Glaxo seeks Shingrix growth injection

A shingles vaccine might not seem like the most obvious candidate to be Glaxosmithkline’s biggest pipeline hope. But the company’s non-live vaccine Shingrix, just filed with the FDA, will be going into a market where there is little competition – which might help justify the blockbuster sellside expectations (see graphic/table below).

And Glaxo hopes to take market share from the current option, Merck & Co and Sanofi’s Zostavax, pointing to better efficacy data with Shingrix and the fact that Zostavax, a live attenuated vaccine, is contraindicated in immunocompromised people. Glaxo expects data on Shingrix in this subgroup next year.

Immunocompromised people are at a higher risk of shingles, which is caused by the reactivation of latent chickenpox virus, so use in this population should expand the existing market. A natural age-related decline in the immune system is the reason why shingles is more common in older people.

And Shingrix looks particularly effective in the older population. The Zoe-70 phase III trial, in people aged 70 or older, found efficacy of 90%. Meanwhile, Zostavax’s label cites efficacy of 41% in those aged 70-79, falling to 18% in people aged 80 or above.

Across all age groups studied, Shingrix has shown efficacy of 90-97%, versus 51% with Zostavax. However, no head-to-head studies have been carried out, so direct comparison is imperfect.

Merck & Co has another shingles vaccine in its pipeline in the form of V212, which uses an inactivated rather than live virus. Phase III data with V212 are expected next year, and could give an indication of how the vaccines compare.

In the meantime, Glaxo will no doubt be making the most of its head start with Shingrix – assuming that it does gain approval. According to EvaluatePharma sellside consensus this is the only potential blockbuster in Glaxo’s current pipeline.

Glaxo’s top 10 products in 2022 ($m)
Product Description 2015 2022e First approved Patent expiry
Triumeq HIV drug 1,116 4,774 2014 Oct 2027
Tivicay HIV drug 899 2,156 2013 Oct 2027
Breo Ellipta Asthma/COPD inhaler 393 1,884 2013 Sep 2022
Advair Asthma/COPD inhaler 5,625 1,477 1998 Aug 2016
Nucala Asthma antibody 2 1,430 2015 Jun 2022
Shingrix Shingles vaccine - 1,142 - -
Pediarix Childhood diseases vaccine 1,120 1,133 2001 Dec 2018
Anoro Ellipta COPD inhaler 121 1,066 2014 Oct 2030
Ventolin HFA Asthma inhaler 947 892 2001 Sep 2017
Rotarix Rotavirus vaccine 637 866 2005 -
Source: EvaluatePharma.

The list of the group’s biggest products in 2022 makes depressing reading, showing its continuing reliance on ageing drugs, with Advair still set to feature heavily in spite of the expected entry of generic competition.

Shingrix has taken a step closer to approval, but even if it gets the go-ahead it is unlikely, on its own, to turn Glaxo’s fortunes around. The company’s incoming chief executive, Emma Walmsley, might need to think about M&A to refresh the group’s pipeline sooner rather than later.

To contact the writer of this story email Madeleine Armstrong in London at [email protected] or follow @ByMadeleineA on Twitter

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