Health Canada approves once-daily JANUVIA(TM), the first treatment in a new class of medicines for type 2 diabetes


    TORONTO, Jan. 3 /CNW/ - Merck Frosst Canada Ltd. announced today that
JANUVIA(TM) (sitagliptin phosphate monohydrate), a once-daily, oral medication
in a new class of anti-hyperglycemic agents known as DPP-4 (dipeptidyl
peptidase-4) inhibitors, has been approved by Health Canada. Sitagliptin is
approved in combination therapy with metformin, a commonly prescribed diabetes
medication, to improve blood sugar (glucose) control in adult patients with
type 2 diabetes when diet and exercise plus metformin do not provide adequate
glycemic control.
    "Many Canadians with type 2 diabetes continue to face challenges in
optimizing their diabetes control. The introduction of sitagliptin provides an
important and innovative new option for the management of type 2 diabetes,
which will be welcome news for patients and health care providers across
Canada," said Dr. Daniel Drucker, Professor of Medicine and Director of the
Banting and Best Diabetes Centre in Toronto.

    Enhances a natural body system to significantly lower elevated blood

    Sitagliptin represents a new and different approach to lowering blood
sugar in patients with type 2 diabetes. Sitagliptin enhances a natural body
system called the incretin system, which helps regulate glucose levels in the
blood. Incretins are hormones produced in the gut in response to a meal. When
blood sugar is elevated, incretins work in two ways to help the body regulate
high blood sugar levels: they trigger the pancreas to increase the release of
insulin and signal the liver to reduce its production of glucose. Sitagliptin
keeps these hormones active for a longer period of time by preventing their
    One in two Canadians being treated for type 2 diabetes does not achieve
the targeted HbA1c level (average blood sugar level over three months) of less
than or equal to 7 per cent as per the Canadian Diabetes Association
Guidelines. The percentage of patients with type 2 diabetes who do not achieve
adequate blood sugar control increases the longer the patients have the

    More than twice as many patients reached an HbA1c of less than 7 per
    cent with sitagliptin added to metformin

    In a 24-week study of 701 patients with type 2 diabetes who were
inadequately controlled on metformin alone, sitagliptin 100 mg was added to
metformin. In this study, more than twice as many patients uncontrolled on
metformin alone reached a level of HbA1c less than 7 per cent when sitagliptin
was added, (47 per cent with sitagliptin and metformin vs. 18 per cent for
patients continuing on metformin alone) (p less than 0.001). The regimen of
sitagliptin and metformin also provided significant improvements in FPG
(fasting plasma glucose) and 2-hour PPG (postprandial blood glucose).(2)

    Not associated with weight gain or increased risk of hypoglycemia

    In a pre-specified analysis, the incidence of hypoglycemia (very low
blood sugar) in patients treated with sitagliptin plus metformin (1.3%) was
similar to patients treated with placebo and metformin (2.1%).(2)
    Long-term maintenance of effect was evaluated in a 52-week, double-blind,
glipizide (a sulfonylurea agent)-controlled trial in patients with type 2
diabetes and inadequate glycemic control on metformin monotherapy at greater
than or equal to 1500 mg/day. In this study, the incidence of hypoglycemia in
the sitagliptin group (4.9%) was significantly lower than that in the
glipizide group (32.0%). Patients treated with sitagliptin exhibited a
significant mean decrease from baseline in body weight compared to a
significant weight gain in patients administered glipizide (-1.5 kg vs. +1.1
    Sitagliptin was generally well tolerated in controlled clinical studies
in combination therapy with an overall incidence of side effects similar to
that reported with placebo.(2)

    Diabetes, an emerging health problem

    Currently there are more than two million Canadians living with type 1
and type 2 diabetes.(3) It is estimated that over three million Canadians will
be diagnosed with diabetes by 2010.(3) Type 2 diabetes accounts for 90 per
cent of all diagnosed cases of diabetes(4) but it has been estimated that
about one third of adults with type 2 diabetes are unaware of their
    Most patients with type 2 diabetes eventually require multiple drugs with
different mechanisms of action to achieve glycemic control because of the
progression of the disease. There is a need for new therapies to help patients
manage their blood glucose levels.

    Commitment to diabetes

    Recognizing the toll that diabetes is taking globally, Merck Frosst is
committed to the research and development of diabetes medications to bring new
treatment options to physicians and patients who struggle with managing the
complexity of type 2 diabetes.
    JANUVIA(TM) was awarded the Prix Galien USA 2007 Award for the Best
Pharmaceutical Agent. The Prix Galien recognizes outstanding achievement in
the pharmaceutical industry in the development of new medicines.

    About Merck Frosst

    At Merck Frosst, patients come first. Merck Frosst Canada Ltd. is a
research-driven pharmaceutical company. Merck Frosst discovers, develops and
markets a broad range of innovative medicines to improve human health. Merck
Frosst is one of the top 20 R&D investors in Canada, with an investment of
$114 million in 2006. The Company is committed to fostering partnerships to
deliver the most valuable health outcomes for Canadian patients. More
information about Merck Frosst is available at

    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

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

    NOTE: A b-roll will be distributed today via satellite from 10:00 to
    11:00 am EST. The English b-roll will loop into the French version.

    The b-roll will also be available from 1:00 to 1:30 pm EST. This will be
    the English version only.

    Anik F2C 1B
    Vertical Polarization, Freq. 3740 MHz
    Audio subcarriers 6.2 and 6.8


    (1) Harris SB, Ekoé J-M, et al. Glycemic Control and Morbidity in the
    Canadian Primary Care Setting (Results of the Diabetes In Canada
    Evaluation Study). Diabetes Research and Clinical Practice.
    October 2005.
    (2) JANUVIA(TM) Product monograph.
    (3) Diabetes Progress Report 2005, Canadian Diabetes Association. Website
    accessed at
    (4) Health Canada website, It's Your Health - Type 2 Diabetes. Website
    accessed at
    (5) Young, TK and Mustard, CA. Undiagnosed diabetes: Does it matter?
    CMAJ. 2001,164: 24-28

For further information:

For further information: Martine Drolet, Public Affairs, Merck Frosst
Canada Ltd., (514) 833-6780; Kyle Rooks, Cohn & Wolfe/Toronto, (416) 924-5700,
ext. 4098

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