Dermavant Bags GSK Phase III-Ready Psoriasis Treatment in $330 Million Deal
By Alex Keown
Months after tapping GlaxoSmithKline dermatology division executive David Rubenstein as its new chief scientific officer, Vivek Ramaswamy’s Dermavant Sciences has returned to the pharma giant to acquire a Phase III-ready psoriasis treatment.
Unlike past moves where a Ramaswamy company has acquired cast-off drugs for pennies on the dollar, Dermavant ponied up $330 million for Tapinarof, a topical treatment for psoriasis and atopic dermatitis. Dermavant provided an initial payment of nearly $200 million to GSK for the medication. The remaining monies will be handed over to the U.K.-based company if future milestones are hit, according to a statement issued by GlaxoSmithKline.
Tapinarof is an investigational therapeutic aryl hydrocarbon receptor modulating agent (TAMA). Dermavant Executive Chairperson Jackie Fouse, a Celgene alumnus, said Tapinarof will be the “cornerstone of Dermavant’s pipeline.” She said it has the potential to provide an important treatment option for millions of patients affected by psoriasis and atopic dermatitis.
With the acquisition of Tapinarof, Dermavant is taking aim at multiple companies who have already fielded drugs for these indications. Sanofi and Regeneron have the powerhouse atopic dermatitis treatment Dupixent on the market. AbbVie is eying a potential launch of 2019 for risankizumab, a drug that blew away its own blockbuster drug Humira and Johnson & Johnson’s Stelara in treating patients with moderate to severe chronic plaque psoriasis during Phase III trials.
The deal is expected to be finalized during the second half of this year, GSK said. Dermavant will have global rights to Tapinarof, except in China. Dermavant will acquire global rights to the preclinical topical backup program to Tapinarof and will assume responsibility for all development milestones owed to third parties. As part of the transaction, GSK, Roivant and Dermavant will enter into agreements for supply of the investigational medicine for the phase III program and commercial supply.
For GSK the deal is part of the company’s global strategy to divest assets that no longer fit with its strategic focus. John Lepore, head of GSK’s R&D pipeline, said the sale of Tapinarof is part of that model. In a statement, he noted that Tapinarof “has the potential to be a first-in-class therapy and a convenient, once-daily topical agent that postpones or potentially eliminates the need for systemic treatment” of the two dermatological indications.
“We are confident that Dermavant is well positioned to progress rapidly with the Tapinarof development program into phase III and registration,” Lepore said.
In a Phase IIb trial for the treatment of patients with plaque psoriasis, Tapinarof hit its primary endpoint of demonstrating clinically meaningful improvements. GSK said that 56 percent of patients in the Tapinarof 1 percent once-daily group, and 46 percent of patients in the Tapinarof 0.5 percent once-daily group, achieved 75 percent or greater improvement in Psoriasis Area and Severity Index scores (PASI 75) after 12 weeks of treatment, compared to 5 percent in the placebo once-daily group.
In atopic dermatitis, Tapinarof also fared well and achieved primary endpoints in a Phase IIb study.
This is the second big licensing deal for Dermavant in the past few months. In April the company also strengthened its pipeline by licensing RVT-504 (previously THVD-102), an investigational drug for the treatment of multi-focal hyperhidrosis. Dermavant licensed the treatment from TheraVida, which had mixed results in a previous Phase II trial.