- VTAMA® (tapinarof) cream, 1% demonstrated early, significant, and meaningful achievement of both no-to-minimal itch (mean weekly PP-NRS≤1) and sleep improvement in ADORING 1 and ADORING 2. - 31.4% and 33.0% of patients treated with VTAMA cream in ADORING 1 and ADORING 2, respectively achieved no-to-minimal itch at Week 8 (P=0.0072 and P=0.0003 versus vehicle). Results were statistically significant at Week 1, with continued improvement through Week 8. - Similarly, sleep improvements with VTAMA cream were statistically significant for patients ≥12 years old and <12 years old versus vehicle at Week 8 (both P<0.0001), with statistical significance achieved at Week 1, the earliest assessment. LONG BEACH, Calif., and BASEL, Switzerland--(BUSINESS WIRE)--Dermavant Sciences, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, will present data on the achievement of no-to-minimal itch (weekly mean Peak Pruritus Numerical Rating Scale (PP-NRS≤1); also referred to as an itch-free state) and sleep improvement in patients with atopic dermatitis as young as two years old at the American College of Allergy, Asthma and Immunology Annual Meeting, being held in Boston, MA, October 24-28, 2024. The data presented were generated from Dermavant’s Phase 3 ADORING 1 and ADORING 2 pivotal trials studying VTAMA cream, 1% in patients with moderate to severe atopic dermatitis as young as two years old. In the ADORING pivotal trials, adults and children (n=813) were randomized to VTAMA cream or vehicle once daily for eight weeks. In ADORING 1 and ADORING 2, vIGA-AD TM success, defined as vIGA-AD=0 or 1 and ≥2-grade improvement from baseline at Week 8, was achieved by 45% and 46% of patients on VTAMA cream vs 14% (P<0.0001) and 18% (P<0.0001) of patients on vehicle, respectively. The most common adverse reactions (incidence ≥1%) in patients treated with VTAMA cream were folliculitis, nasopharyngitis, headache, asthma, and influenza. Peak Pruritus Numerical Rating Scale (PP-NRS) data, a patient reported outcome, were used to assess pruritus (itch) relief. Sleep improvement was assessed using question two, (Over the last week, on how many nights has your/your child’s sleep been disturbed because of eczema?) on the Patient Oriented Eczema Measure (POEM), using a 5-point scale. Results: A statistically significant improvement in sleep, achievement of no-to-minimal itch (PP-NRS≤1), and mean weekly PP-NRS<2 targets were observed as early as Week 1 (first assessment) with continued improvement observed through Week 8 in patients with atopic dermatitis treated with VTAMA cream versus vehicle. The proportion of patients with atopic dermatitis achieving no-to-minimal itch was statistically significantly higher in VTAMA cream groups compared with vehicle as early as Week 1 (the first assessment) and continued through Week 8 in both ADORING 1 and ADORING 2: 31.4% vs 17.4% (P=0.0072) and 33.0% vs 14.0% (P=0.0003). The proportion of patients with atopic dermatitis achieving PP-NRS<2 was statistically significantly higher in VTAMA cream groups compared with vehicle as early as Week 1 (the first assessment) and continued through Week 8 in both ADORING 1 and ADORING 2: 48.1% vs 28.4% (P=0.0006) and 46.8% vs 19.6% (P<0.0001). Sleep improvement reached statistical significance with VTAMA cream versus vehicle at Week 1, the earliest assessment, and continued through Week 8 in a pooled analyses for ADORING 1 and ADORING 2 in both patients with atopic dermatitis aged 2-11 years and ≥12 years: -1.7 vs -1.0 (P<0.0001) and -1.4 vs -0.8 (P<0.0001). “In the ADORING 1 and ADORING 2 trials, VTAMA cream demonstrated an early, significant, and meaningful achievement of no-to-minimal itch and improvement in sleep, for patients with atopic dermatitis” said Eric Simpson, MD, MCR, the Frances J. Storrs Medical Dermatology Professor and Director of the CLEAR Eczema Center, at the Oregon Health & Science University. “Itch frequently causes sleep disturbance in patients with atopic dermatitis, which can be especially burdensome for young patients and their families. In the ADORING pivotal trials, VTAMA cream demonstrated significant itch reduction and sleep improvement, in patients with atopic dermatitis, versus vehicle and was well-tolerated in both adults and children down to two years of age. Subject to FDA approval, VTAMA cream could become a compelling new treatment option for atopic dermatitis patients, most of whom regard itch as one of the most bothersome symptoms of their disease.” About Dermavant’s Phase 3 Program for VTAMA cream in Atopic Dermatitis ADORING is Dermavant’s Phase 3 atopic dermatitis (AD) clinical development program for VTAMA® (tapinarof) cream, 1%, which consists of ADORING 1 (NCT05014568) and ADORING 2 (NCT05032859), as well as ADORING 3 (NCT05142774), a 48-week open-label, long-term extension study. About Atopic Dermatitis Atopic dermatitis (AD), commonly referred to as eczema, is one of the most common inflammatory skin diseases, affects over 26 million people in the U.S. alone and up to 10% of adults worldwide. AD occurs most frequently in children, affecting up to 20% worldwide. The disease results in itchy, red, swollen, and cracked skin, often affecting the folds of the arms, back of the knees, hands, face, and neck. Itching is an especially bothersome symptom in AD, and tends to worsen at night, disturbing sleep and causing fatigue, which in children can lead to inattention at school. People with AD may also experience social and emotional distress due to the visibility and discomfort of the disease. About Dermavant Dermavant Sciences, a subsidiary of Roivant Sciences, is a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology. Dermavant’s focus is to develop therapies that have the potential to address high unmet medical needs while driving greater efficiency in research and clinical development. The company’s medical dermatology pipeline includes earlier-development, late-stage and commercialized, product candidates that target specific unmet needs in two of the largest growing immuno-dermatology markets, plaque psoriasis and atopic dermatitis, as well as other immunological and inflammatory diseases. Dermavant is marketing VTAMA® (tapinarof) cream, 1%, for the topical treatment of plaque psoriasis in adults. The FDA approved VTAMA cream for the topical treatment of mild, moderate, and severe plaque psoriasis in May 2022. Dermavant has been developing VTAMA cream for the treatment of atopic dermatitis in adults and children 2 years of age and older and released positive topline results from its ADORING 1 and 2 pivotal Phase 3 clinical trials in 1H 2023. Dermavant’s pipeline includes DMVT-506, a next generation aryl hydrocarbon receptor (AhR) agonist under development as a potential treatment option for immunological and inflammatory diseases with multiple potential routes of administration. IMPORTANT SAFETY INFORMATION Indication: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults. Adverse Events: The most common adverse reactions (incidence ≥ 1%) in subjects treated with VTAMA cream were folliculitis (red raised bumps around the hair pores), nasopharyngitis (pain or swelling in the nose and throat), contact dermatitis (skin rash or irritation, including itching and redness, peeling, burning, or stinging), headache, pruritus (itching), and influenza (flu). You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. See full Prescribing Information and Patient Information. For more information, please visit and follow us on Twitter ( @dermavant ) and LinkedIn ( Dermavant Sciences ). © 2024 Dermavant Sciences, Inc. All Rights Reserved. Dermavant and VTAMA are the registered trademarks of Dermavant Sciences, GmbH. vIGA-AD is the trademark of Eli Lilly and Co. Contacts dna Communications: Jillian Parker Account Director, Media Relations, Healthcare jparker@dna-comms.com 732-501-2624

临床结果临床3期上市批准

2024-09-18

·PipelineReview

Organon to Acquire Dermavant including its Innovative Dermatologic Therapy, VTAMA® (tapinarof) Cream, 1%

VTAMA cream is a novel, non-steroidal topical therapy approved for treatment of plaque psoriasis in adults and is under FDA review for an additional indication to treat atopic dermatitis Proposed acquisition extends Organon’s international dermatology capabilities to the U.S. JERSEY CITY, NJ, USA I September 18, 2024 I Organon (NYSE: OGN), a global healthcare company with a mission to improve the health of women throughout their lives, and Dermavant Sciences Ltd. announced today that they have entered into a definitive agreement, under which Organon will acquire Dermavant, a Roivant (NASDAQ: ROIV) company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology. Dermavant’s novel product, VTAMA® (tapinarof) cream, 1%, for the topical treatment of mild, moderate, and severe plaque psoriasis in adults, was approved by the U.S. Food and Drug Administration (FDA) in May 2022. VTAMA cream is a once-daily, steroid-free, topical applied to affected areas with no safety label warnings or precautions and without restrictions on location and duration of use or body surface area. The FDA is reviewing a Supplemental New Drug Application (sNDA) for VTAMA cream 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. Psoriasis is a common chronic inflammatory skin disease affecting over 8 million Americans 20 years of age or older 1 and 125 million people worldwide 2 . Atopic dermatitis is one of the most common inflammatory skin conditions impacting approximately 16.5 million adults and more than 9.6 million children in the U.S. 3 In adults, women are impacted disproportionately 4 . Psoriasis presents a significant impact to quality of life 5 and atopic dermatitis is associated with a higher disease burden 6 for women compared to men. “We look forward to combining Dermavant’s strong dermatology commercial and field medical organization in the U.S., 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, Organon Chief Executive Officer. “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 another example of Roivant’s ability to offer creative win-win collaborations. We are able to meet Organon’s structural objectives and to create a transaction that is very attractive to both Roivant and Dermavant stakeholders, while still preserving meaningful economics tied to the potential future success of VTAMA,” said Matt Gline, Chief Executive Officer of Roivant. “Additionally, we are excited for VTAMA cream to benefit from Organon’s commercial scale. We believe they have the capabilities and reach to ensure patients globally can access this important medicine.” “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. “I am certain that this merger will provide us the scope and global scale to unleash the potential of VTAMA cream.” “We structured the deal economics to be heavily weighted towards success-based milestones and royalties, similar to other transactions we have executed to date. This is consistent with our commitment to disciplined capital allocation as we look to continue to reduce our leverage, but also strategically add growth assets,” said Matthew Walsh, Organon Chief Financial Officer. Terms of the Transaction Organon has agreed to 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 upon regulatory approval in AD, as well as payments of up to $950 million for the achievements of certain commercial milestones. In addition, Organon will pay Dermavant shareholders tiered royalties on net sales. Dermavant owns the rights to VTAMA cream globally excluding China and has out licensed Japan rights. Completion of the transaction is subject to review under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. Closing of the transaction is currently expected to take place in the fourth quarter of 2024. Upon closing of the transaction, as part of the purchase price consideration, Organon would assume Dermavant liabilities with an approximate value of $286 million reported by Roivant as of June 30, 2024, which would be subject to fair value accounting by Organon. Given the transaction is expected to close in the fourth quarter 2024, revenue contribution from VTAMA as well as expenses associated with onboarding the product are not expected to impact the full year 2024 non-GAAP guidance ranges provided on August 6 th , 2024. The transaction is expected to be modestly dilutive to Adjusted EBITDA in 2025, turning accretive in 2026. Organon expects net leverage to be elevated above 4.0x as a result of the transaction. The transaction is not expected to result in a revision to Organon’s capital allocation priorities. Roivant was represented by Freshfields Bruckhaus Deringer LLP as legal advisor and Goldman Sachs & Co. LLC as financial advisor. Organon was represented by Covington & Burling LLP as legal advisor. About VTAMA® (tapinarof) cream, 1% VTAMA cream is a non-steroidal once-daily topical treatment that works by activating aryl hydrocarbon receptors in the skin to reduce inflammation and normalize the skin barrier. The safety and effectiveness of VTAMA cream was evaluated via randomized, double-blind, vehicle-controlled trials, PSOARING-1 and 2 for psoriasis. The safety and efficacy of VTAMA for the treatment of atopic dermatitis was also evaluated as part of the ADORING-1 and 2 Phase III clinical studies, and is currently under review with the FDA. Important Safety Information Indication: VTAMA ® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults. VTAMA cream is for use on the skin (topical) only. Do not use VTAMA cream in your eyes, mouth, or vagina. Adverse Events: The most common adverse reactions (incidence ≥ 1%) in subjects treated with VTAMA cream were folliculitis (red raised bumps around the hair pores), nasopharyngitis (pain or swelling in the nose and throat), contact dermatitis (skin rash or irritation, including itching and redness, peeling, burning, or stinging), headache, pruritus (itching), and influenza (flu). 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 strategy 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 a global footprint with significant scale and geographic reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey. For more information, visit http://www.organon.com and connect with us on LinkedIn , Instagram , X (formerly known as Twitter) and Facebook . About Dermavant Dermavant Sciences, a subsidiary of Roivant Sciences, is a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology. Dermavant’s focus is to develop therapies that have the potential to address high unmet medical needs while driving greater efficiency in research and clinical development. The company’s medical dermatology pipeline includes earlier-development, late-stage and commercialized, product candidates that target specific unmet needs in two of the largest growing immuno-dermatology markets, plaque psoriasis and atopic dermatitis, as well as other immunological and inflammatory diseases. Dermavant is marketing VTAMA ® (tapinarof) cream, 1%, for the topical treatment of plaque psoriasis in adults. The FDA approved VTAMA cream for the topical treatment of mild, moderate, and severe plaque psoriasis in May 2022. Dermavant has been developing VTAMA cream for the treatment of atopic dermatitis in adults and children 2 years of age and older and released positive topline results from its ADORING 1 and 2 pivotal Phase 3 clinical trials in 1H 2023. Dermavant’s pipeline includes DMVT-506, a next generation aryl hydrocarbon receptor (AhR) agonist under development as a potential treatment option for immunological and inflammatory diseases with multiple potential routes of administration. For more information, please visit http://www.dermavant.com and follow us on Twitter ( @dermavant ) and LinkedIn ( Dermavant Sciences ). About Roivant Roivant is a commercial-stage biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. In addition to VTAMA, Roivant’s pipeline includes IMVT-1402 and batoclimab, fully human monoclonal antibodies targeting the neonatal Fc receptor (“FcRn”) in development across several IgG-mediated autoimmune indications, and brepocitinib, a potent small molecule inhibitor of TYK2 and JAK1 for the treatment of dermatomyositis and non-infectious uveitis, 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 . 1 Armstrong, A., Mehta, M., Schupp, C., Gondo, C., Bell, S., Griffiths, C. Psoriasis Prevalence in Adults in the United States. JAMA Dermatol. 2021 Aug; 157(8):1-7. doi:10.1001/jamadermatol.2021.2007 2 Psoriasis Statistics. National Psoriasis Foundation. Get the Facts About Psoriasis and Psoriatic Arthritis . 3 Eczema Prevalence. National Eczema Foundation. Eczema Prevalence, Quality of Life and Economic Impact. 4 Valentini, R., Shahriari, M. Atopic Dermatitis in Women: Special Considerations in the Childbearing Years. Int J Women’s Dermatol. 2024 Jun; 10(2): e151. doi: 10.1097/JW9.0000000000000151 . 5 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/ 6 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/10.1016%2Fj.jdin.2020.10.002 . https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8362298/ SOURCE: Organon

临床3期上市批准临床结果并购免疫疗法

2024-06-25

·BioSpace

Dermavant Announces Approval of Tapinarof in both Psoriasis and Atopic Dermatitis in Japan

- In 2020, Dermavant licensed Japan rights to Japan Tobacco to develop and commercialize tapinarof for psoriasis and atopic dermatitis - - Dermavant to receive milestone payment of $28 million in connection with approval in Japan - - VTAMA® (tapinarof) cream, 1% is approved in the U.S. for the treatment of plaque psoriasis in adults - - Dermavant recently filed an sNDA in the U.S for the treatment of atopic dermatitis in adults and children two years of age and older, with a PDUFA date in Q4 2024 - LONG BEACH, Calif. & BASEL, Switzerland--(BUSINESS WIRE)-- Dermavant Sciences Inc., a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced that Japan Tobacco has received approval in Japan for tapinarof cream, 1% for the treatment of both adults with psoriasis and patients 12 years of age and older with atopic dermatitis. “I believe Japan Tobacco’s approval speaks to tapinarof’s unique proposition in Japan as a once-daily, cosmetically elegant and steroid-free, topical cream for both acute treatment and long-term management of psoriasis and atopic dermatitis and we applaud our partner’s success,” said Todd Zavodnick, Chief Executive Officer of Dermavant. “Our commitment to bringing VTAMA (tapinarof) cream, 1% to as many U.S. patients as we can remains resolute. We are currently focused on preparing for the commercial launch of VTAMA cream, subject to FDA approval, for its second U.S. indication of atopic dermatitis, and look forward to the PDUFA date for our Supplemental New Drug Application in Q4 2024.” Under the terms of the 2020 license agreement, Dermavant received an upfront payment of $60 million, with up to a further $53 million payable upon the achievement of certain development milestones for tapinarof for the treatment of psoriasis and atopic dermatitis including $28 million for approval in Japan. In addition, Dermavant has the right to receive royalties based on product sales of tapinarof in Japan. VTAMA cream, 1% is a novel, aryl hydrocarbon receptor agonist in development in the U.S. as a once-daily, cosmetically elegant, and steroid-free, topical cream for both acute treatment and long-term management of atopic dermatitis (AD). VTAMA cream, 1% is currently approved for the topical treatment of plaque psoriasis in adults in the U.S. In April 2024, the U.S. Food and Drug Administration (FDA) accepted the company’s sNDA for VTAMA® (tapinarof) cream, 1% for the topical treatment of AD in adults and children 2 years of age and older. The Prescription Drug User Fee Act (“PDUFA”) action date assigned by the Agency is in Q4 2024. IMPORTANT SAFETY INFORMATION Indication: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults. Adverse Events: The most common adverse reactions (incidence ≥ 1%) in subjects treated with VTAMA cream were folliculitis (red raised bumps around the hair pores), nasopharyngitis (pain or swelling in the nose and throat), contact dermatitis (skin rash or irritation, including itching and redness, peeling, burning, or stinging), headache, pruritus (itching), and influenza (flu). You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. See full Prescribing Information and Patient Information. About Dermavant’s Phase 3 Program for VTAMA cream in Atopic Dermatitis ADORING is Dermavant’s Phase 3 atopic dermatitis (AD) clinical development program for VTAMA® (tapinarof) cream, 1%, which consists of ADORING 1 (NCT05014568) and ADORING 2 (NCT05032859), as well as ADORING 3 (NCT05142774), a 48-week open-label, extension trial. About Atopic Dermatitis Atopic dermatitis (AD), commonly referred to as eczema, is one of the most common inflammatory skin diseases, affects over 26 million people in the U.S. alone and up to 10% of adults worldwide. AD occurs most frequently in children, affecting up to 20% worldwide. The disease results in itchy, red, swollen, and cracked skin, often affecting the folds of the arms, back of the knees, hands, face, and neck. Itching is an especially bothersome symptom in AD, and tends to worsen at night, disturbing sleep and causing fatigue, which in children can lead to inattention at school. People with AD may also experience social and emotional distress due to the visibility and discomfort of the disease. About Dermavant Dermavant Sciences, a subsidiary of Roivant Sciences, is a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology. Dermavant’s focus is to develop therapies that have the potential to address high unmet medical needs while driving greater efficiency in research and clinical development. The company’s medical dermatology pipeline includes earlier-development, late-stage and commercialized, product candidates that target specific unmet needs in two of the largest growing immuno-dermatology markets, plaque psoriasis and atopic dermatitis, as well as other immunological and inflammatory diseases. Dermavant is marketing VTAMA® (tapinarof) cream, 1%, for the topical treatment of plaque psoriasis in adults. The FDA approved VTAMA cream for the topical treatment of mild, moderate, and severe plaque psoriasis in May 2022. Dermavant has been developing VTAMA cream for the treatment of atopic dermatitis in adults and children 2 years of age and older and released positive topline results from its ADORING 1 and 2 pivotal Phase 3 clinical trials in 1H 2023. Dermavant’s pipeline includes DMVT-506, a next generation aryl hydrocarbon receptor (AhR) agonist under development as a potential treatment option for immunological and inflammatory diseases with multiple potential routes of administration. For more information, please visit and follow us on Twitter (@dermavant) and LinkedIn (Dermavant Sciences). ©2024 Dermavant Sciences, Inc. All Rights Reserved. All trademarks are the property of Dermavant Sciences, GmbH.

临床3期上市批准引进/卖出临床结果免疫疗法

100 项与 DMVT-506 相关的药物交易

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