Dermavant Sciences, the dermatology-focused subsidiary of Roivant Sciences, has entered into an agreement with Japan Tobacco (JT) for the exclusive rights to develop, register and market tapinarof in Japan for the treatment of dermatological diseases and conditions.
JT has also signed an exclusive license agreement with its subsidiary, Torii Pharmaceutical, for the co-development and commercialisation 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 and the therapeutic is currently in Phase 3 trials for psoriasis in the US (PSOARING 1 and PSOARING 2).
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 FDA in 2021.
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.