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Immunological inhibitor
November 2012
by Ilene Schneider  |  Email the author


TOKYO—Combine a promising drug in clinical 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., under which Janssen has an exclusive right to develop and commercialize ASP015K, an Astellas compound, worldwide except for in Japan.
ASP015K is a novel, oral small-molecule Janus Kinase (JAK) inhibitor that Astellas is developing for rheumatoid arthritis. In addition to being in Phase IIb development for the treatment of moderate-to-severe rheumatoid arthritis (RA) as a once-daily, orally administered therapy, a completed Phase IIa study demonstrated its potential in the treatment of moderate-to-severe plaque psoriasis.

According to President and CEO Yoshihiko Hatanaka, "Astellas believes this transaction will maximize the value of ASP015K through the collaboration with Janssen, which has a strong track record in the development and commercialization of leading products in the field of autoimmune diseases. It also strengthens our commitment to maximizing the enterprise value through optimization of R&D resources."

RA is a highly competitive area with established companies, according to Sanae Miyashita, director of corporate communications at Astellas.

"While Astellas has the development and commercial rheumatology infrastructure in Japan, we do not have it outside Japan," Miyashita says. "Thus, we believed that partnering with a company like Janssen would maximize the value of ASP015K."
Astellas believes that collaboration with a partner like Janssen would maximize the value of this compound in autoimmune indications like RA.

Janssen has a global presence in the immunology therapeutic area with products such as Remicade, Simponi and Stelara. The company is collaborating with Janssen in maximizing the potential of ASP015K, according to Miyashita.

"We identified an opportunity to develop a mutually beneficial collaboration that would seek to advance ASP015K as a potential oral therapy for the treatment of immune-mediated inflammatory diseases," says Dr. Sue Dillon, global immunology area head at Janssen Research & Development LLC. "We see ASP015K as having potential in the treatment of diseases within our focus areas, which include inflammatory bowel disease (IBD), psoriatic arthritis and others. We look forward to collaborating with Astellas."

In a six-week, Phase-IIa proof-of-concept study of patients with psoriasis, ASP015K was well tolerated and demonstrated dose-dependent improvements in the Psoriasis Areas Severity Index change from baseline. Astellas is currently conducting three Phase-IIb studies in patients with RA in the United States, Europe and Japan.

Astellas is entitled to receive an upfront payment of $65 million from Janssen in return for the exclusive license to develop and commercialize ASP015K in Japan. In addition, Astellas is eligible to receive contingent milestone payments upon the achievement of certain development, regulatory and commercial milestones, which could total up to $880 million, and to receive double-digit royalty payments on net sales of ASP015K in Japan from Janssen. After completion of the Phase IIb studies in Japan, Janssen is responsible for all future costs associated with the development and commercialization of ASP015K for rheumatoid arthritis and other autoimmune indications in Japan. Astellas will continue development and commercialization of ASP015K in Japan.

Dillon says Janssen is looking forward to results from the ongoing ASP015K Phase IIb RA studies and is continuing to follow data emerging from other JAK programs that are ongoing to better understand the risks of this new drug class and potential points of differentiation for ASP015K.

As to commercial opportunities for ASP015K, Dillon says it "adds to the depth of our innovative immunology pipeline, which consists of novel large- (biologic) and small-(oral) molecule programs. This collaboration represents an opportunity to expand future therapeutic options for patients living with debilitating immune-mediated diseases like RA, a condition that affects more than 23.5 million people worldwide."

Code: E111222



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