Organon has completed the acquisition of Dermavant Sciences Ltd. from Roivant including tapinarof cream, 1% (Vtama, Dermavant).
Tapinarof cream, 1%, an aryl hydrocarbon receptor agonist, is approved by the U.S. Food and Drug Administration (FDA) for treatment of mild, moderate, and severe plaque psoriasis in adults. The FDA is reviewing a supplemental New Drug Application (sNDA) for tapinarof cream, 1%, as a potential treatment for atopic dermatitis (AD) in adults and children two years of age and older, with Prescription Drug User Fee Act (PDUFA) action expected in the fourth quarter of calendar year 2024.
“The future of dermatology depends on innovative treatments like VTAMA, and Organon’s acquisition of Dermavant allows us to further expand our existing portfolio of established brands and biosimilar dermatology treatments,” says Kevin Ali, Chief Executive Officer of Organon, in a news release. “Integrating the expertise of Dermavant into Organon’s U.S. organization marks the beginning of a new chapter in dermatology. We are excited to bring this nonbiologic non-steroidal topical option to the millions of patients suffering from a chronic skin condition like plaque psoriasis and, potentially in the future, atopic dermatitis.”
“I would like to thank Kevin and the entire Organon team for their partnership in the acquisition of Dermavant,” adds Mayukh Sukhatme, MD, President and Chief Investment Officer of Roivant. “This deal represents a true win-win outcome for Organon and Roivant in our mutual goal to address patient needs and is emblematic of Roivant’s ability to form non-traditional, value-enhancing collaborations on important medicines. We believe that Organon’s strong global commercial footprint will maximize the impact of VTAMA for patients globally, and we are excited to continue to share meaningfully in the success of VTAMA along the way.”