensive Phase II programme, is the furthest developed oral spleen tyrosine kinase (SYK) inhibitor being evaluated for RA.
Inhibiting SYK is thought to block the intracellular signalling of various immune cells, resulting in the rampany destruction of bone and cartilage characteristic of RA, which affects approximately one in 100 people.
As part of the agreement AstraZeneca will make an upfront payment to Rigel of $100m with up to an additional $345m payable if specified development, regulatory and first commercial sale milestones are achieved.
Rigel will also be eligible to receive up to an additional $800m of specified sales-related milestone payments if the product achieves considerable levels of commercial success, as well as stepped double-digit royalties on net sales worldwide.
AstraZeneca will be responsible for all development, regulatory filings and manufacturing and global commercialisation activities in all licensed indications under the contract.
AstraZeneca will also design a global Phase III programme, anticipated to begin in the second half of 2010, with the goal of filing new drug applications with the US Food and Drug Administration and the European Medicines Agency in 2013.