Incobotulinum toxinA (Biotecon)

The article published in Aesthetic Surgery Journal supports safety and duration of effect for temporary improvement in the appearance of moderate to severe glabellar lines presented at the 2023 ASDS Annual Meeting Data showed duration effect of 26 weeks, or 6 months, based on a ≥ 1-point Glabellar Line Scale (GLS) improvement and return to baseline value using the Global Aesthetic Improvement Scale NEWPORT BEACH, Calif.--(BUSINESS WIRE)-- Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a focus on building an aesthetic portfolio of consumer brands, today announced that the Aesthetic Surgery Journal has published the safety and duration of effect results from the Phase 2 study of 40U Jeuveau® (prabotulinumtoxinA-xvfs) for the treatment of moderate to severe glabellar lines in adult patients. The “extra-strength” glabellar line study is a multicenter, double-blind, randomized, Phase 2 trial following 150 patients for up to 12 months or until the patient loses their correction. The study has three arms: Jeuveau® Extra-Strength 40U and two active controls, BOTOX® 20U and Jeuveau® 20U. Efficacy results demonstrated 26 weeks, or 6 months duration across the multiple metrics presented, including the time it took for patients to return to their baseline GLS score after their treatment, the duration of effect for a patient with at least a one-point GLS improvement, and the time it took a patient to return to their baseline using the Global Aesthetic Improvement Scale. The safety pro similar across all three arms and overall, 88.9% of adverse events were rated as mild and no serious adverse events were identified. “This publication provides the details of the study design along with the efficacy and safety data from the Phase 2 Jeuveau extra-strength study and makes it accessible to all,” said Dr. Rui Avelar, MD, Chief Medical Officer and Head of R&D of Evolus. “The study confirms the correlation between increasing dose and increasing duration, while maintaining a similar safety profile, with the majority of adverse events rated as mild.” Jeuveau® is approved for the temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines) in adults below 65 years of age. Through the company’s TRANSPARENCY Clinical Program, Jeuveau® was clinically proven to temporarily improve moderate to severe glabellar lines or “11’s” in adults and included the largest head-to-head pivotal study versus BOTOX®. The product is approved for sale in the U.S. under the brand name Jeuveau® and in Europe and Canada under the brand name Nuceiva® and received regulatory approval in Australia in January 2023. About “Extra-Strength” Glabellar Line Study The “Extra-Strength” Glabellar Line Study is a multicenter, double-blind, randomized trial that followed 150 patients until they lost their correction or up to 12 months at five study sites. The study includes two active controls – the currently approved 20 units of Jeuveau® and 20 units of BOTOX® – which were compared to 40 units of Jeuveau® in addition to evaluating the safety, efficacy, and duration of effect. 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 , and follow us on LinkedIn, X, Instagram or Facebook. 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 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 that involve risks and uncertainties, including statements 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 or current facts are 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 market conditions and consumer demand; expectations regarding regulatory approvals, product launches, and market adoption for extra-strength formulation of Jeuveau®. The forward-looking statements included herein are based on our current expectations, assumptions, estimates and projections, which we believe to be reasonable, and 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 Medytox Settlement Agreements, our ability to fund our future operations or obtain financing to fund our operations, unfavorable global economic conditions and the impact on consumer discretionary spending, uncertainties related to customer and consumer adoption of Jeuveau® and Evolysse™, the efficiency and operability of our digital platform, competition and market dynamics, our ability to successfully launch and commercialize our products in new markets, including the Evolysse™ dermal filler product line in the U.S., our ability to maintain regulatory approvals of Jeuveau® or obtain regulatory approvals for new product candidates or indications, our reliance on Symatese to achieve regulatory approval for the Evolysse™ dermal filler product line in the U.S., and other risks described in our filings with the Securities and Exchange Commission, including in the section entitled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the Securities and Exchange Commission on March 7, 2024. These filings can be accessed online at . 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. Jeuveau®, Nuceiva®, and Evolysse™ are trademarks of Evolus, Inc. Hi-Pure™ is a trademark of Daewoong Pharmaceutical Co, Ltd. Estyme® is a trademark of Symatese Aesthetics S.A.S.

Trading in Acorda’s stock was suspended on 12 April. Image credit: Shutterstock/NPS_87. Acorda Therapeutics has been delisted from the Nasdaq Stock Market as a result of non-compliance with Nasdaq’s listing rules. Nasdaq listing rules stipulate that companies maintain stockholders’ equity of at least $10m. As Acorda can no longer meet this requirement due to the company’s recent bankruptcy filing earlier this month, trading in the company’s common stock was suspended on 12 April, with Acorda reporting the delisting on 15 April. The absence on Nasdaq caps the company’s journey to the end of the twilight zone. The biotech’s closure date is set for 15 June, leaving the remaining 97 employees at its site in New York without a job, as per a labour notice filing . Over the past decade, Acorda saw success with its drugs for neurological disorders. Inbrija (levodopa inhalation powder) and Ampyra (dalfampridine) — also marketed as Fampyra (fampridine) outside of the US — were the company’s lead assets. Inbrija is used to treat patients with Parkinson’s disease while Ampyra/Fampyra is approved to help improve the walking ability of patients with multiple sclerosis. According to GlobalData’s Pharma Intelligence Centre, Fampyra used to see sales of more than $500m in 2017. However, after losing exclusivity to generics in 2018, Inbrija and Fampyra sales dropped to $31m and $73m respectively in 2023. See Also: Influenza [strains A/H1N1 + A/H3N2 + B/Victoria + B/Yamagata] (quadrivalent, split virion) vaccine by Sinovac Biotech for Seasonal Influenza: Likelihood of Approval INZ-701 by Inozyme Pharma for End-Stage Kidney Disease (End-Stage Renal Disease or ESRD): Likelihood of Approval GlobalData is the parent company of Pharmaceutical Technology. Acorda struggled to balance the books as sales of its drugs weakened. Amid poor drug sales, Biogen, which had a 2009 licence agreement for Fampyra outside the US, exercised an option to the rights to Acorda earlier this year. Acorda responded to financial difficulty by laying off much of its workforce but its share values continued to dive, with a bankruptcy filing occurring in April 2024. Merz Therapeutics, known for its Botox rival Xeomin (incobotulinumtoxinA), swooped in a day later to buy Acorda’s assets , including Inbrija and Ampyra. Merz acted as a “stalking horse” bidder, a type of bid used in cases involving bankrupt companies. As it stands, Merz is set to acquire the therapies for $185m, though this could increase if another bidder comes in at a higher price. The sale process is expected to end in June 2024.