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Research at the University of Sheffield has demonstrated that zoledronic acid is an effective and safe treatment for osteoporosis. It resulted in a new drug intervention (Aclasta/Reclast) which has been licensed in more than 100 countries and shows increased positive outcomes for patients.
As a result of the licensing of the drug, clinical guidelines have changed globally. For patients, the drug provides a preferred method of treatment, evidenced in surveys which show the majority of patients preferred an annual infusion of zoledronic acid to the alternative, which is the standard treatment of weekly oral alendronate.
Industry has invested in research and development of the drug. Novartis has funded studies into the efficacy and safety profile (up to 2012); in 2011, sales of Aclasta/Reclast were US$0.6 billion.
Bone cement is widely used in joint replacement surgery, both for implant fixation and to enhance screw fixation in osteoporotic bone. Specific impacts include the development of two new orthopaedic cement systems by Summit Medical (Gloucester), also enabling that firm to obtain product approval and achieve significant new penetration of UK and international markets (UK bowl 70%; UK syringe 35%; US overall 15% — translating to total global sales 2009-2012 of £36M: 2012 = £9M).
Research outcomes have also impacted as a key element in the bid by Stryker Orthopaedics to obtain EU clinical approval and undertake US submission (ongoing) of injectable cements for augmenting bone screw fixation. Approval enabled the firm to establish Hydroset as a mainstream product with a cumulative total income of $180M since 2008 (income 2012 = $32M). The reach of these impacts also extends to improved clinical outcomes, resulting in improved quality of life and reduced healthcare costs.
Research by Professor Joost de Bruijn and team at QMUL from 2004 was critical to demonstrating the efficacy and commercial viability of a novel Instructive Bone Graft (IBG) product, AttraXTM. The technology, commercialised via the spin-out business Progentix Orthobiology BV (founded in 2007) was sufficiently mature by 2008 to attract series A investment of €1 million series A financing by BioGeneration Ventures. The development of AttraXTM has led to a trade sale totalling up to US$ 80 million to the global top 5 spine company NuVasive Inc. in 2009. In 2011 an exclusive distribution deal with a global top 3 dental company was signed for use of the technology in the field of dentistry and craniomaxillofacial surgery. After regulatory approval of AttraXTM in Europe (CE mark), the product was commercialised in 2011 and has been used successfully in more than eleven thousand patients (as of 2013Q3) with global reach (including EU, US, Australia, New Zealand and Brazil). Within 1 year of commercialisation, a 1.1% share of the estimated US$2 billion global spinal bone graft market has been achieved. This research has seen an economical benefit in terms of newly formed jobs from 2 FTE in 2008 to 25 FTE in 2013 at Progentix Orthobiology BV.
Seminal materials research at QMUL and its technological transfer via the QMUL spin-out ApaTech™, has led to the development of a range of cost-effective synthetic bone graft (SBG) products (ApaPore™, Actifuse™ and Inductigraft™), which safely and effectively stimulate rapid bone healing and are more reliable than previous autograft procedures. The successful use of the ApaTech™ range of products has delivered impact on health and welfare by reducing post-operative infection risks and improving recovery rates. To date, ApaTech™ products have been used to treat over 370,000 patients in over 30 countries. In 2010, ApaTech™ had 4% of the US SBG market, a $20 million annual turnover, employed 160 people in nine countries, and was sold to Baxter International for £220 million. By 2012, ApaTech™ products had attained a 10% share of the global SBG market (treating 125,000 patients per annum), estimated to be around $510 million. Other impacts include altering surgical clinical practice away from the use of autograft.
NovaBone® (NovaBone Products LLC) is a synthetic bone graft. It is a Bioglass® (a specific composition of bioactive glass) powder that orthopaedic surgeons use to regenerate (heal) bone defects (holes in bone). Research by Larry Hench, Julia Polak and their student Ioannis Xynos, that was published in 2001, showed that the dissolution products of the glass particles stimulated bone cells to produce new bone. This gave NovaBone a competitive edge over all other synthetic bone grafts at the time. Due to the data, NovaBone coined the term Osteostimulation, which describes this property. The Federal Drug Agency in the USA (FDA) allowed the claim, which led to a 20% increase in sales for NovaBone.
GlaxoSmithKline (GSK) released a new toothpaste in 2011, Sensodyne Repair and Protect and in the first 16 weeks attracted a 2.7% (£10M) market share. The active ingredient is Bioglass (NovaMin®). The fundamental research was carried out in the Department beginning with the work of Larry Hench and Julian Jones in 1999. They reported the effect of glass particle size on active ion release. 57% of people suffer from hypersensitivity (tooth pain) caused by fluid flow into exposed tubules in dentin that lead to nerve endings. When teeth are brushed with toothpaste containing NovaMin®, the particles bind to the dentine, where they dissolve and produce mineral with similar composition to enamel, which occludes the tubules. GSK developed a new toothpaste based on this research — Sensodyne Repair and Protect. Sensodyne delivered remarkable growth of 14% driven largely by the successful rollout of Sensodyne Repair and Protect.