Proveca gains fourth key agreement with EMA
North West pharmaceutical company Proveca Limited has reached its fourth key agreement with the European Medicines Agency (EMA) that will enable the development of a fourth drug designed specifically 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 captopril – a drug designed to treat heart failure in children.
The adoption of the PIP provides Proveca 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 captopril for children throughout Europe.
“Children can develop heart failure from any age,” explains Dr Helen Shaw, co-founder of Proveca Limited, based at Sci-Tech Daresbury in Cheshire. “Heart failure in infants is mainly seen as a failure to thrive, with symptoms presented including 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. “
Simon Bryson, co-founder of 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.”
Dr Helen Shaw added: “Captopril has the capability to make a huge improvement to the quality of life of those affected. Now that we have reached this milestone agreement with the 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.
“This PIP agreement perfectly complements the company’s agreement for a PIP on our drug enalapril earlier this year. The two drugs form part of the bedrock of heart failure treatment in children with captopril being prescribed initially, usually moving to enalapril somewhere in the first five years of life.”
The PIP agreement with the EMA follows a successful 18 months for Proveca, which included the granting of a PIP for glycopyrronium for chronic drooling, the appointment of Chris Brinsmead, the former president of Astra Zeneca UK, as chairman, winning Start-Up Company of 2013 at the BioNow awards, and granting of the enalapril PIP.
For further information, please contact:
Dr Helen Shaw MBChB, Director, Proveca Limited,
Mb: 07775 704497, Email: firstname.lastname@example.org.
Notes to editors:
About Proveca Limited: Proveca is a pharmaceutical company specialising in identifying, researching and licensing off-patent medicines with un-met priority health care needs.
It is focused on the paediatric market, specifically the re-engineering of existing generic medicines to make them appropriate for use by young people, many of whom have chronic conditions requiring long term drug treatment. Proveca is regarded as specialising in often technically complex new pharmaceuticals and its current activities include developing medicines for children in the fields of cardiology, neurology and pain management.
The company was co-founded in 2010 by Simon Bryson and Helen Shaw. Simon Bryson has twenty-one years’ experience as a technical and operations manager within the pharmaceutical and biopharmaceutical industry, including GlaxoSmithKline, PowderJect and Chiron Vaccines. As co-founder of Auralis Ltd, Simon led the company through a x5.4 fold return on investment when the company was acquired in May 2010 for £20m. Helen Shaw is a qualified doctor with over twenty years experience as a medical professional in the pharmaceutical industry. She has a proven track record in providing strategic direction and focus in product development and innovation. Her global experience covers drug and device classifications, and all stages of development and marketing. She was formerly Medical Director of Boots Healthcare International and a non-executive director at Auralis.
Proveca was created to bring much needed licensed medicines to children (and adults) in Europe. Currently, fifty to ninety percent of the medicines children take are in the wrong format and/or are unlicensed. Using the Paediatric Use Marketing Authorisation (PUMA) regulatory process, Proveca seeks to provide children with the medicines they need in an appropriate format and with a valid licence. Some of Proveca’s paediatric development opportunities are also relevant to the adult market and where this is the case the organisation will seek adult marketing authorisations.
Proveca won the ‘Start-Up Company of 2013’ at the prestigious BioNow Awards. Its Chairman is Chris Brinsmead, the former president of Astra Zeneca UK.
Proveca, based at Sci-Tech Daresbury near Warrington, secured a £2.6 million investment from Albion Ventures in December 2012, and has been the recipient of numerous grants including Technology Strategy Board (TSB) Smart Awards, Framework Seven Programme and Biomedical Catalyst, a joint programme from the TSB and Medical Research Council.