Organon to Acquire Dermavant Sciences and Tapinarof Cream

Organon recently announced that it will acquire Dermavant Sciences, a Roviant company, and its novel product, tapinarof cream 1% (Vtama). Organon is a global health care company with the mission to “improve the health of women throughout their lives.”¹

Tapinarof cream 1% is a once-daily, non-steroidal topical that was approved by the FDA for the treatment of mild, moderate, and severe plaque psoriasis in adults in May 2022.² Additionally, the FDA is currently reviewing Dermavant’s supplement new drug application (sNDA) of tapinarof cream for the treatment of atopic dermatitis in adults and pediatric patients aged 2 years and older. A Prescription Drug User Fee Act action date is anticipated in the fourth quarter of 2024.^1,3

Currently, Organon’s portfolio includes more than 60 medications and products in women’s health, biosimilars, and various therapeutic areas. The company states that it invests in innovative solutions and research to drive future growth opportunities in women’s health and biosimilars.

"Women were excluded from clinical trials until 1993 when their inclusion became law and for the longest time, many clinical trials ran under the assumption that the only difference between women and men was their sexual and reproductive organs. However, we now understand that many diseases, in particular inflammatory skin diseases, impact women differently. It is known that despite lower PASI scores, psoriasis can have greater negative impacts on quality of life in women in comparison to men," said Mona Shahriari, MD, assistant clinical professor of dermatology at the Yale University School of Medicine, the associate director of clinical trials at CCD Research, and a Dermatology Times Editorial Advisory Board member, in an exclusive statement.

According to Organon’s announcement, psoriasis presents a significant impact to quality of life and atopic dermatitis is associated with a higher disease burden for women compared to men.”

"It is known that the diagnosis and therapy initiation for plaque psoriasis in women oftentimes overlaps with peak reproductive years with more than 75% of women being diagnosed before age 40. And despite lower PASI scores, psoriasis can have greater negative impacts on quality of life in women in comparison to men. It is also known that AD is more common in women than men with menstrual and pregnancy-related deteriorations of this disease. So, it is truly refreshing to see a health care company like Organon prioritize improving the health of women. We have certainly come a long way since the 90s," added Shahriari.

The efficacy and safety of tapinarof cream, an aryl hydrocarbon receptor agonist, for plaque psoriasis was evaluated in the phase 3 PSOARING-1 and PSOARING-2 clinical trials. The efficacy and safety of tapinarof cream for atopic dermatitis was evaluated in the phase 3 ADORING-1 and ADORING-2.

“We look forward to combining Dermavant’s strong dermatology commercial and field medical organization in the US, with Organon’s market access capabilities, regulatory expertise and worldwide commercial reach. This will allow us to bring Vtama cream, a patient-focused innovation in dermatology, providing an effective, well-tolerated, non-steroidal treatment option to the millions of people living with plaque psoriasis and potentially atopic dermatitis,” said Kevin Ali, chief executive officer of Organon, in the news release. “The acquisition will deliver on Organon’s objective of improving the health of women throughout their life stages by investing in treatments for conditions that affect women differently.”

“This is an unparalleled opportunity for continued growth and innovation for Dermavant, preserving our values and vision and allowing them to thrive in the new structure at Organon. We set out to revolutionize the standard of care in dermatology, and we delivered—becoming the #1 branded topical for plaque psoriasis within just two months after launching Vtama cream, and providing over 275,000 patients with the relief they desperately needed,” said Todd Zavodnick, chief executive officer of Dermavant, in the news release. “I am certain that this merger will provide us the scope and global scale to unleash the potential of Vtama cream.”

Organon will acquire Dermavant for aggregate consideration of up to approximately $1.2 billion, with an upfront payment of $175 million and a $75 million milestone payment once tapinarof cream is approved for atopic dermatitis, as well as payments of up to $950 million for the achievements of “certain commercial milestones.”

References

1. Organon to acquireDermavant including its innovative dermatologic therapy, VTAMA (tapinarof) cream, 1%. News release. Organon. September 18, 2024. Accessed September 18, 2024. https://www.organon.com/news/organon-to-acquire-dermavant-including-its-innovative-dermatologic-therapy-vtama-tapinarof-cream-1/
2. FDA approves Dermavant’s Vtama (Tapinarof) cream, 1% for the treatment of plaque psoriasis in adults: first topical novel chemical entity launched for psoriasis in the US In 25 years. News release. Dermavant Sciences. May 24, 2022. Accessed September 18, 2024. https://dermavant.com/u-s-fda-approves-our-novel-topical-treatment-for-adults-with-plaque-psoriasis/
3. Dermavant announces FDA acceptance of supplemental new drug application (sNDA) for VTAMA (tapinarof) cream, 1% for the treatment of atopic dermatitis in adults and children 2 years of age and older. News release. Dermavant Sciences. April 29, 2024. Accessed September 18, 2024. https://dermavant.com/dermavant-announces-fda-acceptance-of-supplemental-new-drug-application-snda-for-vtama-tapinarof-cream-1-for-the-treatment-of-atopic-dermatitis-in-adults-and-children-2-years-of-age-and-old/