TOXINS 2021: New analyses of pivotal Phase III trial data highlight long duration of response for Dysport® (abobotulinumtoxinA) in five therapeutic indications

Analyses of pivotal study data of Dysport^® reveal a large proportion of study patients did not require retreatment for at least 12 weeks (and at least 16 weeks for pediatric upper limb spasticity)
This new analysis concluded that Dysport^® is associated with a long duration of response
These data form one of 26 abstracts Ipsen is presenting at the TOXINS 2021 conference, taking place virtually between 16-17 January 2020, which brings new insights in research, development and manufacturing, including findings with clinical and economic implications for the management of cervical dystonia and spasticity^1-28

PARIS, France, 15 January 2021 – Ipsen (Euronext: IPN; ADR: IPSEY) announced results from new analyses of pivotal Phase III clinical trial data to assess treatment intervals over repeat cycles of Dysport^® (abobotulinumtoxinA [aboBoNT-A]) in five patient populations. AbobotulinumtoxinA: Evidence for Long Duration of Response from 5 Patient Populations is being shared during the TOXINS 2021 conference, which is taking place virtually between 16-17 January 2020 and is organized by the International Neurotoxin Association.^1-28 Ipsen is sharing 26 abstracts during the congress, with data including updates from the recently published surveys into the experience of patients and caregivers, data from the Phase IV ULIS-III trial, and ten abstracts focused on basic science research into neurotoxins.^1-27

Spasticity is one of the most common and disabling conditions associated with many neurological conditions in adults and is characterized by velocity-dependent muscle hypertonia. Spasticity can lead to disabilities related to muscle stiffness, including impaired walking and hand use, pain, disfigurement and contractures.²⁹

The new analyses of pivotal Phase III clinical trial data included randomized clinical trials and respective open-label extensions to assess treatment intervals over repeat cycles of Dysport^® in the management of cervical dystonia (CD), adult lower-limb (ALL) and upper-limb (AUL) spasticity, and pediatric lower-limb (PLL) and upper-limb (PUL) spasticity. Flexible study designs allowed patients to be reinjected after week 12 (or, for PUL, week 16), according to clinical need.¹

Results from the five patient populations highlighted that Dysport^® offered a long duration of response when injected at the recommended and approved dose, with a large proportion of study patients not requiring retreatment for more than 12/16 weeks (% patients injected week-16 or later): in the CD study: 72.6-81.5%, ALL study: 20.1-32.0%, AUL study: 24.0-36.9%, PLL studies: 72.8-93.8%; (% children injected week-22 or later in PUL study: 19.6-67.0%) in the five pivotal studies of Dysport^®, whilst safety outcomes were as expected.¹

The results observed in Ipsen’s Phase III clinical studies were reinforced by real-world data from the ULIS-III observational study – the largest observational study investigating a structured approach to goal setting and outcome measurement.

Dr. Alberto Esquenazi, Sheerr Gait and Motion Analysis Laboratory, MossRehab, U.S. and lead author of the research commented: “Waning symptom relief can lead to pain and movement difficulties between treatments. These data showed the duration of response that Dysport^® can offer to patients decreases the chance of patients experiencing symptomatic recurrence before the next injection.”

“We are constantly striving to uncover new insights into the therapeutic use of botulinum toxins, including key aspects of treatment such as duration of response,” said Prof. Dr. Steven Hildemann, Executive Vice President, Chief Medical Officer, Head of Global Medical Affairs and Patient Safety, Ipsen. “The breadth and depth of our data shared at TOXINS 2021 underscores Ipsen’s commitment to advancing the science and understanding the real-world impact of spasticity and dystonia to deliver treatments with individual and clinical benefits.”

Follow Ipsen on Twitter via @IpsenGroup and keep up to date with TOXINS 2021 news and updates by using the hashtag #ina_toxins.

Overview of Ipsen presentations at TOXINS 2021 Congress:^1-27

Abstract title

AbobotulinumtoxinA: Evidence for Long Duration of Response from 5 Patient Populations

Alberto Esquenazi, Mauricio R. Delgado, Robert A. Hauser, Andreas Lysandropoulos, Jean-Michel Gracies

The Systematic Approach to Developing a Cell-Free Platform Process for Recombinant Toxin Production

Williams Olughu, Kevin Moore, Cillian Paget, David Gruber

Digitisation of Toxin Development

Alison Mason, Sian Richardson, Alina Bugajewska-Waller, David Gruber

Automated fermentation platform for Toxin-based Therapeutics

Stanislav Pepeliaev

Quantity of Prabotulinumtoxin Type A in 100U vials

David Allcock, Andrew Splevins, Hamzah Baig, Daniel Higazi

3D reconstruction and analysis of neuromuscular junction distribution in whole skeletal muscles in the rat using light-sheet microscopy

Denis Carré, Renaud Morin, Marine Norlund, Aurélie Gomes, Jean-Michel Lagarde, Stephane Lezmi

BoNT Intoxication: Functional Genomics Reveals an Unexpected Trafficking Route

Jeremy Yeo, Omar Loss, Iwona Ziomkiewicz, Johannes Krupp, Felicia Tay, Keith Foster, Matthew Beard, Frederic Bard

Effects of recombinant botulinum neurotoxin type A1 on CFA-induced mechanical allodynia and sensory neurone responses to mechanical stimulation monitored with GCaMP fluorescence in mice

Beatrice Oehler, Cindy Perier, Amy Fisher, Mikhail Kalinichev and Stephen McMahon

Management of Symptom Re-Emergence in Patients Living with Spasticity and Cervical Dystonia: Findings from 2 Online Patient Surveys

Alberto Esquenazi, Joaquim J. Ferreira, Jorge Jacinto, Andreas Lysandropoulos, Cynthia Comella

Patients Experiences of Symptom Re-Emergence: Findings from 2 Online Patient Surveys in Spasticity and Cervical Dystonia

Alberto Esquenazi, Joaquim J. Ferreira, Jorge Jacinto, Andreas Lysandropoulos, Cynthia Comella

Patient Perceptions of Spasticity and Treatment Satisfaction Over the Course of a Botulinum Neurotoxin A (BoNT-A) Treatment Cycle: An Ethnographic Study of Stroke Survivors

Jorge Jacinto, Andreas Lysandropoulos, Antony Fulford Smith

Longitudinal Goal Attainment with Integrated Upper Limb Spasticity Management Including Botulinum Toxin A: Primary Results from the ULIS-III Study

Lynne Turner-Stokes, Klemens Fheodoroff, Jorge Jacinto, Allison Brashear, Pascal Maisonobe, Andreas Lysandropoulos, Stephen Ashford

Real-Life Data on the Time to Retreatment with Botulinum Toxin A in Upper Limb Spasticity Management

Jorge Jacinto, Stephen Ashford, Klemens Fheodoroff, Allison Brashear, Pascal Maisonobe, Andreas Lysandropoulos, Lynne Turner-Stokes

Pain in Cervical Dystonia: A Meta-Analysis of Outcomes Following Treatment with AbobotulinumtoxinA in Randomized, Controlled Clinical Studies

Raymond L. Rosales, Lorraine Cuffe, Benjamin Regnault, Richard M Trosch

Impact of patient input on the study execution of an observational study assessing the effectiveness of abobotulinumtoxinA treatment in leg spasticity management in adults

Alberto Esquenazi, Pascal Maisonobe, Carlos Durán Sánchez, Andreas Lysandropoulos, Stephen Ashford

Improvement of Spastic Paresis and Cervical Dystonia Management: Assessment of Seven Years of the Innovative International Educational Program Ixcellence Network^®

Nigar Dursun, Tae Mo Chung, Carlo Colosimo, Roongroj Bhidayasiri, Kailash Bhatia, Julie Tiley, Jorge Jacinto

Long-Term Efficacy and Safety of Liquid Formulation AbobotulinumtoxinA for the Treatment of Moderate-to-Severe Glabellar Lines: A Phase III, Double-Blind, Placebo-Controlled and Open-Label Repeat Injection Study

Philippe Kestemont, Said Hilton, Bill Andriopoulos, Inna Prygova, Catherine Thompson, Magali Volteau, Benjamin Ascher

Patient satisfaction with abobotulinumtoxinA for aesthetic use in the upper face: A Systematic literature review and post hoc analysis of the APPEAL study

Riekie Smit, Elena Gubanova, Joely Kaufman, Marina Landau, Beatriz Molina, Bill Andriopoulos, Pascal Maisonobe, Inna Prygova, Alessio Redaelli

BoNT-As for Adult Spasticity and Cervical Dystonia: Cost-Effectiveness Analysis and the Cost of Response in the United Kingdom

Karissa Johnston, Natalya Danchenko, Talshyn Bolatova, John Whalen

Economic outcomes in real-world use of botulinum toxin-A products for adult patients with upper limb spasticity: a UK perspective

Lynne Turner-Stokes, Stephen Ashford, Jorge Jacinto, Klemens Fheodoroff, Natalya Danchenko, Pascal Maisonobe, Michael Williams, John Whalen

Cost-Effectiveness of BoNT-A Products for Treatment of Pediatric Spasticity in the United Kingdom

Natalya Danchenko, Karissa Johnston, Talshyn Bolatova, John Whalen

The Spasticity-Related Quality of Life 6-Dimensions Tool (SQOL-6D) in Upper Limb Spasticity: A First Psychometric Evaluation

Lynne Turner-Stokes, Klemens Fheodoroff, Jorge Jacinto, Jeremy Lambert, Christine de la Loge, John Whalen, Pascal Maisonobe, Stephen Ashford

AbobotulinumtoxinA in the Management of Hallux Valgus in Adult Patients: Results of a Randomized and Placebo-Controlled Phase II Trial

Selene G Parekh, David G Armstrong, Lawrence A DiDomenico, Babak Baravarian, Magali Volteau, Robert Silva

Dosing from a Phase 3, Pivotal Study of AbobotulinumtoxinA Injection in Upper-Limb Muscles in Pediatric Patients with Cerebral Palsy

Joyce Oleszek, Ann Tilton, Jorge Carranza, Nigar Dursun, Marcin Bonikowski, Edward Dabrowski, Benjamin Regnault, Mauricio R. Delgado on behalf of the Dysport in PUL study group

Efficacy and Safety of AbobotulinumtoxinA in Pediatric Lower Limb Spasticity: 2^nd Interim Results from a Phase IV, Prospective, Observational, Multicenter Study

Mark Gormley, Edward Dabrowski, Ann Tilton, Asare Christian, Sarah Helen Evans, Pascal Maisonobe, Stefan Wietek

Development of the Hygiene Extension Limb Position Pain (HELP) Tool to Monitor Waning of Clinical Efficacy in Patients with Spasticity or Cervical Dystonia Treated with Botulinum Toxins

Atul Patel, Stefan Wietek, Edward Dabrowski

References

Esquenazi et al., TOXINS 2021. AbobotulinumtoxinA: Evidence for Long Duration of Response from 5 Patient Populations.
Olughu et al., TOXINS 2021. The Systematic Approach to Developing a Cell-Free Platform Process for Recombinant Toxin Production.
Mason et al., TOXINS 2021. Digitisation of Toxin Development
Pepeliaev S., TOXINS 2021. Automated fermentation platform for Toxin-based Therapeutics.
Allcock et al., TOXINS 2021. Quantity of Prabotulinumtoxin Type A in 100U vials.
Pryazhnikov et al., TOXINS 2021. Local cortical injection of AbobotulinumtoxinA (Dysport®) enhances the laser injury-induced microglial cell migration and process extension in in mice.
Carré et al., TOXINS 2021. 3D reconstruction and analysis of neuromuscular junction distribution in whole skeletal muscles in the rat using light-sheet microscopy.
Yeo et al., TOXINS 2021. BoNT Intoxication: Functional Genomics Reveals an Unexpected Trafficking Route.
Oehler et al., TOXINS 2021. Effects of recombinant botulinum neurotoxin type A1 on CFA-induced mechanical allodynia and sensory neurone responses to mechanical stimulation monitored with GCaMP fluorescence in mice.
Esquenazi et al., TOXINS 2021. Management of Symptom Re-Emergence in Patients Living with Spasticity and Cervical Dystonia: Findings from 2 Online Patient Surveys
Esquenazi et al., TOXINS 2021. Patients Experiences of Symptom Re-Emergence: Findings from 2 Online Patient Surveys in Spasticity and Cervical Dystonia.
Jacinto et al., TOXINS 2021. Patient Perceptions of Spasticity and Treatment Satisfaction Over the Course of a Botulinum Neurotoxin A (BoNT-A) Treatment Cycle: An Ethnographic Study of Stroke Survivors.
Turner-Stokes et al., TOXINS 2021. Longitudinal Goal Attainment with Integrated Upper Limb Spasticity Management Including Botulinum Toxin A: Primary Results from the ULIS-III Study.
Jacinto et al., TOXINS 2021. Real-Life Data on the Time to Retreatment with Botulinum Toxin A in Upper Limb Spasticity Management.
Rosales et al., TOXINS 2021. Pain in Cervical Dystonia: A Meta-Analysis of Outcomes Following Treatment with AbobotulinumtoxinA in Randomized, Controlled Clinical Studies.
Esquenazi et al., TOXINS 2021. Impact of patient input on the study execution of an observational study assessing the effectiveness of abobotulinumtoxinA treatment in leg spasticity management in adults.
Dursun et al., TOXINS 2021. Improvement of Spastic Paresis and Cervical Dystonia Management: Assessment of Seven Years of the Innovative International Educational Program Ixcellence Network^®.
Kestemont et al., TOXINS 2021. Long-Term Efficacy and Safety of Liquid Formulation AbobotulinumtoxinA for the Treatment of Moderate-to-Severe Glabellar Lines: A Phase III, Double-Blind, Placebo-Controlled and Open-Label Repeat Injection Study.
Smit et al., TOXINS 2021. Patient satisfaction with abobotulinumtoxinA for aesthetic use in the upper face: A Systematic literature review and post hoc analysis of the APPEAL study.
Johnston et al., TOXINS 2021. BoNT-As for Adult Spasticity and Cervical Dystonia: Cost-Effectiveness Analysis and the Cost of Response in the United Kingdom.
Turner-Stokes et al., TOXINS 2021. Economic outcomes in real-world use of botulinum toxin-A products for adult patients with upper limb spasticity: a UK perspective.
Danchenko et al., TOXINS 2021. Cost-Effectiveness of BoNT-A Products for Treatment of Pediatric Spasticity in the United Kingdom
Turner-Stokes et al., TOXINS 2021. The Spasticity-Related Quality of Life 6-Dimensions Tool (SQOL-6D) in Upper Limb Spasticity: A First Psychometric Evaluation
Parekh et al., TOXINS 2021. AbobotulinumtoxinA in the Management of Hallux Valgus in Adult Patients: Results of a Randomized and Placebo-Controlled Phase II Trial.
Oleszek et al., TOXINS 2021. Dosing from a Phase 3, Pivotal Study of AbobotulinumtoxinA Injection in Upper-Limb Muscles in Pediatric Patients with Cerebral Palsy.
Gormley et al., TOXINS 2021. Efficacy and Safety of AbobotulinumtoxinA in Pediatric Lower Limb Spasticity: 2nd Interim Results from a Phase IV, Prospective, Observational, Multicenter Study.
Patel et al., TOXINS 2021. Development of the Hygiene Extension Limb Position Pain (HELP) Tool to Monitor Waning of Clinical Efficacy in Patients with Spasticity or Cervical Dystonia Treated with Botulinum Toxins
TOXINS 2021 Virtual Congress. Virtual Congress Hall. TOXINS. Available at: https://www.neurotoxins.org/toxins-2021-virtual/#:~:text=The%20TOXINS%202021%20virtual%20conference%20will%20provide%20participants%20with%20important,head%20and%20neck%2C%20limb%20dystonia%2C. Accessed January 2021.
Mayo Clinic. Cervical Dystonia. Available at https://www.mayoclinic.org/diseases-conditions/cervical- dystonia/symptoms-causes/syc-20354123. Accessed December 2020.
John Hopkins Medicine. Spasticity. Accessed: December 2020. Available at: https://www.hopkinsmedicine.org/health/conditions-and- diseases/spasticity. Accessed December 2020.
American Association of Neurological Surgeons. Spasticity. Available at: https://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Spasticity. Accessed December 2020.
American Association of Neurological Surgeons. Movement Disorders. Available at: https://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Movement-Disorders. Accessed December 2020.
Kuo C. Post-stroke Spasticity: A review of epidemiology, pathophysiology, and treatments. Int J Gerontol 2018;12:280-284.
Royal College of Physicians, British Society of Rehabilitation, “Spasticity in adults: management using botulinum toxin. National Guidelines”; 2018
Claypool D, et al. Epidemiology and outcome of cervical dystonia (spasmodic torticollis) in Rochester, Minnesota. Movement Disorders 1995;10: 608-614.
National Institute of Neurological Disorders and Stroke. Dystonias Fact Sheet. Available at https://www.ninih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Dystonias-Fact-Sheet. Accessed December 2020.
Castelão M, et Botulinum toxin type A therapy for cervical dystonia. Cochrane Database of Systematic Reviews 2017;12:CD003633.
American Association of Neurological Surgeons. Dystonia. Available at http://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Dystonia. Accessed December 2020.

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References

Esquenazi et al., TOXINS 2021. AbobotulinumtoxinA: Evidence for Long Duration of Response from 5 Patient Populations.

Olughu et al., TOXINS 2021. The Systematic Approach to Developing a Cell-Free Platform Process for Recombinant Toxin Production.

Mason et al., TOXINS 2021. Digitisation of Toxin Development

Pepeliaev S., TOXINS 2021. Automated fermentation platform for Toxin-based Therapeutics.

Allcock et al., TOXINS 2021. Quantity of Prabotulinumtoxin Type A in 100U vials.

Pryazhnikov et al., TOXINS 2021. Local cortical injection of AbobotulinumtoxinA (Dysport®) enhances the laser injury-induced microglial cell migration and process extension in in mice.

Carré et al., TOXINS 2021. 3D reconstruction and analysis of neuromuscular junction distribution in whole skeletal muscles in the rat using light-sheet microscopy.

Yeo et al., TOXINS 2021. BoNT Intoxication: Functional Genomics Reveals an Unexpected Trafficking Route.

Oehler et al., TOXINS 2021. Effects of recombinant botulinum neurotoxin type A1 on CFA-induced mechanical allodynia and sensory neurone responses to mechanical stimulation monitored with GCaMP fluorescence in mice.

Esquenazi et al., TOXINS 2021. Management of Symptom Re-Emergence in Patients Living with Spasticity and Cervical Dystonia: Findings from 2 Online Patient Surveys

Esquenazi et al., TOXINS 2021. Patients Experiences of Symptom Re-Emergence: Findings from 2 Online Patient Surveys in Spasticity and Cervical Dystonia.

Jacinto et al., TOXINS 2021. Patient Perceptions of Spasticity and Treatment Satisfaction Over the Course of a Botulinum Neurotoxin A (BoNT-A) Treatment Cycle: An Ethnographic Study of Stroke Survivors.

Turner-Stokes et al., TOXINS 2021. Longitudinal Goal Attainment with Integrated Upper Limb Spasticity Management Including Botulinum Toxin A: Primary Results from the ULIS-III Study.

Jacinto et al., TOXINS 2021. Real-Life Data on the Time to Retreatment with Botulinum Toxin A in Upper Limb Spasticity Management.

Rosales et al., TOXINS 2021. Pain in Cervical Dystonia: A Meta-Analysis of Outcomes Following Treatment with AbobotulinumtoxinA in Randomized, Controlled Clinical Studies.

Esquenazi et al., TOXINS 2021. Impact of patient input on the study execution of an observational study assessing the effectiveness of abobotulinumtoxinA treatment in leg spasticity management in adults.

Dursun et al., TOXINS 2021. Improvement of Spastic Paresis and Cervical Dystonia Management: Assessment of Seven Years of the Innovative International Educational Program Ixcellence Network®.

Kestemont et al., TOXINS 2021. Long-Term Efficacy and Safety of Liquid Formulation AbobotulinumtoxinA for the Treatment of Moderate-to-Severe Glabellar Lines: A Phase III, Double-Blind, Placebo-Controlled and Open-Label Repeat Injection Study.

Smit et al., TOXINS 2021. Patient satisfaction with abobotulinumtoxinA for aesthetic use in the upper face: A Systematic literature review and post hoc analysis of the APPEAL study.

Johnston et al., TOXINS 2021. BoNT-As for Adult Spasticity and Cervical Dystonia: Cost-Effectiveness Analysis and the Cost of Response in the United Kingdom.

Turner-Stokes et al., TOXINS 2021. Economic outcomes in real-world use of botulinum toxin-A products for adult patients with upper limb spasticity: a UK perspective.

Danchenko et al., TOXINS 2021. Cost-Effectiveness of BoNT-A Products for Treatment of Pediatric Spasticity in the United Kingdom

Turner-Stokes et al., TOXINS 2021. The Spasticity-Related Quality of Life 6-Dimensions Tool (SQOL-6D) in Upper Limb Spasticity: A First Psychometric Evaluation

Parekh et al., TOXINS 2021. AbobotulinumtoxinA in the Management of Hallux Valgus in Adult Patients: Results of a Randomized and Placebo-Controlled Phase II Trial.

Oleszek et al., TOXINS 2021. Dosing from a Phase 3, Pivotal Study of AbobotulinumtoxinA Injection in Upper-Limb Muscles in Pediatric Patients with Cerebral Palsy.

Gormley et al., TOXINS 2021. Efficacy and Safety of AbobotulinumtoxinA in Pediatric Lower Limb Spasticity: 2nd Interim Results from a Phase IV, Prospective, Observational, Multicenter Study.

Patel et al., TOXINS 2021. Development of the Hygiene Extension Limb Position Pain (HELP) Tool to Monitor Waning of Clinical Efficacy in Patients with Spasticity or Cervical Dystonia Treated with Botulinum Toxins

TOXINS 2021 Virtual Congress. Virtual Congress Hall. TOXINS. Available at: https://www.neurotoxins.org/toxins-2021-virtual/#:~:text=The%20TOXINS%202021%20virtual%20conference%20will%20provide%20participants%20with%20important,head%20and%20neck%2C%20limb%20dystonia%2C. Accessed January 2021.

Mayo Clinic. Cervical Dystonia. Available at https://www.mayoclinic.org/diseases-conditions/cervical- dystonia/symptoms-causes/syc-20354123. Accessed December 2020.

John Hopkins Medicine. Spasticity. Accessed: December 2020. Available at: https://www.hopkinsmedicine.org/health/conditions-and- diseases/spasticity. Accessed December 2020.

American Association of Neurological Surgeons. Spasticity. Available at: https://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Spasticity. Accessed December 2020.

American Association of Neurological Surgeons. Movement Disorders. Available at: https://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Movement-Disorders. Accessed December 2020.

Kuo C. Post-stroke Spasticity: A review of epidemiology, pathophysiology, and treatments. Int J Gerontol 2018;12:280-284.

Royal College of Physicians, British Society of Rehabilitation, “Spasticity in adults: management using botulinum toxin. National Guidelines”; 2018

Claypool D, et al. Epidemiology and outcome of cervical dystonia (spasmodic torticollis) in Rochester, Minnesota. Movement Disorders 1995;10: 608-614.

National Institute of Neurological Disorders and Stroke. Dystonias Fact Sheet. Available at https://www.ninih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Dystonias-Fact-Sheet. Accessed December 2020.

Castelão M, et Botulinum toxin type A therapy for cervical dystonia. Cochrane Database of Systematic Reviews 2017;12:CD003633.

American Association of Neurological Surgeons. Dystonia. Available at http://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Dystonia. Accessed December 2020.

Associated Documents

News Center

Dursun et al., TOXINS 2021. Improvement of Spastic Paresis and Cervical Dystonia Management: Assessment of Seven Years of the Innovative International Educational Program Ixcellence Network^®.