Date: 2012-06-19
Type of information: Licensing agreement
Compound: R256 (inhaled JAK inhibitor)
Company: AstraZeneca (UK) Rigel Pharmaceuticals (USA)
Therapeutic area: Respiratory diseases - Inflammatory diseases - Allergic diseases
Type agreement: licensing
development
commercialisation
Action mechanism: In preclinical studies, R256, a JAK inhibitor, has been shown to be a potent inhibitor of IL-13 and IL-4 signaling at the primary cellular level. Patients with moderate to severe chronic asthma experience persistent inflammation and cellular remodeling of their airways, which may result in permanently reduced lung function if left untreated. In preclinical models, R256 reduces the severity of inflammation and improves lung function by mechanisms associated with several hallmarks of asthma such as bronchoconstriction, mucus overproduction and airway remodeling.
Disease: chronic asthma
Details: AstraZeneca and Rigel Pharmaceuticals have announced an exclusive worldwide license agreement for the global development and commercialization of R256, which is being investigated as a treatment for moderate to severe chronic asthma.
AstraZeneca will be responsible for beginning first-in-human clinical studies for R256, and for designing and conducting the clinical development of the compound. AstraZeneca will have exclusive rights to commercialize R256 around the world. This is the second licensing agreement between AstraZeneca and Rigel Pharmaceuticals. The companies previously announced a worldwide license agreement in February 2010, whereby AstraZeneca agreed to develop and commercialize fostamatinib, the first oral SYK inhibitor in development, as a novel therapeutic approach for rheumatoid arthritis. The Phase 3 clinical program, called OSKIRA (Oral SYK Inhibition in Rheumatoid Arthritis) enrolled its first patient in September of 2010 and is designed to investigate fostamatinib as a therapeutic option for patients who have an inadequate response to currently available therapies such as traditional disease modifying anti-rheumatic drugs (DMARDs) and parenteral anti-TNFs.
Financial terms: Under the terms of the agreement, Rigel will receive an upfront payment of $1 million with an additional $8.25 million in early milestone payments anticipated by the end of 2013. Together with other specified developmental, regulatory and launch milestone payments, the R256 collaboration could be worth up to $100 million. Additionally, upon marketing approval of R256, Rigel will be eligible to receive tiered royalty payments on product sales.
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