Evolus Receives Regulatory Approval for Nuceiva® in Australia
24 January 2023 - 01:00AM
Business Wire
- Australia among the largest countries in the
world for aesthetic neurotoxins1
Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a
customer-centric approach focused on delivering breakthrough
products, today announced that the Australian Therapeutic Goods
Administration (TGA) has provided regulatory approval for Nuceiva®
(prabotulinumtoxinA)▼, a neurotoxin dedicated exclusively to
aesthetics. Nuceiva® was approved for the temporary improvement in
the appearance of moderate to severe glabellar lines in adult
patients. Glabellar lines are the vertical lines between the
eyebrows seen at maximum frown.
“We are thrilled to gain regulatory approval for Nuceiva® in
Australia, one of the largest market opportunities for aesthetic
neurotoxins outside of the United States, where we are rapidly
gaining market share, and Great Britain, where we recently launched
commercial operations,” said David Moatazedi, President and Chief
Executive Officer, Evolus. “This approval is the latest example of
our commitment to broaden our international presence, which is a
key component to reaching our aspiration of $500 million in total
revenue by 2028.”
Evolus plans to launch Nuceiva® in Australia during the second
half of 2023 after commencing additional launches in Europe –
beginning with Germany and Austria – in the first half of 2023. In
addition to Great Britain, Nuceiva® is also commercially available
in Canada.
The safety and efficacy of Nuceiva® was evaluated through the
company’s global TRANSPARENCY clinical program, which included two
Phase III U.S. trials, the largest head-to-head aesthetic pivotal
study versus BOTOX® (onabotulinumtoxinA) to date, and two long-term
safety studies. The product is approved for sale in the U.S. under
the brand name Jeuveau®.
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), the first and only neurotoxin
dedicated exclusively to aesthetics and 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
that involve risks and uncertainties, including statements based on
our current expectations, assumptions, estimates and projections
about future events, our business, financial condition, results of
operations and prospects, our industry and the regulatory
environment in which we operate. Any statements contained herein
that are not statements of historical facts may be deemed to be
forward-looking statements. In some cases, you can identify
forward-looking statements by terms such as “anticipate,”
“believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,”
“potential,” “predict,” “project,” “should,” “will,” “would” or the
negative of those terms, or other comparable terms intended to
identify statements about the future. The company’s forward-looking
statements include, but are not limited to, statements related to
the company’s financial outlook in 2023 and beyond, expectations
regarding share growth and international product launches.
The forward-looking statements included herein are subject to
risks and uncertainties that could cause actual results to differ
materially from those expressed or implied by the forward-looking
statements. These risks and uncertainties, all of which are
difficult or impossible to predict accurately and many of which are
beyond our control, include, but are not limited to uncertainties
associated with our ability to comply with the terms and conditions
in the Allergan/Medytox Settlement Agreements, our ability to fund
our future operations or obtain financing to fund our operations,
the continued impact of COVID-19 or other outbreaks of contagious
diseases on our business, unfavorable global economic conditions
and the impact on consumer discretionary spending, uncertainties
related to customer and consumer adoption of Nuceiva® / Jeuveau®,
the efficiency and operability of our digital platform, competition
and market dynamics, our ability to successfully launch and
commercialize our products in new markets, our ability to
successfully broaden our product portfolio, our ability to maintain
regulatory approvals of Nuceiva® / Jeuveau® or obtain regulatory
approvals for new product candidates or indications and other risks
described in our filings with the Securities and Exchange
Commission, including in the section entitled “Risk Factors” in our
Quarterly Report on Form 10-Q for the quarter ended September 30,
2022 filed with the Securities and Exchange Commission on November
8, 2022. These filings can be accessed online at www.sec.gov.
Readers are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof.
Except as required by law, we undertake no obligation to update or
revise any forward-looking statements to reflect new information,
changed circumstances or unanticipated events. If we do update or
revise one or more of these statements, investors and others should
not conclude that we will make additional updates or
corrections.
▼ This medicinal product is subject to additional monitoring in
Australia. This will allow quick identification of new safety
information. Healthcare professionals are asked to report any
suspected adverse events at Report a problem or side effect.
1Sources: Medical Insights, Inc., DRG/Clarivate and company
estimates
Jeuveau® and Nuceiva® are registered trademarks of Evolus, Inc.
Hi-Pure™ is a trademark of Daewoong Pharmaceutical Co, Ltd. BOTOX®
is a registered trademark of Allergan, Inc.
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version on businesswire.com: https://www.businesswire.com/news/home/20230123005247/en/
Investor Contact: David K.
Erickson, Evolus, Inc. Vice President, Investor Relations Tel:
949-966-1798 Email: david.erickson@evolus.com
Media Contacts: Maura Siefring
Media Relations Lead Tel: 215-837-8450 Email:
Maura.Siefring@uncappedcommunications.com
Janet Kettels International Communications Consultant, Evolus
International Tel: +447738506476 Email:
janet.kettels@evolus.com
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