Evolus Launches Nuceiva® (botulinum toxin type A) in Italy
June 29 2023 - 9:00AM
Business Wire
- Launching in the fourth largest aesthetic toxin injectables
market in Europe1 is part of the company’s geographic expansion
strategy
- GP Dermal Solution will serve as distribution partner in
Italy
Evolus, Inc. (NASDAQ: EOLS), a performance beauty company
focused on building an aesthetic portfolio, has commenced the
commercial launch of Nuceiva® (botulinum toxin type A) in Italy.
The product 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 medical aesthetics
customers in Italy, one of the largest aesthetic toxin markets in
Europe1 and a crucial step in growing our global footprint,” said
David Moatazedi, President and CEO of Evolus Inc. “Expanding within
the dynamic European market continues to be a strategic ambition
and will help fuel Evolus’ market growth, globally.”
Evolus is partnering with GP Dermal Solution, a pioneering
company in the Italian cosmetic and wellness sector. Working
closely with their suppliers, GP Dermal Solution delivers
specialist products to aesthetics practitioners across Italy. In
addition to Italy, Nuceiva® is currently commercially available in
Canada, Germany, Austria and Great Britain. The product is licensed
in the United States under the brand name Jeuveau® and in 2022, was
the fastest growing neurotoxin in the U.S. market.3
“I’m pleased to start offering Nuceiva® to my patients. They are
looking for targeted and natural-looking results to improve the
appearance of facial lines.” said Dr. Erminio Mastroluca, a plastic
and aesthetic surgeon from Rome. “As I’m gaining real world
experience, I have the opportunity to deliver more of what my
patients want - precision-driven results using innovative products
supported by robust clinical data.”
“We understand the needs of our customers and patients are
evolving. That’s why we are thrilled to bring a new neurotoxin to
Italy,” said Dan Stewart, Vice President and General Manager,
Evolus International. “By working with our partner, GP Dermal
Solution, we will bring a range of educational programs and an
easy-to-use online service platform to help customers grow their
practice and deliver patient satisfaction with Nuceiva®.”
The safety and efficacy of Nuceiva® was evaluated through the
company’s TRANSPARENCY clinical program - three Phase III trials4,5
including the largest head-to-head aesthetic pivotal study versus
Botox® (onabotulinumtoxinA) to date, and two long-term safety
studies6,7.
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. Evolus is
expanding its product portfolio having entered into a definitive
agreement to be the exclusive U.S. distributor of Evolysse™, a line
of five unique dermal fillers currently in late-stage development.
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 in our Annual Report on Form 10-K and our Quarterly
Report on Form 10-Q for the quarter ended March 31, 2023 filed with
the Securities and Exchange Commission on May 9, 2023. 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.
Evolysse™ is a trademark 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:
- Decision Research Group (DRG) Aesthetic Injectables Market
Insights, Europe, 2021. Data on file
-
https://www.ema.europa.eu/en/documents/product-information/nuceiva-epar-product-information_en.pdf
(Accessed 23/02/23)
- Medical Insights US Facial Injectables Tracker, March 2023
www.miinews.com (Accessed 23/06/2023)
- Berthold-Josef Rzany, MD, ScM et al. Aesthetic Surgery Journal,
2019, 1–16
- Kenneth R. Beer et al. Dermatol Surgery 2019; 45 (11); 1381 –
1393
- Joely Kaufman-Janette, MD et al. Aesthetic Surgery Journal
2021, 1–14
- Z. Paul Lorenc, MD, FACS et al. Aesthetic Surgery Journal 2021,
1–16
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version on businesswire.com: https://www.businesswire.com/news/home/20230628243406/en/
Investor Contact: David K.
Erickson Vice President, Investor Relations Tel: +1-949-966-1798
Email: david.erickson@evolus.com
Media Contacts: Email:
Media@Evolus.com
Janet Kettels Communications Consultant, Evolus International
Tel: +447738506476 Email: janet.kettels@evolus.com
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