Schering-Plough Canada reports top-line results of first head-to-head study in Hepatitis C



    ~First Large Study Comparing Leading Hepatitis C Therapies Shows Similar
    Sustained Response Rates; Fewer Patients Relapsed Following PEGETRON(R)
    Therapy~

    KIRKLAND, QC, Jan. 18 /CNW/ - Schering-Plough, a leader in hepatitis
research, reported top-line results of the IDEAL (Individualized Dosing
Efficacy vs. Flat Dosing to Assess optimaL pegylated interferon therapy)
study, the first large, randomized, clinical study comparing the leading
therapies for chronic hepatitis C: PEGETRON(R) (pegylated interferon alfa-2b
plus ribavirin) therapy vs. PEGASYS RBV(*) (pegylated interferon alfa-2a plus
ribavirin),(1) as well as a lower dose of PEGETRON in an investigational
regimen. The results showed that sustained virologic response (SVR),(2) the
primary endpoint of the study, was similar for the two leading combination
therapies for hepatitis C. The study also showed that fewer patients treated
with both PEGETRON regimens relapsed after the end of treatment compared to
those receiving PEGASYS RBV.
    "The IDEAL study results provide Canadian physicians with, for the first
time, a large body of well-controlled clinical data comparing the two leading
combination therapies for hepatitis C," said Dr. Stephen Shafran, Professor
and Director of Infectious Diseases at, Walter Mackenzie Health Sciences
Centre in Edmonton. "In my clinical experience, a low rate of relapse can also
play an important role in the patient's overall 48-week treatment."
    In the IDEAL study, both PEGETRON regimens utilized investigational
weight-based ribavirin dosing. The three treatment regimens studied were:

    
        (1)   pegylated interferon alfa-2b 1.5 mcg/kg/week and ribavirin
              800-1,400 mg/day;
        (2)   pegylated interferon alfa-2b 1.0 mcg/kg/week and ribavirin
              800-1,400 mg/day; and
        (3)   pegylated interferon alfa-2a 180 mcg/week and ribavirin
              1,000-1,200 mg/day.
    

    In the study, 3,070 previously untreated U.S. patients with hepatitis C
virus (HCV) genotype 1, the most common form of the virus worldwide and the
most difficult to treat, were randomized to one of the three treatment
regimens and received up to 48 weeks of combination therapy with 24 weeks of
follow-up. SVR, the primary endpoint of the study, was similar for the three
treatment regimens (40 vs. 38 vs. 41 per cent, respectively). IDEAL results
also showed that, while end of treatment response was higher in the PEGASYS
RBV arm, fewer patients receiving PEGETRON therapy relapsed after the end of
treatment (24 vs. 20 vs. 32 percent, respectively).

    About IDEAL

    The IDEAL study was undertaken by Schering-Plough as an important step in
meeting the needs of the hepatitis C medical and patient communities to
identify improved treatment strategies to optimize outcomes for patients.
IDEAL, a Phase IIIb, randomized, parallel-group study, was conducted at
118 academic and community centres across the United States. The study treated
3,070 naive adult patients with chronic HCV genotype 1. Of these, 82 per cent
of patients had high viral load (greater than or equal to 600,000 IU/mL),(3)
11 per cent had grade F3/4 fibrosis/cirrhosis, and 19 per cent were African
Americans. Patient demographics and disease characteristics were similar
across the three treatment arms.
    The comparison of the two combination therapy doses (peginterferon
alfa-2b and ribavirin) (1.5 vs. 1.0 mcg/kg/week) was conducted as a
post-approval commitment to the U.S. Food and Drug Administration (FDA). The
comparison of the PEGETRON and PEGASYS combination therapy regimens was added
to the study because no randomized, controlled head-to-head study of the two
available peginterferon regimens had been conducted to date. Cross-study
comparisons and retrospective analyses of previous data are difficult to
interpret because of differences in study designs, patient populations and
assay limits.

    About Hepatitis C in Canada

    Hepatitis C is a serious and potentially life-threatening disease. The
virus spreads primarily through exposure to infected blood, with intravenous
(IV) drug use being the most common source of infection in Canada.(4)
Hepatitis C is the most common blood-borne infection in Canada, and the most
common form of liver disease, affecting approximately 240,000 people in
Canada.(5) It is the leading cause of cirrhosis and liver cancer, and the
number one reason for liver transplants in Canada.(6)

    About PEGETRON(R)(7)

    PEGETRON was approved by Health Canada on May 31, 2002 for the treatment
of adult patients histologically proven chronic hepatitis C who have elevated
transaminases without liver decompensation and who are positive for HCV-RNA or
anti-HCV. This indication is based upon the results from a controlled clinical
study in 1530 patients with confirmed chronic hepatitis C treated with
ribavirin plus pegylated interferon alfa-2b or ribavirin plus interferon
alfa-2b for 48 weeks.
    The most frequently reported adverse events were fatigue (64%), headache
(62%), myalgia (56%), rigors (48%), fever (46%), and insomnia (40%), which
were also the most frequently reported adverse events with the combination of
ribavirin plus interferon alfa-2b.
    Hemolytic anemia (hemoglobin levels to (less than)10 g/dL) was observed
in up to 14% of patients treated with ribavirin in combination with
peginterferon alfa-2b in clinical trials.
    PEGETRON therapy should be used with extreme caution in patients with a
history of pre-existing psychiatric disorders who report a history of severe
depression.
    PEGETRON must not be used by women who are pregnant or by men whose
female partners are pregnant.

    About Schering-Plough

    Schering-Plough Canada Inc. is a country operation of Schering-Plough
Corporation that employs over 950 people across Canada. Schering-Plough Canada
Inc.'s web site is www.schering-plough.ca.
    Schering-Plough is an innovation-driven, science-centered global health
care company. Through its own biopharmaceutical research and collaborations
with partners, Schering-Plough creates therapies that help save and improve
lives around the world. The company applies its research-and-development
platform to human prescription and consumer products as well as to animal
health products. In November 2007, Schering-Plough acquired Organon
BioSciences, with its Organon human health and Intervet animal health
businesses, marking a pivotal step in the company's ongoing transformation.
Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors,
patients, customers and other stakeholders served by its approximately
50,000 people around the world. The company is based in Kenilworth, N.J.,
U.S.A. and its Web site is www.schering-plough.com.

    PEGETRON(R) is a registered trademark of Schering-Plough Ltd., used under
license by Schering-Plough Canada Inc.
    (C) Schering-Plough Canada Inc. 2008. All rights reserved.

    NOTE:  Medical experts are available for interviews in English and
    French.

    References:

    -------------------------------
    (1) (*) Pegasys and Pegasys RBV are registered trademarks of F. Hoffmann-La
Roche AG Please see the Pegasys and Copegus product inserts for information on
these products.
    (2) SVR, the protocol specified primary efficacy endpoint, is defined as
achievement of undetectable HCV-RNA at 24 weeks after the end of treatment.
Per protocol, if a patient did not have a 24-week post-treatment assessment,
the patient's 12-week post-treatment assessment was utilized.
    (3) Roche Cobas Taqman 1.0 assay; lower limit of detection is 15 IU/mL.
    (4) Public Health Agency Canada. Hepatitis C Prevention, Support and
Research Program.
http://www.phac-aspc.gc.ca/hepc/pubs/psrpmideval-ppsrevalinter/i_problem_e.htm
l
    (5) Public Health Agency Canada. Hepatitis C Prevention, Support and
Research Program.
http://www.phac-aspc.gc.ca/hepc/pubs/psrpmideval-ppsrevalinter/i_problem_e.htm
l
    (6) Public Health Agency Canada. Hepatitis C Prevention, Support and
Research Program.
http://www.phac-aspc.gc.ca/hepc/pubs/psrpmideval-ppsrevalinter/i_problem_e.htm
l
    (7) Pegetron(R) Product Monograph, May 31, 2002




For further information:

For further information: Julie Wu, Schering-Plough Canada Inc., (514)
426-7300, julie.wu@spcorp.com; Rosalind O'Connell, Manning Selvage & Lee,
(416) 847-1321, rosalind.oconnell@mslpr.ca

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