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Agreement

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Date: 2010-02-16
Biotech partner: Rigel Pharmaceuticals (USA)
Pharma Partner: AstraZeneca (UK)
Type of agreement: * commercialization/ distribution
* development
Compound: fostamatinib disodium (R788) (oral Spleen Tyrosine Kinase (Syk) inhibitor)
Disease area: rheumatoid arthritis and additional indications
Development phase: Fostamatinib disodium has completed a comprehensive Phase II programme (Three Phase II trials have been completed. TASKi1 and TASKi2 studied patients with an incomplete response to methotrexate. TASKi3 studied patients who had failed treatment with biologic therapies)
Nature of the agreement: AstraZeneca and Rigel Pharmaceuticalshave announced an exclusive worldwide license agreement for the global development and commercialisation of fostamatinib disodium (R788).

AstraZeneca is responsible for all development, regulatory filings, manufacturing and global commercialisation activities in all licensed indications under the contract.
AstraZeneca will 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 FDA and EMA in 2013.
Under the terms of the agreement, AstraZeneca will also receive exclusive rights to Rigel’s portfolio of oral Syk inhibitors, as well as for additional indications for fostamatinib disodium beyond rheumatoid arthritis.
Financial terms of the agreement: Once the agreement is effective, AstraZeneca will make an upfront payment to Rigel of $100 million with up to an additional $345 million payable if specified development, regulatory and first commercial sale milestones are achieved.
Rigel will also be eligible to receive up to an additional $800 million of specified sales-related milestone payments if the product achieves considerable levels of commercial success, as well as significant stepped double-digit royalties on net sales worldwide.


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