Glaxo's Shingles Vaccine Shingrix Gets Approval In China
Zacks Investment Research | May 27, 2019 05:55AM ET
GlaxoSmithKline plc (NYSE:GSK) announced on May 23 that its vaccine Shingrix has been approved in China for the prevention of shingles (herpes zoster) in older patients (aged 50 years or older).
The company plans to launch the vaccine in China in several phases starting 2020.
Notably, Shingrix is already approved in the United States and Canada for preventing shingles. In March 2019, the vaccine was approved in Europe and Japan. The candidate is also approved in Australia for the same indication.
Glaxo’s shares have outperformed the industry so far this year. The stock has increased 5.2% compared with the industry’s 0.7% rise.
The approval of Shingrix in China was based on data from a clinical trial program comprising two phase III studies — ZOE-50 and ZOE-70. The studies evaluated the safety, efficacy and immunogenicity of the candidate in more than 38,000 individuals. Significantly, Shingrix is the only shingles vaccine to achieve 90% efficacy or more in adults aged 50 and above.
Shingrix has driven sales of Glaxo’s Vaccine segment for the past few quarters on strong demand. Sales of the vaccine increased more than 60% sequentially in the first quarter of 2019, crossing $450 million (£357 million) globally.
The encouraging performance of the vaccine is expected to continue on strong demand in the United States as well as approval and potential launch in new geographies. Shingrix enjoys preferential recommendation from the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (“ACIP”). In 2017, the ACIP recommended the preferential use of Shingrix for the prevention of shingles over Merck’s (NYSE:MRK) Zostavax.
Shingrix is also being evaluated in immuno-compromised patient populations, including solid and hematological cancer patients, hematopoietic stem cell and renal transplant recipients and HIV infected people.
Per the company’s press release, around one in three people worldwide is vulnerable to develop shingles in a lifetime with increasing age. Additionally, 30% of shingles patients develop PNH. Hence, the potential market opportunity to prevent this serious life-threatening disease is huge.
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