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Jan. 15 Company Quick Takes: Japan Tobacco gets rights to Dermavant therapy; plus Clovis, BMS, Recordati, BeiGene, Insilico-Pfizer, Novartis

January 16, 2020 1:01 AM UTC
Updated on Jan 16, 2020 at 1:31 AM UTC

Japan Tobacco gets Japanese rights to Dermavant’s dermatology therapy
Japan Tobacco Inc. (TOKYO:2914) licensed from Dermavant Sciences exclusive rights to develop and commercialize tapinarof in Japan for dermatology indications including psoriasis and atopic dermatitis. The Roivant Sciences GmbH subsidiary will receive $60 million up front and up to $53 million in milestones, plus royalties. The topical compound, which modulates AHR activity, is approved for psoriasis vulgaris in China, where Beijing Wenfeng Tianji Pharmaceuticals Co. Ltd. holds rights; Dermavant plans to submit next year an NDA in the U.S. for tapinarof to treat plaque psoriasis.

Priority Review for Clovis, BMS drugs in new settings
FDA accepted and granted Priority Review to supplemental applications from Clovis Oncology Inc. (NASDAQ: CLVS) and Bristol-Myers Squibb Co. (NYSE:BMY), giving each a PDUFA date of May 15. The agency is reviewing an sNDA for Clovis' PARP inhibitor Rubraca rucaparib to treat BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer. FDA is also reviewing a combination of BMS's anti-PD-1 mAb Opdivo nivolumab and anti-CTLA4 mAb Yervoy ipilimumab to treat first-line metastatic or recurrent non-small cell lung cancer without EGFR or ALK mutations...