Evolus Initiates Phase II Program with “Extra Strength” Dose for Extended Duration
Evolus has initiated a clinical program for an 'extra strength' dose of Jeuveau® (prabotulinumtoxinA-xvfs) aimed at enhancing its aesthetics product line. The company expects to enroll its first patient in Q1 2022, with the study's completion anticipated in the first half of 2023. CEO David Moatazedi states that the strategy aims to provide an expanded offering tailored to consumer performance preferences. This follows the successful approval of the original Jeuveau® in over 31 countries and is supported by a seasoned clinical development team.
- Initiated clinical program for an 'extra strength' Jeuveau® dose to expand product line.
- First patient enrollment expected in Q1 2022, indicating progress in clinical development.
- Proven approval track record for Jeuveau® with rapid success across multiple countries.
- None.
- Program Designed to Offer Consumers an “Extra Strength” Dosing Option
- Evolus is Uniquely Positioned to Capitalize on this Opportunity with the Company’s Aesthetics-Only Strategy and Jeuveau® Product Precision
- First Patient Enrollment Expected in Q1 2022; Expected Completion in 1H 2023
NEWPORT BEACH, Calif., Nov. 02, 2021 (GLOBE NEWSWIRE) -- Evolus, Inc. (Nasdaq: EOLS), a performance beauty company with a customer-centric approach focused on delivering breakthrough products, today announced that it has initiated a clinical program to study an “extra strength” dose for extended duration of Jeuveau® (prabotulinumtoxinA-xvfs), its flagship neurotoxin product and first and only neurotoxin dedicated exclusively to aesthetics.
“With this program, Evolus is pursuing a neurotoxin development strategy with an ‘extra strength’ dose that complements our ‘original strength’ Jeuveau®. We believe Evolus is the only company that can capitalize on this opportunity given the combination of our aesthetics-only business model, together with the precision of the Jeuveau® product,” said David Moatazedi, President and Chief Executive Officer. “This strategy would provide an expanded product offering for consumers who may desire a different performance profile with a longer duration.”
“Our original Jeuveau® clinical program rapidly achieved approval in the U.S., Canada and 31 European countries in five years. Our proven clinical development team has initiated Phase II study preparation, and we look forward to enrolling our first patient in the first quarter of 2022 with final results expected in the first half of 2023,” said Rui Avelar, M.D., Chief Medical Officer and Head of Research and Development. “One of the primary safety considerations of neurotoxins is related to their spread, and we believe that the precise nature of Jeuveau® is well suited for a trial exploring a higher dose.”
About the Study
This planned glabellar line (“frown line”) study is a randomized, prospective, double blind, three arm trial following patients out to a maximum of 12 months. Three arms will be enrolled: the currently approved 20 units of Botox® Cosmetic, 20 units of Jeuveau®, and 40 units of “extra strength” Jeuveau®. Study initiation activity has already begun with an open Investigational New Drug (“IND”) application and the first patient is expected to be enrolled during the first quarter of 2022. The company anticipates completing the study in the first half of 2023.
About Evolus, Inc.
Evolus is a performance beauty company with a customer-centric approach focused on delivering breakthrough products. Approved in 2019 by the U.S. Food and Drug Administration, Jeuveau® (prabotulinumtoxinA-xvfs) is 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.
IMPORTANT SAFETY INFORMATION FOR JEUVEAU® (prabotulinumtoxinA-xvfs)
JEUVEAU may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of JEUVEAU:
- Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months.
- Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing.
Do not use JEUVEAU if you: are allergic to any of the ingredients in JEUVEAU (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as rimabotulinumtoxinB (MYOBLOC®), onabotulinumtoxinA (BOTOX®/BOTOX® Cosmetic), abobotulinumtoxinA (DYSPORT®), or incobotulinumtoxinA (XEOMIN®); have a skin infection at the planned injection site; or are a child.
JEUVEAU dosing units are not the same as, or comparable to, any other botulinum.
Tell your healthcare provider about all your muscle or nerve conditions, such as ALS or Lou Gehrig’s disease, Myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including difficulty swallowing and difficulty breathing from typical doses of JEUVEAU.
Tell your healthcare provider about all your medical conditions, including: any side effects from botulinum toxin products, including dry eye; breathing, swallowing, bleeding, or heart problems; plans to have surgery; weakness of forehead muscles; drooping eyelids; have had surgery on your face; are pregnant or breastfeeding or plan to become pregnant or breastfeed (it is not known if JEUVEAU can harm your unborn baby or passes into breast milk).
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using JEUVEAU with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your healthcare provider that you have received JEUVEAU in the past.
Especially tell your healthcare provider if you: have received any other botulinum toxin product in the past and the last 4 months, and exactly which product you received (such as BOTOX, BOTOX Cosmetic, MYOBLOC, DYSPORT, or XEOMIN).
JEUVEAU may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of treatment with JEUVEAU. If this happens, do not drive a car, operate machinery, or do other dangerous activities.
JEUVEAU can cause other serious side effects including: allergic reactions such as itching, rash, red itchy welts, wheezing, trouble breathing, asthma symptoms, or dizziness or feeling faint. Tell your healthcare provider or get emergency medical help right away if you develop wheezing or trouble breathing, or if you feel dizzy or faint. Heart problems. Irregular heartbeat and heart attack that have caused death, have happened in some people who received botulinum toxin products. Eye problems such as dry eye, reduced blinking, and corneal problems. Tell your healthcare provider if you develop eye pain or irritation, sensitivity to light, or changes in your vision.
The most common side effects include: headache; eyelid drooping, upper respiratory tract infection, and increased white blood cell count.
APPROVED USE
JEUVEAU is a prescription medicine that is injected into muscles and used in adults for a short period of time (temporary) to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines).
The risk information provided here is not complete. For more information about JEUVEAU, see the full Prescribing Information including BOXED WARNING, and Medication Guide, visit evolus.com or talk to your healthcare provider.
To report side effects associated with use of JEUVEAU, please call 1-877-EVOLUS1/1-877-386-5871. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Exclusively licensed and manufactured for: Evolus, Inc., 520 Newport Center Drive, Suite 1200, Newport Beach, CA 92660
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 made by Mr. Moatazedi and Mr. Avelar regarding conduct of the Company’s proposed Phase II clinical trial, the potential performance profile of an extra-strength dose, including longer duration, effectiveness of the Company’s pricing flexibility and the precision of Jeuveau®, and the timing of potential enrollment of patients, receipt of interim data and completion of the study. 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 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, including the effect on our pricing, discounts we may offer to our customers and the volume of purchases by our customers, the ability to successfully complete the Phase II clinical trial, ability to achieve FDA approval and ultimate commercial acceptability and pricing for an “extra strength” Jeuveau® dose, the continued impact of COVID-19 on our business and the economy generally, uncertainties related to customer and consumer adoption of Jeuveau®, the efficiency and operability of our digital platform, competition and market dynamics, and our ability to maintain regulatory approval of Jeuveau® and other risks described in the section entitled “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2021 as filed with the Securities and Exchange Commission on August 4, 2021 and in the section entitled “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2021 that we expect to file with the Securities and Exchange Commission on or about November 2, 2021. 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, 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 Evolus, Inc.
Hi-Pure™ is a trademark of Daewoong Pharmaceutical Co, Ltd
Botox® is a registered trademark of Allergan, Inc., an AbbVie company
Evolus, Inc. Contacts:
Investor/Media Contact:
David K. Erickson
Vice President, Investor Relations
Tel: 949-966-1798
Email: david.erickson@evolus.com
FAQ
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