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When the West meets the East
A Asia begins to hold its own in life science/pharmaceutical research and development, many Big Pharmas acknowledge this by setting up partnerships and collaborations with research institutes and top universities in the region. One such example is the recent partnership between Janssen and Astellas for ASP015K, an oral, small molecule Janus Kinase (JAK) inhibitor. The new drug is undergoing clinical trials for treatment of immunological diseases such as rheumatoid arthritis and psoriasis. Janssen's Global Therapeutic Area Head of immunology, Susan Dillon speaks to Sulastri Kamis on this exciting new partnership.

What influenced Janssen's decision to tap into the Japanese market and partner up with Astellas?

The Immunology Therapeutic Area within Janssen R&D remains committed to building a pipeline of differentiated medicines. We actively and selectively pursue external partnerships to complement our internal expertise with a focus on developing innovative therapeutics for significant unmet needs that remain in the treatment of diseases like rheumatoid arthritis. We recognize that different patient populations around the globe respond to treatments differently, and thus, physicians need options in the treatment of heterogeneous patient populations.

We maintain a strong tie to the Japanese market. Our efforts in the region have led to approvals for our biologic medicines, SIMPONI® (golimumab) for the treatment of rheumatoid arthritis, STELARA® (ustekinumab) for the treatment of plaque psoriasis, and REMICADE® (infliximab), which is approved for multiple immunological diseases. We maintain successful internal and external partnerships in the market/region supporting the portfolio. Moreover, we continue to pursue clinical programs for internally discovered products in Japan, including sirukumab, an anti-interleukin-6 antibody being investigated for rheumatoid arthritis, and we also seek to identify collaborations that may help advance medicines for patients living with immune-mediated inflammatory diseases. Through our recent agreement with Astellas, we look to maintain this focus and collaborative approach in the worldwide development and commercialization of ASP015K, an oral, small molecule Janus kinase (JAK) inhibitor in clinical study for the treatment of rheumatoid arthritis.

How has Astellas stood out from the myriad of Japanese biopharma companies for this partnership?

We recognized an opportunity to develop a mutually beneficial collaboration with Astellas that would seek to advance ASP015K as a potential small molecule oral therapy for the treatment of immune-mediated inflammatory diseases.

Under the terms of the agreement, Janssen gains exclusive worldwide rights to develop and commercialize ASP015K, except in Japan. Astellas will be responsible for completing the on-going Phase IIb studies. Janssen will be responsible for all other development, clinical and regulatory filing activities in its territories and Astellas will continue development and commercialization of ASP015K in Japan.

ASP015K is an oral, small molecule Janus kinase (JAK) inhibitor currently in Phase IIb development for the treatment of moderate-to-severe rheumatoid arthritis and is being studied as a once-daily orally administered therapy. We see ASP015K as having potential in the treatment of diseases within our focus areas at Janssen R&D, including inflammatory bowel disease.

Was there a particular reason for the company to move into the area of inflammation/immunology?

Janssen R&D has a legacy of developing, launching and successfully commercializing transformational immunology therapies spanning rheumatology, gastroenterology and dermatology. We look forward to building on the success of our marketed products in the years to come and continuing our understanding of the diseases to advance science and bring innovative solutions to patients living with these chronic inflammatory conditions.

The addition of ASP015K adds to the depth of our innovative Immunology pipeline, which consists of novel large (biologic) and small (oral) molecule programs, and will further strengthen the current Janssen leadership position in Immunology. This collaboration represents an opportunity to expand future therapeutic options for patients living with debilitating immune-mediated diseases like rheumatoid arthritis, a condition that affects more than 23.5 million people worldwide. We look forward to results from the ongoing ASP015K Phase IIb rheumatoid arthritis studies, and we continue to follow data emerging from other on-going JAK programs to better understand the risks of this new drug class and potential points of differentiation for ASP015K.

Our commitment to treating immune-mediated diseases has never been stronger, and through our pipeline and a network of current and future collaborations, like Astellas, we look to lead advancements in this disease area for many years to come.

Could you describe some of the challenges/hurdles Janssen faced in trying to enter the Japanese market?

Janssen maintains a strong global presence. In fact, the Immunology Therapeutic Area within Janssen R&D has developed biologics in partnership with our colleagues in the Asia Pacific region, including Japan, as well as other partners in the region. With that in mind, we look forward to the opportunity to collaborate with Astellas and combine experiences from both companies to inform a fruitful partnership to hopefully advance ASP015K through a successful clinical development program.

Why is the company targeting rheumatoid arthritis specifically?

Rheumatoid arthritis affects between one and two percent of the world's population and results in pain and inflammation, and in some cases, joint destruction and disability. Based on our heritage in the rheumatology space with medicines like REMICADE and SIMPONI, we are committed to developing additional therapeutic options for patients battling the crippling effects of this disease, for which there is no cure.

About the Interviewee

Susan B. Dillon, Ph.D. is the Global Therapeutic Area Head, Immunology, Janssen Research & Development, LLC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. In this role, Sue has end-to-end responsibility for Immunology small and large molecule research, drug discovery, biomarkers, translational medicine, clinical development and the life cycle management of REMICADE® (infliximab), SIMPONI® (golimumab) and STELARA® (ustekinumab). She leads a global team focused on combining internal and external innovation approaches to discover and develop new solutions for patients with serious autoimmune, inflammatory and respiratory diseases.

Sue joined Johnson & Johnson through the Centocor R&D Discovery Research Group in 2001 and has held positions of increasing responsibility leading to her 2007 appointment as Senior Vice President, Research, and Head of Early Development, Biologics. Under Sue's leadership, the discovery organization produced a strong pipeline of novel biologic new molecular entities and built world-class capabilities in protein drug discovery through a combination of internal efforts, acquisitions and partnerships.

An experienced leader in large and small molecule drug discovery, Sue has held senior positions at several pharmaceutical companies, including SmithKline Beecham Pharmaceuticals (now GlaxoSmithKline), and Kosan Biosciences (acquired by Bristol Myers Squibb).

Sue earned her Ph.D. in microbiology and immunology from Thomas Jefferson University in Philadelphia, Pennsylvania, USA. She completed a National Institutes of Health (NIH)-sponsored postdoctoral fellowship in immunology at Duke University, has published over 50 scientific articles, and is inventor on three issued patents. In 2007, Sue was awarded the Distinguished Alumni Award from Thomas Jefferson University.

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