WOOBURN GREEN, England, May 18, 2016 /PRNewswire/ --
Launch of Early Access Programme for Noyada, First Novel Oral Liquid Formulation of Captopril Targeting Paediatric Cardiovascular Conditions and Type 1 Diabetic Nephropathy
Martindale Pharma, a UK-based international specialty pharmaceutical company, today announced the approval and supply of Noyada in France, under an ATU de' Cohorte ("Temporary Authositaion for Use") programme which will commence in June. Noyada is an oral liquid version of captopril used in the treatment of paediatric chronic heart failure. Cevidra Laboratories, a French-based pharmaceutical company which specialises in ATU programmes will distribute Noyada in France.
Martindale Pharma has also started the process to seek Marketing Authorisation Approval in France. Noyada is the only approved oral liquid formulation of captopril in Europe and has been available in the UK for 2 years. Noyada is targeted for use in children with serious cardiovascular conditions who can benefit from an oral liquid product. Noyada is a clear, colourless solution available in 100ml amber glass bottles with child resistant and tamper evident caps, and specific dosage syringes and dosage cups to assist in administration. The doses of the oral liquid product can be easily adjusted using dosing syringes/measuring cups provided in the pack. Noyada 5mg/5ml and 25mg/5ml Oral Solution is used principally in the treatment of paediatric chronic heart failure and in children between the ages of 0 and 6 years old.
Michael Harris, CEO of Martindale Pharma, said: "Martindale Pharma is committed to developing innovative presentations of known drugs that improve patients' lives and we are very pleased to have received approval to supply Noyada for paediatric patients in France. Noyada is already an established product in use in paediatric cardiology in the UK and is a hugely positive treatment option for healthcare professionals. We are delighted to be able to provide this much needed oral liquid version of captopril through the ATU de' Cohorte programme in France with Cevidra."
Noyada will be supplied under a specific protocol of therapeutic use which forms part of the ATU de' Cohorte programme. The process involves specialist physicians identifying suitable patients for Noyada and enrolling them in a registry-style programme.
About Martindale Pharma®
Martindale Pharma is a leading UK-based, international specialty pharmaceutical company providing essential medicines to over 28 countries around the world.
Our strategy is to build leading positions in defined business segments where there is a high unmet medical need and a demand for improved product presentations. Our focus is on Opioid Addiction, Emergency Care, Hospital-initiated Medicines, Ophthalmics and Unlicensed Medicines (also called "Specials").
With a strong UK presence with expertise in marketing hospital and specialty medicines, Martindale Pharma is recognised as a strategic partner to the NHS and other healthcare providers and supplying over 100 licensed products and with a track record of successful new specialty product launches.
The business also includes a rapidly growing international organisation currently centred on three geographical regions: Saudi Arabia and the Gulf Co-Operation Council territory, Australia and South East Asia and Northern Europe (focused on Scandinavia).
Uniquely as an independent pharma company the company is underpinned by our own modern, efficient UK manufacturing facility which enables us to develop and compete globally to supply high quality, low cost specialty pharmaceuticals in sterile injection and oral liquid formats.
For further information visit our new website http://www.martindalepharma.co.uk
Cevidra is a leading French-based company supplying medicines to patients and health establishments for rare diseases or unmet medical need. Cevidra has 10 years of experience of long-term partnership with pharmaceutical companies located in Europe and North America.
Cevidra is a key partner for early access program (EAP) as well as for post-marketing authorisation (MA), providing services in regulatory affairs, pharmacovigilance, marketing & sales and administrative management & logistics for both medicines and medical devices.
For further information please visit http://www.cevidra.com
SOURCE Martindale Pharma