ZOSTAVAX(TM) approved in Canada - The first and only vaccine for the prevention of shingles



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    TORONTO, Aug. 26 /CNW Telbec/ - Adult Canadians will soon have the
opportunity to protect themselves against shingles - a reactivation of the
virus that causes chickenpox. Merck Frosst Canada Ltd. announced today the
Health Canada approval of ZOSTAVAX(TM) for the prevention of shingles (herpes
zoster) in individuals 60 years of age or older. The vaccine should be
available sometime in 2009 through Canadian physicians and pharmacists.
    "Anyone who has been infected with the chickenpox virus is at risk of
developing shingles, and about 95 per cent of Canadians have been infected by
the age of 15," said Dr. Alison McGeer, Microbiologist and Infectious Disease
Specialist at Mount Sinai Hospital in Toronto. "Shingles is a disease that
starts with a painful skin rash and can lead to weeks, months or even years of
severe, debilitating nerve pain. Shingles is common, unpredictable and very
distressing for both those who get it and their families. Until now there was
no way to prevent shingles, so the new vaccine is a welcome development."

    The painful reality of shingles

    When people suffer from shingles, they may initially feel itching,
tingling, burning or pain(1) in a defined section of their skin and within a
few days a characteristic skin rash with fluid-filled blisters appears. For
most people, the pain associated with a shingles rash usually lessens as it
heals. However, for more than 50 per cent of shingles sufferers over 60,
shingles can progress into debilitating pain called post-herpetic neuralgia
(PHN)(2), which can persist long after the blisters have healed.
    "Shingles has dramatically changed my life for the worse," says Andy
Vallière from Oshawa, Ontario. "I couldn't go on with my daily activities and
since the doctors were not able to diagnose the disease early on in the
process, I truly thought I was dying. It has been two and a half years that I
have symptoms and I am still suffering to this day."
    "In March 2000, I became ill with shingles. Today I regret that at the
time I was not aware of the painful consequences of this illness," says Rachel
Weisz from Toronto, Ontario. "Eight and a half years later I have to cope with
unrelenting pain and am still searching for relief."

    Serious complications

    In addition to severe pain, shingles can cause fatigue, disrupted sleep,
social withdrawal and depression(3), and 50 to 72 per cent of people with
shingles of the eye suffer from recurrent ocular disease and vision loss(4).
Up to 10 per cent of shingles patients 65 and older are hospitalized(5) with
an average length of stay of 20 days(6). PHN - debilitating pain - is the most
common serious complication of shingles(7).
    "As you get older, your body cannot defend itself against the
shingles-causing virus as well as it could when you were younger, so that your
chances of getting shingles increases with age," explained Dr. McGeer. "In
fact, two out of three cases of shingles occur in people over 50. This newest
adult vaccine will contribute to keeping Canadian adults healthy and active."

    64 per cent efficacy in people aged 60 to 69

    ZOSTAVAX(TM) is a powder form of the Oka/Merck strain of live
varicella-zoster virus that is attenuated, meaning it can no longer cause
disease. The vaccine uses essentially the same ingredients as VARIVAX(R),
Merck Frosst's chickenpox vaccine, but has higher potency in order to induce a
significant immune response to varicella-zoster virus in older adults(8).
    In the Shingles Prevention Study (SPS) of 38,546 subjects 60 years of age
or older, the new shingles vaccine reduced the risk of developing herpes
zoster compared with placebo by 64 per cent in people aged 60 to 69(9) and by
51 per cent for all age groups(10). The vaccine also reduced the incidence of
severe and long-lasting zoster-associated pain by 73 per cent compared with
placebo(11). In addition, among vaccinated individuals who developed zoster,
the vaccine reduced zoster-associated pain compared with placebo by
22 per cent(12).
    In clinical studies, the most common side effects reported were redness,
pain, swelling, itching, warmth and bruising at the injection site.(13) The
overall incidence of vaccine-related injection-site adverse experiences was
significantly greater for subjects vaccinated with ZOSTAVAX(TM) compared to
placebo (48 per cent for the vaccine and 17 per cent for placebo).(14)
Headache, fever and allergic reactions were also reported.(15)
    It is estimated that nearly one in three people will develop shingles in
their lifetime(16) and up to one in two for people who reach age 85(17). There
is no way to predict if and when the varicella zoster virus will reactivate or
who will develop shingles(18).

    About Merck Frosst

    At Merck Frosst, patients come first. Merck Frosst Canada Ltd. is a
research-driven pharmaceutical company discovering, developing and marketing a
broad range of innovative medicines and vaccines to improve human health.
Merck Frosst is one of the top 25 R&D investors in Canada, with an investment
of close to $110 million in 2007. More information about Merck Frosst is
available at http://www.merckfrosst.com.

    Forward-Looking Statement

    This press release contains "forward-looking statements" as that term is
defined in the Private Securities Litigation Reform Act of 1995. These
statements are based on management's current expectations and involve risks
and uncertainties, which may cause results to differ materially from those set
forth in the statements. The forward-looking statements may include statements
regarding product development, product potential or financial performance. No
forward-looking statement can be guaranteed, and actual results may differ
materially from those projected. Merck undertakes no obligation to publicly
update any forward-looking statement, whether as a result of new information,
future events, or otherwise. Forward-looking statements in this press release
should be evaluated together with the many uncertainties that affect Merck's
business, particularly those mentioned in the cautionary statements in Item 1
of Merck's Form 10-K for the year ended Dec. 31, 2006, and in its periodic
reports on Form 10-Q and Form 8-K, which the Company incorporates by
reference.

    (TM) Trademark of Merck & Co., Inc. Used under license.

    NOTE TO EDITORS:

    A bilingual b-roll will be distributed by satellite today from 10:00 to
11:00 am EDT. The English version of the b-roll will be distributed again from
1:00 to 1:30 pm EDT.

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    References:
    -----------------------

     (1) Oxman MN. Clinical manifestations of herpes zoster. In: Arvin AM,
         Gershon AA, editors. Varicella-zoster virus virology and clinical
         management. Cambridge Press 2000:246-75.
     (2) Oxman MN. Clinical manifestations of herpes zoster. In: Arvin AM,
         Gershon AA, editors. Varicella-zoster virus virology and clinical
         management. Cambridge Press 2000:246-75.
     (3) Schmader K. Postherpetic neuralgia in immunocompetent elderly
         people. Vaccine 1998;16:1768-70.
     (4) Pavan-Langston D. Ophthalmic zoster. In: Arvin AM, Gershon AA,
         editors. Varicella-zoster virus virology and clinical management.
         Cambridge Press 2000:276-98.
     (5) Product Monograph for Health Canada dated August 21, 2008. Page 10.
     (6) Weir, E. Vaccination boosts adult immunity to varicella zoster
         virus. CMAJ, August 2, 2005; 173(3). (Web site accessed at:
         http://www.cmaj.ca/cgi/content/full/173/3/249?maxtoshow=&HITS=
         10&hits=10&RESULTFORMAT=&fulltext=shingles+vaccine&andorexactfulltext
         =and&searchid=1&FIRSTINDEX=0&sortspec=relevance&resourcetype
         =HWCIT)
     (7) Product Monograph for Health Canada dated August 21, 2008. Page 10.
     (8) National PBM Drug Monograph: Zoster Vaccine, Varicella Virus Vaccine
         Live (Oka / Merck) (Zostavax(R)). November 2006. VHA Pharmacy
         Benefits Management Strategic Healthcare Group and the Medical
         Advisory Panel. Page 3. (Web site accessed at:
         http://www.pbm.va.gov/monograph/Zoster%20Vaccine,%20Monograph.pdf)
     (9) Product Monograph for Health Canada dated August 21, 2008. Page 15.
    (10) IBID. Page 15.
    (11) IBID. Page 17.
    (12) IBID. Page 17.
    (13) IBID. Page 23.
    (14) IBID. Page 6.
    (15) IBID. Page 23.
    (16) Brisson M et al. Epidemiology of varicella zoster virus infection in
         Canada and the United Kingdom. Epidemiol Infect 2001;127:305-14.
    (17) Katz J, et al. Acute pain in herpes zoster and its impact on health-
         related quality of life. Clin Infect Dis 2004;39:342-8.
    (18) International Council of Nurses Web site. (Web site accessed at:
         http://www.icn.ch/matters_shingles.htm)
    




For further information:

For further information: Sheila Murphy, Manager, Public Affairs, Merck
Frosst Canada Ltd., (514) 428-2748; Dan Brennan, NATIONAL PharmaCom, (514)
843-2325; Jacqueline Zonneville, NATIONAL PharmaCom, (416) 848-1398


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