HORSHAM, Pa.—Janssen Biotech, Inc., one of the JanssenPharmaceutical Companies of Johnson & Johnson, has announced theestablishment of a license agreement with Northbrook, Ill.-based AstellasPharma Inc. The agreement covers the worldwide development andcommercialization (excluding Japan) of ASP015K, an oral, small molecule JanusKinase (JAK) inhibitor.
Per the terms of the agreement, Janssen will gain exclusiveworldwide rights for the development and commercialization of the compound,except in Japan, as an oral treatment for immune-mediated inflammatorydiseases. The companies have agreed upon an upfront payment as well as futuremilestone and royalty payments based on the achievement of certain developmentand commercialization milestones, and the deal could have a potential total of$945 million. Astellas will be responsible for the completion of currentongoing Phase IIb studies, and will continue to develop and commercializeASP015K in Japan. Janssen will be responsible for all other development,clinical and regulatory filing activities in its territories.
"Janssen has a heritage of innovation and deliveringtransformative medicines to address unmet needs in immunologic diseases,"Susan Dillon, Ph.D., global therapeutic area head of Immunology at JanssenResearch & Development, LLC, said in a press release. "We arecommitted to expanding the portfolio of new treatments for patients withserious immune-mediated diseases and are excited to add Astellas' ASP015K toour pipeline."
At present, ASP015K is in Phase IIb development as aonce-daily oral treatment for moderate to severe rheumatoid arthritis. Thecompound has already made it through a successful Phase IIa study todemonstrate its potential as a treatment for moderate to severe plaque psoriasis.
JAK inhibitors function by blocking pivotal components ofsignaling mechanisms that are utilized by a variety of inflammatory cytokines,among them cytokines that are thought to play significant roles in themediation of disease in people who suffer from immune-mediated inflammatorydiseases.
Rheumatoid arthritis is a long-term, autoimmune diseasecharacterized by inflammation of the joints and surrounding tissues, with thepotential to affect other organs as well. In addition to pain and inflammation,the disease can also lead to joint destruction and disability. Though it canset in at any time, it appears most often in middle age, affecting women moreoften than men. Currently, approximately 1 to 2 percent of the world'spopulation suffers from rheumatoid arthritis, with roughly 2.1 million peopleafflicted in the United States.
Psoriasis is another chronic inflammatory disease, and iscaused by the overproduction of skin cells. The condition can range from mild,with only occasional flare-ups in select locations on the body, to severe,and an estimated 125 million people suffer from the condition worldwide.
SOURCE: Janssen Biotech press release
