Drug Development

Zeroing in on Merck rival, GSK steps up to the FDA with its top new vaccine prospect

Just weeks after GlaxoSmithKline lined up a slate of promising Phase III data for its shingles vaccine Shingrix, the pharma giant has filed its pitch with the FDA in search of an approval that could generate some substantial revenue.

GlaxoSmithKline investigators have patiently amassed considerable data for this product. The two-dose vaccine posted a 90% efficacy rate among patients over 70 in one big Phase III that tracked patients for 4 years. The pooled data from two late-stage studies hit 89% for people over 70 and 91% for those over 50.

GSK didn’t do a head-to-head study against Merck’s rival Zostamax, but you can guarantee that the company will do all it can to spotlight Merck’s much lower rates of success, ranging from 18% to 70%, depending on the age group.

Zostavax brought in $749 million for Merck last year, which is encouraging a group of analysts to project annual revenue of $700 to $900 million in about 4 years for GSK.

Agenus’s adjuvant QS-21 plays a big role in Shingrix’s success. The biotech, though, sold off future royalties last fall for $115 million. The royalties will be used to pay down the loan plus 13.5% interest and then the revenue will shift back to Agenus.

GSK is also motivated to make the most of Shingrix as its Advair franchise is blasted by generics. Of all the Big Pharma companies, GSK has had one of the toughest R&D records over the past decade, failing to turn in the batch of big new blockbusters it needs to keep investors excited about the future. Vaccines is a big field, though, in which GSK plays a growing role around the world.

Marketing applications are also being prepped for Europe, Canada and Japan.

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