This past week, GlaxoSmithKline (GSK) won FDA approval for its new shingles vaccine, known as Shingrix. The vaccine was approved to treat people with shingles who are 50 and older. The shingles disease is a reactivation of the chicken pox that has been dormant in the body for many years. It causes patients a painful rash burdened with blisters. There are more than 200,000 cases each year in the United States. The beauty of the vaccine is that it works really well. So well, that in the prior month, an FDA advisory panel unanimously recommended that it should be approved for marketing. GlaxoSmithKline is also waiting for a meeting this week on Wednesday, where the U.S. Centers for Disease Control and Prevention's advisory committee is expected to vote on a recommendation for the use of Shingrix.
Competition
The approval of Shingrix does not necessarily mean it will have an easy time in the market. That's because it will have to go up against Merck (MRK) Zostavax. Although, there are a few advantages that Shingrix has over Zostavax that may help put it over the top. The first is that Shingrix seems to have a better handle on improved efficacy in older patients over time. For example, four years after patients received an injection of Shingrix, it remained 90% effective. On the other hand, those that take Zostavax saw the effectiveness of the vaccine drop over time. In addition, because Shingrix is given in two doses that are two months apart, it helps relieve the pain that is associated with the disease.
Market Opportunity
GlaxoSmithKline has a lot of products in its pipeline. But Shingrix is one that is up at the top in terms of potential. That's because the vaccine is expected to reach an annual sales forecast of $1 billion by 2023. Merck has done pretty well with its Zostavax vaccine over the years. Sales of Zostavax reached $685 million in 2016. Even better news for GlaxoSmithKline is that just last week it received approval for Shingrix in Canada. The company is also in line with regulatory filings for potential approval of Shingrix in Europe, Japan, and Australia.
Source: seekingalpha
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