GSK seeks regulatory review of first malaria vaccine
pharmafile | July 26, 2014 | News story | Manufacturing and Production, Research and Development, Sales and Marketing | China, GSK, malaria, rts, s
GSK has submitted a regulatory application to the European Medicines Agency for its malaria vaccine candidate RTS,S and hopes it could be available by the end of next year.
RTS,S is intended for use against the Plasmodium falciparum malaria parasite, which is most prevalent in sub-Saharan Africa (SSA). Around 90% of estimated deaths from malaria occur in SSA, and 77% of these are in children under the age of five.
If a positive opinion from the EMA is granted, the World Health Organization (WHO) has told GSK that it would recommend the treatment for the SSA region by the end of next year.
It may seem unusual that the EMA is assessing this medicine when it is designed to be used in the SSA and not Europe, but this is because the majority of African countries use the Agency as its regulator before using a medicinal product that’s manufactured in Europe.
GSK says a large-scale roll-out of a vaccination programme could begin from 2015 should both the EMA and WHO recommend the drug’s approval.
Study results
Data for the submission comes from a large-scale Phase III trial published in October last year which showed RTS,S – currently the most clinically advanced malaria vaccine candidate – continued to protect young children and infants from clinical malaria up to 18 months after vaccination.
This builds on 2011 data showing that the vaccine could cut the disease risk by half. These latest results demonstrate that after over 18 months of follow-up, RTS,S was also shown to almost halve the number of malaria cases in young children (aged 5-17 months at first vaccination) and to reduce by around a quarter the malaria cases in infants (aged 6-12 weeks at first vaccination).
Vaccine efficacy was also assessed separately at each of the trial sites, which represent a wide range of malaria transmission settings. Efficacy was found to be statistically significant at all sites in young children and at four sites in infants.
Long path for a vaccine
Malaria is a significant public health burden and results in around 660,000 deaths a year and mostly affects children in sub-Saharan Africa, meaning health bodies like the WHO are keen to see these types of treatment available as soon as possible.
The vaccine which was invented by GSK Biologicals in the 1980s is being developed in partnership with the PATH Malaria Vaccine Initiative (MVI), which gets the majority of its funding from the Bill & Melinda Gates Foundation.
Dr Sophie Biernaux, head of the malaria vaccine franchise at GSK, says: “This is a key moment in GSK’s 30-year journey to develop RTS,S and brings us a step closer to making available the world’s first vaccine that can help protect children in Africa from malaria.”
Current treatments include the antimalarial drug quinine which has been used for decades, but does not vaccinate against the disease, and can have adverse side effects.
GSK has already said that the eventual price of RTS,S will cover the cost of manufacture, plus a 5% return to be reinvested in R&D for second-generation malaria vaccines or vaccines for other tropical diseases.
Good news after a tough month
This is a much needed boost for the firm as its latest financial results for the second quarter, released last week, showed revenue had dropped 4% and profit by 12% as key respiratory drugs failed to perform for the firm.
It is also dealing with the fallout from a major scandal in China that this month moved into its second year with no signs of abating.
Chinese authorities have accused GSK staff or bribing doctors across the country a total of £320 million to prescribe their drugs whilst also keeping medicine prices artificially high.
A former investigator for the firm, Briton Peter Humphrey, is also set to take the stand in early August in what could prove to be a public dressing down of GSK.
As if this wasn’t bad enough, Reuters has also reported that the company is now investigating fresh allegations of corruption, this time in Syria.
Britain’s biggest drugmaker says it received an email from a whistle-blower last week detailing alleged ethical breaches in its former consumer healthcare operations in Syria. The business was shut down in 2012 due to the civil war in the country.
The email to Sir Andrew Witty, its chief executive, alleged that GSK had paid bribes to promote adoption of products including its Panadol painkiller. The money involved is thought to be much less than the sums alleged in the China scandal.
This latest allegation adds to the ones not only in China, but also Poland, Iraq, Jordan and Lebanon. The UK is also now investigating the firm to assess whether it has broken its international bribery laws, and could face a hefty fine if found guilty.
Ben Adams
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