We entered into a worldwide licence agreement with Rigel Pharmaceuticals for Fostamatinib disodium (previously known as R788) for the treatment of Rheumatoid Arthritis (RA) in February 2010. Fostamatinib is a Phase III-ready, small molecule, spleen tyrosine kinase (syk) inhibitor being developed as a next generation oral RA therapy. AstraZeneca is responsible for development, regulatory filings, and manufacturing and global commercialisation activities in all licensed indications under the contract.
Unmet medical need
- Approximately 1 in 100 people suffer from RA, a painful, disabling, chronic systemic autoimmune inflammatory disease which causes damage to the joints and organs.
- Fostamatinib is an oral spleen tyrosine kinase (syk) inhibitor. In its class, this compound is at the most advanced stage of clinical evaluation.
- Fostamatinib may provide a new and valuable oral treatment option for RA; a condition that requires a range of therapeutic approaches due to the nature of the disease pathology and its progression. Fostamatinib has the potential to provide a new alternative for RA patients who respond inadequately to either traditional disease modifying anti-rheumatic drugs (DMARDs) such as methotrexate (MTX), who would have to switch to parenteral anti-TNFs or biologics, or to a TNF antagonist.
A key element of AstraZeneca’s strategic vision for rheumatology is a new approach to RA, challenging current treatment paradigms, by bringing to the market a novel, oral, small molecule as an alternative to injectable therapies. Fostamatinib was identified at an early-stage as a compound available for licensing with potential to deliver the required profile. It was eventually prioritised over AstraZeneca’s own in-house programme which did not meet the challenging efficacy criteria for progression into Phase III. Fostamatinib met this criteria and Rigel wanted a partner who was well positioned with the infrastructure and expertise in place to rapidly progress Phase III development and commercialisation.
The programme started with a phase III clinical trial called OSKIRA (Oral syk Inhibition in Rheumatoid Arthritis) in September 2010.
- Rapid start from closing the deal to initiation of Phase III studies
- Continued shared vision for the drug and view of risks
- On track to meet 2013 US and European regulatory filing dates
- Worldwide licence agreement
- Upfront payment to Rigel of USD$100m
- Up to USD$345m if specified development, regulatory and first commercial sale milestones are achieved
- An additional USD$800m 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
Why Rigel chose AstraZeneca:
- Unique combination of technical and commercial expertise
- Prepared and ready for rapid initiation of phase III
- Global footprint and ability to establish and commercialise major brands in new therapy areas
- The speed to initiate Phase III trials and file the drug
AstraZeneca has a 40-year history in small molecule research and a best-in-class pipeline of biologic candidates for respiratory, inflammatory and autoimmune diseases. Our goal is to lead the advancement of innovative medicines with greater efficacy, improved safety and enhanced convenience. We are particularly interested in asthma, chronic obstructive pulmonary disease, rheumatoid arthritis, systemic lupus erythematosus and novel inhalation approaches.
Partnering leadership team
|Small molecule business development||R&D Strategy Head||Biologics business development|
VP SPBD, R&I and New Opportunities
VP Strategy, R&I
Associate Director, Business Development