Dermavant Sciences, a dermatology-focused subsidiary of Roivant Sciences, announced 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.”