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Evolus Initiates Nuceiva® Launch in Germany and Austria
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Rhea-AI Summary
Evolus, Inc. (NASDAQ: EOLS) has launched Nuceiva® in Germany and Austria, marking a significant expansion in the European aesthetic toxin market. This product, approved by the European Commission, targets moderate to severe vertical lines between the eyebrows in adults under 65. The company is partnering with Novvia for distribution in these regions and anticipates entering more European countries and Australia in 2023. The launch follows extensive clinical trials demonstrating the effectiveness of Nuceiva® compared to Botox®. Evolus aims to enhance its market presence and meet growing consumer demand for aesthetic treatments.
Positive
Launch of Nuceiva® in Germany and Austria enhances market presence.
Partnership with Novvia supports effective distribution.
Nuceiva® is approved by the European Commission, indicating regulatory compliance.
The product is backed by comprehensive clinical trial data, including a pivotal head-to-head study with Botox®.
Negative
None.
Launch in second-largest European aesthetic toxin market1 represents a significant step in company’s geographic expansion
Novvia will serve as distribution partner in Germany and Austria
NEWPORT BEACH, Calif.--(BUSINESS WIRE)--
Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a customer-centric approach focused on delivering breakthrough products, has commenced the commercial launch of Nuceiva® (botulinum toxin type A) in Germany and Austria, and is now available for direct order and delivery to customers.
Nuceiva® is approved by the European Commission for the temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines), when the severity of the above facial lines has an important psychological impact in adults below 65 years of age2.
“We are excited to introduce Nuceiva® to customers in Germany and Austria, the second largest aesthetic toxin market in Europe1,” said David Moatazedi, President and CEO of Evolus Inc. “Entering this dynamic European market is the latest in a series of geographical expansion milestones that will help fuel Evolus’ above market average growth in the underpenetrated aesthetic neurotoxin market.”
Evolus is partnering with Novvia, a leading supplier of specialist products to aesthetics practitioners, to commercialize the product in Germany and Austria. The company expects to enter additional European countries as well as Australia in 2023. In addition to Germany and Austria, Nuceiva® is currently commercially available in Canada and Great Britain – the largest aesthetic market in Europe1. The product is also approved for sale in the U.S. under the brand name Jeuveau®.
“With the availability of Nuceiva® in Germany, I will now have more choice. My practice has the opportunity to deliver more of what my patients want - precision-driven results using innovative products supported by robust clinical data,” said Dr. med. Thomas Zimmermann, Dermatologist, international aesthetic expert and founder of Dr. Zimmermann Aesthetic Institute. “This product, along with the company’s medical education and training programs and modern manufacturing standards, will be instrumental in evolving my practice and ultimately meeting the needs of my patients.”
“We understand the importance of choice – not just to patients, but also to our customers, and we’re thrilled to bring a new neurotoxin to Germany and Austria,” said Dan Stewart, Vice President and General Manager, Evolus International. “Along with our distributor partner Novvia, we are offering educational programs to aesthetic doctors so they can learn more about how to use this specific product and evolve their practice.”
The safety and efficacy of Nuceiva® was evaluated through the company’s TRANSPARENCY clinical program - three Phase III trials3,4 including the largest head-to-head aesthetic pivotal study versus Botox® (onabotulinumtoxinA) to date, and two long-term safety studies5,6.
About Evolus, Inc.
Evolus (Nasdaq: EOLS) is a performance beauty company evolving the aesthetic neurotoxin market for the next generation of beauty consumers through its unique, customer-centric business model and innovative digital platform. Our mission is to become a global, multi-product aesthetics company based on our flagship product, Jeuveau® (prabotulinumtoxinA-xvfs), globally licensed under the brand name Nuceiva®. The product is manufactured in a state-of-the-art facility using Hi-Pure™ technology. Visit us at www.evolus.com, and follow us on LinkedIn, Twitter, Instagram or Facebook.
Forward Looking Statements
This press release contains forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including statements that relate to the status of regulatory processes, future plans, events, prospects or performance and statements containing the words “plans,” “expects,” “believes,” “strategy,” “opportunity,” “anticipates,” “outlook,” “designed,” or other forms of these words or similar expressions, although not all forward-looking statements contain these identifying words. The company’s forward-looking statements include, but are not limited to, statements related to the company’s prospects, geographical expansion, milestones and programs.
Forward-looking statements involve risks and uncertainties that could cause actual results or experiences to differ materially from those expressed or implied by the forward-looking statements. Factors that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements include uncertainties associated with our ability to address all of our losses, costs, expenses, liabilities and damages resulting from the settlement agreement with Daewoong and our ability to comply with the terms and conditions in the Allergan/Medytox Settlement Agreements, the continued impact of COVID-19 on our business and the economy generally, uncertainties related to customer and consumer adoption of Nuceiva® / Jeuveau®, the efficiency and operability of our digital platform or commercialization strategies, competition and market dynamics, and our ability to maintain regulatory approval of Nuceiva® / Jeuveau® and other risks described in Evolus’ filings with the Securities and Exchange Commission, including in the section entitled “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2021 filed with the Securities and Exchange Commission on March 3, 2022 and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, filed with the SEC on November 8, 2022. These filings can be accessed online at www.sec.gov. Except as required by law, Evolus undertakes no obligation to update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events. If the company does update or revise one or more of these statements, investors and others should not conclude that the company will make additional updates or corrections.
Jeuveau® and Nuceiva® are registered trademarks of Evolus, Inc. Hi-Pure™ is a trademark of Daewoong Pharmaceutical Co, Ltd.
Botox® (Botulinum toxin type A) is a registered trademark of Allergan, Inc.
References:
1. Data on file: Decision Research Group (DRG) Aesthetic Injectables Market Insights, Europe, 2021.
2. https://www.ema.europa.eu/en/documents/product-information/nuceiva-epar-product-information_en.pdf (Accessed 23/02/23)
3. Berthold-Josef Rzany, MD, ScM et al. Aesthetic Surgery Journal, 2019, 1–16
4. Kenneth R. Beer et al. Dermatol Surgery 2019; 45 (11); 1381 – 1393
5. Joely Kaufman-Janette, MD et al. Aesthetic Surgery Journal 2021, 1–14
6. Z. Paul Lorenc, MD, FACS et al. Aesthetic Surgery Journal 2021, 1–16
Janet Kettels Communications Consultant, Evolus International Tel: +447738506476
Email: janet.kettels@evolus.com
Source: Evolus, Inc.
FAQ
What is the significance of Evolus launching Nuceiva® in Germany and Austria?
The launch of Nuceiva® in Germany and Austria represents a crucial step in Evolus' geographic expansion, tapping into the second-largest aesthetic toxin market in Europe.
When was Nuceiva® launched in Germany and Austria?
Nuceiva® was commercially launched in Germany and Austria as announced in the press release dated February 27, 2023.
What are the benefits of Nuceiva® as stated in the press release?
Nuceiva® is designed for the temporary improvement of moderate to severe vertical lines between the eyebrows and is supported by robust clinical data.
What clinical studies support Nuceiva®'s efficacy?
Nuceiva®'s efficacy is supported by three Phase III trials, including a pivotal head-to-head study against Botox®.
Who is responsible for distributing Nuceiva® in Germany and Austria?
Evolus has partnered with Novvia, a specialist supplier, for the distribution of Nuceiva® in Germany and Austria.
