Isotretinoin

Rosacea is thought to affect around 5% of the global population. Credit: Alona Siniehina / Shutterstock. The US’ Food and Drug Administration (FDA) has approved Journey Medical’s Emrosi, the brand name for its 40mg minocycline hydrochloride extended-release capsules, to be used in the treatment of dermatological condition rosacea. Developed in collaboration with Dr Reddy’s Laboratories, Emrosi – previously known as DFD-29 – is supported by positive data collected over two 16-week Phase III clinical trials. The results were shared in July 2023 and showed that DFD-29 successfully met all co-primary and secondary endpoints, establishing both safety and efficacy in comparison to placebo and current standard-of-care treatment Oracea, owned by Galderma Laboratories. Journey Medical now intends “to establish Emrosi as a new standard of care in the treatment of rosacea.” This is according to CEO Claude Maraoui, who believes the drug “has the potential to become the best-in-class oral medication to treat the condition”. Journey has reported that it is in the process of completing the manufacturing of Emrosi for the US market. It anticipates that the initial supply will be available to adult rosacea patients in the first half of 2025. The launch will mark a change in the treatment landscape. GlobalData’s 2022 ‘ Rosacea Marketed and Pipeline Drugs Assessment, Clinical Trials and Competitive Landscape ‘ report stated that Galderma was “the most prominent player in the rosacea space, offering a comprehensive portfolio of solutions”. However, it also warned that with “no presence in the late-stage pipeline and with its existing marketed products widely genericised, the company may lose its position in the rosacea market”. This balance is perhaps tipping, and Journey Medical – which GlobalData called a “less prominent player” in 2022 – is making a bid for the top spot in rosacea treatment. GlobalData is Pharmaceutical Technology’s parent company. Rosacea is a chronic inflammatory skin condition, which causes reddening of the skin, lesions and ‘spider veins’, usually around the nose and cheeks. Early symptoms may come and go, but the condition usually becomes more prominent over time. According to Yale Medicine, around 5% of the global population is affected , and untreated rosacea will progress over time, eventually leading to more severe symptoms such as facial swelling, thickened skin and eye inflammation. Rosacea treatment Emrosi will mark the latest offering in Journey Medical’s portfolio of dermatological treatments. Others include Accutane, Ximino and Amzeeq (all for varying severities of acne) and Zilxi, a topical rosacea treatment.

BALLERUP, Denmark--( BUSINESS WIRE )-- NOT FOR UK USE – NOT INTENDED FOR UK MEDIA During the first six months of 2024, LEO Pharma continued to execute on its strategy with the dermatology portfolio as the primary growth driver. With revenue growth of 11% in constant exchange rates (CER) and EBITDA margin of 9% in the first half of the year, LEO Pharma remains on course to deliver solid financial performance for the full year and the financial outlook has been updated accordingly. “ We are very pleased with the consistent, solid sales increase in H1 2024, reflecting that 100 million people are now benefiting from our innovative treatments across the globe, especially within dermatology where revenue grew by 13% (CER). The continued improvement in our earnings is the result of our strategy, commercial success, and decisive actions on cost structure. We continue to make progress on our strategic aspirations. Our focus for the rest of 2024 will be on paving the way for the potential launch of delgocitinib in Europe, progressing and expanding our pipeline, and remaining firm in our strategic execution,” says CEO Christophe Bourdon. H1 2024 financial highlights Revenue grew 11% (CER) to DKK 6,375 million (H1 2023: DKK 5,797 million). Reported growth was 10%. Dermatology revenue grew 13% (CER) to DKK 5,101 million (H1 2023: DKK 4,576 million), driven by strong growth of Adtralza®/Adbry® for atopic dermatitis (AD) and solid growth in the core dermatology portfolio. Adbry®/Adtralza® revenue increased by 84% (CER) driven by continued uptake across markets, especially in North America. Core dermatology portfolio delivered growth of 5% (CER) across markets. Growth was largely driven by Enstilar® and Protopic®. Growth across all regions: North America up 43%, Europe up 7%, Rest of the World up 6% (CER). North America continues to be the key growth driver with revenue of DKK 1,022 million. Thrombosis revenue increased by 8% (CER) driven by sales across European markets and positively impacted by certain extraordinary items during H1 2024, with underlying growth being 4%. Adjusted EBITDA was DKK 599 million (H1 2023: DKK 488 million) corresponding to a EBITDA margin of 9%, benefiting from revenue growth and operational efficiencies. EBIT was negative DKK 235 million, which represents an improvement of DKK 99 million compared to H1 2023. Free cash flow for H1 2024 was a net outflow of DKK 779 million, improved compared to H1 2023 (H1 2023: DKK (2,035) million). Progress on strategic priorities With a solid track record of delivering on the financial turnaround and consistent double-digit revenue growth, LEO Pharma remains fully committed to transforming the company into a global leader in medical dermatology. An established commercial platform with a diversified product portfolio, along with strong launch capabilities, is in place ahead of the planned launch of delgocitinib in Germany in Q4. Positive Committee for Medicinal Products for Human Use (CHMP) opinion recommending European approval of delgocitinib for the treatment of adult patients with moderate to severe chronic hand eczema (CHE), for whom topical corticosteroids are inadequate or inappropriate. Publication of results from pivotal DELTA 1 and DELTA 2 trials with delgocitinib in The Lancet, one of the most influential peer-reviewed medical periodicals in the world. The DELTA 1 and DELTA 2 trials investigated the safety and efficacy of investigational delgocitinib cream in adult patients with moderate to severe CHE. U.S. business strengthened with the FDA approval of Adbry® 300 mg single-dose autoinjector for adult patients. Successful Enstilar® phase 3 trial results in China confirms LEO Pharma’s commitment to expanding its presence in China. Phase 3 trial of TMB-001 in congenital ichthyosis did not show a statistically significant difference between active treatment and vehicle. 2024 financial outlook With our consistent increase in sales performance in H1 2024, LEO Pharma is revising its full-year revenue growth outlook upwards compared to what was shared on 3rd May 2024. Full-year revenue growth is now projected to be 9-11% in CER (before: 5-8%). The upwards revision is driven by stronger financial performance in the U.S. in addition to delayed impact from price reforms and generic competition in selected geographies. As a result of the solid first half year results, LEO Pharma is also revising its outlook upwards for adjusted EBITDA margin from a positive mid-single digit margin to a positive margin range of 6-8%. We continue to expect significant improvements in EBIT and net result relative to 2023, although still expecting to deliver both negative EBIT and net result for full year 2024. Potential changes in key assumptions for market growth and unexpected health care and pricing reforms are key risk factors, among others, which could change the outlook for the year. About LEO Pharma LEO Pharma is a global company dedicated to advancing the standard of care for the benefit of people with skin conditions, their families and society. Founded in 1908 and majority owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, and today, the company offers a wide range of therapies for all disease severities. LEO Pharma is a limited liability company and is headquartered in Denmark with a global team of approx. 4,200 people, serving millions of patients across the world. In 2023, the company generated net sales of DKK 11.4 billion. Forward-looking statements This announcement contains forward-looking statements, including forecasts of future revenue and operating profit, as well as expected business-related events. Such statements are subject to risks and uncertainties, as various factors, some of which are beyond LEO Pharma’s control, may cause actual results and performance to differ materially from the forecasts made in this announcement.