SHINGRIX approved in Canada as the first non-live adjuvanted vaccine to help protect against shingles

MISSISSAUGA, ON, Oct. 13, 2017 /CNW/ - SHINGRIX has been approved in Canada for the prevention of shingles (herpes zoster) in people aged 50 years or older^.i  SHINGRIX is a non-live, recombinant subunit adjuvanted vaccine given intramuscularly in two doses and is expected to be available through physicians' offices and pharmacies in early 2018.

Shingles is caused by reactivation of the varicella zoster virus (VZV), the same virus that causes chickenpox.ⁱⁱ More than 90 percent of those over 50 years old have had chickenpox and are at risk for shingles. A person's risk for shingles increases with age and an estimated 30% of Canadians will develop shingles in their lifetime^.iii,iv,v

"One of the biggest challenges in vaccine research is to create vaccines that are effective in older adults, who are at greater risk for certain diseases, like shingles. As we age, our immune system loses the ability to mount a strong and effective response to infection.^vi SHINGRIX was developed specifically to overcome the age-related decline in immunity," said Dr Thomas Breuer, Senior Vice President and Chief Medical Officer of GSK Vaccines.

SHINGRIX is the first shingles vaccine to combine a non-live antigen, to trigger a targeted immune response, with a specifically designed adjuvant to enhance this response and help address the natural age-related decline of the immune system.

The approval of SHINGRIX in Canada, the first received worldwide, was based on a comprehensive Phase III clinical trial program evaluating its efficacy, safety and immunogenicity involving more than 37,000 people.^vii  GSK's global clinical trial program for the vaccine includes involvement of 31 trial sites and over 2100 participants across Canada.

Dr Susie Barnes, Vice President and Country Medical Director, GSK Canada, said: "We're very pleased to provide SHINGRIX as a new option to help protect Canadians 50 years and older against shingles. Shingles is a common and potentially serious condition with approximately 130,000 new cases each year in Canada. It can cause lasting pain and other complications which can severely impact the quality of people's lives."

About SHINGRIX
SHINGRIX [Herpes Zoster vaccine (non-live recombinant, AS01_B adjuvanted)] is a non-live, recombinant subunit adjuvanted vaccine to help prevent herpes zoster (shingles) in adults 50 years of age and older. The vaccine combines an antigen (VZV glycoprotein E) and an adjuvant system (AS01_B) ^viii

SHINGRIX is to be given intramuscularly in two doses with a two-to-six month interval between doses. The Product Monograph, posted at www.ca.gsk.com, should be consulted for complete administration and safety information. Prior to being posted online, the Product Monograph is also available by calling 1-800-387-7374.

About shingles
Shingles is caused by varicella zoster virus (VZV), the same virus that causes chickenpox.^ix

Shingles typically presents as a rash, with painful blisters across the chest, abdomen or face. The pain is often described as aching, burning, stabbing or shock-like. Following the rash, a person can also experience post-herpetic neuralgia (PHN), pain that can last for months or years. ^ix PHN is the most common complication of shingles, occurring in up to 30 percent of all shingles cases.^x

Shingles affects an estimated 130,000 Canadians annually.^v Incidence rates are similar throughout North America, Europe and Asia-Pacific regions.^xiii Older adults and those with conditions that compromise the immune system have the greatest risk for developing shingles. Nearly all adult Canadians (>90%) have had chickenpox and are therefore at risk for shingles. An estimated 30% will develop shingles in their lifetime and the risk increases to 50% for those who live to 85 years of age.^i,ix

GSK – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com.

© GSK group of companies or its licensor. Trademarks are owned by or licensed to the GSK group of companies

Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Principal risks and uncertainties' in the company's Annual Report on Form 20-F for 2016.

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ⁱ SHINGRIX Canadian Product Monograph, October 2017
ⁱⁱ Harpaz R, Ortega-Sanchez IR, Seward JF; Advisory Committee on Immunization Practices (ACIP), Centers for Disease Control and Prevention (CDC). Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2008 Jun;57(RR-5):1-30
ⁱⁱⁱ National Advisory Committee on Immunization (NACI). Statement on the Recommended use of Herpes Zoster Vaccine. January 2010, 36(ASC-1):1-19.
^iv Brisson, M, et al. Modelling the impact of immunization on the epidemiology of varicella zoster virus. Epidemiol. Infect. 2000; 125, 651-669
^v CIG, 2014 Canadian Immunization Guide, accessed August 15, 2017.  http://healthycanadians.gc.ca/publications/healthy-living-vie-saine/4-canadian-immunization-guide-canadien-immunisation/index-eng.php?page=8
^vi Black S et al. Sci Transl Med. 2015.
^vii GlaxoSmithKline. Data on File. 2017.
^viii The GSK proprietary AS01 adjuvant system contains QS-21 Stimulon® adjuvant licensed from Antigenics LLC, a wholly owned subsidiary of Agenus Inc. (NASDAQ: AGEN), MPL and liposomes.
^ix Harpaz, et al. MMWR Recomm Rep. 2008; 57(5): 1-30. Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices.
^x Kawai, et al. BMJ Open. 2014; 4(6). Systematic review of incidence and complications of herpes zoster: towards a global perspective.

SOURCE GlaxoSmithKline Inc.

GSK enquiries: Canada media inquiries: Michelle Smolenaars Hunter, 905 819 3363 (Mississauga); Emmanuel Fritsch, [phone] (Laval)

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