Cosmo Pharmaceuticals NV

New Delhi: Cosmo Pharmaceuticals and Glenmark announced that they have received approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) to market Winlevi , a topical treatment for acne vulgaris in patients aged 12 years and old. Winlevi is a 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, the company stated. 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. “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,” said Christoph Stoller, President & Business Head - Europe and Emerging Markets, Glenmark Pharmaceuticals . By Online Bureau ,

Cosmo Pharmaceuticals has announced that Glenmark has 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 3 studies demonstrated that clascoterone cream,1 percent, applied topically twice daily for 12 weeks, was more effective than the application of vehicle cream in achieving the Investigator’s Global Assessment (IGA) of success, reducing non-inflammatory lesion count (NILC) and inflammatory lesion count (ILC) in patients with facial acne vulgaris. clascoterone cream, 1 percent, was generally well tolerated. 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 Glenmark’s and Cosmo’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. 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," said Christoph Stoller, President & Business Head - Europe and Emerging Markets, Glenmark Pharmaceuticals. “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,” added Mesrobian. Acne vulgaris is one of the most common skin conditions, impacting more than 90 percent of the world’s population at some point in their lives. It can have both physical and emotional consequences, affecting individuals’ self-esteem and mental health.

Breaking new ground so quickly was one of the biggest technical challenges for the Cosmo Pharmaceuticals division that developed the latest version of Medtronic’s GI Genius ColonPro system, Medtronic Endoscopy Chief Artificial Intelligence Officer Ha Hong said. “It’s not easy to innovate at such speed, because they worked on several different algorithms and for each algorithm, you need to obtain high quality data and also high quality for each data point,” he said in an interview with Medical Design & Outsourcing. “That means the right amount of diversity, and also for each data point, a high quality label.” MDO also interviewed Cosmo Intelligent Medical Devices President Nhan Ngo Dinh and Science, AI and Data SVP Andrea Cherubini to learn more about the system’s development and what tips and advice they had for other device developers. In our second post from that interview (read the first one here), we discussed how the Cosmo AI team developed the latest version of GI Genius so quickly. And because Cosmo Intelligent Medical Devices was a startup called Linkverse before its acquisition by Cosmo Pharmaceuticals, we also asked how other startups should approach the medtech space. (Editor’s note: While MDO prefers live interviews to offer readers medtech expertise without the filter of marketing or public relations staff, we conducted this Q&A by email through a Medtronic representative because Cherubini and Ngo Dinh live and work in Italy. The following has been lightly edited for space and clarity.) MDO: Ha Hong said he was impressed by how quickly your team came through on this project. Can you offer some details about how long the Medtronic project took and how that breaks down into the different stages/phases? Ngo Dinh: “The GI Genius project saw a tremendous number of achievements within a short timeframe, with progress accelerating at an exponential rate. From 2017 to 2019, we laid the groundwork by utilizing Cosmo Pharmaceuticals’ extensive video resources and clinical expertise, establishing a specialized AI division, and forging a strategic partnership with Medtronic. Our efforts between 2020 and 2022 rapidly accelerated as we achieved CE certification, launched in the European market, obtained the FDA de novo clearance , and substantiated our technology’s clinical benefits through pivotal clinical studies. In the final phase, from 2023 to 2024, we experienced exponential advancements, including the rebranding of our AI division, the inauguration of the AI Access initiative, expanding our collaboration with Medtronic , and receiving FDA clearance for the latest GI Genius iteration .” Related: 9 tips for implementing AI in medical devices from Medtronic’s Ha Hong MDO: When expanding the data sets, how did you balance data quantity and quality? And how did you get this Medtronic project over the finish line as quickly as you did? Cherubini: “In expanding the datasets for training our AI, we achieved a balance between data quantity and quality by implementing a multi-tiered data collection strategy. High-quality images were sourced from several leading medical institutions globally, and these underwent rigorous validation. Our close collaboration with these institutions ensured that data collection did not disrupt their workflows. Our internal team, with expertise in data security, clinical studies, regulatory compliance, cloud management, video processing, biomedical engineering, and data annotation, ensured adherence to stringent privacy and security standards, maintaining compliance with both current and future regulations like GDPR, HIPAA, the EU AI Act, and ISO/IEC 42001. “Transparency was a cornerstone of our approach. We communicated the purposes of data collection clearly to all stakeholders, fostering trust and enabling continuous feedback. Privacy and ethical concerns were addressed rigorously through anonymization protocols, protecting patient identities. Our project management framework emphasized agile methodologies and iterative development, allowing us to swiftly integrate feedback and optimize our algorithms. This approach ensured the efficiency of the project, which of course is still ongoing to further improve our AIs.” Related: Medtronic leaders pick three technologies that are key for the future of endoscopy MDO: Hong was saying that your team has maintained and benefitted from a small startup mentality, and he encouraged me to ask what advice you would share to help small startups approach the medical device field? Ngo Dinh: “For small startups entering the medical device field, maintaining a startup mentality is crucial. Originally called Linkverse, our company was rebranded to Cosmo Intelligent Medical Devices after being acquired by Cosmo Pharmaceuticals. This transition endowed us with extensive experience in conducting high-quality clinical studies and adhering to stringent regulatory requirements. Our collaboration with Medtronic since early phases further enhanced our knowledge about how to scale and commercialize innovative technologies on a global level. Additionally, having the opportunity to bring the first real-time AI-enhanced medical device to the market was both an incredible privilege and a significant learning experience. “We learned that startups should focus on maintaining agility and embracing rapid prototyping. This allows for quick adjustments based on real-time feedback and emerging clinical needs. Integrating regulatory compliance from the beginning is essential to avoid costly setbacks later. Building strong connections with healthcare professionals for continuous feedback and validation is critical. These relationships provide insights into practical challenges and help tailor your product to meet clinical needs effectively. Establishing a multidisciplinary team that combines expertise in medical science, engineering, regulatory affairs, and business development will help navigate the complexities of the medical device landscape. Maintaining flexibility and continuously updating your knowledge base with evolving clinical and regulatory standards will ensure that your solutions remain relevant and effective.” Look for more from Cherubini and Ngo Dinh at MDO in the weeks ahead, including how device developers can work with Cosmo on GI Genius apps and tips for using AI in medtech.