Cosmo and Glenmark Announces UK MHRA Approval of Winlevi(R) for Treatment of Acne
Cosmo Pharmaceuticals and Glenmark Pharmaceuticals announced that Glenmark has received MHRA approval to market Winlevi® in the United Kingdom for treating acne vulgaris in patients aged 12 and older. Winlevi® is the first topical acne treatment in nearly 40 years with a novel mechanism of action, featuring clascoterone as its active ingredient.
The treatment is the first commercially available topical androgen receptor inhibitor, targeting sebaceous glands without systemic anti-androgen effects, making it safe for both males and females. Two phase III studies showed that clascoterone cream 1%, applied twice daily for 12 weeks, outperformed vehicle cream in achieving Investigator's Global Assessment success and reducing lesion counts.
This approval stems from a September 2023 agreement where Glenmark in-licensed the product from Cosmo for distribution in Europe and South Africa. The treatment addresses a significant market, as acne affects over 90% of the global population at some point in their lives.
Cosmo Pharmaceuticals e Glenmark Pharmaceuticals hanno annunciato che Glenmark ha ricevuto l'approvazione MHRA per commercializzare Winlevi® nel Regno Unito per il trattamento dell'acne vulgaris in pazienti di età pari o superiore a 12 anni. Winlevi® è il primo trattamento topico per l'acne dopo quasi 40 anni con un nuovo meccanismo d'azione, con clascoterone come principio attivo.
Il trattamento è il primo inibitore topico del recettore androgeno disponibile in commercio, che prende di mira le ghiandole sebacee senza effetti antiandrogeni sistemici, rendendolo sicuro per entrambi i sessi. Due studi di fase III hanno dimostrato che la crema di clascoterone all'1%, applicata due volte al giorno per 12 settimane, ha superato la crema veicolo nel raggiungimento del successo nella Valutazione Globale dell'Investigatore e nella riduzione del numero delle lesioni.
Questa approvazione deriva da un accordo di settembre 2023 in cui Glenmark ha acquisito in licenza il prodotto da Cosmo per la distribuzione in Europa e in Sudafrica. Il trattamento affronta un mercato significativo, poiché l'acne colpisce oltre il 90% della popolazione globale a un certo punto della propria vita.
Cosmo Pharmaceuticals y Glenmark Pharmaceuticals anunciaron que Glenmark ha recibido la aprobación de MHRA para comercializar Winlevi® en el Reino Unido para el tratamiento de acne vulgaris en pacientes de 12 años o más. Winlevi® es el primer tratamiento tópico para el acné en casi 40 años con un nuevo mecanismo de acción, que presenta clascoterona como su ingrediente activo.
El tratamiento es el primer inhibidor tópico del receptor de andrógenos disponible comercialmente, dirigido a las glándulas sebáceas sin efectos antiandrogénicos sistémicos, lo que lo hace seguro tanto para hombres como para mujeres. Dos estudios de fase III mostraron que la crema de clascoterona al 1%, aplicada dos veces al día durante 12 semanas, superó a la crema vehicular en lograr el éxito en la Evaluación Global del Investigador y en la reducción del recuento de lesiones.
Esta aprobación se deriva de un acuerdo de septiembre de 2023 en el que Glenmark obtuvo la licencia del producto de Cosmo para su distribución en Europa y Sudáfrica. El tratamiento aborda un mercado significativo, ya que el acné afecta a más del 90% de la población mundial en algún momento de sus vidas.
코스모 제약과 글렌마크 제약은 글렌마크가 영국에서 윈레비®를 여드름 치료제로 승인받았다고 발표했습니다. 윈레비®는 12세 이상의 환자를 위한 여드름 치료제로, 거의 40년 만에 새로운 작용 기전을 갖춘 첫 번째 국소 여드름 치료제입니다. 이 약물의 활성 성분은 클라스코테론입니다.
이 치료제는 상업적으로 이용 가능한 첫 번째 국소 안드로겐 수용체 억제제로, 전신적인 항안드로겐 효과 없이 피지선만을 목표로 하기 때문에 남성과 여성 모두에게 안전합니다. 두 개의 3상 연구에서는 클라스코테론 크림 1%를 12주 동안 하루 두 번 적용했을 때, 차량 크림과 비교하여 연구자의 전반적인 평가 성공률을 더욱 높이고 병변 수를 감소시키는 데 효과적임을 보여주었습니다.
이번 승인은 2023년 9월의 합의에서 비롯된 것으로, 글렌마크가 유럽 및 남아프리카에서 유통하기 위해 코스모로부터 제품 라이센스를 취득한 결과입니다. 이 치료법은 여드름이 인생의 어느 시점에서든 90% 이상의 전 세계 인구에 영향을 미치는 중요한 시장을 겨냥하고 있습니다.
Cosmo Pharmaceuticals et Glenmark Pharmaceuticals ont annoncé que Glenmark a reçu l'approbation de la MHRA pour commercialiser Winlevi® au Royaume-Uni pour traiter l'acné vulgaire chez les patients âgés de 12 ans et plus. Winlevi® est le premier traitement topique contre l'acné depuis près de 40 ans, avec un nouveau mécanisme d'action, contenant du clascotérone comme principe actif.
Ce traitement est le premier inhibiteur des récepteurs androgènes topiques commercialement disponible, ciblant les glandes sébacées sans effets antiandrogéniques systémiques, ce qui le rend sûr pour les hommes et les femmes. Deux études de phase III ont montré que la crème de clascotérone à 1 %, appliquée deux fois par jour pendant 12 semaines, a surpassé la crème véhicule en atteignant le succès de l'évaluation globale des enquêteurs et en réduisant le nombre de lésions.
Cette approbation découle d'un accord de septembre 2023 par lequel Glenmark a acquis la licence du produit auprès de Cosmo pour sa distribution en Europe et en Afrique du Sud. Le traitement répond à un marché significatif, puisque l'acné touche plus de 90 % de la population mondiale à un moment donné de sa vie.
Cosmo Pharmaceuticals und Glenmark Pharmaceuticals haben angekündigt, dass Glenmark die MHRA-Zulassung erhalten hat, um Winlevi® im Vereinigten Königreich zur Behandlung von Acne vulgaris bei Patienten ab 12 Jahren zu vermarkten. Winlevi® ist die erste topische Aknebehandlung seit fast 40 Jahren mit einem neuartigen Wirkmechanismus, der Clascoteron als Wirkstoff enthält.
Die Behandlung ist der erste kommerziell verfügbare topische Androgenrezeptor-Inhibitor, der auf die Talgdrüsen abzielt, ohne systemische antiandrogene Effekte zu zeigen, was sie sowohl für Männer als auch für Frauen sicher macht. Zwei Phase-III-Studien zeigten, dass die Clascoteron-Creme mit 1%, die zweimal täglich über 12 Wochen angewendet wird, die Vehikelcreme in der erfolgreichen Erreichung der globalen Bewertung des Prüfers und der Reduzierung der Läsionszahlen übertroffen hat.
Diese Genehmigung stammt aus einer Vereinbarung im September 2023, in der Glenmark das Produkt von Cosmo für den Vertrieb in Europa und Südafrika lizenziert hat. Die Behandlung spricht einen signifikanten Markt an, da Akne über 90 % der Weltbevölkerung zu irgendeinem Zeitpunkt in ihrem Leben betrifft.
- First new topical acne treatment mechanism in 40 years
- Successful Phase III clinical trials demonstrating efficacy
- Safe for both male and female patients
- Expanding market reach through UK MHRA approval
- Strategic partnership securing European and South African distribution rights
- None.
Dublin, Ireland, and Mumbai, India and London, United Kingdom--(Newsfile Corp. - February 10, 2025) - Cosmo Pharmaceuticals N.V. (SIX: COPN) (FSE: C43) (“Cosmo”) and Glenmark Pharmaceuticals Limited (Glenmark), a global research-led pharmaceutical company, today announced that Glenmark had received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) to market Winlevi® in the United Kingdom. Winlevi® is a topical treatment for acne vulgaris in patients aged 12 years and older, marking a significant milestone in the commitment of both companies to providing innovative, patient-focused dermatology solutions.
Winlevi® is the first topical acne treatment in nearly 40 years with a first-in-class mechanism of action. Its active ingredient, clascoterone, is the first commercially available topical androgen receptor inhibitor, targeting androgen receptors in sebaceous glands with no systemic anti-androgen effects, and as such it can be used safely in both males and females. This approach is believed to help reduce sebum production and intervene early in acne pathogenesis. Two identical phase III studies demonstrated that clascoterone cream
As part of the agreement signed in September 2023, Glenmark has in-licensed the product from Cosmo Pharmaceuticals for distribution in Europe and South Africa. This collaboration underscores Cosmo’s and Glenmark’s dedication to expanding its dermatology portfolio and addressing the unmet needs of patients with acne vulgaris, a condition that affects millions of individuals worldwide and can cause both physical discomfort and psychological distress.
Giovanni Di Napoli, Chief Executive Officer of Cosmo, commented: “We are thrilled that Winlevi® has been approved for the UK market, bringing an innovative approach to acne treatment. This milestone underscores our commitment, alongside Glenmark, to providing patients with breakthrough solutions that address not just the physical symptoms of acne, but also its emotional impact. We take great pride in expanding access to this game-changing therapy and making a real difference in patients’ lives.”
“We are excited to receive the approval and bring Winlevi® to the UK market, offering patients a new and efficacious treatment for acne,” said Christoph Stoller, President & Business Head – Europe and Emerging Markets, Glenmark Pharmaceuticals. “This approval by the MHRA represents a significant step forward in our mission to enhance dermatology care. Our partnership with Cosmo Pharmaceuticals plays an important role in enabling us to expand our dermatology portfolio, and we are proud to offer this new treatment to market that can improve the quality of life for those living with acne.”
“The approval of Winlevi® for the UK market marks a crucial milestone in Glenmark’s ongoing efforts to evolve dermatology treatments,” said Xavier Mesrobian, Executive Vice President and Business Head – Europe, Glenmark SA. “We are focused on delivering therapies that address the clinical needs of patients and with Winlevi®, we are looking forward to offering an efficacious treatment option for individuals managing acne, a condition that can significantly impact self-confidence and daily life.”
Acne vulgaris is one of the most common skin conditions, impacting more than
About Cosmo
Cosmo Pharmaceuticals N.V. is committed to revolutionizing healthcare and transforming people’s lives by researching and developing innovative products that tackle unfulfilled healthcare demands. As a pharmaceutical company, Cosmo is active in the areas of Healthtech/AI, dermatology, gastroenterology and contract manufacturing & development. For the commercialization and distribution of its products, Cosmo collaborates with leading partners worldwide, including Medtronic and Sun Pharma. Founded in 1997, Cosmo is headquartered in Dublin (Ireland) and has offices also in San Diego (USA), and Lainate/Rome/Catania (Italy). The Company has approximately 330 employees at the end of 2024, all dedicated to making a significant impact in the field of healthcare. For more information, please visit www.cosmopharma.com.
About Glenmark
Glenmark Pharmaceuticals Ltd. (BSE: 532296) (NSE: GLENMARK) is a research-led, global pharmaceutical company, having a presence across Branded, Generics, and OTC segments; with a focus on the therapeutic areas of respiratory, dermatology, and oncology. The company has 11 world-class manufacturing facilities spread across 4 continents, and operations in over 80 countries. In Vivo/Scrip 100 positions Glenmark amongst the Top 100 Companies Ranked by R&D and Pharmaceutical Sales, 2022; while Generics Bulletin/In Vivo places it in the Top 50 Generics and Biosimilar Companies Ranked by Sales, 2022. Glenmark’s Green House Gas (GHG) emission reduction targets have been approved in 2023 by the Science Based Target initiative (SBTi), making it only the second pharmaceutical company in India to achieve this. The organization has impacted over 3.3 million lives over the last decade through its CSR interventions.
Cosmo financial calendar
| 2024 Full-Year Results (unaudited) | March 6, 2025 |
| J.P. Morgan European Opportunities Forum, London | March 12, 2025 |
| 2024 Annual Report Publication | March 20, 2025 |
| 26th Kepler Cheuvreux Swiss Seminar, Zurich | March 20, 2025 |
| Life Sciences Conference, Amsterdam | April 2-3, 2025 |
| 2025 Half-Year Results and Report | July 23, 202 |
For further information, please contact:
| Glenmark Shweta Munjal Chief Communications & CSR +91 9920762233 | Cosmo Hazel Winchester Head of Investor Relations +353 1 817 03 70 |
Attachments
250210_Cosmo Pharma_Media Release_Winlevi_UK approval_EN_final
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/240229
FAQ
What makes Winlevi different from other acne treatments?
How effective was Winlevi in clinical trials?
What is the market potential for Winlevi in the UK?
What territories are covered under the Glenmark-Cosmo partnership for Winlevi?
How is Winlevi administered to patients?
