IPSEN

Regulatory News:

Ipsen (Euronext: IPN; ADR: IPSEY) today announced the presentation of 12 abstracts during the 11^th World Congress for Neurorehabilitation (WCNR), taking place virtually between 7-11 October 2020.^1-13

Spasticity is a disabling condition in adults and children, characterized by velocity-dependent muscle hyperactivity. It is the consequence of many neurological diseases, such as stroke, multiple sclerosis (MS), Traumatic Brain and Spinal Cord Injury and Cerebral Palsy. Spasticity can have significant impact on the lives of patients, causing multi-level disability, including impaired walking and hand use, pain, disfigurement and contractures.¹⁴ Cervical dystonia is a rare disorder of unknown origin in most of the primary cases, characterized by involuntary contractions of the neck muscles.¹⁵

“Our goal at Ipsen is to put the patient at the center of everything we do; our research aims to understand and address the unmet needs and support care optimization by providing tailored therapeutic solutions that help patients regain more control of their lives,” said Dr. Andreas Lysandropoulos, Vice President Medical Affairs Neuroscience, Ipsen.

Overview of Ipsen presentations at the WCNR 2020 Congress:^1-12

Abstract title	Poster number/Session timing (CEST)
Differences in the patient experience of spasticity management with botulinum toxin type A: A comparison of European versus American survey findings	Poster number: P0274 Session timing: 09.00-20.00 7/10/2020
An international, multicentre, observational, longitudinal study to assess the effectiveness of abobotulinumtoxinA injections for adult lower limb spasticity: The AboLiSh study	Poster number: P0275 Session timing: 09.00-20.00 7/10/2020
Longitudinal goal attainment with integrated upper limb spasticity management including botulinum toxin A: Primary results from the ULIS-III study	Poster number: P0276 Session timing: 09.00-20.00 7/10/2020
Real-life data on the time to retreatment with botulinum toxin A in upper limb spasticity management	Poster number: P0278 Session timing: 09.00-20.00 7/10/2020
Perceptions of burden of spasticity and treatment satisfaction among post-stroke patients over the course of a botulinum neurotoxin A (BoNT-A) treatment cycle: an ethnographic study	Poster number: P0279 Session timing: 09.00-20.00 7/10/2020
7-Year Experience from the Ixcellence Network® : An International Innovative Educational Program To Improve Cervical Dystonia And Spastic Paresis Management	Poster number: P0301 Session timing: 09.00-20.00 7/10/2020
Importance of Training and Practice Regarding Rehabilitation Approaches Integrated with Botulinum Neurotoxin-A Guided Injection in Cervical Dystonia & Spastic Paresis: results from the INPUT survey	Poster number: P0302 Session timing: 09.00-20.00 7/10/2020
Efficacy and safety of abobotulinumtoxinA in pediatric lower limb spasticity: 2nd interim results from a phase IV, prospective, observational, multicenter study	Poster number: P0304 Session timing: 09.00-20.00 7/10/2020
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	Poster number: P0306 Session timing: 09.00-20.00 7/10/2020
Economic analysis of real-world use of BotulinumtoxinA products (BoNTA) for treatment of adult upper limb spasticity (AUL)	Poster number: P0311 Session timing: 09.00-20.00 7/10/2020
AbobotulinumtoxinA for upper limb spasticity in children with cerebral palsy: Efficacy and safety findings from an international, Phase 3, pivotal study	Poster number: P0503 Session timing: 09.00-20.00 7/10/2020
Neuromodulation of cortical beta oscillatory activity following botulinum injection in post-stroke.	Oral presentation number: OP068 Session timing: 9.45 11/10/2020

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Notes to editors

About spasticity

Spasticity is estimated to affect more than 12 million people worldwide.¹⁶ It is a condition in which certain muscles are continuously contracted causing stiffness or tightness of the muscles, which can interfere with normal movement, gait and speech.¹⁷ Spasticity is usually caused by damage to the parts of the brain or spinal cord that control voluntary movement,^17-18 leading to a change in the balance of signals between the nervous system and the muscles which leads to increased activity in the muscles.¹⁷ Spinal cord injury, multiple sclerosis, cerebral palsy, stroke, brain or head trauma and metabolic diseases can all cause spasticity.¹⁸ Spasticity is experienced by approximately 34% of stroke survivors within 18 months following a stroke.¹⁹

About cervical dystonia

Cervical dystonia (CD), also known as spasmodic torticollis, is a movement disorder in which involuntary muscular contractions occur primarily in the neck muscles.^15,20 This can cause the head to turn to one side or to be pulled backward or forward.^15,21 CD is relatively uncommon, affecting 57 to 280 people per million.²² It can occur at any age, although symptoms generally appear in middle age, often beginning slowly and usually reaching a plateau over a few months or years.²³ The degeneration of the spine, irritation of nerve roots or frequent headaches can make CD particularly painful.²³ In most cases the cause is unknown and no cure exists.²²

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 85 countries and more than 30 years of clinical 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 specialty-driven biopharmaceutical group focused on innovation and Specialty Care. The Group develops and commercializes innovative medicines in three key therapeutic areas – Oncology, Neuroscience, and Rare Diseases. Ipsen also has a well-established Consumer Healthcare business. With total sales over €2.5 billion in 2019, Ipsen sells more than 20 drugs in over 115 countries, with a direct commercial presence in more than 30 countries. Ipsen’s R&D is focused on its innovative and differentiated technological platforms located in the heart of the leading biotechnological and life sciences hubs (Paris-Saclay, France; Oxford, UK; Cambridge, US). The Group has about 5,800 employees worldwide. Ipsen is listed in Paris (Euronext: IPN) and in the United States through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information on Ipsen, visit www.ipsen.com

Ipsen’s Forward Looking Statement

The forward-looking statements, objectives and targets contained herein are based on the Group’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 the Group’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 the Group’s expectations regarding future events, including regulatory filings and determinations, and the outcome of this study or other studies. 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 the Group. 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. The Group 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 the Group 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, the Group 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 6 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; the Group'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 the Group’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The Group 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 the Group’s activities and financial results. The Group 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 the Group’s partners could generate lower revenues than expected. Such situations could have a negative impact on the Group’s business, financial position or performance. The Group 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. The Group’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 the Group’s 2019 Universal Registration Document available on its website (www.ipsen.com ).

References

1. Jacinto et al., WCNR 2020. Differences in the patient experience of spasticity management with botulinum toxin type A – a comparison of European versus American survey findings.
2. Esquenazi et al., WCNR 2020. An international, multicentre, observational, longitudinal study to assess the effectiveness of abobotulinum toxin A injections for adult lower limb spasticity – The AboLiSh study.
3. Turner-Stokes et al., WCNR 2020. Longitudinal goal attainment with integrated upper limb spasticity management including botulinum toxin A – Primary results from the ULIS-III study.
4. Jacinto et al., WCNR 2020. Real-life data on the time to retreatment with botulinum toxin A in upper limb spasticity management.
5. Jacinto et al., WCNR 2020. Perceptions of burden of spasticity and treatment satisfaction among post-stroke patients over the course of a botulinum neurotoxin A (BoNT-A) treatment cycle – an ethnographic study.
6. Dursun et al., WCNR 2020. 7-year experience from the Ixcellence Network® – an international innovative educational program to improve cervical dystonia and spastic paresis management.
7. Jacinto et al., WCNR 2020. Importance of training and practice regarding rehabilitation approaches integrated with botulinum neurotoxin-A guided injection in cervical dystonia & spastic paresis – results from the INPUT survey.

8. Gormley et al., WCNR 2020. Efficacy and safety of abobotulinum toxin A in pediatric lower limb spasticity – 2nd interim results from a phase IV, prospective, observational, multicenter study.

9. Patel et al., WCNR 2020. 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.
10. Schnitzler et al., WCNR 2020. Economic analysis of real-world use of Botulinum toxin A products (BoNTA) for treatment of adult upper limb spasticity (AUL).
11. Dabrowski, et al., WCNR 2020. Efficacy and safety of abobotulinum toxin A for upper limb spasticity in children with cerebral palsy.
12. Chalard et al., WCNR 2020. Neuromodulation of cortical beta oscillatory activity following botulinum injection in post-stroke.
13. WCNR Virtual Congress 2020: Abstracts. WCNR. Accessed: October 2020. Available: https://programm.conventus.de/index.php?id=wcnr2020&tx_coprogramm_programm%5Baction%5D=index&tx_coprogramm_programm%5Bcontroller%5D=Search&cHash=78d3ab876b3e7fb1f4bb50cd9cfe44c5
14. Royal College of Physicians, British Society of Rehabilitation, “Spasticity in adults: management using botulinum toxin. National Guidelines”; 2018
15. Mayo Clinic. Cervical Dystonia. Available at https://www.mayoclinic.org/diseases-conditions/cervical-dystonia/symptoms-causes/syc-20354123 . Accessed October 2020.
16. John Hopkins Medicine. Spasticity. Available at: https://www.hopkinsmedicine.org/health/conditions-and-diseases/spasticity Accessed October 2020
17. American Association of Neurological Surgeons. Spasticity. Available at: https://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Spasticity . Accessed October 2020
18. American Association of Neurological Surgeons. Movement Disorders. Available at: https://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Movement-Disorders .Accessed October 2020
19. Kuo C. Post-stroke Spasticity: A review of epidemiology, pathophysiology, and treatments. Int J Gerontol 2018;12:280-284.
20. Claypool D, et al. Epidemiology and outcome of cervical dystonia (spasmodic torticollis) in Rochester, Minnesota. Movement Disorders 1995;10: 608-614.
21. National Institute of Neurological Disorders and Stroke. Dystonias Fact Sheet. Available at https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Dystonias-Fact-Sheet . Accessed October 2020.
22. Castelão M, et al. Botulinum toxin type A therapy for cervical dystonia. Cochrane Database of Systematic Reviews 2017;12:CD003633.
23. American Association of Neurological Surgeons. Dystonia. Available at http://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Dystonia . Accessed October 2020.

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