GALDERMA

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 www.ipsen.com.

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: www.galderma.com.

References:

1. 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.
2. 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.
3. 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.
4. Galderma data on file: initial results of the phase IIIb 43QM2106 trial
5. Galderma data on file: initial results of the phase IIIb 43QM2107 trial
6. 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.
7. 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.
8. Alluzience^® Summary of Product Characteristics, 2023.
9. Dysport^® Summary of Product Characteristics, 2022.

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