GSK says it is pleased with the launch of its shingles vaccine Shingrix but supply going forward is limited by a lack of manufacturing capacity.
In October 2017, GlaxoSmithKline received approval from the US Food and Drug Administration (FDA) for Shingrix (Zoster Vaccine Recombinant, Adjuvanted), its non-live, recombinant subunit vaccine for the prevention of shingles (herpes zoster).
A year on, the Big Pharma firm announced Shingrix sales of £286 million ($372 million) for its third quarter, helping to boost its vaccines business by 17% year-on-year. And for the full year, the firm said it expects Shingrix sales of between £700 million and £750 million.
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“For Shingrix, we are on track with good momentum, and this is a very large opportunity,” Luke Miels, president of Global Pharmaceuticals said on a call discussing Q3 results.
“We’re very pleased with the execution of our Shingrix launch, and in particular, how we’ve been able to accelerate our production plans. By the end of Q3, approaching seven million doses have been administered globally since launch. We now expect to be able to deliver enough doses in 2018 to take Shingrix revenues for this year to between £700 million and £750 million.”
Supply shortage
However, in the near-term, the firm’s ability to grow sales will be limited by its supply, Miels added.
There is currently a shortage of the vaccine, which the US Centers for Disease Control and Prevention (CDC) has attributed to high levels of demand. GSK has implemented order limits on shipments and has previously stated there are no manufacturing issues surrounding Shingrix.
“Shingrix should be an important growth driver for a number of years as we continue to expand capacity. More specifically, over the next two to three years, we plan to increase our annual capacity to levels of doses in the high-teens millions, and build further from there. But please keep in mind, the ramp-up is very unlikely to be linear.”
Modular ramp-up
Simon Dingemans, CFO at GSK, said on the call capacity expansion will not be linear. “It sort of comes in modules as you put in additional vessels on the secondary capacity, so it’s not going to go up smoothly, but we are moving as quickly as we can,” he told investors.
“We are really pleased with how the vaccines team has performed this year to pull forward some of the plans we previously had. I hope it gives you a sort of sense of where we are headed after a very rapid ramp-up this year with now suggesting that and we will move forward into ’19 and ’20 and beyond,” he said.
“We are seeing lot more potential as we get global on this product from there on. But clearly, we’ve got to get on top of the short-term demand we have particularly in the US.”
According to the FDA’s label information, Shingrix is manufactured at GSK’s facility in Rixensart, Belgium.
GSK did not respond to a request for further information from BioProcess Insider at the time of going to press.