ADK

Galderma will share exciting results from the Sculptra® Cheek Wrinkle study showing the long-lasting effectiveness and safety of Sculptra, as well as high aesthetic improvement and patient satisfaction over two yearsi The company will also present 10 research posters, including positive outcomes from the Alluzience® STAR study. This study shows high patient satisfaction and investigator preference for Alluzience over powder solutions and long duration of effect at six monthsii Two symposia will build on Galderma’s Holistic Individualized Treatment (HIT™) approach through programs Kiss & Smile™ and Balanced Pro and on another new solution offering an innovative long-term treatment approach ZUG, Switzerland--(BUSINESS WIRE)-- Galderma will be showcasing the latest updates from across its portfolio at the International Master Course on Aging Science (IMCAS) World Congress 2023 in Paris from January 26-28, 2023. Events will include several ‘meet the expert’ sessions and interactive booth activities. In addition, Galderma will share 10 research posters and host two symposia, featuring data from its broad, highly differentiated portfolio of neuromodulators, biostimulators and fillers. Presenters and contributors will draw from the company’s research into serious skin conditions, such as rosacea and actinic keratosis. Galderma is the only pure-play dermatology category leader, with more than 40 years of heritage in dermatology. Its significant presence at IMCAS underscores its commitment to delivering science, innovation and a premium experience for physicians, consumers and patients throughout the treatment journey. Galderma is a leader in bringing cutting-edge products to market and in providing the scientific community with individualized treatment approaches, training and business support. “The strength and span of our presence at IMCAS 2023 reinforce our enduring commitment to providing physicians, consumers and patients with truly innovative and individualized solutions. We look forward to connecting with the dermatology community at the congress. We will not only share our latest data but also support physicians as they take the best approach in education, assessment and technique.” BALDO SCASSELLATI SFORZOLINI, M.D., Ph.D. GLOBAL HEAD OF R&D GALDERMA Presenting the latest in clinical findings and educational efforts Galderma will be sharing important data at IMCAS on Sculptra® (injectable poly-L-lactic acid, PLLA-SCA). This is the first and only U.S. Food and Drug Administration (FDA)-approved PLLA facial injectable treatment that helps stimulate the skin’s type I collagen production.iii,iv Sculptra helps restore fullness and firmness to areas of the face that become loose or saggy. The results of the innovative Sculptra Cheek Wrinkle study, which were measured using state-of-the-art technology, show the early onset, long-lasting effectiveness and safety of the treatment for cheek wrinkle correction over 24 months. These findings were complemented by high aesthetic improvement, high subject satisfaction with cheek appearance, and improvement in skin quality parameters including radiance and skin firmness (tightness) after treatment.i Additional exciting data will be presented for Galderma’s neuromodulators, in particular for Alluzience® (abobotulinumtoxinA solution), including the latest data from Alluzience’s first phase IV study, STAR. Approved in Europe in June 2021, Alluzience is Europe’s first ready-to-use liquid neuromodulator for the treatment of moderate to severe glabellar lines (frown lines). Results from the unique STAR study show high patient satisfaction, with most investigators preferring Alluzience to powder solutions. Both investigators and patients also reported long-duration aesthetic improvement following a six-month follow-up period.ii Galderma’s symposia at IMCAS highlight its dedication to providing not only innovative products but also cutting-edge approaches to support physician assessment and technique. The first symposium builds on Galderma’s Holistic Individualized Treatment (HIT™) series with a focus on two new programs: HIT Kiss & Smile™ and Balanced Profile™. HIT is a patient-centric, science-based, individualized treatment approach that enables injectors to leverage their expertise with the renowned Galderma portfolio and optimize aesthetic outcomes while prioritizing patient satisfaction. The event is taking place in the Amphitheatre Bleu, Level 2 on Friday, January 27, from 8:30 to 10:00 AM CET. The second symposium, Our Aesthetic Lives: A long-term journey into aesthetic treatments, will deep-dive into the aesthetic lives of patients and the medical professionals who treat them as they shape the future of this field. It will take place in the Amphitheatre Bleu, Level 2 on Friday, January 27, from 4:00 to 6:00 PM CET. Showcasing cutting-edge research with 10 research posters Neuromodulators Galderma will be sharing several updates on its neuromodulators, Alluzience and Azzalure® (abobotulinumtoxinA), including: Ready-to-use abobotulinumtoxinA solution versus powder onabotulinumtoxinA for treating glabellar lines: Subjects’ and Investigators’ experiences ii Subject and physician satisfaction with abobotulinumtoxinA for glabellar line treatment in a real-world study in Chinese subjectsv How glabellar line severity at baseline can affect efficacy in neurotoxin trialsvi Biostimulators Posters on Sculptra, the first and only U.S. FDA-approved PLLA facial injectable treatment, include: Effectiveness and safety of cheek wrinkle correction using a biostimulatory poly-L-lactic acid injectable implant – clinical study data up to 24 months i Product manufacturing process for poly-L-lactic acid (PLLA-SCA)vii Skin movement and volume changes with poly-L-lactic acid (PLLA-SCA) injectable implant: a subgroup analysis of the cheek wrinkle trialviii Fillers Galderma will also be sharing the latest data on its portfolio of fillers, including Restylane® Defyne for chin. Restylane Defyne has demonstrated results across a wide range of participants, including participants with all skin types, males, and those over the age of 52.ix Posters include: Improvement of chin retrusion in Chinese subjects using a hyaluronic acid filler: a randomized, controlled, evaluator-blinded studyx Differentiation of NASHATM and OBT TM hyaluronic acid gels according to firmness and flexibility and associated clinical significancexi Actinic keratosis and rosacea For decades, Galderma has been researching these serious and often severe skin conditions that affect a significant cross-section of society, reflecting its expertise and demonstrating its commitment to advancing dermatology for every skin story. Posters include: Cosmetic outcomes in patient-centered management of AK – Personalizing Actinic Keratosis Treatment (PAKT) expert consensusxii A customized skin care routine benefits patients with severe rosacea under combination therapy with ivermectin 1% cream and doxycycline 40-mg or ivermectin and placeboxiii About Alluzience® Alluzience (abobotulinumtoxinA solution) is the first ready-to-use BoNT-A liquid neuromodulator formulation to be introduced in Europe. Alluzience is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines seen at maximum frown in adult patients under 65 years, when the severity of these lines has an important psychological impact on the patient.xiv It should only be administered by a physician with appropriate qualifications and expertise in this treatment using the required equipment.xiv Dosing and treatment intervals depend on assessment of the individual patient’s response.xiv The treatment interval should be no more frequent than every three months.xiv For more information, please see the Summary of Product Characteristics.xiv Alluzience is a product under license from Ipsen. Alluzience is a registered trademark of Ipsen. Galderma has an exclusive license from Ipsen to develop, promote and distribute Alluzience in the approved indication in Europe (excluding Greece, Lithuania, Estonia, Latvia, Hungary). About Azzalure® / Dysport® Dysport (abobotulinumtoxinA) is a prescription injection indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adult patients less than 65 years of age, the treatment of adults with cervical dystonia, the treatment of upper limb spasticity in adults, and the treatment of lower limb spasticity in pediatric patients two years of age and older.xv Dysport is also marketed as Azzalure in the European Union for the treatment of glabellar lines and lateral canthal lines. Dysport has more than 30 years of clinical experience globally for therapeutic indications and 13 years for aesthetics indications, with extensive clinical evidence of safety and efficacy. It is licensed for aesthetic indications in more than 85 markets worldwide, Dysport is one of the world’s leading brands of aesthetic neuromodulators with over 100 million treatments delivered in the aesthetics indications to date. Dysport is a product under license from Ipsen and is manufactured by them. Since 2009, Galderma and Ipsen have had a strategic partnership under which Galderma has promoted and distributed Ipsen’s botulinum toxin type A products in aesthetic indications. The Ipsen-Galderma strategic partnership now covers China, the United States, Europe and the Middle East, Australia, South Korea, Canada, Brazil, Argentina and certain other countries. Ipsen continues to promote Dysport within certain therapeutic indications in countries around the world. For more information on Ipsen, visit . About Galderma’s Restylane® portfolio RESTYLANE is the original non-animal stabilized hyaluronic acid filler with over 26 years of achievement and over 55 million treatments worldwide. NASHA™ and OBT™ technologies make RESTYLANE the world’s most diverse range of fillers to deliver truly individualized results.xvi,xvii The RESTYLANE portfolio of products includes RESTYLANE, RESTYLANE® LYFTTM, RESTYLANE® KYSSETM, RESTYLANE® VOLYMETM, RESTYLANE® DEFYNETM, RESTYLANE® REFYNETM, RESTYLANE® EYELIGHTTM and RESTYLANE® SKINBOOSTERS VITALTM. About Sculptra® SCULPTRA is the first and original injectable collagen stimulator containing microparticles of unique poly-L-lactic acid (PLLA-SCA) which gradually revitalizes the skin’s structural foundation, providing long-term results for more than two years.xviii SCULPTRA was first approved in 1999 in Europe, and it is currently available in more than 40 countries globally. SCULPTRA works to stimulate the skin’s own collagen productionxix to provide firm and radiant skin. It is suitable for increasing the volume of depressed areas, particularly to correct skin depressions such as skin creases, wrinkles, folds, and scars, and for signs of skin aging.xx About Galderma Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermo-Cosmetics and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we’re in shapes our lives, we are advancing dermatology for every skin story. Galderma’s portfolio of flagship brands includes Restylane, Dysport, Azzalure, Alluzience and Sculptra in Injectable Aesthetics; Soolantra®, Epiduo®, Differin®, Aklief®, Epsolay®, Twyneo®, Oracea®, Metvix®, Benzac® and Loceryl® in Therapeutic Dermatology; and Cetaphil® and Alastin® in Dermo-cosmetics. For more information, visit References i Fabi S. Poster presented at IMCAS 2023. ii Arne Gerber P. Poster presented at IMCAS 2023. iii Sculptra injectable poly-L-lactic acid. Instructions for Use. Galderma Laboratories. 2023. iv Stein P. et al. J Dermatol Sci. 2015;78:26-33. v Song W. Poster presented at IMCAS 2023. vi Kaufman-Janette J. Poster presented at IMCAS 2023. vii Morgan P. Poster presented at IMCAS 2023. viii Fabi S. Poster presented at IMCAS 2023. ix Data on file. 43USCH1702 Clinical Study Report. Fort Worth, TX: Galderma Laboratories, L.P., 2020. x Xie Y. Poster presented at IMCAS 2023. xi Öhrlund A. Poster presented at IMCAS 2023. xii Haedersdal M. Poster presented at IMCAS 2023. xiii Schaller M. Poster presented at IMCAS 2023. xiv Alluzience Summary of Product Characteristics, 2022. xv Dysport Summary of Product Characteristics, 2022 xvi Data on file (MA-33939). xvii Öhrlund A. Poster presented at AMWC 2019. xviii Brown SA et al. Plast Reconstr Surg 2011;127(4):1684–92. xix Bohnert K et al. Plast Reconstr Surg 2019;127(4):1684–92. xx Sculptra IFU. 2018. View source version on businesswire.com: Contacts For further information: Christian Marcoux, M.Sc. Chief Communications Officer christian.marcoux@galderma.com +41 76 315 26 50 Rachel Mooney Global Franchise Communications rachel.mooney@galderma.com +41 76 261 64 41 Sébastien Cros Corporate Communications Director Sebastian.cros@galderma.com +41 79 529 59 85 Source: Galderma View this news release online at:

A study provides compelling evidence of the important role of hepatocyte adenosine kinase in the progression of nonalcoholic fatty liver disease, NAFLD. A study led by Texas A&M AgriLife Research provides compelling evidence of the important role of hepatocyte adenosine kinase in the progression of nonalcoholic fatty liver disease, NAFLD. The study, "Hepatocyte Adenosine Kinase Promotes Excessive Fat Deposition and Liver Inflammation," appeared in September in the scientific journal Gastroenterology. Hepatocytes are cells that play pivotal roles in liver function, including in metabolism, detoxification, protein synthesis and innate immunity. An important player in the proper function of hepatocytes is an enzyme called adenosine kinase, ADK. However, the current study shows that ADK can also drive liver disease progression. "We aimed to study whether hepatocyte ADK functions to promote excessive fat deposition and liver inflammation," said Chaodong Wu, M.D., Ph.D., an AgriLife Research Faculty Fellow in the Texas A&M Department of Nutrition. Wu is also a Presidential Impact Fellow of Texas A&M University and the corresponding author for the study. Wu said NAFLD is highly associated with obesity and progresses to an advanced stage when the liver develops overt inflammatory damage. This study pointed to the idea that hepatocyte ADK may be an important therapeutic target for managing obesity and NAFLD. "The research demonstrated that hepatocyte adenosine kinase promotes excessive fat deposition and liver inflammation and is a key factor in the pathogenesis of nonalcoholic fatty liver disease," he said. "There is already some evidence as to how making dietary changes can be effective in helping prevent or reduce the severity of NAFLD. If further research validates the effects of dietary components on inhibiting adenosine kinase in hepatocytes, scientists could develop new approaches for managing this disease. About the study The researchers examined how changes in ADK activity relate to levels of liver inflammation and amount of fat in the liver. The team studied mice that were genetically engineered to have either more or less ADK activity than normal. The team fed the mice a high-fat diet for 12 weeks or a methionine-choline deficient diet, which is known to contribute to liver injury, for five weeks. Under these diets, mice with lowered ADK activity in their hepatocytes had lower levels of fat and inflammation in the liver than controls. In contrast, mice with elevated ADK activity had greater body weight and increased body fat, liver fat and liver inflammation levels than normal mice. Going further, the team conducted experiments to clarify exactly how ADK activity causes these effects. Wu said the study included the analysis of cell-to-cell crosstalk using single-cell RNA sequencing, which was done with assistance from James Cai, Ph.D., a researcher in Texas A&M's Department of Veterinary Integrative Biosciences. "The study's analysis of lipid profiles in mouse liver samples indicated increased presence of lipids that promote mitochondrial dysfunction, leading in turn to liver inflammation," Wu said. The team went on to analyze ADK activity and liver health in human liver samples. Like in mice, the data showed that decreased levels of ADK correlated with lower levels of NAFLD, while increased levels of the enzyme were linked to exacerbated liver steatosis and inflammation. The results also showed that ADK promotes excessive fat deposition and liver inflammation through suppressing fatty acid oxidation in liver cells. "The amount of hepatocyte ADK protein was positively correlated with the degrees of hepatic steatosis in livers from human subjects," Wu said. "This novel finding highlights the enzyme's pathological importance in human NAFLD." Diet and NAFLD A 2020 study by Chaidong Wu, Ph.D., and his team showed that indole, a natural compound found in cruciferous vegetables, may be effective against nonalcoholic fatty liver disease. (Photo courtesy of Texas A&M Department of Horticultural Sciences) Wu said the new study strongly indicates that an unhealthy diet, such as a diet with enriched saturated fatty acids, has a stimulatory effect on increasing the adenosine kinase protein amount in the liver. "This, in turn, positively correlates with the degrees of obesity, NAFLD and systemic insulin resistance," he said. Wu previously investigated the role of diet in NAFLD in a 2020 study led by AgriLife Research scientists. The study, published in Hepatology, showed that indole -- a natural compound found in gut bacteria and cruciferous vegetables such as cabbage, kale, cauliflower and Brussels sprouts -- may be effective in fighting the disease. "This natural compound may lead to new treatments or preventive measures for NAFLD," Wu said. "Healthy foods with high capacity for indole production are important in preventing NAFLD and are beneficial for improving the health of those with it." He said preventing NAFLD's development and progression may depend on nutritional approaches to ensure that gut microbes allow indole and other metabolites to function effectively.