AstraZeneca, Rigel announce license agreement

MOLNDAL, Sweden—A new exclusive worldwide license agreementhas been announced between AstraZeneca and Rigel Pharmaceuticals Inc. for theglobal development and commercialization of R256, Rigel's inhaled JAKinhibitor. Preclinical research has shown R256 to be capable of both reducingairway inflammation and improving lung function.

Per the agreement, Rigel will receive $1 million upfront,with the possibility of an additional $8.25 million in early milestone paymentsanticipated by the end of 2013. If all specified development, regulatory andlaunch milestones are met as well, the collaboration could be worth up to $100million all told. In addition, Rigel is also eligible to receive tiered royaltypayments on product sales once R256 secures marketing approval.

"We are pleased to be expanding our relationship withRigel and to develop and commercialize this novel asset, R256," MenePangalos, executive vice president of Innovative Medicines at AstraZeneca, saidin a press release. "Despite the number of medicines available to asthmapatients today, there remains a need for more targeted therapies for moderateto severe chronic asthma. Through this agreement, R256 will benefit from thewealth of experience AstraZeneca has in bringing innovative treatments forrespiratory diseases to millions of patients around the world."

AstraZeneca will begin first-in-human clinical studies forthe compound, and will also be in charge of designing and conducting theclinical development of R256. In return, AstraZeneca will have exclusive rightsto commercialize the compound globally.

So far, in preclinical studies, R256 has shown to be apotent inhibitor of both IL-13 and IL-4 signaling at the primary cellularlevel, and inhibition of IL-13 and IL-4 signaling is under investigation as atreatment for moderate to severe chronic asthma. Patients with moderate tosevere chronic asthma suffer from persistent inflammation and cellularremodeling of their airways, which can lead to permanently diminished lungfunction if left untreated. Preclinical models of R256 have shown that thecompound reduces the severity of lung inflammation and also improves lungfunction via mechanisms often associated with asthma, such asbronchoconstriction, mucus overproduction and airway remodeling.

"R256 emerged from Rigel's comprehensive study ofchronic and severe asthma and lung inflammation. With AstraZeneca as ourdevelopment partner, severely asthmatic people may one day have inhalable R256as an additional, useful treatment option. This marks our second collaborationwith AstraZeneca in the area of immunology and we are confident it will be asmutually rewarding as the first," Donald Payan, M.D., executive vicepresident and president of Discovery and Research at Rigel Pharmaceuticals,said in a press release.

The arrangement represents the second licensing agreementbetween the two companies. The first, also a worldwide agreement, was announcedin February 2010 and established that AstraZeneca would develop andcommercialize fostamatinib, the first oral SYK inhibitor, under development asa novel therapeutic approach for rheumatoid arthritis. The Phase III clinicalprogram, OSKIRA (Oral SYK Inhibition in Rheumatoid Arthritis) enrolled itsfirst patient in September 2010, and is investigating fostamatinib as apotential therapeutic option for patients who present an inadequate response toexisting therapies such as traditional disease-modifying anti-rheumatic drugsand parenteral anti-TNFs.

SOURCE: AstraZeneca press release