IPSEN

Regulatory News:

Ipsen (Euronext: IPN; ADR: IPSEY) announced findings from a new U.S. healthcare database analysis to assess the current treatment patterns of adults living with spasticity in a real-life setting. The analysis focused on the proportion of people living with active spasticity who received botulinum neurotoxin type A (BoNT-A) treatment.¹ The abstract, Analysis of US Commercial Claims to Understand Patient Treatment Pathways in Spasticity , is being presented during the International Society of Physical and Rehabilitation Medicine (ISPRM) 2021 Congress, which is taking place virtually between 12-15 June 2021.¹

Spasticity is usually caused by damage to the parts of the brain or spinal cord that control voluntary movement, leading to a change in the balance of signals between the nervous system and the muscles, which results in increased activity in the muscles.^2,3 When injected into specific muscles of people living with movement disorders, BoNT injections cause temporary muscle relaxation, which can ease symptoms and aid rehabilitation.⁴ BoNT-A injections are considered as a recommended first-line treatment for adults living with spasticity in several countries, including the U.S.⁵

Ipsen analyzed data from two large U.S. commercial claims databases: IBM Watson’s MarketScan^® and the IQVIA Anonymous Longitudinal Patient Data (APLD) database:

• A total of 4,974,859 records were accessed in the MarketScan^® database, and 10,685,964 records in the IQVIA database.¹
• Spasticity was identified from the two sources using International Classification of Disease (ICD) codes for spastic conditions (e.g., monoplegia, diplegia, hemiplegia and contracture).¹
• This revealed 126,465 and 1,151,127 people living with spasticity in the MarketScan^® and IQVIA databases, respectively.¹
• In the MarketScan^® database, only 5,111 people living with spasticity (4%) were treated with BoNT-A. In the IQVIA database, an even smaller percentage were treated with BoNT-A (31,176 patients, 3%).¹

Isabelle Bocher-Pianka, Chief Patient Affairs Officer at Ipsen, commented: “Real-world studies help us better understand the patient’s medical journey and their unmet needs. While effective treatment of spasticity requires a multidisciplinary approach, which may involve a combination of exercise, physical therapy, medication, or surgery, it is concerning to see that many people living with spasticity in the U.S. are not receiving a recommended first-line treatment. The pandemic has been disruptive to the management of spasticity; these new data have, however, put a spotlight on the broader issues in the treatment of this condition that pre-date the pandemic.”

“We need to address barriers to treatment and find innovative ways to address the access issues in the treatment of this debilitating condition,” said Dr. Alberto Esquenazi, Sheerr Gait and Motion Analysis Laboratory, MossRehab, U.S. “Despite being a recommended first-line treatment, these data highlight a significant disconnect between the patient journey and the guidelines, since BoNT-A is only used for a small proportion of people living with spasticity in the U.S. and this is likely to be true in other parts of the world.”

“At Ipsen, we are fully committed to improving health outcomes for people living with debilitating neurological disorders,” said Dr. Andreas Lysandropoulos, Vice President, Head of Global Medical Affairs Neuroscience at Ipsen. “Poor control of spasticity can result in the breakthrough of painful symptoms such as muscle stiffness, spasms and involuntary contractions, which means the person living with spasticity may find it difficult to walk or perform certain tasks. These data show there is an urgent need to build on these findings and gather further insights into the underlying reasons for this disconnect.”

Follow Ipsen on Twitter via @IpsenGroup and keep up to date with ISPRM 2021 news and updates by using the hashtag #ISPRM2021.

About the databases

MarketScan^® holds healthcare data on approximately ~8% of the U.S. population insured commercially or as part of the national Medicare program. IQVIA is derived from electronic healthcare claims data generated as part of the normal reimbursement process and covers 50% of the U.S. population. All database records were de-identified and fully compliant with U.S. patient confidentiality requirements.

About spasticity

Spasticity is estimated to affect more than 12 million people worldwide.⁶ 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.² Spasticity is usually caused by damage to the parts of the brain or spinal cord that control voluntary movement, leading to a change in the balance of signals between the nervous system and the muscles which results in increased activity in the muscles.^2,3 Spinal cord injury, multiple sclerosis, cerebral palsy, stroke, brain or head trauma and metabolic diseases can all cause spasticity.² Spasticity is experienced by approximately 34% of stroke survivors within 18 months following a stroke.⁷

Ipsen

Ipsen is a global, mid-sized biopharmaceutical company focused on transformative medicines in Oncology, Neuroscience and Rare Disease; it also has a well-established Consumer Healthcare business. With Total Sales of over €2.5bn in FY 2020, Ipsen sells more than 20 medicines in over 115 countries, with a direct commercial presence in more than 30 countries. 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 c.5,700 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 .

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References

1. Lamontagne A. et al . ISPRM 2021. Analysis of US Commercial Claims to Understand Patient Treatment Pathways in Spasticity. Poster No. EP04-58
2. American Association of Neurological Surgeons. Spasticity. Available from: https://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Spasticity . Accessed: June 2021
3. American Association of Neurological Surgeons. Movement Disorders. Available from: https://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Movement-Disorders . Accessed: June 2021
4. Field M. et al . AbobotulinumtoxinA (Dysport^® ), OnabotulinumtoxinA (Botox^® ), and IncobotulinumtoxinA (Xeomin^® ) Neurotoxin Content and Potential Implications for Duration of Response in Patients. Toxins (Basel). 2018 Dec; 10(12): 535. doi: 10.3390/toxins10120535
5. Simpson D. et al . Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache: Report of the Guideline Development Subcommittee of the American Academy of Neurology. Practice Guideline. Neurology. 2016 May 10;86(19):1818-26. doi: 10.1212/WNL.0000000000002560.
6. John Hopkins Medicine. Spasticity. Available from: https://www.hopkinsmedicine.org/health/conditions-and-diseases/spasticity Accessed: June 2021
7. Kuo C. Post-stroke Spasticity: A review of epidemiology, pathophysiology, and treatments. Int J Gerontol 2018;12:280-284.

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