Business Wire

Galderma Continues Global Growth Ambition With Sculptra ® (injectable poly-L-lactic Acid) Re-launch in Europe

Share

Galderma today announced a European re-launch of Sculptra® (injectable poly-L-lactic acid) - a collagen stimulator - with an updated administration protocol. This means that the product is ready for use more quickly following reconstitution, with increased levels of comfort for patients. Sculptra® can now be used immediately following a two-minute reconstitution and with the optional addition of lidocaine for patient comfort. Previously, healthcare professionals had to wait two hours following reconstitution to administer the product. Sculptra® now has the fastest reconstitution protocol of any injectable poly-L-lactic acid (PLLA) available in Europe, representing a significant growth opportunity for Galderma.

Sculptra® has been my go-to tool for treating skin laxity resulting from aging and collagen loss in my patients’ skin, helping restore a youthful appearance,” said Dr. Christoph Martschin, Dermatologist, Akademikliniken, Department of Dermatology, Stockholm, and a featured speaker at the Sculptra® European re-launch virtual event. “This new reconstitution protocol for Sculptra® represents an exciting benefit as we are able to save valuable clinic time for clinicians while improving overall procedure comfort for our patients.”

Collagen provides structure and support to the skin. With facial aging, the skin’s natural collagen supply may decrease and could lead to skin laxity, wrinkles and roughness as skin quality worsens.1,2 Sculptra® is a collagen stimulator that may help replenish lost collagen by gradually stimulating and increasing an individual’s own natural collagen production, helping restore skin quality and firmness.2-5

The updated protocol is based on new data from physiochemical studies,6 as well as results from a randomized, evaluator-blinded, parallel-group, multi-center study (NCT03780244) evaluating the safety and effectiveness of two different dilutions of Sculptra®. This study demonstrated that treatment immediately following a two-minute reconstitution using the higher reconstitution volume (9 mL including lidocaine) was well tolerated, caused less pain on injection and was comparable to that of the reference group (Sculptra®5 mL) in reducing wrinkle severity of nasolabial folds (NLF) at Week 48 (n=80). Additionally, the mean change in wrinkle assessment scale (WAS) from baseline (assessed by Blinded Evaluator) was similar in both Sculptra®study groups across 48 weeks and investigator assessed improvement using the Global Aesthetic Improvement Scale (GAIS) was > 90% in both Sculptra® study groups.

As part of this European re-launch and in line with the company’s intensified commitment to Sculptra®, Galderma held a dedicated interactive, virtual event with over 1,000 healthcare professionals to provide additional training and support related to this new administration protocol. The event also facilitated best practice sharing among physicians based on their clinical experiences.

“We are delighted to bring this expanded Sculptra®offering to healthcare professionals in Europe, and yesterday’s launch event was an exciting, well-attended re-introduction to Sculptra®and Galderma’s larger aesthetics portfolio,” said Alexandre Brennan, Global Business Unit Head, Aesthetics. “We continue to build a unique and extensive aesthetics offering at Galderma, and are proud to re-launch Sculptra®in Europe as the foundation of our portfolio alongside a range of complementary treatments to deliver impressive and long-lasting results for healthcare professionals and their patients.”

Sculptra® was first approved in Europe in 1999, in the United States in 2009 and in Brazil in 2004. Sculptra® is now available in more than 40 countries globally, and additional regulatory reviews of applications for Sculptra® in various regions are ongoing.

About Sculptra®
Sculptra® works to stimulate the skin’s own collagen production and is suitable for increasing the volume of depressed areas, particularly to correct skin depressions such as skin creases, wrinkles, folds, scars and for skin aging. Sculptra® is also suitable for large volume corrections of the signs of facial fat loss (lipoatrophy).

Sculptra®is an injectable biostimulator containing microparticles of Poly-L-Lactic Acid (PLLA) which gradually revitalizes the skin’s structural foundation, providing natural-looking, long-term results for up to 25 months. Sculptra® was first approved in 1999 in Europe and it is currently available in more than 40 countries globally. To learn more about Sculptra® products, visit www.galdermaaesthetics.com

About Galderma
Galderma, the world's largest independent global dermatology company, was created in 1981 and is now present in approximately 100 countries with an extensive product portfolio of prescription medicines, aesthetic solutions and consumer care products. The company partners with healthcare professionals 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 www.galderma.com

  1. Shuster S, Black MM, McVitie E. The influence of age and sex on skin thickness, skin collagen and density. Br J Dermatol. 1975;93:639-643.
  2. Bohnert K et al. Plast Reconstr Surg 2019;127(4):1684–92.
  3. Stein P et al. J Dermatol Sci 2015;78(1):26–33.9.
  4. Goldberg D et al. Dermatol Surg 2013;39(6):915–22.
  5. Vleggaar D et al. J Drugs Dermatol 2014;13 (4 suppl):s29–31.
  6. Baumann K et al. J Drugs Dermatol. 2020;19(12):1199-1203.

###

Contact information

Investor and media relations
Christian Marcoux, M.Sc.
Chief Communications Officer
christian.marcoux@galderma.com
+41 76 315 26 50

Media Contact
Lauren Starr
Head of Franchise Communications
media@galderma.com
+41 79 771 52 45

About Business Wire

Business Wire
Business Wire



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

RoboSense Teams Up With Webasto On Smart Roof Module With Integrated MEMS LiDAR23.4.2021 20:00:00 CEST | Press release

During the Shanghai Auto Show, RoboSense (https://robosense.ai/), a smart and automotive LiDAR system provider, and Webasto (https://www.webasto-group.com/), the global Top 100 automotive supplier and market leader for roof systems, announced cooperation on the Smart Roof Sensor Module that integrated with RoboSense automotive-grade MEMS LiDAR RS-LiDAR-M1 for Level 3 to Level 5 autonomous driving vehicles, largely simplifying the structure and mounting process of conventional sensor sets of self-driving vehicles and ensures advanced safety perception. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210423005484/en/ The M1 is seamlessly embedded into Webasto Roof Sensor Module (Photo: Business Wire) Through this strategic cooperation, Webasto is committed to seamlessly embedding the RoboSense M1, camera and other sensor systems to the panoramic roof of vehicles to provide safer and more reliable environment perception informat

LEO Pharma Presents Long-Term Safety and Efficacy Data for Tralokinumab in Adults With Moderate-to-Severe Atopic Dermatitis at AAD VMX 202123.4.2021 16:05:00 CEST | Press release

LEO Pharma A/S, a global leader in medical dermatology, today announced results on the long-term safety and efficacy profile of tralokinumab in adult patients with moderate-to-severe atopic dermatitis. Results were shared as an oral presentation during the American Academy of Dermatology Virtual Meeting Experience (AAD VMX) 2021. Tralokinumab is a high affinity, human monoclonal antibody that specifically binds to and inhibits the IL-13 cytokine, a key driver of atopic dermatitis signs and symptoms.2,3 It is an investigational therapy in clinical development, and its safety and efficacy are currently being evaluated by regulatory authorities. The interim analysis at 56 weeks in the ECZTEND trial (NCT03587805) showed tralokinumab 300 mg every other week plus optional topical corticosteroids (TCS) demonstrated long-term improvements in itch, sleep, and in atopic dermatitis signs and symptoms.1 Patients who had enrolled in pivotal Phase 3 trials ECZTRA 1 and 2 who continued into ECZTEND w

Merck Announces New Data Strengthening Evidence for Continued Safe and Effective MAVENCLAD ® Use During the COVID-19 Pandemic23.4.2021 15:11:00 CEST | Press release

Not intended for UK and U.S. based media Merck, a leading science and technology company, today announced a new analysis from the MAGNIFY-MS sub-study showing a specific immune repopulation pattern in patients with relapsing multiple sclerosis (RMS) treated with MAVENCLAD® (cladribine tablets), which may contribute to their ability to fight infections and develop protective antibodies from vaccines. The data were presented at the 2021 American Academy of Neurology (AAN) Annual Meeting that was held virtually 17-22 April 2021. In the MAGNIFY-MS study, reduction of memory B cells occurred as early as one month after MAVENCLAD initiation with lowest levels sustained for up to 12 months, while naïve B cells, which are typically required for the generation of antibody responses following vaccination, began recovering immediately. Previously shared data from MAGNIFY-MS indicated that patients receiving MAVENCLAD are able to mount responses to influenza and varicella zoster vaccines, irrespec

Xsolla Offers Exit Strategies to Game Studios for Exit Advising and Planning23.4.2021 15:00:00 CEST | Press release

Xsolla, the video game commerce company powered by its Transaction Engine and Business Engine to help developers and publishers market, sell, connect and optimize their games globally, has announced Xsolla Exit Strategies. The new service will connect development studios with financial and transaction advisors, guiding them through the process of selling their game property or studio, from due diligence preparation to exiting. The unveil of Xsolla Exit Strategies comes full circle from Xsolla Funding Club, launched March 2019, which provides matchmaking between vetted game projects and qualified investors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210423005013/en/ Let Xsolla Exit Strategies match you with a financial and transaction advisor to help meet your exit goals. (Graphic: Business Wire) The gaming industry continues to flourish as demand is high for strategic partnerships and acquisitions for both game companies

Wipro Achieves Google Cloud Partner Specialization in Application Development23.4.2021 14:33:00 CEST | Press release

Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO), a leading global information technology, consulting and business process services company, today announced that it has achieved the Google Cloud Partner Specialization in application development. This marks the fourth Partner Specialization badge that Wipro has received from Google Cloud, following recognition for outstanding cloud security, migration, and work transformation. This specialization demonstrates Wipro’s capabilities across multiple areas as a Google Cloud SI partner. As a trusted Google Cloud partner, Wipro can help customers leverage the best of Google Cloud platform as they develop and manage cloud-native business applications, enabling faster time to market, increasing scalability of applications and integrating them with external and internal systems in the IT landscape. This specialization will allow Wipro’s team of certified professionals to accelerate the customer modernization journey, increase agility and adapta

LEO Pharma Receives Positive CHMP Opinion of Adtralza ® (tralokinumab) for the Treatment of Adults With Moderate-to-Severe Atopic Dermatitis23.4.2021 13:59:00 CEST | Press release

LEO Pharma A/S, a global leader in medical dermatology, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting a marketing authorization of Adtralza® (tralokinumab) for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy. The CHMP positive opinion is one of the final steps before the European Commission makes its decision on the Marketing Authorization Application for use of Adtralza, an investigational therapy in clinical development, throughout the European Union. This final decision is expected in the coming months and if authorized, Adtralza will be the first fully human, monoclonal antibody available to specifically target the IL-13 cytokine, a key driver of atopic dermatitis signs and symptoms. Adtralza specifically targets IL-13 with high affinity and is developed to improve the symptoms of atopic derma

Schlumberger Announces First-Quarter 2021 Results23.4.2021 12:50:00 CEST | Press release

Schlumberger Limited (NYSE: SLB) today reported results for the first-quarter 2021. First-Quarter Results(Stated in millions, except per share amounts)Three Months EndedChange Mar. 31, 2021 Dec. 31, 2020 Mar. 31, 2020 SequentialYear-on-yearRevenue* $5,223 $5,532 $7,455 -6% -30% Income (loss) before taxes - GAAP basis $386 $471 $(8,089) -18% n/m Net income (loss) - GAAP basis $299 $374 $(7,376) -20% n/m Diluted EPS (loss per share) - GAAP basis $0.21 $0.27 $(5.32) -22% n/m Adjusted EBITDA** $1,049 $1,112 $1,347 -6% -22% Adjusted EBITDA margin** 20.1% 20.1% 18.1% 0 bps 203 bps Pretax segment operating income** $664 $654 $776 1% -14% Pretax segment operating margin** 12.7% 11.8% 10.4% 88 bps 230 bps Net income, excluding charges & credits** $299 $309 $351 -3% -15% Diluted EPS, excluding charges & credits** $0.21 $0.22 $0.25 -5% -16% Revenue by Geography International $4,211 $4,343 $5,225 -3% -19% North America* 972 1,167 2,180 -17% -55% Other 40 22 50 n/m n/m $5,223 $5,532 $7,455 -6% -30%

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