Third key agreement with ema

Third key agreement with EMA for pharma company Proveca

North West pharmaceutical company Proveca Limited has reached its third key agreement with the European Medicines Agency (EMA) that will enable the development of a third drug designed for children and young people.

The EMA’s Paediatric Committee (PDCO) adopted a positive opinion on the paediatric investigation plan (PIP) for the development of enalapril – a drug designed to treat heart failure in children.

Children can develop heart failure from any age. Heart failure in infants is mainly seen as a failure to thrive, presenting with poor feeding, poor weight gain and chronic breathing difficulties. Older children and adolescents present with exercise intolerance, shortness of breath, cool extremities, dizziness and fainting. 

The adoption of the PIP provides Proveca, based at Sci-Tech Daresbury in Cheshire, with an agreed programme for the future development of the drug. It will deliver the required quality, safety and efficacy data needed for a future licence of enalapril for children throughout Europe.

Dr Helen Shaw, director at Proveca Limited, said: “Chronic heart failure in children is a disabling condition and presents a huge burden on families. Currently children need to take an adult tablet, usually crushed and suspended in a drink, or have a ‘special’ one-off liquid formulation made up each time. Inconsistencies in formulation and dose can lead to poor disease control with an increase in symptoms and visits to hospital.”

Co-director Simon Bryson added: “Enalapril has the capability of making a huge improvement to the quality of life of those affected. Now that we have reached this milestone agreement with EMA, we are looking forward to conducting our clinical programme and licensing this product to greatly improve the lives of those affected by childhood heart failure.”

Proveca is currently developing innovative medicines in the fields of cardiology, neurology, pain management and anti-rejection, largely for young people.

The PIP agreement with the EMA follows a successful 2013 for the company which included the granting of a PIP for glycopyrronium, for chronic drooling in May, the appointment of Chris Brinsmead, the former president of Astra Zeneca UK, as chairman in September and winning the title Start-Up Company of 2013 at the BioNow awards in November.