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A pharmaceutical manufacturer in the middle of England has been granted a Europe-wide licence for a liquid formulation of mercaptopurine, a pivotal drug in the treatment of acute lymphoblastic leukaemia.
‘Xaluprine’ (mercaptopurine 20mg/ml oral suspension) will be distributed to hospital pharmacies across Europe after being granted an exclusive licence as an ‘orphan’ product by the European Commission, according to a press release from the Leicester-based manufacturer.
Nova will start to ship commercial supplies at the beginning of July, with hospitals in every European country due to be supplied within the next few months.
Development of an age-appropriate formulation to treat this disease was identified as a priority research area by the European Medicines Agency’s Paediatric Committee, and Nova has spent more than three years on the project.
Mercaptopurine has been available as a 50mg tablet for many years, but because the dose has to be adjusted according to body surface area, it has always been extremely difficult for parents or carers to administer an accurate dose to young children.
Xaluprine offers more consistent absorption than the tablet and allows doses to be individualised to an accuracy of 2mg. It is also easier for young patients to swallow and the natural raspberry flavour ensures good palatability.
Nova Laboratories Ltd was established in 1994 by ex-NHS pharmacy staff, and has since gained a global reputation for manufacturing complex and innovative experimental medicines and delivery devices, on behalf of a wide range of pharmaceutical and biotechnology companies.
Dr Peter White, Nova’s Managing & Technical Director, said it was a significant development in the treatment of childhood leukaemia.
“Xaluprine will bring great benefits to young children and their carers, in terms of improved accuracy of dosage and consistency of formulation, and we will therefore ensure that supplies are available in every European country over the next few months.” he said.
“This is our first own-brand product, and will help secure Nova’s long-term future. It has taken a great deal of effort from many of Nova’s employees to reach this milestone.”
The product will be exclusively distributed in Europe by Trimedica Limited.