Lower limb spasticity

Phase III READY-3 study met its co-primary endpoints, with RelabotulinumtoxinA significantly improving both frown lines and crow’s feet when treated alone or simultaneously1 Results demonstrate high patient satisfaction at one month and long duration of effect for six months1 Data further reinforce RelabotulinumtoxinA’s long duration of effect first observed in the phase III READY-1 and READY-2 trials, validating it as a well-tolerated and highly effective treatment for frown lines and crow’s feet1-3 READY-3 study results will be presented at the upcoming TOXINS 2024 conference, alongside data from Galderma’s broad portfolio of innovative neuromodulators, including Alluzience® and Dysport® ZUG, Switzerland--(BUSINESS WIRE)-- Galderma announced today positive topline results from the phase III READY-3 clinical trial investigating the use of RelabotulinumtoxinA for the treatment of glabellar lines (frown lines) and lateral canthal lines (crow’s feet), either alone (single-area) or simultaneously. The study met its co-primary endpoints, demonstrating that a single dose of RelabotulinumtoxinA significantly improves both frown lines and crow’s feet, when treated alone or simultaneously, with long duration of effect for six months.1 These and other results from the READY phase III clinical trial program, as well as from Galderma’s broad and innovative aesthetics portfolio, will be presented at the TOXINS 2024 International Conference in Berlin, held from January 17-20, 2024. “We’re looking forward to sharing the latest updates from our world-leading injectable aesthetics portfolio at TOXINS 2024, particularly first data from our phase III READY-3 trial. These results build on those previously seen in the READY-1 and READY-2 trials, further reinforcing RelabotulinumtoxinA’s ability to provide long-lasting improvement for frown lines and crow’s feet when treated simultaneously.” BALDO SCASSELLATI SFORZOLINI, M.D., Ph.D. GLOBAL HEAD OF R&D GALDERMA The READY clinical trial program is composed of four phase III trials which enrolled more than 1,900 participants. READY-3 is a phase III randomized, double-blind, placebo-controlled trial designed to assess the safety and efficacy, as measured by aesthetic improvement, of RelabotulinumtoxinA in patients with moderate to severe frown lines or crow’s feet, either administered as a single-area treatment or simultaneously on both frown lines and crow’s feet, when compared to placebo. The trial met its co-primary endpoints, with patients and investigators reporting at least a two-grade improvement in line severity after single-area treatment of frown lines (71%) or crow’s feet (45%) and simultaneous treatment (72% frown lines and 55% crow’s feet), compared to placebo at one month (p<0.001).1 Investigator-reported response rates at one month were high, with 94-96% reporting none or mild frown lines when treated alone or simultaneously with crow’s feet, compared to placebo (2%, p<0.001), and 79-84% reporting none or mild crow’s feet when treated alone or simultaneously with frown lines, compared to placebo (20%, p<0.001). The median time of return to baseline line severity on both investigator- and patient-assessed scales was approximately six months after single-area (24-25 weeks) or simultaneous treatment (25-27 weeks), reinforcing previous results demonstrating the long duration of effect of RelabotulinumtoxinA. Patient satisfaction was high, with up to 91% reporting satisfaction with simultaneous treatment at one month. RelabotulinumtoxinA was well tolerated with low rates of treatment-related adverse events reported (4-9% compared to 5% for placebo); there were no serious treatment-related adverse events.1 “Patients often want their aesthetic look to last longer or to receive treatment on multiple facial areas simultaneously, and practitioners want to deliver consistent results for their patients. These new data highlight the ability of RelabotulinumtoxinA to address all these key needs for frown lines and crow’s feet, while also being a ready-to-use formulation that’s easy to administer.” DR. VINCE BERTUCCI, M.D. CO-DIRECTOR, DERMATOLOGIC LASER SURGERY & AESTHETIC DERMATOLOGY FELLOWSHIP, UNIVERSITY OF TORONTO, CANADA These results further reinforce the positive safety, efficacy and long duration of effect data observed in the READY-1 and READY-2 trials, which – together with recent phase IIIB results – also demonstrated RelabotulinumtoxinA’s rapid onset of action on frown lines and crow’s feet as early as day 1.2-5 Data from the READY-1 and READY-2 studies will be presented at the TOXINS 2024 conference, highlighting that:2,3 Both studies met their primary endpoints, with significantly higher responses than placebo after one month for both frown lines and crow’s feet. Results showed rapid onset of action, with over a third of patients seeing results on day 1 for frown lines (39%) and crow’s feet (34%), and demonstrated long duration of effect for six months. RelabotulinumtoxinA is currently under investigation by Galderma and is not approved for any indication in any jurisdiction. At the conference, Galderma will also present data from its broad and innovative neuromodulator portfolio, including: Results from the phase IV STAR study demonstrating the innovative science of Alluzience® (abobotulinumtoxinA solution) for the treatment of frown lines. In 81% of the treatment sessions, the investigators preferred Alluzience over onabotulinumtoxinA. The majority of patients maintained aesthetic improvement in frown lines and reported high satisfaction, including a natural and refreshed look, throughout six months.6 Results from a phase IV non-interventional study investigating the real-world use of Dysport® (abobotulinumtoxinA) for the treatment of frown lines in 250 patients in China, reinforcing the long-term duration results and providing further evidence of Dysport use in clinical practice.7 Additionally, a Galderma-sponsored educational symposium on Alluzience will be chaired by Dr. Magdalena Korwin and Dr. Christoph Martschin, on Friday, January 19, from 3:35 – 4:05PM CET. More details on Galderma’s scientific presentations at TOXINS 2024 can be found here. About RelabotulinumtoxinA (QM1114) Developed by Galderma, RelabotulinumtoxinA is a highly-active, innovative, complex-free, and ready-to-use liquid botulinum toxin A with a proprietary strain and manufactured using a unique state-of-the-art process. It is designed as a ready-to-use liquid solution, avoiding the traditional requirement to reconstitute from powder and eliminating variability, errors and risks associated with reconstitution, which would be expected to improve the consistency of results. RelabotulinumtoxinA is currently being investigated globally by Galderma, to expand its neuromodulator portfolio as part of the broadest Injectable Aesthetics portfolio on the market. 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. It should only be administered by a physician with appropriate qualifications and expertise in this treatment using the required equipment. Dosing and treatment intervals depend on assessment of the individual patient’s response. The treatment interval should be no more frequent than every three months. For more information, please see the Summary of Product Characteristics.8 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. About 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.9 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 Galderma is the emerging 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 though Injectable Aesthetics, Dermatological Skincare 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 are in shapes our lives, we are advancing dermatology for every skin story. For more information: . References: Bertucci V, et al. Efficacy and Safety of a Novel Formulation Liquid Botulinum Toxin, RelabotulinumtoxinA, when used for Combination Treatment of Glabellar and Lateral Canthal Lines. Abstract presented at TOXINS 2024. Solish N, et al. Treatment of Moderate-to-Severe Glabellar Lines with RelabotulinumtoxinA, an Investigational Liquid Botulinum Toxin: Clinical Efficacy and Safety Results from the READY-1 Phase III trial. Abstract presented at TOXINS 2024. Ablon G, et al. Treatment of Lateral Canthal Lines with RelabotulinumtoxinA, an Investigational Liquid Botulinum Toxin: Clinical Efficacy and Safety Results from the READY-2 Phase III Trial. Abstract presented at TOXINS 2024. Galderma data on file: initial results of the phase IIIb 43QM2106 trial Galderma data on file: initial results of the phase IIIb 43QM2107 trial Persson C, et al. Patient and Investigator Treatment Experience with Ready-to-Use AbobotulinumtoxinA Solution Versus Powder BotulinumtoxinA for Treatment of Glabellar Lines. Abstract presented at TOXINS 2024. Persson C, et al. A Real-World Study of Patient and Physician Satisfaction with AbobotulinumtoxinA Treatment of Glabellar Lines in Chinese Patients. Abstract presented at TOXINS 2024. Alluzience® Summary of Product Characteristics, 2023. Dysport® Summary of Product Characteristics, 2022. View source version on businesswire.com: Contacts Christian Marcoux, M.Sc. Chief Communications Officer christian.marcoux@galderma.com +41 76 315 26 50 Sébastien Cros Corporate Communications Director sebastien.cros@galderma.com +41 79 529 59 85 Céline Buguet Franchise and R&D Communications Director celine.buguet@galderma.com +41 76 249 90 87 Emil Ivanov Head of Strategy, Investor Relations, and ESG emil.ivanov@galderma.com +41 21 642 78 12 Jessica Cohen Investor Relations and Strategy Director jessica.cohen@galderma.com +41 21 642 76 43 Source: Galderma View this news release online at:

Merz Therapeutics’ XEOMIN is injected intramuscularly to improve muscle tone. Credit: Mufid Majnun on Unsplash. The UK’s medicines and healthcare products regulatory agency (MHRA) has granted approval for a new indication for Merz Therapeutics’ XEOMIN (incobotulinumtoxinA) to treat focal spasticity of the lower limbs affecting the ankle joint. The therapy was previously approved in the UK to treat upper limb spasticity. Recommended Reports Reports LOA and PTSR Model - Carboxyamidotriazole Orotate in Glioblastoma Multiforme (GBM) GlobalData Reports LOA and PTSR Model - Valbenazine Tosylate in Chorea GlobalData View all The expanded approval allows the company to provide holistic support to those living with spasticity who need comprehensive treatment. The active ingredient in XEOMIN is incobotulinumtoxinA. It is injected intramuscularly to improve muscle tone. The therapy blocks nerve impulses to the muscles to weaken voluntary muscle contraction. It relieves abnormal muscle tone by inhibiting the release of acetylcholine from the peripheral nerve endings. Merz Therapeutics stated that XEOMIN can now be used to treat lower and upper limbs individually or simultaneously, by adjusting the dose as required. Merz Therapeutics CEO Stefan König stated: “The label extension in the UK is an important step for Merz Therapeutics and the patients that we serve. “With the UK becoming the second market, following Japan, to grant approval for the treatment of lower limb spasticity affecting the ankle joint, it establishes the UK as the pioneering European country in this area.” The company noted that 400 units per injection is the maximum dose of XEOMIN required to treat lower limbs. 500 units is the maximum dose for the combined treatment of upper and lower limb spasticity. XEOMIN has already received approval in more than 75 countries across the world for the treatment of blepharospasm, cervical dystonia, upper and lower limb spasticity and sialorrhea.

FRANKFURT, Germany--( BUSINESS WIRE )-- Merz Therapeutics, a business of the Merz Group and a leader in the field of neurotoxins, received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) for the use of XEOMIN ® for the treatment of focal spasticity of the lower limb affecting the ankle joint. The approval, which previously included upper limb spasticity, has now been extended, enabling Merz Therapeutics to offer holistic support to people in the UK living with spasticity who require comprehensive treatment. “The label extension in the UK is an important step for Merz Therapeutics and the patients that we serve. With the UK becoming the second market, following Japan, to grant approval for the treatment of lower limb spasticity, affecting the ankle joint, it establishes the UK as the pioneering European country in this area. This approval supports our strong commitment to bringing better outcomes to more patients,” says Stefan König, CEO Merz Therapeutics. Enabling holistic treatment for people living with spasticity Lower limb spasticity is a consequence of upper motor neuron damage as may occur following e.g. a stroke. Each year, around 41,800 people in England have a stroke that results in spasticity, approximately 66 % of which suffer from spasticity in the ankle. 1 XEOMIN ® with the active ingredient incobotulinumtoxinA is injected intramuscularly to improve tone. Appropriately qualified healthcare practitioners can now use XEOMIN ® to treat lower and upper limbs individually or concomitantly, adjusting the dosage as needed. John Lambert, Country Manager of Merz Therapeutics UK & Ireland: “This new therapeutic indication supports an extension of the benefit XEOMIN ® can bring in the treatment of spasticity. We are very proud that we can now offer an alternative product to help patients in the UK.” With the new therapeutic indication, the maximum dose of XEOMIN ® for the treatment of the lower limb is 400 units per injection. For the combined treatment of upper and lower limb spasticity, the maximum dose per administration is 500 units for the first injection and rising to 600 units for following injections. Accepting that patients should always be administered the lowest effective dose possible, with an increase in total dose patients can now be treated with XEOMIN ® for more patterns of spasticity simultaneously than before this new indication. The dosing interval should be at least 12 weeks. The therapeutic indication is based on trial data from Japan, where XEOMIN ® was also approved for treatment of the lower limb region in 2021. Going forward, Merz Therapeutics can thus offer UK patients being treated for their spasticity a more holistic solution for their treatment. 1. National Institute for Health and Care Excellence Draft scope for the proposed appraisal of botulinum toxin type A (Botox, Dysport and Xeomin) for treating upper and lower limb spasticity associated with stroke Issue Date: July 2014. Available at: https://www.nice.org.uk/guidance/gid-tag499/documents/spasticity-after-stroke-botulinum-toxin-type-a-draft-scope-for-consultation-prereferral-july-20142 . (Accessed: 02 June, 2023). About XEOMIN ® XEOMIN ® is effective by weakening the contraction of voluntary muscles. It relieves the muscle tone by inhibiting the release of a neurotransmitter called acetylcholine from the peripheral nerve endings. XEOMIN ® is free from complexing proteins and has a low risk of neutralizing antibody formation. XEOMIN ® is approved in more than 75 countries worldwide to treat patients with upper and lower limb spasticity, cervical dystonia, blepharospasm and sialorrhea. About Merz Therapeutics Merz Therapeutics GmbH is dedicated to improving the lives of patients around the world. With its relentless research, development, and culture of innovation, Merz Therapeutics strives to serve unmet patient needs and realize better outcomes. Merz Therapeutics seeks to address the unique needs of people who suffer from movement disorders, neurological conditions, liver disease, and other health conditions that severely impact patients’ quality of life. Merz Therapeutics is headquartered in Frankfurt am Main, Germany and is represented in more than 90 countries, with a North America affiliate based in Raleigh, North Carolina. Merz Therapeutics GmbH is part of the Merz Group, a privately held, family-owned company that has dedicated more than 110 years to developing innovations that serve unmet patient and customer needs. Please visit www.merztherapeutics.com About Merz Merz Group is a global, diversified company with its headquarters in Frankfurt, Germany. Its commitment to innovation, long-term perspective, and focus on profitable growth depict the privately owned company that has been around for more than 110 years. Merz Group has the businesses Merz Aesthetics, Merz Therapeutics, Merz Consumer Care, Merz Real Estate and Financial Investments. The company employs 3,969 people in 28 countries worldwide. To learn more, please visit www.merz.com .