Loading, Please Wait...
IRVINE, Calif., Aug. 17, 2018 (GLOBE NEWSWIRE) -- Evolus, Inc. (NASDAQ: EOLS), a company dedicated to aesthetic medicine, today announced that Health Canada has granted approval of DWP-450 (prabotulinumtoxinA) for the temporary improvement in the appearance of moderate to severe glabellar lines (vertical lines between the eyebrows seen at maximum frown) in adult patients under 65 years of age. The first marketing approval for Evolus’ DWP-450 product candidate represents a major milestone achievement for the company.
Evolus will market DWP-450 in Canada through its partner Clarion Medical Technologies, Inc, a leading Canadian provider of medical and aesthetic equipment and consumables to hospitals, aesthetic clinics and private medical practices.
David Moatazedi, President and Chief Executive Officer of Evolus, commented, “The marketing approval of DWP-450 in Canada represents a key achievement for Evolus in our regulatory efforts as it is the first approval worldwide of our neurotoxin, and ahead of our guided timeline in Canada. DWP-450 offers a significant and valuable competitive opportunity given the meaningful gap between the neurotoxin market leader and other available products, and we look forward to our partner providing DWP-450 to physicians and consumers in Canada in the first half of 2019.”
Rui Avelar, MD, Chief Medical Officer and Head of R&D of Evolus, added, “This marketing approval positions Evolus with a competitive advantage as the first known 900 kda molecule approved since Botox®. The approval from Health Canada is based on the results from our clinical program that included our EV-001 and EV-002 pivotal phase III studies in the United States and supported by our EVB-003 pivotal Phase III study in the European Union and Canada.”
As stated in prior communications, Evolus has also resubmitted a Biologics License Application to the U.S. Food and Drug Administration (the “FDA”) and submitted a Marketing Authorization Application (a “MAA”) to the European Medicines Agency. The Company expects to launch DWP-450 in the United States in Spring 2019 and expects an opinion from the Committee for Medicinal Products for Human Use (“CHMP”) by the first quarter of 2019. If the CHMP provides a favorable opinion, we would expect approval of our MAA in the first half of 2019.
About Evolus, Inc.
Evolus is a company dedicated to aesthetic medicine focused on providing physicians and their patients with expanded choices in aesthetic treatments and procedures. Evolus’ lead candidate DWP-450, also known by the chemical name prabotulinumtoxinA, is a 900 kDa purified botulinum toxin type A complex that was approved by Health Canada for the temporary improvement in the appearance of moderate to severe glabellar lines in adult patients under 65 years of age and is being evaluated for marketing approval in the United States and other areas.
Statements made in this press release that relate to future plans, events, prospects or performance are 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 containing the words “planned,” “expect,” “believes,” “strategy,” “opportunity,” “anticipates,” “outlook,” “designed,” and similar words. While these forward-looking statements are based on the current expectations and beliefs of management, such forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results to differ materially from the expectations expressed in this press release, including the risks and uncertainties disclosed in Evolus’ periodic filings with the Securities and Exchange Commission, including factors described in the section entitled “Risk Factors” in its Annual Report on Form 10-K for the year ended December 31, 2017; its Quarterly Report on Form 10-Q for the Quarter ended June 30, 2018, as filed with the Securities and Exchange Commission on March 29, 2018, May 10, 2018 and August 2, 2018, 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.
Brian Johnston, The Ruth Group
Tel: +1 646-536-7028
Kirsten Thomas, The Ruth Group
Botox®, is a registered trademarks of Allergan, Inc.