Clinigen : granted additional indication for Glycopyrronium Bromide to treat paediatric and adolescent severe hypersalivation

22 February 2019

Clinigen granted additional indication for Glycopyrronium Bromide to treat paediatric and adolescent severe hypersalivation

Clinigen Group plc (AIM: CLIN, 'Clinigen'), the global pharmaceutical and services company, has been granted by the Medicines and Healthcare products Regulatory Agency (MHRA), an additional indication for Glycopyrronium Bromide 1mg/5ml Oral Solution ('Glyco'). The new indication covers the use of Glyco in children and adolescents aged three years and older with chronic neurological disorders as symptomatic treatment of hypersalivation (severe sialorrhoea).

Hypersalivation is the excessive production of saliva, presenting as drooling in patients with a neurodisability, such as cerebral palsy. Chronic drooling affects one in five cerebral palsy patients and can impact on a person's quality of life, making everyday tasks and interactions more difficult. (1,2,3)

This additional indication extends the Glyco franchise and has been developed to address a previously unmet medical need. Clinigen aims to establish Glyco as the product of choice for prescribers in the UK when treating paediatric patients with severe hypersalivation and will look to globalise the franchise by using Clinigen's own international infrastructure as well as out-licensing to commercial partners where necessary.

Benjamin Miny, Senior Vice President of Commercial Medicines, Clinigen, said:

"Adding another indication to Glyco was a result of listening to feedback from prescribers about the unmet medical need and having the in-house expertise to develop and extend the life cycle of the product further, in line with our owned-product strategy.

"We continue to engage with our customers to understand their needs and invest in identifying and developing products to offer further benefits to prescribers and patients globally."

- Ends -

Contact details

Clinigen Group plc	Tel: [phone]
Shaun Chilton, Group Chief Executive Officer
Benjamin Miny, Senior Vice President of Commercial Medicines
Instinctif Partners	Tel: [phone]
Melanie Toyne-Sewell / Alex Shaw / Deborah Bell	Email:[e-mail]

Notes to Editors

About Glycopyrronium Bromide 1mg/5ml Oral Solution

Glycopyrronium Bromide 1mg/5ml Oral Solution is indicated for children and adolescents aged 3 years and older with chronic neurological disorders as symptomatic treatment of severe sialorrhoea. It is available with a graduated syringe included in the pack and offers dosing in simple-to-measure 0.5ml weight increments.

About Clinigen Group

Clinigen Group plc (AIM: CLIN) is a global pharmaceutical and services company with a unique combination of businesses focused on providing ethical access to medicines. Its mission is to deliver the right medicine to the right patient at the right time through three areas of global medicine supply: clinical trial, unlicensed and licensed medicines.

For more information, please visitwww.clinigengroup.com

References

• 1. Novak, I., Hines, M., Goldsmith, S. & Barclay, R. (2012) Clinical prognostic messages from a systematic review on cerebral palsy. Paediatrics, 130(5), e12851312. doi: 10.1542/peds.2012-0924

• 2. Fairhurst, C.B.R., Cockerill, H., Management of drooling in children. Arch Dis Child: Ed Practice Ed 2011;96:25-30.

• 3. Parkes. J., Hill, N., Platt, M.J., et al. Oromotor dysfunction and communication impairments in children with cerebral palsy; a register study. Dev Med Child Neurol 2010;52:1113-9