GlaxoSmithKline Plc (NYSE:GSK) has moved to expand the target market for its blockbuster vaccine, Shingrix, with the filing of a regulatory application in Europe. The London-based drug maker is seeking marketing authorization for the use of the vaccine to prevent herpes zoster, AKA shingles, in people over the age of 50. The regulatory application follows a similar application in the U.S.
Shingrix Vaccine
The vaccine has already shown huge promise with analysts expecting it to generate blockbuster sales given its market disruption potential. The vaccine is designed to help prevent shingles among other complications. Phase 3 clinical trials showed that it could be relied upon to reduce the incidence of shingles as well chronic pain associated with shingles and commonly referred to as postherpetic neuralgia.
The company is seeking approval for the use of the vaccine candidate in two doses of two to six month intervals. In addition to seeking EMA approval in the US and Europe, GlaxoSmithKline has filed in Canada with Japan to follow suit next year.
“GSK’s shingles candidate vaccine has consistently shown high efficacy in older people in its phase III development program. 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.,” said GSK senior vice president Dr. Emmanuel Hanon.
Expected Sales
The Shingrix vaccine belongs to one of the six core areas of scientific research and development that GlaxoSmithKline is dedicating more resources and time. The vaccine is also one of the more than 40 assets that the company unveiled to investors at a recent briefing.
If approved, the vaccine candidate would fight for market share against Merck & Co., Inc. (NYSE:MRK) Zostavax, which generated $749 million in sales last year. Analysts are however optimistic that Shingrix will generate more sales having posted higher lasting efficacy numbers than its rival in clinical trials. Given the stellar Phase 3 clinical results, analysts believe Shingrix peak sales could top highs of $1 billion by 2022.
GlaxoSmithKline plc (ADR) (NYSE:GSK) stock was unchanged in Tuesday trading session having shed 0.05% in market value to close the day at $38.27 a share.