Cyto-014

NASHVILLE, Tenn.--(BUSINESS WIRE)-- Revance Therapeutics, Inc., (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved DAXXIFY™ (DaxibotulinumtoxinA-lanm) for injection for the temporary improvement of moderate to severe frown lines (glabellar lines) in adults.1 DAXXIFY™ is the first and only neuromodulator stabilized with Peptide Exchange Technology™ (PXT) and is free of both human serum albumin and animal-based components.1-2,7-11 Most importantly, DAXXIFY™ has the ability to address duration of treatment effect, which we believe is the greatest unmet need with existing neuromodulators for both consumers and injectors.12 The FDA approval, Revance’s first, augments the company’s innovative aesthetics portfolio and expands the company’s access to the growing $3.2 billion U.S. facial injectables market, further establishing Revance as an innovation leader in the industry and laying the groundwork for potential future therapeutic indications.13 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220908005320/en/ “The FDA approval of DAXXIFY™ is a foundational achievement for the company as it marks the culmination of years of pioneering research and development made possible by the outstanding execution of our talented team, along with strong support from the medical and investor communities. It has been an incredible and rewarding journey to realize our vision and bring this disruptive innovation to an industry that has remained largely unchanged for over 30 years,” said Mark J. Foley, Chief Executive Officer. “Importantly, we are very pleased DAXXIFY™’s label includes data demonstrating the achievement of none or mild wrinkle severity based on investigator and subject assessments, as this provides the foundation for our marketing claims around duration of effect. We look forward to continuing to set new standards in aesthetics and to establishing a new category of long-lasting, peptide-enhanced neuromodulators.1,11” Jeffrey Dover, MD, co-director of SkinCare Physicians of Chestnut Hill, commented, “As a SAKURA investigator, I’m pleased to see DAXXIFY™ now approved as the first and only peptide-formulated, long-acting neuromodulator in the market. Compelling data from the largest Phase 3 clinical program ever conducted for glabellar lines demonstrated that DAXXIFY™ was well tolerated and achieved clinically significant improvement with long-lasting results and high patient satisfaction. Notably, DAXXIFY™ was able to demonstrate a long duration of effect while only utilizing 0.18 ng of core active ingredient in the 40-unit labeled indication for glabellar lines. With today’s approval, I look forward to helping patients, who have been accustomed to a 3 to 4-month duration pro conventional neuromodulators, achieve year-long results with as few as two treatments per year.2-5 *” The U.S. approval of DAXXIFY™ was based on the data generated in the SAKURA Phase 3 clinical trial program (SAKURA 1,2,3), which included more than 2,700 patients and approximately 4,200 treatments. In the pivotal trials: 74% of subjects achieved a > two-grade improvement in glabellar lines at week 4 per both investigator and patient assessment1,4¶ 88% achieved > two-grade improvement at week 4 per investigator assessment1¶ 98% of subjects achieved none or mild wrinkle severity at week 4 per investigator assessment 4¶ 6-month median duration3,4* Some patients maintained treatment results at 9 months2-4‡ Results seen as early as one day after treatment, typically seen within two days14¶ DAXXIFY™ is generally safe and well tolerated with no serious treatment-related adverse events reported in the clinical trials and has a safety pro with other currently available neuromodulators in the aesthetics market.1-5,7-10 The most common treatment-related adverse events with DAXXIFY™ observed in the pivotal trials were headache (6%) followed by eyelid ptosis (2%) and facial paresis, including facial asymmetry (1%).1 “With DAXXIFY’s innovative and differentiated performance profile, alongside our portfolio that includes the RHA® Collection of dermal fillers and the OPUL® Relational Commerce platform, we have a real opportunity to build on our commercial success while setting a new standard for neuromodulator formulation,” said Dustin S. Sjuts, President. “The strong inroads that we have made in the prestige market with our products and services will serve as a solid foundation upon which to launch DAXXIFY™. Consistent with our commercial strategy, DAXXIFY™ will be available through Revance Aesthetics’ elite partners, known for delivering exceptional consumer outcomes and experiences. We are excited to be launching DAXXIFY™ shortly with an early training and education program at our world-class headquarters and experience center in Nashville, followed by a broader commercial launch.” Practices interested in receiving more information on DAXXIFY™ may reserve their spot at RevanceAesthetics.com. Conference Call Revance will host a corresponding conference call and a live webcast today at 5:00 a.m. PT / 8:00 a.m. ET to discuss the FDA approval. Individuals interested in listening to the conference call may do so by registering via the webcast link in the investor relations section of the company's website at: www.revance.com. To access the call by phone, please use this registration link, and you will be provided with dial in details. To avoid delays, we encourage participants to dial into the conference call fifteen minutes ahead of the scheduled start time. A webcast replay will be available in the investor relations section on the company's website for 90 days following the completion of the call. * At least 50% of patients treated with DAXXIFY™ in SAKURA 1 and 2 had none or mild frown lines per investigator or patient assessments for 24 weeks and 23.9 weeks (6 months) or longer (respectively) after treatment. ‡ 5% of patients in SAKURA 1 and 3% of patients in SAKURA 2 achieved glabellar line severity of none or mild with DAXXIFY™ at Week 36 (9 months) per investigator’s assessment. In SAKURA 1 and 2, and SAKURA 3 Treatments 1 and 2, a total of 7.5%, 5.4%, 17.4%, 11.6% of treated patients had not returned to baseline severity per both investigator and patient assessment at 9 months. ¶ Per pooled data from SAKURA 1 and SAKURA 2. INDICATION DAXXIFY™ (daxibotulinumtoxinA-lanm) for injection is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients. WARNING: DISTANT SPREAD OF TOXIN EFFECT The effects of DAXXIFY™ and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. DAXXIFY™ is not approved for the treatment of spasticity or any conditions other than glabellar lines. IMPORTANT SAFETY INFORMATION Contraindications DAXXIFY™ contraindications include hypersensitivity to any botulinum toxin preparation or any of the components in the formulation and infection at the injection site(s). Warnings and Precautions Please refer to Boxed Warning for Distant Spread of Toxin Effect. The potency units of DAXXIFY™ are not interchangeable with other preparations of other botulinum toxin products. Recommended dose and frequency of administration should not be exceeded. Patients should seek immediate medical attention if respiratory, speech or swallowing difficulties occur. Use caution when administering to patients with pre-existing cardiovascular disease. Concomitant neuromuscular disorders may exacerbate clinical effects of treatment. Adverse Reactions The most commonly observed adverse reactions (≥1%) were headache (6%), eyelid ptosis (2%) and facial paresis (1%). Drug Interactions Co-administration of DAXXIFY™ and aminoglycoside antibiotics, anticholinergic agents or any other agents interfering with neuromuscular transmission or muscle relaxants should only be performed with caution as the effect of DAXXIFY™ may be potentiated. The effect of administering different botulinum neurotoxins during course of treatment with DAXXIFY™ is unknown. Use in Specific Populations DAXXIFY™ is not recommended for use in children or pregnant women. Please see DAXXIFY™ full Prescribing Information, including Boxed Warning and Medication Guide. About DAXXIFY™ DAXXIFY™ (DaxibotulinumtoxinA-lanm) for injection is the first and only FDA approved long-lasting peptide-formulated neuromodulator product for use in adults for the temporary improvement of moderate to severe frown lines (glabellar lines).1-2,7-11 DAXXIFY™ has the ability to deliver year-long results for patients with potentially only two treatments per year and has been proven to be effective, and generally safe and well tolerated.2-5 * DAXXIFY™ is powered by a cell-penetrating peptide technology (Peptide Exchange Technology™), Revance's proprietary, synthetic, 35-amino-acid stabilizing excipient with a highly positive charge, and is free of human serum albumin or animal-based components.1,2,11 Manufactured exclusively in the U.S., DAXXIFY™ is the first true innovation in neuromodulator product formulation in over 30 years. Revance has evaluated this neuromodulator formulation in other Phase 2 clinical studies in aesthetics, including the full upper face, forehead lines and crow’s feet as well as in therapeutic indications, including cervical dystonia and upper limb spasticity. Learn more at RevanceAesthetics.com. About Revance Revance is a commercial stage biotechnology company setting the new standard in healthcare with innovative aesthetic and therapeutic offerings that elevate patient and physician experiences. Revance’s aesthetics portfolio of expertly created products and services, including DAXXIFY™ (DaxibotulinumtoxinA-lanm) for injection, the RHA® Collection of dermal fillers, and OPUL®, the first-of-its-kind Relational Commerce platform for aesthetic practices, deliver a differentiated and exclusive offering for the company’s elite practice partners and their consumers. Revance has also partnered with Viatris Inc. to develop a biosimilar to BOTOX®, which will compete in the existing short-acting neuromodulator marketplace. Revance’s therapeutics pipeline is currently focused on muscle movement disorders including evaluating DaxibotulinumtoxinA for Injection in two debilitating conditions, cervical dystonia and upper limb spasticity. Revance is headquartered in Nashville, Tennessee, with additional office locations in Newark, Pleasanton and Irvine, California. Learn more at or connect with us on LinkedIn. “Revance” and the Revance logo and OPUL are registered trademarks of Revance Therapeutics, Inc. Resilient Hyaluronic Acid® and RHA® are trademarks of TEOXANE SA. BOTOX® is a registered trademark of Allergan, Inc.

Submission based on data from the pivotal international Phase III CONTENT clinical program, also recently published in European Urology1 CONTENT showed that Dysport® decreased incontinence episodes, detrusor pressure and increased bladder capacity versus placebo, and improved quality of life1 PARIS--(BUSINESS WIRE)-- Regulatory News: Disclaimer: Intended for international media and investor audiences only Ipsen (Euronext: IPN; ADR: IPSEY) today announced that Dysport® (abobotulinumtoxinA) has received positive opinion in Europe for the management of urinary incontinence (UI) in adults with neurogenic detrusor overactivity (NDO) due to spinal cord injury (SCI) (traumatic or non-traumatic) or multiple sclerosis (MS), who are regularly performing clean intermittent catheterization (CIC). This positive opinion for Dysport® now permits individual European country Health Authorities to grant national approvals, according to their country regulations. In addition, Ipsen is also currently in the process of obtaining approvals in other countries outside the European Union. Dysport® is an injectable form of a botulinum neurotoxin type A (BoNT-A) product, which has previously shown clinically meaningful benefit in the symptomatic treatment of focal spasticity and cervical dystonia. ENDS About the CONTENT Phase III program Dysport® was assessed in CONTENT, a large, international, Phase III clinical program. The CONTENT1 and CONTENT2 Phase III trials included 485 patients living with NDO and UI who were regularly undergoing CIC and inadequately managed by oral therapy.1 Patients recorded the number of UI episodes they experienced per day over a 7-day period in an eDiary at baseline and at weeks 2, 6, and 12, and every 12 weeks thereafter. The volume per void during a 24-hour period was also recorded in the eDiary.1 About neurogenic detrusor overactivity Neurogenic detrusor overactivity (NDO) incontinence is a chronic condition caused by lesions of the central nervous system that result in urinary incontinence (UI).1,2 Up to 99% of patients living with MS and up to 84% of patients living with SCI suffer from NDO2,3 and it can cause a substantial impairment to quality of life, social isolation, and embarrassment.4 About Dysport® Dysport® (abobotulinumtoxinA) is an injectable form of a botulinum neurotoxin type A (BoNT-A) product, which is a substance derived from Clostridium bacteria producing BoNT-A that inhibits the effective transmission of nerve impulses and thereby reduces muscular contractions. It is supplied as a lyophilized powder. AbobotulinumtoxinA has marketing authorization in more than 90 countries, more than 30 years of clinical experience and 6 million treatment years of patient experience. The detailed recommendations for the use of Dysport are described in the Summary of Product Characteristics (SmPC) for Dysport (300 units) Powder and Dysport (500 units) Powder, and the U.S. Prescribing Information (PI). NOTE: Dysport® labels and approved indications may vary from country to country. About Ipsen Ipsen is a global, mid-sized biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease and Neuroscience. With Specialty Care sales of over €2.6bn in FY 2021, Ipsen sells medicines in over 100 countries. Alongside its external-innovation strategy, the Company’s research and development efforts are focused on its innovative and differentiated technological platforms located in the heart of leading biotechnological and life-science hubs: Paris-Saclay, France; Oxford, U.K.; Cambridge, U.S.; Shanghai, China. Ipsen has around 4,500 colleagues worldwide and is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com. Ipsen’s Forward-Looking Statements The forward-looking statements, objectives and targets contained herein are based on Ipsen’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect Ipsen’s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words "believes", "anticipates" and "expects" and similar expressions are intended to identify forward-looking statements, including Ipsen’s expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by Ipsen. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising product in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons Ipsen must face or might face competition from generic products that might translate into a loss of market share. Furthermore, the research and development process involves several stages each of which involves the substantial risk that Ipsen may fail to achieve its objectives and be forced to abandon its efforts with regards to a product in which it has invested significant sums. Therefore, Ipsen cannot be certain that favorable results obtained during preclinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the product concerned. There can be no guarantees a product will receive the necessary regulatory approvals or that the product will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Ipsen’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Ipsen’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. Ipsen also depends on third parties to develop and market some of its products which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to Ipsen’s activities and financial results. Ipsen cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of Ipsen’s partners could generate lower revenues than expected. Such situations could have a negative impact on Ipsen’s business, financial position or performance. Ipsen expressly disclaims any obligation or undertaking to update or revise any forward-looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. Ipsen’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to Ipsen’s 2021 Universal Registration Document, available on ipsen.com. References 1. Kennelly M et al., Efficacy and Safety of AbobotulinumtoxinA in Patients with Neurogenic Detrusor Overactivity Incontinence Performing Regular Clean Intermittent Catheterization: Pooled Results from Two Phase 3 Randomized Studies (CONTENT1 and CONTENT2). European Urology. 2022; S0302-2838(22)01680–3 2. Mehnert U, et al., The Management of Urine Storage Dysfunction in the Neurological Patient. SN Comprehensive Clinical Medicine. 2019; 1:160–182 3. Alsulihem A and Corcos J. Evaluation, treatment, and surveillance of neurogenic detrusor overactivity in spinal cord injury patients. Neuroimmunol Neuroinflammation. 2019; 6:13 4. Ginsberg, D. The Epidemiology and Pathophysiology of Neurogenic Bladder. Am J Manag Care. 2013; 19(10)191–6 View source version on businesswire.com: Contacts Investors Craig Marks Vice President, Investor Relations +44 7584 349 193 Adrien Dupin de Saint-Cyr Investor Relations Manager +33 6 64 26 17 49 Media Michelle Cammack Senior Director & Global Head of Neuroscience Franchise Communications Global Communications & External Affairs +44 7768 502 091 Source: Ipsen View this news release online at: