KENILWORTH, N.J., May 18 /PRNewswire-FirstCall/ -- Eight oral
presentations and 23 poster presentations highlighting clinical
data for Schering-Plough's hepatitis products, including
PEG-INTRON(R) (peginterferon alfa-2b) and REBETOL(R) (ribavirin,
USP) combination therapy, will be presented by leading researchers
at the 37th annual Digestive Disease Week (DDW) meeting. The
meeting will be held at the Los Angeles Convention Center in Los
Angeles, Calif., from Saturday, May 20, 2006 through Thursday, May
25, 2006. Study investigators will report findings from the WIN-R
trial (Weight- Based Dosing of PEG-INTRON and REBETOL), a
community-based trial and the largest clinical study in hepatitis C
ever conducted in the United States, including key learnings
surrounding treatment outcome as associated with differences in
patient HCV genotype, degree of fibrosis or cirrhosis, viral load
and stratification, cigarette smoking and prior HCV treatment
experience. Hepatitis C is the most common blood-borne infection in
America and the most common form of liver disease, affecting nearly
5 million people in the United States and 200 million people
worldwide. For program information, please visit the Digestive
Disease Week Web site at http://www.ddw.org/. Key Data
Presentations: The WIN-R Trial Differences In Treatment Outcome To
Antiviral Therapy Based On Genotype And Viral Load In Hepatitis C
Genotypes 2 And 3 In The WIN-R Trial; R. Brown et al., Oral
Presentation, Tuesday, May 23, 9:30 am, Room 411 The effect of
liver fibrosis and cirrhosis on SVR in 4913 patients with hepatitis
C; Results from the WIN-R trial; N. Afdhal et al., Oral
Presentation, Tuesday, May 23, 3:15-3:30 pm, Room 408 A/B
Stratification of High Viral Load: Impact on Sustained Virologic
Response in the WIN-R Trial; I.M. Jacobson et al., Poster
Presentation, Tuesday, May 23, 8:00 am West Hall A The influence of
cigarette smoking on response to treatment with pegylated
interferon alfa-2b and ribavirin in patients with chronic hepatitis
C; M.P. Pauley et al., Poster Presentation, Sunday, May 21, 8:30 am
West Hall A Prior HCV Treatment Experience and its Relationship To
Sustained Virologic Response (SVR): An Analysis of the WIN-R Study
Database, A US Academic Community based Trial; P. Kwo et al.,
Poster Presentation, Tuesday, May 23, 8:00 am, West Hall A HCV
Patient Support Effect on Adherence Evaluation of an HCV Patient
Support Program's Impact on Patient Adherence; M. Hussein et al.,
Oral Presentation, Sunday, May 21, 5:15 pm, Room 408 A/B
Peginterferon Comparative Data Predictors of SVR in patients with
treatment-naive chronic HCV treated with PEG-IFN alfa-2b vs.
PEG-IFN alfa-2a + ribavirin: A hierarchical linear regression
analysis of retrospective data from 6 clinic sites; F. Poordad et
al., Poster Presentation, Tuesday, May 23, 8:00 am, West Hall A
HIV/HCV Co-Infection Growth Factors Versus Dose Reduction for
Pegylated Interferon Alfa-2b and Ribavirin Associated Neutropenia
and Anemia in HIV/HCV Co-Infected Patients; J.S. Kadam et al.,
Poster Presentation, Tuesday, May 23, 8:00 am, West Hall A
Schering-Plough Sponsored CME Symposium "Treating Hepatitis C in
Difficult-to-Treat Patients and Special Populations" Monday, May
22, beginning at 6:15 pm, The Westin Bonaventure Hotel and Suites,
404 South Figueroa Street, Los Angeles, Calif. FACULTY: Eugene R.
Schiff, MD, MACP, FRCP, MACG (Chair) Leonard Miller Professor of
Medicine Chief, Division of Hepatology Director, Center for Liver
Disease University of Miami School of Medicine Miami, Florida
Kenneth E. Sherman, MD, PhD Gould Professor of Medicine Director,
Division Digestive Diseases University of Cincinnati College of
Medicine Cincinnati, Ohio Robert S. Brown, Jr., MD, MPH Associate
Professor of Medicine and Surgery Chief, Division of Liver Disease
and Transplantation Columbia University College of Physicians &
Surgeons New York Presbyterian Hospital New York, New York About
PEG-INTRON PEG-INTRON is approved in the United States as
monotherapy and for use in combination therapy with REBETOL
(ribavirin, USP) for the treatment of chronic hepatitis C in
patients with compensated liver disease who are at least 18 years
of age. Important Safety Information Regarding U.S. Labeling for
PEG-INTRON and REBETOL WARNING Alpha interferons, including
PEG-INTRON, cause or aggravate fatal or life- threatening
neuropsychiatric, autoimmune, ischemic, and infectious disorders.
Patients should be monitored closely with periodic clinical and
laboratory evaluations. Patients with persistently severe or
worsening signs or symptoms of these conditions should be withdrawn
from therapy. In many but not all cases these disorders resolve
after stopping PEG-INTRON therapy. Ribavirin causes hemolytic
anemia. Anemia associated with REBETOL therapy may exacerbate
cardiac disease that has led to fatal and nonfatal myocardial
infarctions. Patients with a history of significant or unstable
cardiac disease should not be treated with REBETOL. It is advised
that complete blood counts (CBC) be obtained at baseline and at
weeks 2 and 4 of therapy or more frequently if clinically
indicated. REBETOL and combination REBETOL/PEG-INTRON therapy must
not be used by women, or male partners of women, who are or may
become pregnant during therapy and during the 6 months after
stopping therapy. REBETOL and combination REBETOL/PEG-INTRON
therapy should not be initiated until a report of a negative
pregnancy test has been obtained immediately prior to initiation of
therapy. Women of childbearing potential and men must use effective
contraception (at least two reliable forms) during treatment and
during the 6-month post-treatment follow-up period. Significant
teratogenic and/or embryocidal effects have been demonstrated for
ribavirin in all animal species in which adequate studies have been
conducted. These effects occurred at doses as low as one twentieth
of the recommended human dose of REBETOL. If pregnancy occurs in a
patient or partner of a patient during treatment or during the 6
months after treatment stops, physicians are encouraged to report
such cases by calling (800) 727-7064. PEG-INTRON There are no new
adverse events specific to PEG-INTRON as compared to INTRON(R) A
(interferon alfa-2b, recombinant) for Injection, however, the
incidence of some (e.g., injection site reactions, fever, rigors,
nausea) were higher. The most common adverse events associated with
PEG-INTRON were "flu-like" symptoms, occurring in approximately 50%
of patients, which may decrease in severity as treatment continues.
Application site disorders were common (47%), but all were mild
(44%) or moderate (4%) and no patient discontinued, and included
injection site inflammation and reaction (i.e., bruise, itchiness,
irritation). Injection site pain was reported in 2% of patients
receiving PEG-INTRON. Alopecia (thinning of the hair) is also often
associated with alpha interferons including PEG-INTRON. Psychiatric
adverse events, which include insomnia, were common (57%) with
PEG-INTRON, but similar to INTRON A (58%). Depression was most
common at 29%. Suicidal behavior including ideation, suicidal
attempts, and completed suicides occurred in 1% of patients during
or shortly after completing treatment with PEG-INTRON.
PEG-INTRON/REBETOL is contraindicated in patients with autoimmune
hepatitis, decompensated liver disease, and in patients with
hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia).
The following serious or clinically significant adverse events have
been reported at a frequency less than or equal to 1% with
PEG-INTRON or interferon alpha: Severe decreases in neutrophil or
platelet counts, hypothyroidism, hyperglycemia, hypotension,
arrhythmia, ulcerative and hemorrhagic colitis, development or
exacerbation of autoimmune disorders including thyroiditis, RA,
systemic lupus erythematosus, psoriasis, pulmonary disorders
(dyspnea, pulmonary infiltrates, pneumonitis and pneumonia, some
resulting in patient deaths), urticaria, angioedema,
bronchoconstriction, anaphylaxis, retinal hemorrhages, and cotton
wool spots. In the PEG-INTRON/REBETOL combination trial the
incidence of serious adverse events was 17% in the
PEG-INTRON/REBETOL groups compared to 14% in the INTRON A/REBETOL
group. The incidence of severe adverse events in the PEG-
INTRON/REBETOL combination therapy trial was 23% in the INTRON
A/REBETOL group and 31-34% in the PEG-INTRON/REBETOL groups. Dose
reductions due to adverse reactions occurred in 42% of patients
receiving PEG-INTRON (1.5 mcg/kg)/ REBETOL and in 34% of those
receiving INTRON A/REBETOL. REBETOL should not be used in patients
with creatinine clearance less than 50 mL/min. Schering-Plough is a
global science-based health care company with leading prescription,
consumer and animal health products. Through internal research and
collaborations with partners, Schering-Plough discovers, develops,
manufactures and markets advanced drug therapies to meet important
medical needs. Schering-Plough's vision is to earn the trust of the
physicians, patients and customers served by its more than 32,000
people around the world. The company is based in Kenilworth, N.J.,
and its Web site is http://www.schering-plough.com/. NOTE TO
EDITORS: Schering-Plough press releases are available on the
company's Web site at http://www.schering-plough.com/.
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Schering-Plough CONTACT: For further information or to schedule a
media interview with a thought leader and-or Schering-Plough
executive: Robert Consalvo, +1-908-298-7409, office,
+1-908-295-0928, mobile onsite, , or Investor Contact - Alex Kelly,
+1-908-298-7436, both for Schering-Plough Web site:
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