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Post-patent
Towards the end of patent protection, products may be reformulated to extend the patent. In this project, the product was reformulated to include vitamin D prior to patent expiry. The indication for the new product was treatment of postmenopausal osteoporosis in patients at risk of vitamin D insufficiency.
In order for the product to be successful, and be used within its licence, it was essential to identify the burden of disease, since there was a lack of data regarding the prevalence of vitamin D insufficiency in the UK.
JBM carried out work in Glasgow, Medway, Belfast, London, Southampton and Carshalton to establish vitamin D levels in the elderly.
The work revealed that low levels of vitamin D were extremely common in the elderly population, particularly so in patients with fragility fracture. Patients with hip fracture had the lowest level of vitamin D with one audit in Glasgow revealing that 98% of patients had vitamin D levels below a threshold of 70 nmol/l.
The work achieved a high level of press coverage with articles in local and national press, and was presented at the National Osteoporosis Society.
Dixon T, Mitchell P, Beringer T et al. An overview of the prevalence of 25-hydroxy-vitamin D inadequacy amongst elderly patients with or without fragility fracture in the United Kingdom. Curr Med Res Opin 2006;22:405-415. PubMed abstract.
