Normally, if some of the world’s largest players in their field announced they were collaborating to develop a new product, one would expect competition regulators to be crawling all over every detail.
However, these are not normal times, so news that GlaxoSmithKline and Sanofi – respectively the world’s first and third largest players in vaccines – are entering into a collaboration to develop a vaccine for COVID-19 is instead being welcomed. Shares of both GSK in London and Sanofi in Paris have risen.
The collaboration is without precedent in the normally fiercely competitive world of global pharmaceuticals.
And, while there are hundreds of businesses currently trying to come up with vaccines for COVID-19, this collaboration is being seen as particularly significant because it brings together two of the global pharmaceutical industry’s biggest names.
Crucially, GSK and Sanofi are also big drug manufacturers, which – with hundreds of millions of vaccines likely to be needed – will be critical in mass-producing any vaccine that the pair develop.
The two are bringing together two specific types of technology.
Emma Walmsley, chief executive of GSK, told Daily Week News that, while there was an enormous amount of work still to do, there was room for optimism: “These are two proven technologies in a pandemic scenario.”
Emma Walmsley became CEO of GSK in April 2017
The vaccine on which the pair are working is known as an adjuvant vaccine. An adjuvant is something that boosts the potency of a vaccine – reducing the amount of vaccine needed in each dose and, as a result, allowing more doses to be produced.
In this particular instance, Sanofi is contributing an antigen – a substance that stimulates the immune system in a patient’s body – based on a genetic match to proteins found on the surface of the coronavirus. GSK, meanwhile, is contributing its pandemic adjuvant technology.
Ms Walmsley said such technology pairings had been proven to work in the past.
She added: “In the H1N1 [‘swine flu’] crisis [in 2009], we needed four times less antigen. That matters because then you can get to protecting more people as possible and, obviously, the race is on here – this is one of seven vaccines partnerships we have, because we believe we’re going to need more than one to manufacture at scale.
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“So there’s a lot to do but, if we’re successful, we should be able to target hundreds of millions of vaccines by the end of next year.”
Ms Walmsley said that GSK had 70 different factories around the world with over 20,000 people going to work there daily.
She stressed that other drugs would continue to be manufactured and that their production would not be disrupted: “Obviously, it’s also absolutely critical at the moment that we are supplying the world with the medicines that people rely on…and that they need now.”
But coming up with a vaccine for COVID-19 would, she added, have to take priority over some other clinical trial work.
Global drug-makers all compete, at various times, for government grants to support their work.
Yet Ms Walmsley insisted the usual competition dynamic would not apply here because governments would need more than one solution.
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She added: “Now is not the moment to be thinking competitively but think about how we can work together to confront this global challenge.”
Developing drugs is a costly and time-consuming process. It can take a decade for a medicine to go from the laboratory to being made available for patients.
As an example of the urgency involved here, GSK and Sanofi hope to begin ‘phase 1’ clinical trials on human patients during the second half of this year.
It usually takes at least two years to reach phase 1 – the first of three phases of clinical trials typically involved before regulators allow a drug to go to market. Fewer than one in 10 so-called ‘candidate’ vaccines go on to make it to market.
At present, around the world, an estimated 70 vaccine ‘candidates’ have been identified by different companies but, to date, just three have entered ‘phase 1’ clinical trials.
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Ms Walmsley said regulators around the world would also have to move more quickly than they were accustomed to doing.
She added: “We’re all doing this in partnership with regulators in all the key markets around the world to support global solutions here.
“We don’t expect to make profit from this group of collaborations we’re looking at in vaccines because any short term profits we make we want to invest in long term pandemic preparedness and further COVID research.
“It’s extremely important that we are ready next time and we want to be a key contributor to that – and an element of that will be partnering with regulators.”
Any vaccine the pair successfully launch is likely to be manufactured in both the US and Europe.
Ms Walmsley also said that GSK’s plans to separate itself, which were confirmed before COVID-19 struck the West, would not be interrupted.
She went on: “There’s no change in our long-term goals. In fact these two new companies, their purpose has never been more relevant – one to be a leader in everyday consumer wellness, the other one a biopharma company focused on the science of immunology, the leader in vaccines and respiratory.
“So these are still very important goals for us but of course my first priority through all this is our people – so we are being flexible and thoughtful about how and when we execute different aspects of that – but there’s no change in our broad timeline or long term goals.”