Dermavant out-licenses tapinarof in Japan

Dermavant Sciences, a dermatology-focused subsidiary of Switzerland-based Roivant Sciences, has entered into a collaboration and license agreement with Japan Tobacco (TYO: 2914) 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 for co-development and commercialization of tapinarof in Japan.

USA-based Dermavant acquired rights to tapinarof, an investigational therapeutic aryl hydrocarbon receptor modulating agent (TAMA) for the treatment of psoriasis and atopic dermatitis and back-up programs, from UK pharma major GlaxoSmithKline (LSE: GSK) in July 2018 for a total consideration of £250 million ($326 million), including an initial payment of £150 million and a potential future milestone payment of £100 million.

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 III trials for psoriasis in the US (PSOARING 1 and PSOARING 2), having previously demonstrated clinically meaningful and statistically-significant responses in Phase II trials for both psoriasis and atopic dermatitis. Assuming positive Phase III results, Dermavant expects to file a New Drug Application for tapinarof topical cream for the treatment of plaque psoriasis with the US Food and Drug Administration in 2021.