Ipsen: Patients Living with Spasticity Want Long-lasting Symptom Relief

Regulatory News:

This press release features multimedia. View the full release here:
https://www.businesswire.com/news/home/20190117005697/en/

Carenity Infographic

Ipsen (Euronext: IPN; ADR: IPSEY) today presents at TOXINS, results from
an international survey revealing the hidden burden of spasticity and
the need for longer periods of symptomatic relief¹. Affecting
12 million people around the world², spasticity is one of the
most common and disabling conditions associated with neurological
diseases in adults (stroke, traumatic brain, etc.) and characterised by
an abnormal increase in muscle tone or stiffness³. A survey
of 615 respondents from 6 participating countries confirms that
spasticity has a profound impact on ability to perform everyday tasks,
including the ability to carry items, walk, and drive and reduces
independence overall.

The survey¹ also found that spasticity affects the ability to
work (22% of patients surveyed did not work) and impacts sex life as
well as self-esteem. For 94% of patients surveyed, satisfaction with
life improves with botulinum toxin type A treatment - injection of
BoNT-A is one of the reference treatments for spasticity that acts by
blocking neuromuscular transmission⁴.

Alexandre Lebeaut, M.D., Executive Vice President, Research &
Development and Chief Scientific Officer, Ipsen stated: “Spasticity
is not always the first symptom that is managed in adult or children
central nervous system insult, but it has a long term and chronic
profound impact on fundamental aspects of patients and caregivers’ daily
lives. The hallmark of good patient care is providing access to
effective treatments that can control symptoms, and improve quality of
life.”

The survey¹, undertaken in association with Carenity, a
social media platform for people living with chronic diseases, also
exposes the practical issues related to spasticity and its treatment.
Most patients (78%) have to take time off work because of their
condition. Treatment also represents a financial burden with average
out-of-pocket expenses of 150 Euros per injection. 9 out of 10
respondents want long periods without symptoms, and expect it would have
a positive impact on their quality of life. An interim analysis of
ULIS-III⁵ – a phase IV study on attainment of person-centered
goals after BoNT-A treatment for adult upper limb spasticity – reporting
on treatment intervals is presented at TOXINS 2019.

Jorge Jacinto, PM&R Senior Consultant, Head of Department of Adult
Neuro-rehabilitation, Centro de Medicina de Reabilitação de Alcoitão,
Portugal, concluded: “The Carenity survey as well as
observational studies like ULIS-III⁵ provide priceless
patients insights to clinicians. It will allow us to not only consider
the burden of spasticity in its entirety, but also rethink the treatment
paradigm to improve patients’ and caregivers’ quality of life.”

Ipsen will be presenting the results of this survey as part of 50
posters submitted to TOXINS 2019 in Copenhagen, which include:

• Burden of spasticity among patients and caregivers: results of a
  multinational survey; Patel et al.
• The patients’ perspective on botulinum neurotoxin A treatment: results
  of a multinational survey for patients with spasticity; Bahroo et al.
• Fewer injections of botulinum toxin type A for treatment of spasticity
  are perceived as beneficial by both patients and caregivers; Wein et
  al.
• Time to retreatment with botulinum toxin A in upper limb spasticity
  management: upper limb international spasticity (ULIS)-III study
  interim analysis; Turner-Stokes et al.

About the survey

Individuals (615 respondents: 69% patients and 31% caregivers) from
Western Europe and the USA were asked to complete a survey via the
online platform Carenity. Eligible participants were over 18 years old
and had (or cared for someone with) spasticity treated with BoNT-A for
at least one year. To assess burden of spasticity for patients and
caregivers, participants were asked about the impact of spasticity (on
ability to work, functioning and quality of life) and of BoNT-A therapy
(on their lives and potential benefits of fewer injections).

About spasticity

Spasticity is a condition characterised by velocity-dependent muscle
hyperactivity³. Spasticity is usually caused by damage to
nerve pathways in the brain or spinal cord that control muscle movement,
and may occur in association with cerebral palsy, spinal cord injury,
multiple sclerosis, stroke, and brain or head trauma ^2–4.Spasticity,
is experienced by 34% of stroke survivors within one year after a first
stroke^6–8. Around 84% of patients with multiple sclerosis
live with some form of spasticity².

References:

1. Patel, A. et al. An international survey examining patient and
   caregiver perspectives on the burden of spasticity and impact of
   botulinum neurotoxin therapy. Eur J Neurol.
2. AANS. AANS Website - Spasticity.
3. AAN. Practice guideline update summary: Botulinum neurotoxin for the
   treatment of blepharospasm, cervical dystonia, adult spasticity, and
   headache. (2016). doi:10.1212/WNL.0000000000002560
4. Dystonia.org.uk. Dystonia explained. 1–4 (2014).
5. Turner-Stokes, L. et al. Impact of integrated upper limb
   spasticity management including botulinum toxin A on patient-centred
   goal attainment: rationale and protocol for an international
   prospective, longitudinal cohort study (ULIS-III). Open 6,
   11157 (2016).
6. Kuo, C. L. & Hu, G. C. Post-stroke Spasticity: A Review of
   Epidemiology, Pathophysiology, and Treatments. Int. J. Gerontol.
   1–5 (2018). doi:10.1016/j.ijge.2018.05.005
7. Thibaut, A. et al. Spasticity after stroke: Physiology,
   assessment and treatment. Brain Inj. 27, 1093–1105
   (2013).
8. Esquenazi, A. The human and economic burden of poststroke spasticity
   and muscle overactivity. J. Clin. Outcomes Manag. 18,
   34–44 (2011).

About Ipsen

Ipsen is a global 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
€1.9 billion in 2017, 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 5,400 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.

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. 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 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 2017 Registration Document available on its website
(www.ipsen.com).

View source version on businesswire.com: https://www.businesswire.com/news/home/20190117005697/en/