FDA, Vaccines

GSK lines up a shot at a blockbuster market as new CEO prepares to tackle Merck rival head on

New GlaxoSmithKline CEO Emma Walmsley is one big step closer to taking a shot at a blockbuster marketing program today after an FDA panel review ended with a unanimous thumbs up for their new shingles vaccine.

Emma Walmsley

GSK earned some glowing praise on Wednesday as the advisory group looked at a vaccine that just a few months ago proved it could generate a protective response in patients already jabbed with Merck’s Zostavax, a $759 million earner last year that is the only product for this indication now on the market. That’s significant as the effect of Zostavax is also known to wane over time.

GSK’s vaccine also posted significantly better response rates than the Merck rival demonstrated ahead of its approval.

The near-term prospects for Shingrix underscores the continued strength of GSK’s vaccine and HIV business, where researchers have also been making impressive progress on product development. Where GSK has been woefully lacking is on the pharma R&D side of the business. Walmsley has acknowledged that the pharma pipeline lacks pizzazz — a painfully obvious conclusion for the past 4 years now.

Emmanuel Hanon

So the new CEO has swept the deck, dumping an unimpressive Tanzeum while posting mixed data on Nucala as they look to expand the franchise value there while rivals cluster around key indications. GSK also dropped sirukumab just before its partners at J&J were snubbed by experts on another FDA panel.

Big changes may be coming soon at GSK, in a followup to its Adaptimmune pact. But first they have to get a formal OK on Shingrix and start to prove just how effective GSK’s commercial operations can be when handed a competitive advantage.

GSK’s vaccine R&D chief Emmanuel Hanon noted:

Shingles is a painful and potentially serious condition. The risk of developing shingles increases with age and it is estimated that up to one in three people in the United States will develop shingles. Today’s vote brings us one step closer to approval of Shingrix, which is specifically designed to overcome age-related weakening of the immune system.


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