Plotting a global path to blockbuster sales, GSK grabs Shingrix nods in Europe, Japan

GSK's Shingrix won approvals in Europe and Japan as it steps up its rivalry with Merck & Co.'s Zostavax. (FiercePharma)

As GlaxoSmithKline presses ahead with its Shingrix launch, the company picked up two important nods on Friday from regulators in Europe and Japan. These two leading drug markets are key to the shingles vaccine rollout already begun in the U.S. and Canada.

A joint venture between GSK and Daiichi Sankyo will sell the shot in Japan, Glaxo said Friday. 

Along with COPD med Trelegy and HIV drug Juluca, Shingrix is among a cadre of new drugs with big sales expectations at Glaxo. They'll need to deliver as the company's respiratory blockbuster Advair braces for generic competition. So far, would-be copycat drugmakers have been thwarted in their attempts to win FDA approval, but market watchers predict the drug could succumb to generic competition later this year.

Numerous studies have shown GSK's new shingles shot offers stronger protection than Merck & Co.'s older Zostavax and that Shingrix's protection lasts at least four years.

Last week, the company got a boost from CVS, which announced it's stocking more than 9,800 pharmacies with the vaccine. Walgreens has also begun stocking the GSK shot, as has grocery chain Albertsons, which is acquiring Rite-Aid locations that will boost its pharmacy network to almost 5,000 locations.

RELATED: GlaxoSmithKline's Shingrix launch gets a jump-start with CVS move to stock thousands of pharmacies 

Analysts predict Shingrix will reach sales of $1.368 billion by 2022, according to a new report from Clarivate Analytics. Shingrix was the only vaccine to make the research firm's new list of pharma's 2018 blockbuster launches. 

Glaxo's climb in the shingles vaccine market is expected to trigger Merck's decline. Zostavax sales have already slipped, turning in a 45% drop in the fourth quarter to $121 million. Merck has warned sales will continue to fall because of Shingrix's approval and the GSK shot's victory at the CDC's Advisory Committee on Immunization Practices. That body, whose recommendations are key to vaccine adoption, said Shingrix was preferred over Zostavax. 

Shingles affects about 1 in 3 people in the U.S., according to CDC figures. The notoriously painful condition is caused by latent varicella infection and the risk increases with age as immune systems weaken.