Organon Completes Acquisition of Dermavant, including Innovative Dermatologic Therapy, VTAMA® (tapinarof) Cream, 1%
Organon (NYSE: OGN) has completed its acquisition of Dermavant Sciences from Roivant, expanding its dermatology portfolio with VTAMA® (tapinarof) cream. VTAMA is a novel nonbiologic, non-steroidal topical therapy FDA-approved for plaque psoriasis in adults, with no safety label warnings or use restrictions. The FDA is reviewing VTAMA for atopic dermatitis treatment in adults and children, with a decision expected in Q4 2024. The acquisition strengthens Organon's dermatology capabilities, particularly in treating chronic inflammatory skin conditions that affect millions globally, with psoriasis and atopic dermatitis having significant impact on quality of life.
Organon (NYSE: OGN) ha completato l'acquisizione di Dermavant Sciences da Roivant, ampliando il proprio portafoglio dermatologico con la crema VTAMA® (tapinarof). VTAMA è una nuova terapia topica non biologica e non steroidea, approvata dalla FDA per la psoriasi placca negli adulti, senza avvertenze sulla sicurezza o restrizioni d'uso. La FDA sta esaminando VTAMA per il trattamento della dermatite atopica negli adulti e nei bambini, con una decisione attesa nel quarto trimestre del 2024. L'acquisizione rafforza le capacità dermatologiche di Organon, in particolare nel trattamento delle condizioni cutanee infiammatorie croniche che colpiscono milioni di persone a livello globale, con la psoriasi e la dermatite atopica che hanno un impatto significativo sulla qualità della vita.
Organon (NYSE: OGN) ha completado su adquisición de Dermavant Sciences de Roivant, ampliando su portafolio dermatológico con la crema VTAMA® (tapinarof). VTAMA es una nueva terapia tópica no biológica y no esteroidea, aprobada por la FDA para la psoriasis en placa en adultos, sin advertencias de seguridad ni restricciones de uso. La FDA está revisando VTAMA para el tratamiento de la dermatitis atópica en adultos y niños, con una decisión esperada en el cuarto trimestre de 2024. La adquisición refuerza las capacidades dermatológicas de Organon, particularmente en el tratamiento de enfermedades cutáneas inflamatorias crónicas que afectan a millones de personas a nivel mundial, siendo la psoriasis y la dermatitis atópica de gran impacto en la calidad de vida.
Organon (NYSE: OGN)은 Roivant로부터 Dermavant Sciences를 인수하여 VTAMA® (tapinarof) 크림으로 피부과 포트폴리오를 확장했습니다. VTAMA는 성인의 판상 건선 치료를 위해 FDA에서 승인된 새로운 비생물학적, 비스테로이드성 국소 요법으로, 안전 경고나 사용 제한이 없습니다. FDA는 성인과 아동의 아토피 피부염 치료에 대해 VTAMA를 검토 중이며, 2024년 4분기에 결정이 예상됩니다. 이번 인수는 피부 질환에 대한 Organon의 치료 능력을 강화하여, 전 세계적으로 수백만 명에게 영향을 미치는 만성 염증성 피부 질환 치료에 집중하고 있으며, 판상 건선과 아토피 피부염은 삶의 질에 상당한 영향을 미칩니다.
Organon (NYSE: OGN) a finalisé son acquisition de Dermavant Sciences auprès de Roivant, élargissant ainsi son portefeuille dermatologique avec la crème VTAMA® (tapinarof). VTAMA est une nouvelle thérapie topique non biologique et non stéroïdienne approuvée par la FDA pour le traitement du psoriasis en plaques chez les adultes, sans avertissements de sécurité ni restrictions d'utilisation. La FDA examine actuellement VTAMA pour le traitement de la dermatite atopique chez les adultes et les enfants, avec une décision attendue au quatrième trimestre 2024. Cette acquisition renforce les capacités dermatologiques d'Organon, en particulier pour le traitement des affections cutanées inflammatoires chroniques qui touchent des millions de personnes dans le monde, le psoriasis et la dermatite atopique ayant un impact significatif sur la qualité de vie.
Organon (NYSE: OGN) hat die Übernahme von Dermavant Sciences von Roivant abgeschlossen und sein dermatologisches Portfolio mit der VTAMA® (tapinarof) Creme erweitert. VTAMA ist eine neuartige nicht-biologische, nicht-steroidale topische Therapie, die von der FDA für die Plaque-Psoriasis bei Erwachsenen zugelassen ist, ohne Sicherheitswarnungen oder Nutzungseinschränkungen. Die FDA prüft VTAMA zur Behandlung der atopischen Dermatitis bei Erwachsenen und Kindern, eine Entscheidung wird im vierten Quartal 2024 erwartet. Die Akquisition stärkt die dermatologischen Fähigkeiten von Organon, insbesondere bei der Behandlung von chronischen entzündlichen Hauterkrankungen, die Millionen von Menschen weltweit betreffen, da Psoriasis und atopische Dermatitis erhebliche Auswirkungen auf die Lebensqualität haben.
- Acquisition expands dermatology portfolio with FDA-approved VTAMA cream
- VTAMA has no safety label warnings or usage restrictions
- Potential market expansion with pending FDA review for atopic dermatitis indication
- Product addresses large market of chronic skin conditions affecting millions
- FDA decision for atopic dermatitis indication pending until Q4 2024
- Significant acquisition cost impact on company's finances (though specific terms not disclosed)
Insights
The acquisition of Dermavant Sciences marks a significant strategic expansion for Organon in the dermatology market. VTAMA, the key asset in this acquisition, represents a differentiated product in the
The deal structure allows Roivant to maintain upside exposure through milestone payments, while Organon gains immediate revenue potential from VTAMA's existing psoriasis indication. This acquisition aligns with Organon's strategy to diversify beyond women's health and should contribute meaningfully to top-line growth, particularly if the AD indication receives approval in Q4 2024.
VTAMA represents a significant advancement in dermatology treatment. Its novel mechanism as a therapeutic aryl hydrocarbon receptor modulating agent (TAMA) offers a unique approach to treating inflammatory skin conditions. The lack of safety warnings and unrestricted use parameters provide a clear clinical advantage over existing topical steroids, which face limitations on duration of use and body surface area coverage.
The potential expansion into atopic dermatitis is particularly noteworthy, as current topical treatment options often have efficacy or safety concerns. VTAMA's clean safety profile could position it as a preferred first-line treatment option, especially for sensitive areas where steroids are contraindicated. The drug's development demonstrates strong clinical evidence supporting both approved and pending indications.
The acquisition expands Organon’s dermatology capabilities with a nonbiologic, non-steroidal topical treatment in the
VTAMA® (tapinarof) cream,
Plaque psoriasis and atopic dermatitis-commonly known as eczema-are common chronic inflammatory skin diseases affecting millions of people in the
“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,” said Kevin Ali, Chief Executive Officer of Organon. “Integrating the expertise of Dermavant into Organon’s
“I would like to thank Kevin and the entire Organon team for their partnership in the acquisition of Dermavant,” said 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.”
About VTAMA® (tapinarof) cream,
VTAMA cream is a non-steroidal once-daily topical treatment. The safety and effectiveness of VTAMA cream was evaluated in randomized, double-blind, vehicle-controlled trials, PSOARING-1 and 2 for plaque psoriasis. The safety and efficacy of VTAMA for the treatment of atopic dermatitis was also evaluated in ADORING-1 and ADORING-2 Phase III clinical studies and is currently under review with the FDA.
Important Safety Information
Indication: VTAMA® (tapinarof) cream,
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
See full Prescribing Information and Patient Information.
About Organon
Organon is an independent global healthcare company with a mission to help improve the health of women throughout their lives. Organon’s diverse portfolio offers more than 60 medicines and products in women’s health, biosimilars, and a large franchise of established medicines across a range of therapeutic areas. In addition to Organon’s current products, the company invests in innovative solutions and research to drive future growth opportunities in women’s health and biosimilars. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical partners and innovators looking to commercialize their products by leveraging its scale and agile presence in fast growing international markets.
Organon has geographic scope with significant reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in
For more information, visit http://www.organon.com and connect with us on LinkedIn, Instagram, X (formerly known as Twitter) and Facebook.
Cautionary Note Regarding Forward-Looking Statements
Except for historical information, this press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the
Risks and uncertainties include, but are not limited to, an inability to execute on our business development strategy or realize the benefits of our acquisition of Dermavant or any other planned acquisitions; weakening of economic conditions that could adversely affect the level of demand for Dermavant’s products; the risk that the business will not be integrated successfully; risks related to the ability to realize the anticipated benefits of the acquisition, including the possibility that the expected benefits from the acquisition will not be realized or will not be realized within the expected time period; the ability to retain key personnel; unknown liabilities; the risk of litigation and/or regulatory actions related to the completed acquisition; pricing pressures globally, including rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to Medicare, Medicaid and health care reform, pharmaceutical reimbursement and pricing in general; an inability to fully execute on Organon’s product development and commercialization plans in
About Roivant
Roivant is a biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes IMVT-1402 and batoclimab, fully human monoclonal antibodies targeting FcRn in development across several IgG-mediated autoimmune indications; brepocitinib, a potent small molecule inhibitor of TYK2 and JAK1 in development for the treatment of dermatomyositis and non-infectious uveitis; and mosliciguat, an inhaled soluble sGC activator in development for pulmonary hypertension associated with interstitial lung disease, in addition to other clinical stage molecules. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. For more information, www.roivant.com.
Roivant Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are usually identified by the use of words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and variations of such words or similar expressions. The words may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act.
Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, and statements that are not historical facts, including statements about the clinical and therapeutic potential of our product candidates, the availability and success of topline results from our ongoing clinical trials and any commercial potential of our product candidates following applicable regulatory approvals. In addition, any statements that refer to projections, forecasts or other characterizations of future events, results or circumstances, including any underlying assumptions, are forward-looking statements. Actual results may differ materially from those contemplated in these statements due to a variety of risks, uncertainties and other factors, including (i) the possibility that the transaction may involve unexpected costs or liabilities, (ii) the risk that disruptions from the transaction will harm relationships with employees, customers and suppliers and other business partners or (iii) the risk that the achievement of the specified milestones or royalties described in the definitive agreement for the transaction may take longer to achieve than expected or may never be achieved and the resulting contingent milestone payments or royalties may never be realized.
Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our filings with the
1 Armstrong, A., Mehta, M., Schupp, C., Gondo, C., Bell, S., Griffiths, C. Psoriasis Prevalence in Adults in
2 Eczema Prevalence. National Eczema Foundation. Eczema Prevalence, Quality of Life and Economic Impact.
3 Carole, G., Corsin, S., Meienberger, N., Valeska Maul, L., Maul, J-T. The Impact of Gender and Sex in Psoriasis: What to be Aware of When Treating Women with Psoriasis. Int J Women’s Dermatol. 2022 Jun; 8(2): e010. doi: 10.1097/JW9.0000000000000010. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9112394/
4 Urban, K., Chu, S., Giesey, RL., Mehrmal, S., Uppal, P., Nedley, N., Delost, GR. The Global, Regional, and National Burden of Atopic Dermatitis in 195 Countries and Territories: An ecological study from the Global Burden of Disease Study 2017. 2021 Mar; 2: 12-18. JAAD International. doi: https://doi.org/
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Source: Organon & Co.
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