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news.AstraZeneca has entered into a worldwide license agreement with Rigel Pharmaceuticals for the development and commercialisation of fostamatinib disodium (R788). Fostamatinib disodium is Rigel's late-stage investigational product for rheumatoid arthritis (RA) and additional indications.
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Fostamatinib disodium, which has completed Phase II programme, is the furthest developed oral Spleen Tyrosine Kinase (Syk) inhibitor being evaluated for RA.
Under 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, and also double-digit royalties on net sales worldwide.
AstraZeneca will be responsible for all development, regulatory filings, manufacturing and global commercialisation activities in all licensed indications under the contract. Effectiveness of the agreement is contingent on expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.
The global Phase III programme for fostamatinib disodium will begin by the end of 2010, which will aim at filing new drug applications with the FDA and the European Medicines Agency (EMEA) in 2013.
Fostamatinib disodium is being developed as a next generation oral RA therapy in adults who have failed to respond adequately to a traditional disease modifying anti-rheumatic drug (DMARD), such as methotrexate, where a TNF biologic add-on treatment would currently be considered.
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 RA.
Anders Ekblom, executive vice president of development at AstraZeneca, said: “There is a very real and pressing unmet medical need in the area of rheumatoid arthritis. Given the debilitating effect this disease can have on patients, AstraZeneca looks forward to working together with Rigel to continue development of this innovative investigational compound. Collaborations such as this one, which further strengthen our late-stage pipeline, demonstrate the key role externalisation continues to play in AstraZeneca’s strategy.”
James Gower, chairman and chief executive officer of Rigel, said: “This collaboration fulfills our expectations in two key ways. First, AstraZeneca has made an expansive commitment to develop fostamatinib disodium for the treatment of RA, which means that the work we have begun for patients with this disease will be completed with a substantially larger clinical programme. Second, Rigel will receive royalties on potential future sales, appropriate to its investment in the development of R788.”