Nova Laboratories to supply leukaemia drug across Europe
pharmafile | July 4, 2012 | News story | Manufacturing and Production |
‘Xaluprine’, a liquid form of childhood leukaemia drug Mercaptopurine, will be distributed to hospital pharmacies across Europe after being granted an exclusive licence as an ‘orphan’ product by the European Commission.
The medicine has been developed by UK pharmaceutical manufacturer Nova Laboratories, who will start to ship commercial supplies at the beginning of July, with every European country due to be supplied within the next few months.
The company is now conducting further clinical work to provide additional data for a license submission in the autumn to market the product in the USA.
Dr Peter White, Nova’s Managing and Technical Director said: “We are very confident that we will retain exclusivity on the European Marketing Authorisation, as we look to broaden supply to other parts of the world.”
Mercaptopurine has been available as an adult tablet for many years, but because the dose has to be adjusted to the physical size of the patient, it has always been extremely difficult for parents or carers to administer the correct dose to young children.
Nova has formulated the medicine as an oral suspension, which offers more consistent absorption and allows doses to be accurately matched to the individual child’s medication needs – right down to 2mg doses, whereas the smallest available tablet is 50mg. It is also easier for patients to swallow and its natural raspberry flavour ensures good palatability.
Dr White added that the drug was an important milestone for the company:
“This is our first own-brand product, and will help secure Nova’s long-term future. We are already in the process of developing other liquid cytotoxic products to add to our portfolio.”
The medicine will be exclusively distributed in Europe by Trimedica Limited. For all enquiries please contact: info@trimedicaltd.com or call Matt Jelley, Commercial Director, on 0044(0)755 752 7112.
ENDS
Notes to editors
Nova Laboratories has developed a worldwide reputation for consistently being at the forefront of technological exploration and clinical standards. The company has MHRA-approved, state-of-the-art facilities at Wigston in Leicester, where it has developed world class expertise in aseptic processing of complex pharmaceuticals, using sterile isolation technology.
Its core activity is manufacturing experimental medicines for some of the world’s biggest pharmaceutical companies and small biotec enterprises, who have spent years of research and development in creating them. The medicines then go on for clinical trials before being licensed for general use.
Nova also has strong business in patient ‘specials’ which are tailored for individual patients, supplying them to almost every NHS hospital in the country as well as pharmacies and GP practices, and now veterinary practices too.
Nova was established – and is still owned – by ex-NHS professionals following a management buy-out in 1994. The majority of the original NHS team is still with the company, which now has 150 highly-qualified employees, and it retains a strong value for money ethos.
Nova is investing heavily in ground-breaking technologies that ensure the highest possible standards of safe drugs manufacture, storage and transportation.
For more information on Mercaptopurine: http://en.wikipedia.org/wiki/Mercaptopurine
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