Ipsen's Dysport® (Clostridium Botulinum Type a Toxin-haemagglutinin Complex) Becomes First and Only Botulinum Toxin Type A to be Granted a Licence Update for Administration by Healthcare Professionals, Such as Physiotherapists, in the UK

SLOUGH, England, June 5, 2019 /PRNewswire/ -- Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a licence update for Dysport^® in the treatment of focal spasticity. The update to the Summary of Product Characteristics (SmPC) means that any appropriately trained and qualified healthcare professionals, which now includes physiotherapists, will be able to administer Dysport^® to patients for the treatment of focal spasticity within its licensed indications, and brings official protocol in line with current UK clinical practice and recommended guidelines.^[1]

Dr Stephen Ashford, Consultant Physiotherapist at Northwick Park Hospital, London said "We are delighted by this news and it means the role of the physiotherapist in administration of botulinum toxin for spasticity management is recognised. This license update will empower the way we already work, reflects what is best for patients and will ensure the standard of spasticity services across the NHS is maintained."

Physiotherapists and other healthcare professionals are required to complete extensive training and educational programmes which are tightly regulated to ensure they have met the expected standards of qualification to administer BoNT-A injections as part of patient treatment and care. Practice is governed by professional organisations and should comply with national guidelines such as the Royal College of Physicians for adult spasticity.^[2]

Dr. Marie-Helene Marion, Chair of the British Neurotoxin Network says "Botulinum toxin type A therapies have been a standard of care for a range of therapeutic areas including spasticity for many years. We wholeheartedly support this expansion to the range of specially trained healthcare professionals who are able to administer these vital medicines".

Spasticity is a physiological consequence of damage to the brain or spinal cord and may typically occur following a stroke or head trauma, and in association with cerebral palsy. Abnormal muscle contraction produced by spasticity cause limbs to lose their flexibility leading to pain and a reduction in mobility.^[3]

Commenting on the news, Asad Mohsin Ali, UK & Ireland General Manager, Ipsen said "We welcome this news not only for physiotherapists and their teams across the UK, but also for adult and paediatric spasticity patients who will benefit from having an additional set of health care professionals being able

to administer our medicine. We are very proud of the fact that Dysport^® (which was originally co‐developed with the UK Government) is leading the way on new standards of care in spasticity services to support patients."

About Dysport^®

Dysport^® was first approved in the U.K. in 1990 for the treatment of blepharospasm and hemifacial spasm and is licensed in more than 85 countries for various therapeutic indication.⁴

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 paediatric 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.¹

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). ¹

Ipsen co-developed Dysport^® in partnership with the UK Government bodies, specifically the Centre for Applied Microbiology and Research⁵ and provides continued value through a quarterly royalty to Public Health England which totalled more than £30m in 2018.⁶

Ipsen in the UK

Our team in the UK is a core part of Ipsen's global biopharmaceutical business and are driven by the belief that patients don't have time to wait. We have a biotech mindset coupled with pharmaceutical capabilities and have invested in a robust business presence in the UK that spans the early stages of R&D (Abingdon, Oxford) through to in-house manufacturing (Wrexham, Wales) so we can effectively deliver on our promise to UK patients. As part of this investment in the heart of UK life sciences, we employ over 800 people across our three UK sites, including our commercial headquarters in Bath Road, Slough.

Our business focuses on oncology, neurosciences and rare diseases, to create innovative therapies in areas of high unmet medical need. In the UK we already provide treatments for a range of conditions, including renal cell carcinoma and neuroendocrine tumours, where there are limited treatment options available for patients. In addition to the eight treatments we have already made available to patients in the UK, our team is continuing to research, develop and commercialise new assets to urgently address the needs of patients who are still waiting.

References

[1]Dysport^® Summary of Product Characteristics, www.medicines.org.uk, last updated 31 May 2019 (last accessed May 2019).

[2] Royal College of Physicians, Spasticity in adults: management using botulinum toxin. National guidelines, 2018. Available at: https://www.rcplondon.ac.uk/file/12449/download?token=zquqYk9H. Last accessed May 2019

[3] KPS Nair. The management of spasticity in adults. BMJ2014;349:g4737. Key fact available at https://www.bmj.com/content/349/bmj.g4737. Last accessed May 2019

⁴ https://www.ipsen.com/our-science/neuroscience/. Accessed May 2019

⁵ Erbguth FJ. From posion to remedy: the chequered history of botulinum toxin. J Nerual Transm 2007;115: 559-65

⁶ Data on File. DYS-UK-003296. May 2019.

SOURCE Ipsen