GlaxoSmithKline (GSK) is banking that it can come back from behind in the race for a Covid-19 vaccine and play an important role preparing for new pandemics after releasing positive trial data.
The vaccine maker is talking to governments, including the UK's, about creating vaccine manufacturing facilities on their home turf, and is investing heavily in mRNA, the technology behind the successful shots from BioNTech/Pfizer and Moderna.
GSK has not contributed to any of the first generation of Covid-19 vaccines, after a trial last year with its French partner Sanofi had to be redone because of a dosing mistake. The company chose to provide an adjuvant that boosts the effectiveness of many vaccines to several partners, rather than develop its own shot.
GSK and Sanofi published data from the second phase trial on Monday, which showed a strong immune response from participants of all ages, with people who had recovered from Covid-19 achieving good antibody levels after just one dose. The companies said they aimed for regulatory approval by the end of the year with phase-3 trials starting in the “coming weeks”.
The results come after positive pre-clinical data on GSK’s second-generation vaccine with German biotech company CureVac was released last week, and as Medicago, its Canadian partner, heads into a phase-3 trial.
Roger Connor, GSK's president of vaccines, told the Financial Times the company had "licked its wounds" after the "disappointing" setback.
Now, he said, it can play a big role in the next stage of the pandemic and as Covid-19 becomes an endemic disease. He said the vaccine with Sanofi looks particularly promising as a booster, and CureVac’s mRNA vaccine could target several variants at once.
“People will see that we haven’t been a front runner, however, we are still in this race,” he added.
The study results are also a boost to Sanofi, which was the second-largest vaccine maker by sales before the pandemic after GSK, but fell behind last year in the race to develop Covid-19 vaccines. It also has another jab under development based on mRNA technology.
Sanofi's failure to bring a Covid-19 vaccine to market has been the subject of much debate in France because critics see it is a symbol of the country's scientific decline. The French vaccination campaign got off to a slow start but has since accelerated to put it in the middle of the pack in the EU, in terms of doses administered by population, but behind Germany, Italy and Spain, according to Our World in Data.
GSK is under pressure from investors to show it is bolstering its pipeline, ahead of spinning off its consumer division next year. Hedge fund Elliott Management has taken a multibillion-pound stake and is pushing for change. The company plans to reveal what the remaining business, combining drugs and vaccines, will look like at an investor day in June.
Connor said GSK’s vaccine business is a “crown jewel” that has been underappreciated, increasing revenue by 50 per cent and doubling profit in the past four years.
Growth has been driven by products such as its Shingrix shot for older adults and he pointed to a potential first vaccine for RSV, a common respiratory disease, as a possible success in the pipeline.
As some analysts float splitting vaccines from the pharma business, Connor argued he works closely with Hal Barron, GSK's head of research and development, and the businesses have synergies because of the emerging science on the immune system.
The pandemic has catapulted new smaller players including Moderna, BioNTech and Novavax into the ranks of the top vaccine makers. While supply is constrained this year, the companies with approved vaccines are dramatically expanding production for 2022 and beyond, which some analysts think will create a crowded market.
But Connor said GSK still has the “strongest technology portfolio in the industry”, which is attracting interest from governments looking to prepare for future pandemics by investing in research and development and production capacity. He said while mRNA is an “exciting platform”, there are many diseases where it is not likely to work and so it is vital to have other options.
“We’re in a strategic inflection point as the vaccines industry,” he said. “Awareness of vaccination is growing, which can only grow market opportunity, [and]the technologies are accelerating at a pace we never thought could happen.” – The Financial Times