Business Wire

Galderma To Present Five Abstracts in Support of Novel Aesthetics Solutions and Pipeline at ASDS 2020 Annual Meeting

Share

Galderma today announced the presentation of data from clinical trials of its aesthetic solutions and pipeline in five abstracts at the virtual American Society for Dermatologic Surgery (ASDS) 2020 Annual Meeting. The company also announced that it has completed patient enrollment in several clinical trials supporting a Phase 3 program of relabotulinumtoxinA (QM1114), its proprietary novel, ready-to-use, liquid formulation of investigational botulinum toxin, for the treatment of glabellar lines and lateral canthal lines. The Phase 3 program, called READY (RElabotulinumtoxin Aesthetic Development studY), enrolled over 1,900 patients across 60 sites in the United States and Canada in four clinical trials – three multi-center, randomized, double-blind, placebo-controlled studies and one long-term open-label study.

RelabotulinumtoxinA clinical trials will evaluate rapid onset, long duration, and additional patient measures as part of the large clinical program for this next generation botulinum toxin. The liquid formulation will be ready to use upon arrival and will not require in-office reconstitution before administration, it will reduce preparation time, and has the potential to increase accuracy and improve patient outcomes, in contrast with current treatments that require reconstitution by clinicians before administration. Derived from Galderma’s proprietary strain of Clostridium botulinum bacteria and created using an animal-origin free process, relabotulinumtoxinA will be manufactured in Galderma’s new state-of-the-art Center of Excellence in Aesthetics in Uppsala, Sweden.

“Our patient-first approach to aesthetics innovation has resulted in seven FDA approvals over the last six years. Based on the success of the latest outcomes we’ve shared today, and our continued work to bring patients safe and long-lasting results, we also expect to receive six more approvals in the next three years,” said Dr. Flemming Ornskov, MD, MPH, Chief Executive Officer, Galderma. “The launch of Restylane® Kysse earlier this year has shown the strong demand for new aesthetic solutions to improve the patient and provider experience throughout 2020. Our robust Phase 3 and Phase 4 clinical programs have helped propel the launch of Restylane® Kysse, and the data presented today underscores our relentless focus on meeting the needs of our customers.”

Galderma’s Data Presentations at ASDS 2020
During the ASDS meeting, Galderma will present clinical research findings across its neurotoxin and dermal fillers portfolio. The company’s oral and poster presentations will highlight results from the DREAM (Dysport Real-world Evaluation and Measured satisfaction) study of Dysport® (abobotulinumtoxinA) for Injection*, which demonstrated high levels of patient satisfaction and natural-looking results with only two treatments per year1. Additionally, Phase 3 clinical research showed that Restylane® Defyne was effective for correction of chin retrusion and was associated with a high degree of patient satisfaction, and Restylane® Kysse was shown to be effective for lip augmentation over a 48-week treatment period with a high degree of patient satisfaction. In a Phase 4 study of Restylane® Kysse, both subjects and their partners were satisfied with the subjects’ lips after treatment.2,3

“The results of the DREAM study showing the long duration of Dysport and high patient satisfaction with treatments given twice a year are especially important as it’s the first toxin to showcase this extended patient satisfaction benefit,”1 said Dr. Carolyn Jacob, MD, FAAD, Founder and Medical Director of Chicago Cosmetic Surgery and Dermatology and an investigator for the DREAM study. “The study data showing that 95% of patients were satisfied or highly satisfied with the aesthetic results of treating the lines between their eyebrows every six months for a year with Dysport should give patients and aesthetic specialists confidence in this treatment regimen.”1

Details about Galderma’s presentations are as follows:

Oral Presentations

  • A randomized, no-treatment controlled, evaluator-blinded, multi-center phase 3 study to evaluate the effectiveness and safety of HARD in the chin for augmentation and correction of chin retrusion – Dr. Anne Chapas (Oral Abstract: Friday October 9, 9:09-9:12 a.m.)
  • A randomized, controlled, evaluator-blinded, multicenter study to evaluate the effectiveness and safety of HAkys versus a control in augmentation of soft tissue fullness of the lip – Dr. Sue Ellen Cox (Oral Abstract: Friday October 9, 9:03-9:06 a.m.)
  • Post marketing study to evaluate lip enhancement, naturalness, and satisfaction of both subject and partner after treatment with HARK – Dr. Vince Bertucci (Oral Abstracts #5: Saturday, October 10, 11:30-11:33 a.m.)

Poster Presentations

  • Subjects are highly satisfied with two treatments of abobotulinumtoxinA a year: results from multi-center, year-long, longitudinal study – Dr. Ava Shamban (e-poster)
  • A randomized, evaluator-blinded, multi-center phase 3 study to evaluate safety and effectiveness of a biostimulatory poly-l-lactic acid injectable implant after changes in reconstitution – Dr. Melanie Palm (e-poster)

About Galderma’s collaboration with Ipsen
Dysport® (abobotulinumtoxinA) is a prescription injection for temporary improvement in the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults less than 65 years of age. Dysport® is also marketed as Azzalure® in the EU for the treatment of glabellar lines with more than 40 million treatments in the EU and U.S. combined and with approvals in 74 countries.

Dysport® is manufactured by Ipsen, a global specialty-driven pharmaceutical company. 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, the European Union, Australia, South Korea, Canada, Brazil, Argentina and certain other countries. Ipsen continues to promote Dysport® within certain neuromuscular disorder indications in countries around the world. For more information on Ipsen, visit www.ipsen.com.

About Galderma
Galderma, the world's largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio of prescription medicines, aesthetic solutions and consumer care products. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin. For more information, please visit http://www.galderma.com/.

Follow Galderma on Instagram at @GaldermaAesthetics

# # #

To learn more about serious but rare side effects and full Important Safety Information, visit www.RestylaneUSA.com.

*For U.S. audiences please see Dysport Full Prescribing Information including Medication Guide at DysportUSA.com.

The Dysport trademark is used under license. All trademarks are the property of their respective owners.

©2020 Galderma All Rights Reserved.

1 Data on file. Study 43USD1802. Galderma, Fort Worth, TX, 2020.
2 Galderma. Clinical Study Report: Post Marketing Study to Evaluate Lip Enhancement, Naturalness and Partner/Subject Satisfaction after Treatment with Restylane® Kysse N/A Restylane Kysse 2020; 29.
3 FDA. Restylane Kysse Instructions for Use (IFU) N/A Restylane Kysse 2020.

Contact information

Investor and media relations
Christian Marcoux, M.Sc.
Chief Communications Officer
christian.marcoux@galderma.com
+41 21 642 71 99

Media
Isabella Laihorinne Smedh
PR & Communications, Galderma
media@galderma.com

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

PerkinElmer Launches Industry First No-Wash Immunoassay For Phospho Ubiquitin Ser65 to Help Drive Neuroscience Disease and Therapeutics Research Forward26.10.2020 22:05:00 EETPress release

PerkinElmer, Inc., a global leader committed to innovating for a healthier world, today launched the life science industry’s first no wash Ubiquitin phosphorylation at Serine 65 immunoassay for studying defective mitophagy biological mechanisms that have been broadly associated with diseases such as Parkinson’s and Alzheimer’s. The new PerkinElmer Cisbio HTRF® Phospho-Ubiquitin (Ser65) Cellular Kit takes analysis efficiency and accuracy to the next level compared to existing techniques such as Western blot and is aimed at helping scientists discover new therapeutic candidates earlier in the disease cycle. The innovative assay leverages TR-FRET technology to bring high sensitivity across a wide range of analytes and greater study specificity to the Phospho-Ubiquitin (Ser65) intersection point that has been shown to play a key role in mitophagy dysfunction and breakdowns in the complex network between neurons and glial cells which can lead to neurodegenerative disease. Efficient and stre

NetApp Brings Optimization and Enterprise Data Services to the Cloud26.10.2020 19:00:00 EETPress release

Global, cloud-led, data-centric software company NetApp® (NASDAQ: NTAP) today unveiled a groundbreaking serverless and storageless solution for containers from Spot by NetApp, a new autonomous hybrid cloud volume platform, and cloud-based virtual desktop solutions. NetApp’s new capabilities help simplify and optimize multicloud management for the highest performance at a low cost, offering true portability for data-rich cloud applications and delivering comprehensive workplace solutions across hybrid cloud environments. “To thrive in the new normal, digital transformation has become a business imperative. To succeed, businesses need to optimize their hybrid multicloud IT architectures,” said NetApp CEO George Kurian. “No matter where customers are on their transformation journey, NetApp can help them build a data fabric to maximize the value of their data, ensure applications are running optimally, and unlock the best of cloud.” The new features and capabilities that NetApp introduced

omni:us Welcomes Insurance Veteran Antonio Derossi to Drive Growth Across US and Europe26.10.2020 18:00:00 EETPress release

omni:us, the insurance claims AI solution provider, welcomes Antonio Derossi as a member of the omni:us Senior Executive Advisory board. Mr. Derossi, with 20+ years of experience in various roles across insurance, consulting, and venture capital, will function as a key advisor on go-to-market and product optimization strategies for the North American and European insurance markets. omni:us seeks to fortify its position as global pioneer of insurance claims transformation with the expert support of Mr. Derossi. Both parties see automation as a defining element of future claims management systems. Mr. Derossi’s understanding of the intricacies of the American and European insurance space will support increased market penetration for the Berlin-based omni:us. He will also act as an effective liaison to insurance companies, solution providers and consulting partners across both continents. Derossi was born in Trieste, Italy. He holds a Laurea degree in physics from Trieste University, and

Dahua Sponsors Omdia Webinars on Next Generation Network Cameras26.10.2020 16:45:00 EETPress release

Dahua Technology, a world-leading video-centric smart IoT solution and service provider, has sponsored one white paper and two webinars hosted by Omdia. The theme of the webinars held on October 22nd is Solving security challenges: Next-generation network cameras. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201026005466/en/ (Photo: Business Wire) Omdia is the new global technology research powerhouse, established in 2019 with the combination of the Informa Tech’s research brands (Ovum, Heavy Reading, and Tractica) and the acquired IHS Markit technology research portfolio. Collaborating with Dahua Technology, the comprehensive webinar has attracted about 1200 registrations. Audiences are experts from various industries such as energy, finance, education, government, retail, etc. With webinar events experts from Omdia, Dahua Technology’s Senior Project Sales Manager Simon Nash and Omdia’s analysts Josh Woodhouse and Tommy Z

26th Yiwu Fair Concludes with Success, Reaching Deals Worth Millions in Small Commodities26.10.2020 16:36:00 EETPress release

The 26th China Yiwu International Commodities (Standards) Fair concluded in Yiwu on October 25, 2020. As the first large-scale foreign trade exhibition presented both online and offline in China amid regular epidemic prevention and control, Yiwu Fair 2020 provided more than 3,400 standard booths with an exhibition area of ​​100,000 square meters at the Yiwu International Expo Center, and attracted nearly 2,000 companies from 19 domestic provinces, municipalities and autonomous regions, covering categories of hardware, electromechanical facilities, electronic & electrical appliances, daily necessities, crafts & ornaments, stationery & office goods, toys, sporting & outdoor products, knitwear, and gift packaging. The Fair attracted a total of 106,000 offline visitors and 160 million online views. Seven overseas online matchmaking sessions were held targeting the United Kingdom, Malaysia, Chile, etc., and achieved an intended turnover of $4.66 million. While expanding the international ma

Interactive Brokers Launches Innovative Sustainable Investing Tool26.10.2020 16:18:00 EETPress release

Interactive Brokers Group (Nasdaq: IBKR), a global brokerage firm, today unveiled an innovative, interactive Impact Dashboard designed to help clients evaluate and invest in companies that align with their values. The dashboard, which is free for all clients to use, sets a new standard for tools that can be used for sustainable, socially responsible, and values-based investing. The launch comes as interest in Environmental, Social and Governance (ESG) investing is soaring. ESG assets are expected to top $53 trillion by 2022, according to research released in September by Celent. “The future of sustainable investing begins with the Impact Dashboard, which allows investors to align their portfolios with their values,” said Will Peterffy, ESG Director at Interactive Brokers. “In a world lacking transparency, the dashboard quickly analyzes and grades your stock portfolio based on your values and presents your holdings through a personalized ‘impact lens’. You can then decide whether to kee

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom