Seeking blockbuster sales, GSK files experimental shingles vax in U.S.

GSK

How do you solve a problem like GlaxoSmithKline ($GSK)? Well, you parachute in a new CEO, and then you file a long-term R&D project that you hope will bring in $1 billion-plus and help boost your noticeably aging portfolio.

This is exactly what the London-based company has done, first with the announcement that Emma Walmsley will take over the top job next year, and today with its filing of a BLA with the U.S. regulator for its shingles vaccine candidate Shingrix.

Analysts believe this can notch up $1 billion in sales, should it gain approval, and is seen as being better than Merck’s ($MRK) rival vax Zostavax. In fact, GSK’s recent studies have shown its offering was 90% effective in people over age 70, who are more likely to have the painful disease.

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The efficacy of Merck’s med, however, varies widely by between 18% and 70%, and drops off noticeably in older people. GSK is hoping its med will become the vax of choice, should it hold up in the real world, eating into the $749 million Merck’s drug made last year.

Dr. Emmanuel Hanon, GSK's SVP and head of vaccines R&D, said: “Shingles is a common and potentially serious condition. It can cause lasting pain and other complications such as scarring or visual impairment, which can severely impact the quality of people’s lives. The risk of developing shingles increases with age and it is estimated that up to one in every three people is at risk. Today’s file submission puts us a step closer to making this vaccine available to help protect more people from shingles and the complications associated with it.”

The drug, not yet approved anywhere, should also see regulatory submissions in Europe and Canada this year and in Japan next year, according to GSK’s statement.

GSK is looking to its pipeline to shore up ailing sales from its aging respiratory portfolio. After it sold off much of its cancer meds to Novartis ($NVS) in a money-asset swap, GSK is also looking to focus more heavily on vaccine development, a decision which in sales terms seems to be working.

Outgoing CEO Andrew Witty, who many believe lost his role as a result of falling sales and few new big-selling drugs coming out of the company’s labs, will be replaced by current consumer chief and L’Oréal alumni Walmsley at the start of 2017.

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