AstraZeneca and Rigel Pharmaceuticals Inc. today announced an exclusive worldwide license agreement for the global development and commercialization of R256, Rigel's inhaled JAK inhibitor shown to inhibit IL-13 and IL-4 signalling, which is being investigated as a treatment for moderate to severe chronic asthma. In preclinical research, R256 has been shown to reduce airway inflammation and improve lung function.
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 commercialise R256 around the world. AstraZeneca now has one of the strongest respiratory and inflammation pipelines in the pharmaceutical industry as well as extensive experience successfully developing and commercialising innovative treatments for a range of respiratory diseases.
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.
"R256 emerged from Rigel's comprehensive study of chronic and severe asthma and lung inflammation. With AstraZeneca as our development partner, severely asthmatic people may one day have inhalable R256 as an additional, useful treatment option. This marks our second collaboration with AstraZeneca in the area of immunology and we are confident it will be as mutually rewarding as the first," said Donald Payan, M.D., executive vice president and president of Discovery and Research at Rigel Pharmaceuticals.
"We are pleased to be expanding our relationship with Rigel and to develop and commercialise this novel asset, R256," said Mene Pangalos, executive vice president of Innovative Medicines at AstraZeneca. "Despite the number of medicines available to asthma patients today, there remains a need for more targeted therapies for moderate to severe chronic asthma. Through this agreement, R256 will benefit from the wealth of experience AstraZeneca has in bringing innovative treatments for respiratory diseases to millions of patients around the world."
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 remodelling 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. In May 2012, Rigel presented two studies on R256 in asthma at the American Thoracic Society International Conference.
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 commercialise fostamatinib, the first oral SYK inhibitor, in development as a novel therapeutic approach for rheumatoid arthritis. The phase III clinical programme, 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.
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