PARIS–(BUSINESS WIRE)–Regulatory News:
Ipsen (Euronext: IPN; ADR: IPSEY) today presents the results of two patient surveys. The surveys involved over 400 respondents from five countries, living with spasticity or cervical dystonia and receiving botulinum neurotoxin type A (BoNT-A) injections. The results show that over 80% of respondents experienced debilitating symptom recurrence, and revealed that a lack of long-lasting symptom control between injections has a profound impact on the personal and professional lives of patients.1-4
“The results from these two important patient surveys provide significant insight into the real-life burden of the two conditions; however, they also highlight a worrying disconnect between patients’ treatment expectations and their actual experience. The findings, which build on our growing understanding of spasticity and cervical dystonia, provide us with the potential to unlock meaningful changes in clinical practice,” said Dr Alberto Esquenazi, Department of Physical Medicine and Rehabilitation, Gait and Motion Analysis Laboratory, MossRehab and Albert Einstein Medical Centre, U.S. and lead investigator on the spasticity survey.
The first survey1,2 investigated the burden of spasticity on patients’ lives. Of the 210 respondents from France, Germany, Italy, the U.K., and the U.S., 83% reported that symptoms of spasticity returned between two sessions of BoNT-A, with 59% of these patients experiencing that return within three months of their last treatment. Symptom recurrence significantly impacted patients’ quality of life, including sleep, relationships, performance of daily tasks and working lives. In addition, 47% of working patients reported being unable to work when symptoms re-emerge and 45% of working patients felt less efficient at work than before.1,2
The second survey3,4 adopted a similar approach, analyzing data from 209 respondents with cervical dystonia from across France, Germany, Italy, the U.K., and the U.S. Of the respondents, 88% reported the reappearance of pre-existing symptoms between BoNT-A injections. The majority of working respondents reported a significant impact on their professional life, with 66% stating that they did not feel comfortable at work and 66% did not feel as efficient at work as usual. Patients’ personal lives were also significantly compromised by their symptom recurrence, with an impact on their ability to socialize, sleep well, drive, or perform daily tasks.3,4
In both surveys, over 70% of patients said they would like longer lasting benefits from their treatment.1-4
The Carenity 2 surveys reveal the debilitating impact that symptom recurrence can have across every aspect of life for patients with spasticity and cervical dystonia, indicating that more needs to be done to relieve the burden of symptoms for patients suffering from these neurological conditions.1-4
Full results of the Carenity 2 survey in spasticity were published in Frontiers in Neurology on 07 May 2020.1
Antony Fulford-Smith, Vice President, Global Medical Affairs, Ipsen, commented: “Spasticity and cervical dystonia have a devastating effect on patients’ lives, seriously affecting their mobility, employment and quality of life. At Ipsen, we are constantly searching for ways to improve disease management and comprehensive care with a patient-centered approach. It’s clear from these surveys that more can be done to relieve the burden of these challenging diseases on patients’ day-to-day lives.”
Spasticity and cervical dystonia are distinct neurological conditions, though they share the characteristics of poor muscle control and spasms and are routinely treated with BoNT-A injections.3,5,6 Spasticity affects more than 12 million people worldwide7 and is generally caused by damage to the area of the brain and spinal cord responsible for controlling muscle and stretch reflexes due to stroke, traumatic brain and spinal cord injury, multiple sclerosis and cerebral palsy.5 Cervical dystonia is a rare disorder of unknown origin in most of the primary cases, characterized by involuntary contractions of the neck muscles.6
About the Carenity 2 surveys
The two patient surveys, commissioned by Ipsen, were conducted between May to September 2019 by Carenity, an online patient community. A total of 419 respondents from France, Germany, Italy, the U.K and the U.S responded to the surveys via the online platform Carenity. Eligible participants were over 18 years old and had (or cared for someone with) spasticity or cervical dystonia (CD) treated with BoNT-A for at least one year. To assess burden of spasticity or CD for patients and their caregivers, the Carenity 2 surveys explored the impact of symptom re-emergence on quality of life.1-4
Ipsen has an ongoing partnership with Carenity, a social media platform for people living with chronic diseases and presented findings from the first Carenity international survey which focused on spasticity at TOXINS 2019.8
Spasticity is estimated to affect more than 12 million people worldwide.7 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.5 Spasticity is usually caused by damage to the parts of the brain or spinal cord that control voluntary movement,5,9 leading to a change in the balance of signals between the nervous system and the muscles which leads to increased activity in the muscles.5 Spinal cord injury, multiple sclerosis, cerebral palsy, stroke, brain or head trauma and metabolic diseases can all cause spasticity.9 Spasticity is experienced by 34% of stroke survivors within 18 months following a stroke.10
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.6,11 This can cause the head to turn to one side or to be pulled backward or forward.6,12 CD is relatively uncommon, affecting 57 to 280 people per million.13 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.14 The degeneration of the spine, irritation of nerve roots or frequent headaches can make CD particularly painful.14 In most cases the cause is unknown and no cure exists.13
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. Its commitment to oncology is exemplified through its growing portfolio of key therapies for prostate cancer, neuroendocrine tumors, renal cell carcinoma and pancreatic cancer. 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—Cautionary Note Regarding Forward-Looking Statements
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. 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 and also taking into consideration assessment delays of certain clinical trials in light of the ongoing COVID-19 pandemic. 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 pre-clinical 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; 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 2018 Registration Document available on its website (www.ipsen.com).
- Jacinto et al. Patient perspectives on the therapeutic profile of botulinum neurotoxin type A in spasticity. Frontiers in Neurology 2020: DOI 10.3389/fneur.2020.00388.
- Esquenazi A, et al. Impact of spasticity and waning of effect of botulinum toxin a treatment on patients’ employment and quality of life: results of a multinational online survey. Abstract presented at the 6th Congress of the European Academy of Neurology. 23-26th May 2020, Vienna, Austria.
- Ferreira J, et al. How do patients with cervical dystonia (CD) experience their botulinum neurotoxin type a (BoNT-A) treatment cycle: results from an international online survey. Abstract presented at the 6th Congress of the European Academy of Neurology. 23-26th May 2020, Vienna, Austria.
- Comella C, et al. Gaps in the Management of Cervical Dystonia with Botulinum Toxin A: Findings from an Online Patient Survey. Poster presented at the 6th Congress of the European Academy of Neurology. 23-26 May 2020, Vienna, Austria.
- American Association of Neurological Surgeons. Spasticity. Available at: https://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Spasticity. Accessed April 2020.
- Mayo Clinic. Cervical Dystonia. Available at https://www.mayoclinic.org/diseases-conditions/cervical-dystonia/symptoms-causes/syc-20354123. Accessed April 2020.
- John Hopkins Medicine. Spasticity. Available at: https://www.hopkinsmedicine.org/health/conditions-and-diseases/spasticity. Accessed April 2020.
- Patel, A. et al. Burden of spasticity among patients and caregivers: results of a multinational survey. Poster presented at TOXINS 2019. 16-19th January 2019, Copenhagen, Denmark.
- American Association of Neurological Surgeons. Movement Disorders. Available at: https://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Movement-Disorders. Accessed May 2020.
- Kuo C.Post-stroke Spasticity: A review of epidemiology, pathophysiology, and treatments. Int J Gerontol 2018;12:280-284.
- 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.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Dystonias-Fact-Sheet. Accessed May 2020.
- Castelão M, et al. 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 May 2020.