AstraZeneca and Rigel sign global license agreement for potential new chronic asthma treatment

Hannah Blake

pharmaphorum

An exclusive worldwide license agreement has been signed between AstraZeneca and Rigel Pharmaceuticals Inc. The agreement was created for the global development and commercialisation of R256, Rigel’s inhaled JAK inhibitor shown to inhibit IL-13 and IL-14 signalling, which is being investigated as treatment for moderate to severe chronic asthma.

An estimated 235 million people suffer from asthma, according to the World Health Organisation (WHO). Patients who suffer 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. Rigel’s R256 has shown, in preclinical research, to reduce airway inflammation and improves lung function associated with several hallmarks of asthma, such as bronchoconstriction, mucus overproduction and airway remodelling.

The exclusive license agreement means that AstraZeneca is now responsible for beginning first-in-human clinical trials for R256, as well as designing and conducting the clinical development of the compound. AstraZeneca now also has exclusive rights to commercialise R256 around the world.

“We are pleased to be expanding our relationship with Rigel and to develop and commercialise this novel asset, R256. 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.”

Menelas Pangolas, executive vice president of Innovative Medicines at AstraZeneca.

Rigel will receive an upfront payment of US $1 million, according to the terms of the agreement, and will receive an additional US $8.25 million in early milestone payments anticipated by the end of 2013. It is thought that the R256 agreement, in collaboration with specified developmental, regulatory and launch milestone payments, could be worth up to US $100 million.

“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.”

Donald Payan, M.D., executive vice president and president of Discovery and Research at Rigel Pharmaceuticals.

This is not the first time AstraZeneca and Rigel Pharmaceuticals have worked together – in February 2010, they announced a worldwide license agreement whereby AstraZeneca agreed to develop and commercialise fostamatinib, the first oral SYK inhibitor, in development as a novel therapeutic approach for rheumatoid arthritis. In September 2010 the first patient was enrolled on the Phase III clinical programme, OSKIRA, which is currently investigating fostamatinib as a therapeutic option for patients who have an inadequate response to therapies available at present.