700094Novel glycopyrronium formulation for the treatment of severe chronic drooling in childrenClosedGRD Proof of MarketInnovate UKSialorrhea or Chronic Drooling (CD) in children is a significant problem and can occur as the manifestation of different neurological disorders such as cerebral palsy (CP) and amyotrophic lateral sclerosis (ALS). Proveca’s objective is to develop a novel oral formulation of glycopyrronium, an off-patent drug for the treatment of sialorrhea or Chronic Drooling (CD) in children. As Glycopyrronium is currently unlicensed in the UK and the rest of the EU for children, Proveca has the opportunity to undertake the required clinical studies and apply for a Paediatric Use Marketing Authorisation (PUMA) to target the children market in these regions. The world market for prescription paediatric drug was estimated to have reached $43 billion in 2011 and to grow to $85 billion by 2017, this growth being mainly driven by new regulations like PUMA recently introduced to incentivize the development and commercialisation of paediatric drugs. The innovation lies in developing a new licensed oral formulation of Glycopyrronium, which unlike tablet formulation does not require compounding before administration. R&D activities will involve conducting the required clinical trials to assess the drug efficacy. The key objective of this Proof of Market project is to assess the commercial viability of Proveca’s new Glycopyrronium, to establish a full validation of the UK and EU market, gaining a thorough understanding of the real needs and requirements of the patients, clinicians, GPs, pharma companies and other stakeholders for the novel formulation. The early mapping of the market opportunities will significantly accelerate the development and realisation of the project and the European scope of the research will help Proveca to understand the wider market requirements.