PARIS - Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a licence update for Dysport for the symptomatic treatment of focal spasticity of upper limbs in pediatric cerebral palsy patients, two years of age and older.

Spasticity in children is most commonly associated with cerebral palsy (CP). 1,2 Approximately 17 million people worldwide are affected by cerebral palsy, with an estimated 1 in 400 babies born with cerebral palsy in the UK, 75-91% of whom will have a specific type known as spastic cerebral palsy. 1,2 For these children, spasticity affects muscle tone, movement, and motor skills, hindering their ability to move in a coordinated and purposeful way, which can consequently impact on their ability to participate in everyday activities.3

'Therapeutic options such as botulinum toxin type A are an important part of the multidisciplinary approach for treating spasticity,' said Alison Smith, Consultant Pediatric Neuro-physiotherapist, NPP Neuro Group, UK. 'They work by interrupting the muscle contraction and thereby reducing stiffness related to spasticity with the aim of helping children with cerebral palsy to not only improve physical functioning but also achieve their goals which can improve their mental and emotional wellbeing. Having a therapeutic option approved for both upper and lower limb indications creates a real benefit for the patient as it allows a holistic treatment approach for any patients with multi-focal spasticity.'

About Pediatric Cerebral Palsy Spasticity

Spasticity is abnormal and involuntary muscle stiffness, or overactivity (contractions) in a group of muscles7, which causes them to have increased tone, leading to stiffness or tightness.8 Cerebral palsy (CP) is the leading cause of childhood disability affecting function and development, and the most frequent cause of spasticity in children. 3 Approximately 17 million people worldwide are affected by cerebral palsy, with an estimated 1 in 400 babies born in the UK have a type of CP, approximately 90% of whom will develop spastic cerebral palsy.1,2

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. 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 wellestablished Consumer Healthcare business. With total sales over EUR2.2 billion in 2018, 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 5,700 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).

About Dysport

Dysport is an injectable form of a botulinum neurotoxin type A product, which is a substance derived from Clostridium bacteria producing botulinum toxin type A (BoNT-A) that inhibits the effective transmission of nerve impulses and thereby reduces muscular contractions.15 It is supplied as a lyophilized powder. As of 31 December 2018, Dysport had marketing authorization in more than 85 countries for therapeutic treatment indications and more than 30 years of clinical experience. Dysport was first approved in the U.K. in 1990 for the treatment of blepharospasm and hemifacial spasm. 1

Dysport is indicated for symptomatic treatment of focal spasticity of upper limbs in adults, lower limbs in adults affecting the ankle joint due to stroke or traumatic brain injury (TBI) and dynamic equinus foot deformity in ambulant pediatric cerebral palsy patients, two years of age or older. Dysport is also indicated in adults for symptomatic treatment of spasmodic torticollis, blepharospasm, hemifacial spasm and severe primary hyperhidrosis of the axillae, which does not respond to topical treatment with antiperspirants or antihidrotics. Dysport should only be administered by appropriately trained physicians. For the treatment of focal spasticity, Dysport can also be administered by healthcare professionals having received appropriate training and qualification in accordance with national guidelines (e.g. Royal College of Physicians).2 Ipsen co-developed Dysport in partnership with the UK Government bodies, specifically the Center for Applied Microbiology and Research14 and provides continued value through a quarterly royalty to Public Health England which totaled more than GBP30m in 2018.17

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Contact:

Christian Marcoux

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