TOKYO—Combine a promising drug inclinical trials with the capability to develop and commercialize it,and you have a winning proposition. That's why Astellas Pharma Inc.has executed a license agreement with Janssen Biotech Inc., underwhich Janssen has an exclusive right to develop and commercializeASP015K, an Astellas compound, worldwide except for in Japan.
ASP015K is a novel, oral small-moleculeJanus Kinase (JAK) inhibitor that Astellas is developing forrheumatoid arthritis. In addition to being in Phase IIb developmentfor the treatment of moderate-to-severe rheumatoid arthritis (RA) asa once-daily, orally administered therapy, a completed Phase IIastudy demonstrated its potential in the treatment ofmoderate-to-severe plaque psoriasis.
According to President and CEOYoshihiko Hatanaka, "Astellas believes this transaction willmaximize the value of ASP015K through the collaboration with Janssen,which has a strong track record in the development andcommercialization of leading products in the field of autoimmunediseases. It also strengthens our commitment to maximizing theenterprise value through optimization of R&D resources."
RA is a highly competitive area withestablished companies, according to Sanae Miyashita, director ofcorporate communications at Astellas.
"While Astellas has the developmentand commercial rheumatology infrastructure in Japan, we do not haveit outside Japan," Miyashita says. "Thus, we believed thatpartnering with a company like Janssen would maximize the value ofASP015K."
Astellas believes that collaborationwith a partner like Janssen would maximize the value of this compoundin autoimmune indications like RA.
Janssen has a global presence in theimmunology therapeutic area with products such as Remicade, Simponiand Stelara. The company is collaborating with Janssen in maximizingthe potential of ASP015K, according to Miyashita.
"We identified an opportunity todevelop a mutually beneficial collaboration that would seek toadvance ASP015K as a potential oral therapy for the treatment ofimmune-mediated inflammatory diseases," says Dr. Sue Dillon, globalimmunology area head at Janssen Research & Development LLC. "Wesee ASP015K as having potential in the treatment of diseases withinour focus areas, which include inflammatory bowel disease (IBD),psoriatic arthritis and others. We look forward to collaborating withAstellas."
In a six-week, Phase-IIaproof-of-concept study of patients with psoriasis, ASP015K was welltolerated and demonstrated dose-dependent improvements in thePsoriasis Areas Severity Index change from baseline. Astellas iscurrently conducting three Phase-IIb studies in patients with RA inthe United States, Europe and Japan.
Astellas is entitled to receive anupfront payment of $65 million from Janssen in return for theexclusive license to develop and commercialize ASP015K in Japan. Inaddition, Astellas is eligible to receive contingent milestonepayments upon the achievement of certain development, regulatory andcommercial milestones, which could total up to $880 million, and toreceive double-digit royalty payments on net sales of ASP015K inJapan from Janssen. After completion of the Phase IIb studies inJapan, Janssen is responsible for all future costs associated withthe development and commercialization of ASP015K for rheumatoidarthritis and other autoimmune indications in Japan. Astellas willcontinue development and commercialization of ASP015K in Japan.
Dillon says Janssen is looking forwardto results from the ongoing ASP015K Phase IIb RA studies and iscontinuing to follow data emerging from other JAK programs that areongoing to better understand the risks of this new drug class andpotential points of differentiation for ASP015K.
As to commercial opportunities forASP015K, Dillon says it "adds to the depth of our innovativeimmunology pipeline, which consists of novel large- (biologic) andsmall-(oral) molecule programs. This collaboration represents anopportunity to expand future therapeutic options for patients livingwith debilitating immune-mediated diseases like RA, a condition thataffects more than 23.5 million people worldwide."