Proveca gets positive ema opinion for its first children's medicine drug (sialanar)

Proveca Limited today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of an EU-wide Paediatric Use Marketing Authorization (PUMA) for Sialanar® (glycopyrronium, oral solution), for the Symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders.   

The CHMP is responsible for issuing the EMA's scientific evaluation and opinions on all Marketing Authorization Applications (MAAs) for medicines for human use. Their positive opinion on Sialanar® forms the scientific basis for the European Commission to issue a binding decision for the PUMA, a centralized marketing authorization which is valid throughout all the Member States of the European Union (EU) as well as in the European Economic Area (EEA), namely Norway, Iceland and Liechtenstein. The anticipated timeframe for the European Commission decision is by the fourth quarter of 2016.  A summary of the CHMP opinion is available here. Please select "S" to access the Sialanar® summary opinion.  

Children living with motor or neurological disorders, such as cerebral palsy, are often unable to effectively swallow the saliva they produce resulting in unavoidable chronic drooling, with significant adverse consequences for the child’s wellbeing and quality of life. Sialanar, will be the first medicine licensed in Europe to treat chronic drooling.

Dr Helen Shaw, Co-founder and Director of Proveca Limited, said: “Incessant drooling associated with neurological disorders such as cerebral palsy can be an incredibly difficult issue to manage. Unfortunately, it is a symptom that comes with a number of health and hygiene implications, and can make a huge impact on a young person’s confidence and self-esteem. As well as causing irritation and infection around the mouth, it can have profound effects on the digestive system, causes dehydration and the constant wetness can often produce a foul odour. ” 

Co-founder and director Dr Simon Bryson added: “Sialanar has the capability of making a huge improvement to the quality of life of many young people. Now that we have reached this significant milestone with EMA, we are looking forward to launching this much needed product across Europe to help in the treatment of children and young people with this disabling condition”

Proveca is a leading pharmaceutical company in the development and licensing of medicines specifically designed for children and adolescents and is currently developing innovative, child-friendly medicines in the fields of cardiology, neurology, epilepsy and pain management.

Proveca gains fourth key agreement with ema

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: helen@proveca.co.uk.

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.

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.