Bexsero and Sirturo clear winners at UK Prix Galien Awards
pharmafile | October 2, 2014 | News story | Medical Communications, Research and Development, Sales and Marketing | 2014, Bexsero, Janssen, Novartis, awards, prix galien, sirturo
The first TB medication to be approved in four decades and the first ever vaccine to treat invasive meningococcal disease were the 2014 winners at last night’s UK Prix Galien Awards.
Novartis’ Bexsero and Janssen’s Sirturo (bedaquiline), fought off competition from the largest‐ever number of finalists to win the top accolades at the Prix Galien – an event hosted every two years to celebrate the best new innovative medicines on the UK market, and held at the House of Commons in London.
Chairman of the judging panel and former NICE chairman Professor Sir Michael Rawlins, said: “We had an outstanding group of contenders this year – with a total of 14 shortlisted products across both the Innovative Product and Orphan Drug awards.
“The submissions were all fascinating and beautifully presented – but there were clear winners in each category.”
The Innovative Product Award was won by Novartis’ Bexsero – the first broad coverage vaccine to help protect against meningitis B. Approved in the EU in 2013, Bexsero is indicated to help protect all age groups against meningococcal serogroup B disease and includes infants, who are the most vulnerable.
Two further drugs were ‘highly commended’ by the judging panel: Dificlir (marketed by Astellas) for Clostridium difficile infection, and Sanofi’s Lemtrada for multiple sclerosis.
But despite the competition: “Bexsero was the unanimous winner of the Innovative Product Award,” explained Sir Michael. “Invasive meningococcal disease manifests as either meningitis and/or septicaemia – which can be difficult to diagnose – and its rapid progression.
“Developing a vaccine, however, has been extremely difficult. It is therefore fantastic that the pioneering research at Novartis has led to the use of genomic techniques in creating a broadly protective vaccine.
“Bexsero has already been recommended for inclusion in the UK’s immunisation schedule for infants – and we warmly applaud our new‐found ability to address what was a big gap in childhood disease prevention.”
Sir Michael failed to mention however, that Novartis is currently in a battle with the government’s JCVI vaccination department over the price of its vaccine, and it had in fact rejected the medicine back in 2013 over its high cost.
The JCVI has since picked up the medicine for a future inoculation programme, but has told Novartis that it will have to significantly lower the price of its meningococcal B offering if it wants the lucrative vaccination contract.
Currently, according to the British National Formulary, the net price of a 0.5ml prefilled syringe of the vaccine costs the NHS £75, and usually requires two to three doses and a booster – depending on the patient’s age.
The UK already has a vaccination programme for meningitis C, the more common form of the disease, and a conjugate vaccination for group C has been adopted in the UK’s routine immunisation since 1999.
Novartis also makes a vaccine for MenC and MenA called Menveo, whilst GlaxoSmithKline markets ACWY Vax.
Orphan Drug Award
The 2014 Orphan Drug Award was won by Janssen’s Sirturo, the first medication for pulmonary multi‐drug resistant tuberculosis (MDR‐TB) with a novel mechanism of action in over forty years.
Sirturo, which is administered by directly observed therapy, is indicated as part of combination therapy in adults with pulmonary MDR‐TB.
“Two million people will develop MDR‐TB between 2011 and 2015,” says Sir Michael. “It is a WHO priority disease. There has also been an increase in the number of MDR‐TB cases in the UK over the last decade.
“Treatment is complex, requiring years of medication and extensive medical support – with less than 50% of patients having a successful outcome. It is against this background that Sirturo emerged as a clear winner.
“The panel was impressed with its novel mechanism of action. Its development represents the first step forward we have seen in the treatment of TB for more than 40 years. Moreover, it will have important public health benefits by reducing the spread of MDR‐TB and preventing progression to more resistant forms.”
Three further orphan drugs were highly commended by the panel; Adempas from Bayer for chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension, as well as InterMune’s Esbriet (pirfenidone) for idiopathic pulmonary fibrosis and Vertex’ Kalydeco (ivacaftor) for cystic fibrosis.
The judges noted that the Kalydeco submission indicated the drug could give cystic fibrosis patients around 16 extra years of life.
It also highlighted Esbriet’s effect on slowing the rate of loss of lung function – a major debilitating symptom of IPF. The drug is currently the only treatment approved for treating IPF in Europe, and is awaiting a marketing licence in the US.
It may shortly come up against competition in the form of Boehringer’s rival IPF medicine nintedanib, which could be on the US and EU market by next year.
Innovative?
Previous winners of the innovation awards include Bayer and J&J’s new generation anticoagulant Xarelto (rivaroxaban), and two separate cervical cancer vaccines from GlaxoSmithKline and Sanofi Pasteur MSD.
But not all medicines that have received the award have gone on to prove the most innovative of its class. In 2012 – the last time the awards were given out – two hepatitis C pills in the form of Janssen-Cilag’s Incivo (telaprevir) and MSD’s Victrelis (boceprevir) won the prize.
These drugs have fallen to the wayside in that time, being overtaken by the juggernaut that is Gilead’s hep C pill Sovaldi (sofosbuvir) which is on course to break the $10 billion marker this year.
Sovaldi was not put on the shortlist for this year as it was not submitted by Gilead – it is however eligible for the 2016 awards should the firm enter.
Ben Adams
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