AstraZeneca and Rigel Pharmaceuticals seal license deal for rheumatoid arthritis drug
AstraZeneca (LSE: AZN) and Rigel Pharmaceuticals (NASDAQ: RIGL) have signed an exclusive worldwide license agreement for the development and commercialisation of Rigel's late-stage investigational product for rheumatoid arthritis (RA), fostamatinib disodium (R788). AstraZeneca will pay Rigel US$100 million upfront, with up to an additional US$345 million payable subject to development, regulatory and first sale milestones.
Rigel is also eligible for up to US$800 million in addition commercially-tied payments, should the drug achieve considerable levels of success. Rigel once the drug has reached commercial stages, Rigel is entitled to significant stepped double-digit royalties on R788's net sales worldwide. Under the terms of the deal, AstraZeneca is responsible for all development, regulatory filings, manufacturing and global commercialisation activities in all licensed indications.
"There is a very real and pressing unmet medical need in the area of rheumatoid arthritis", AstraZeneca Executive VP of Development, Anders Ekblom said. "Collaborations such as this one, which further strengthen our late-stage pipeline, demonstrate the key role externalisation continues to play in AstraZeneca's strategy".
AstraZeneca will design a global phase III programme, and aims to file a new drug application with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) in 2013. The Phase III programme is expected to begin during the second half of 2010.
RA is a systemic autoimmune disease, which causes damage to the joints and other organs. The disease is a major cause of disability which affects approximately 1 in 100 people. R788 has completed a comprehensive Phase II programme, and it 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 implicated in the destruction of bone and cartilage which is characteristic of RA', AstraZeneca said.
According to AstraZeneca, the RA market was estimated to be worth approximately US$13bn globally in 2009, having grown from US$1.3bn in 1998. Also under the terms of deal, AstraZeneca will receive exclusive rights to Rigel's portfolio of oral Syk inhibitors, as well as for additional indications for fostamatinib disodium beyond RA.