January 15, 2020
TOKYO and BASEL, Switzerland—Jan. 15, 2020—Dermavant Sciences, a dermatology-focused subsidiary of Roivant Sciences, announced today that it has entered into a collaboration and license agreement with Japan Tobacco Inc. (JT) for exclusive rights to develop, register and market tapinarof in Japan for the treatment of dermatological diseases and conditions, including psoriasis and atopic dermatitis. Along with this agreement, JT has signed an exclusive license agreement with its subsidiary, Torii Pharmaceutical Co., Ltd. (Torii), for co-development and commercialization of tapinarof in Japan.
Tapinarof is a potential first-in-class, once-daily topical therapeutic aryl hydrocarbon receptor modulating agent (TAMA), which Dermavant is developing for the treatment of psoriasis and atopic dermatitis. To date, over 1,400 subjects have participated in 12 clinical trials for tapinarof. Tapinarof is currently in Phase 3 trials for psoriasis in the U.S. (PSOARING 1 and PSOARING 2), having previously demonstrated clinically meaningful and statistically significant responses in Phase 2 trials for both psoriasis and atopic dermatitis. Assuming positive Phase 3 results, Dermavant expects to file a New Drug Application for tapinarof topical cream for the treatment of plaque psoriasis with the U.S. Food and Drug Administration in 2021.
Under the terms of the license agreement, Dermavant will receive an upfront payment of $60 million and up to $53 million upon the achievement of certain development milestones for tapinarof for the treatment of psoriasis and atopic dermatitis. In addition, Dermavant will have the right to receive royalties based on product sales of tapinarof in the indications.
“Psoriasis and atopic dermatitis affect millions of people worldwide, including nearly 13 million in Japan alone,” said Todd Zavodnick, Chief Executive Officer of Dermavant. “Having seen the very encouraging results from Phase 2b studies for tapinarof conducted in North America and Japan for the treatment of psoriasis and atopic dermatitis, we are grateful to partner with JT and its subsidiary, Torii, two prominent and well-respected leaders in dermatology. JT and Torii share our commitment to finding novel, safe, and effective treatment options for patients in Japan suffering from these debilitating immuno-dermatologic diseases.”
“We are excited to partner with Dermavant for the development and commercialization of tapinarof. We are encouraged with the progress of its clinical trials, and jointly we hope to offer more treatment options for patients suffering with dermatological conditions in Japan,” said Muneaki Fujimoto, President of Pharmaceutical Business, JT.
“Tapinarof demonstrated clinically meaningful and statistically significant responses in five Phase 2 trials, where it met primary endpoints in both psoriasis and atopic dermatitis,” said April Armstrong, M.D., Professor of Dermatology and Associate Dean of Clinical Research at the University of Southern California Keck School of Medicine. “Coupled with a favorable tolerability profile, I believe that tapinarof with its novel mechanism of action could be a first-in-class topical treatment alternative, if approved.”
PSOARING is Dermavant’s pivotal Phase 3 psoriasis clinical program for tapinarof, which consists of two identical, multi-center, randomized, vehicle-controlled, double-blind, parallel group studies—PSOARING 1 and PSOARING 2—to evaluate the safety and efficacy of tapinarof cream 1% dosed once daily (QD) for 12 weeks versus vehicle in adult patients aged 18-75 years diagnosed with plaque psoriasis.
The primary endpoint of both studies will be a Physician Global Assessment (PGA) score assessment of “clear” skin (score of 0) or “almost clear” skin (score of 1), plus at least a 2-grade improvement from baseline, at Week 12. Following the 12-week, vehicle-controlled portion of the PSOARING trials, patients have the option to enroll in a separate, open-label extension study for an additional 40 weeks of treatment.
Psoriasis is a chronic, systemic, inflammatory skin disease characterized by red patches and plaques with silver scales on the skin. Psoriasis affects approximately 8 million people in the U.S. and 125 million worldwide, representing approximately 2% of the total population.
The typical age of onset is 15–25 years, but psoriasis can develop at any age. People with psoriasis are at an increased risk of developing other chronic and serious health conditions. Comorbidities include psoriatic arthritis, inflammatory bowel disease, hypertension, diabetes, obesity, and depression. Psoriasis has a significant impact on quality of life and on psychological health.
About Atopic Dermatitis
Atopic dermatitis (AD), commonly referred to as eczema, is a chronic inflammatory skin disease that results in itchy, red, swollen, and cracked skin, often affecting the folds of the arms, back of the knees, hands, face, and neck. AD is one of the most common inflammatory skin diseases, affecting over 28 million people in the U.S. alone and up to 10% of adults worldwide. AD occurs most frequently in children, affecting up to 30% worldwide.
People with AD are more likely to have other allergic conditions, like asthma, allergic rhinitis, and food allergies. Itching is an especially bothersome symptom in AD, and tends to worsen at night, disturbing sleep and causing fatigue, which in children can lead to inattention at school. People with AD may also experience social and emotional distress due to the visibility and discomfort of the disease.
About Japan Tobacco Inc.’s Pharmaceutical Business
Japan Tobacco Inc. (JT) has a pharmaceutical business which focuses on research and development, manufacturing and sales of prescription drugs. JT’s subsidiary Torii Pharmaceutical Co., Ltd. is in charge of manufacturing as well as sales and promotion in Japan. For more information, visit https://www.jt.com/about/division/pharma/index.html.
Dermavant Sciences, a subsidiary of Roivant Sciences, is a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in medical dermatology. Dermavant leverages the Roivant platform to develop therapies that have the potential to address high unmet medical needs while driving greater efficiency in research and clinical development. The Company’s robust medical dermatology pipeline includes both late-stage and early-development product candidates that target specific unmet needs in two of the largest growing immuno-dermatology markets, psoriasis and atopic dermatitis, as well as other large markets, including vitiligo, primary focal hyperhidrosis, and acne. Dermavant is developing its lead product candidate, tapinarof (DMVT-505), as a novel therapeutic aryl hydrocarbon receptor modulating agent (TAMA) topical cream for the treatment of plaque psoriasis and atopic dermatitis, which affect approximately 8 million and 28 million people in the United States, respectively. For more information, please visit www.dermavant.com.
Roivant Sciences aims to improve health by rapidly delivering innovative medicines and technologies to patients. It does this by building Vants – nimble, entrepreneurial biotech and healthcare technology companies with a unique approach to sourcing talent, aligning incentives, and deploying technology to drive greater efficiency in R&D and commercialization. For more information, please visit www.roivant.com.