SIRTURO® (bedaquiline) Wins UK Prix Galien Award for Most Innovative Orphan Drug
The first new medicine for tuberculosis in over 40 years has received the 2014 UK Prix Galien – regarded as one of the highest accolades for pharmaceutical research and development – at a ceremony held at the House of Commons.
SIRTURO® (bedaquiline), which was approved across Europe earlier this year, received the award in the Orphan Drug category. This category included a record number of entrants this year, reflecting the growing investment pharmaceutical companies are making in the area of rare diseases.
"We are honoured that bedaquiline has received this award," said Dr Peter Barnes, Medical Director of Janssen in the UK . "Multi-drug resistant tuberculosis is a serious global public health issue, which carries a high mortality rate. Individuals infected with drug-resistant strains are often unable to receive adequate treatment, and then risk spreading these resistant strains further, with serious consequences for public health. Janssen is very proud to have discovered an innovative medicine that meets such a significant unmet need for patients around the world, and are delighted that this endeavour has been recognised by the UK Prix Galien committee."
Bedaquiline was discovered by scientists at Janssen and has a unique mechanism of action that inhibits mycobacterial ATP (adenosine 5'triphosphate) synthase, an enzyme that is essential for the generation of energy in Mycobacterium tuberculosis.
In March 2014 bedaquiline received a licence in the European Union for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adult patients, when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. The approval was based on 24-week data from a Phase 2 clinical development programme, which included a controlled, randomised trial that evaluated the safety and efficacy of SIRTURO® versus placebo in the treatment of patients with pulmonary MDR-TB in combination with a background regimen (TMC207-C208) and an open-label study (C209). The durability of effect was supported by 120-week data from the Phase 2 controlled, randomised trial.1 The most frequent adverse drug reactions ( > 10.0% of patients) during treatment with bedaquiline in the controlled trials were nausea, arthralgia, headache, vomiting and dizziness.
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About the Prix Galien awards
The Prix Galien was created in France by pharmacist Roland Mehl, whose aim was to promote the country's significant advances in pharmaceutical research. Until the establishment of the Prix Galien, this discipline remained unrecognized. Mehl brought together an eminent jury consisting of clinicians, toxicologists, pharmacologists and pharmacists to select and honor the most important drugs introduced to the public market and the most significant research teams in the pharmaceutical field. Since then, The Prix Galien has been introduced across Europe and Canada and is now the most prestigious award of its kind in 11 countries. In addition, an International Prix Galien award is given each year, selected from previous winners.
The 2014 competition was one of the most hotly-contested in recent years, having attracted a record number of entrants. The shortlist included a wide spectrum of innovative medicines, and showcases the the valuable role that the UK pharmaceutical industry plays in tackling diverse and evolving global healthcare challenges.