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NEWPORT BEACH, Calif., Oct. 01, 2019 (GLOBE NEWSWIRE) -- Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a customer-centric approach focused on delivering breakthrough products, today announced that the European Commission (EC) has approved the marketing of Nuceiva™ (prabotulinumtoxinA). Similar to other neurotoxins marketed in Europe, Nuceiva™ is approved 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 facial lines has an important psychological impact in adults below 65 years of age. The EC decision is applicable to all 28 European Union member states plus Iceland, Norway and Liechtenstein.
“With the approval in Europe, we have now achieved all key R&D milestones around the world,” said Rui Avelar, MD, Chief Medical Officer and Head of Research & Development. “This approval further validates our TRANSPARENCY clinical development program, which included the largest aesthetics head-to-head pivotal study conducted in Europe and Canada versus BOTOX® out to 150 days.”
The product was approved by the United States Food and Drug Administration in February 2019 and launched under the brand name, Jeuveau®, in May 2019. Nuceiva™ was approved by Health Canada in August 2018. The company expects to launch Nuceiva™ in Canada in the fourth quarter through its partner Clarion. The company also expects Nuceiva™ to launch in Europe in 2020.
Nuceiva™ (prabotulinumtoxinA) is a proprietary 900 kDa purified botulinum toxin type A formulation. Nuceiva™ is produced under strict quality and safety standards in a state-of-the art facility, specifically built to manufacture Nuceiva™. The safety and efficacy of Nuceiva™ has been evaluated in clinical studies with over 2,100 patients enrolled. Nuceiva™ was granted marketing authorization by the EC 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 age.
About Evolus, Inc.
Evolus is a performance beauty company with a customer-centric approach focused on delivering breakthrough products. In 2019, the U.S. Food and Drug Administration approved 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. Jeuveau® is powered by Evolus' unique technology platform and is designed to transform the aesthetic market by eliminating the friction points existing for customers today. Visit us at: www.evolus.com.
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,” “continue,” 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 regarding the Company’s launch into Canada in the fourth quarter of 2019 and launch into the European Market in 2020. Forward-looking statements are based on current estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict.
Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that 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 the success of the launch of Jeuveau®, including customer and consumer adoption of the product, competition and market dynamics, our ongoing legal proceedings and our ability to maintain regulatory approval of Jeuveau® and other risks described in the section entitled ”Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2018 and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2019 as filed with the Securities and Exchange Commission on March 20, 2019 and August 12, 2019, respectively, all of which are available 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, 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® is a registered trademark and NuceivaTM is a trademark of Evolus, Inc.
Botox® is a registered trademark of Allergan, Inc.
Hi-Pure™ is a trademark of Daewoong Pharmaceutical Co, Ltd.
Evolus, Inc. Contacts
Ashwin Agarwal, Evolus, Inc.
Vice President, Finance, Investor Relations & Treasury
Crystal Muilenburg, Evolus, Inc.
Vice President, Corporate Communications & Public Relations