KENILWORTH, N.J., Oct. 30 /PRNewswire-FirstCall/ -- Leading
researchers will present 68 data presentations involving
Schering-Plough's hepatitis products, including PEGINTRON(TM)
(peginterferon alfa-2b) and REBETOL(R) (ribavirin, USP) combination
therapy, a current standard of care in the treatment of chronic
hepatitis C, at the 59th American Association for the Study of
Liver Diseases (AASLD) Annual Meeting in Boston, Nov. 2-6. Among
these are several studies discussing the predictability of response
with PEGINTRON and REBETOL and assessing how results at important
treatment milestones early in the course of therapy can help
physicians and patients make informed treatment decisions.
Researchers will present the final results from the POWeR
(Peginterferon alfa-2b Prospective Optimal Weight-based Dosing
Response) program, a large observational study involving nearly
2,000 patients conducted at academic and community clinics in
Canada between 2002 and 2006. In the study, PEGINTRON and REBETOL
combination therapy achieved consistent sustained virologic
response (SVR) rates across patient weights and consistently low
relapse rates in a "real-life" treatment setting. Investigators
also will present new data on the investigational use of low-dose
PEGINTRON as maintenance therapy in chronic hepatitis C
nonresponder patients with fibrosis or cirrhosis. The goal of
maintenance therapy in this very hard-to-treat patient population
is to prevent or delay the progression of liver disease. 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 American Association of Liver Disease
Web site at http://www.aasld.org/. Key PEGINTRON Presentations:
Predictability of Response Predictability of Response: Positive and
Negative Predictive Values of Rapid and Early Virologic Responses
to Peginterferon Alfa-2b and Ribavirin in the Treatment of Chronic
Hepatitis C; F. Poordad et al., Abstract 305, Saturday, Nov. 3,
2:00 pm, Exhibit Hall C Ultra Rapid Virologic Response Predicts
Sustained Virologic Response in HCV Infected Patients with Genotype
3 and High Viral Load: The Get-C Study; S. Pianko et al., Abstract
349, Saturday, Nov. 3, 2:00 pm, Exhibit Hall C Rapid Virological
Response at Week 4 Is the Best Predictor of Treatment Outcome in
Patients with Chronic Hepatitis C: A Multivariate Analysis; M.
Martinot-Peignoux et al., Abstract 303, Saturday, Nov. 3, 2:00 pm,
Exhibit Hall C Assessment of Both Virological Response at Week 4
and At Week 12 Optimizes Prediction of Treatment Outcome In
Patients with Chronic Hepatitis C Treated with Peginterferon
Alfa-2b Plus Ribavirin; M. Martinot-Peignoux et al., Abstract 304,
Saturday, Nov. 3, 2:00 pm, Exhibit Hall C Viral Kinetics Can
Quickly Predict Sustained Virological Response in HCV Patients with
Normal ALT Treated with Pegylated Interferon Alfa-2b and Ribavirin:
A Prospective Study; P. Deltenre et al., Abstract 312, Saturday,
Nov. 3, 2:00 pm, Exhibit Hall C PEGINTRON POWeR Study Final Results
of the Canadian POWeR (Peginterferon Alfa-2b Prospective Optimal
Weight-Based Dosing Response) Program: Sustained Virologic Response
(SVR) To Weight-Based Peginterferon Alfa-2b plus Ribavirin in a
Large, Mixed Community and Academic Observational Study; Paul
Marotta et al., Abstract 254, Saturday, Nov. 3, 2:00 pm, Exhibit
Hall C Consistency of Sustained Virologic Response (SVR) Across
Weight Categories: Results from the Canadian POWeR (Peginterferon
Alfa-2b Prospective Optimal Weight-Based Dosing Response) Program;
S. Feinman et al., Abstract 302, Saturday, Nov. 3, 2:00 pm, Exhibit
Hall C Response to Peginterferon Alfa-2b plus Ribavirin Combination
Therapy in Genotype 2 and 3 Patients with Poor Baseline Prognostic
Factors: Results of The Canadian POWeR Program; R. Bailey et al.,
Abstract 246, Saturday, Nov. 3, 2:00 pm, Exhibit Hall C Low-Dose
PEGINTRON Maintenance Therapy Tolerability of Low-Dose
Peginterferon Alfa-2b in Hepatitis C Patients with Cirrhosis:
Results from the COPILOT Trial; M. Shah et al., Abstract 1322,
Tuesday, Nov. 6, 8:00 am, Exhibit Hall C Long-Term Low- Dose
Treatment with Pegylated Interferon Alfa-2b Leads to a Significant
Reduction in Fibrosis and Inflammatory Score in Chronic Hepatitis C
Nonresponder Patients with Fibrosis or Cirrhosis; S. Kaiser, et
al., Abstract 1311, Tuesday, Nov. 6, 8:00 am, Exhibit Hall C
Schering-Plough Sponsored CME Symposium "Clinical Approaches to HCV
Management: Community Cases, Expert Analysis" Monday, Nov. 5,
6:30-8:30 p.m., Sheraton Boston Hotel - Grand Ballroom and Liberty
39 Dalton Street, Boston FACULTY: Willis C. Maddrey, M.D. (Chair)
Professor of Internal Medicine and Executive Vice President for
Clinical Affairs, The University of Texas Southwestern Medical
Center at Dallas Steven L. Flamm, M.D. Associate Professor of
Medicine and Medical Director, Liver Transplantation, Feinberg
School of Medicine, Northwestern University, Chicago John B. Gross,
M.D. Associate Professor of Medicine, Mayo Clinic College of
Medicine Division of Gastroenterology and Hepatology, Mayo Clinic,
Rochester, Minn. Stephen Harrison, M.D. Chief of Hepatology and
Associate Program Director, GI Fellowship Brooke Army Medical
Center, Fort Sam Houston, Texas About PEGINTRON In the United
States, PEGINTRON is indicated for use alone or with ribavirin for
the treatment of chronic hepatitis C in patients with compensated
liver disease who have not been previously treated with interferon
alpha and who are at least 18 years of age. Important Safety
Information Regarding U.S. Labeling for PEGINTRON and REBETOL Alpha
interferons, including PEGINTRON and INTRON(R) A, may 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 PEGINTRON and/or
INTRON A therapy. Use with Ribavirin: Ribavirin may cause birth
defects and/or death of the unborn child. Extreme care must be
taken to avoid pregnancy in female patients and in female partners
of male patients. Ribavirin causes hemolytic anemia. The anemia
associated with REBETOL therapy may result in a worsening of
cardiac disease. Ribavirin is genotoxic and mutagenic and should be
considered a potential carcinogen. Contraindications PEGINTRON is
contraindicated in patients with hypersensitivity to PEGINTRON or
any other component of the product, autoimmune hepatitis, and
hepatic decompensation (Child-Pugh score greater than 6 [class B
and C]) in cirrhotic CHC patients before or during treatment.
INTRON A (Interferon alfa- 2b, recombinant) for Injection is
contraindicated in patients with hypersensitivity to INTRON A or
any component of the product, autoimmune hepatitis, and
decompensated liver disease. PEGINTRON or INTRON A in combination
with REBETOL therapy is additionally contraindicated in patients
with hypersensitivity to ribavirin or any other component of the
product, women who are pregnant, men whose female partners are
pregnant, patients with hemoglobinopathies (e.g., thalassemia
major, sickle-cell anemia), and patients with creatinine clearance
less than 50 mL/min. Avoid Pregnancy REBETOL therapy should not be
started until a report of a negative pregnancy test has been
obtained immediately prior to planned initiation of therapy.
Extreme care must be taken to avoid pregnancy in female patients
and in female partners of male patients during therapy and 6 months
post- treatment. Patients should use at least two effective forms
of contraception and have monthly pregnancy tests during therapy
and for 6 months after completion of therapy. A Ribavirin Pregnancy
Registry has been established to monitor maternal-fetal outcomes of
pregnancies in female patients and female partners of male patients
exposed to ribavirin during treatment, and for 6 months following
cessation of treatment. Physicians and patients are encouraged to
report such cases by calling 1-800-593-2214. Incidence of Adverse
Events There are no new adverse events specific to PEGINTRON as
compared to INTRON A; however, the incidence of some (e.g.,
injection site reactions, fever, rigors, nausea) were higher. The
most common adverse events associated with PEGINTRON 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 PEGINTRON. Alopecia (thinning of the hair) is also often
associated with alpha interferons including PEGINTRON. Psychiatric
adverse events, which include insomnia, were common (57%) with
PEGINTRON 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 PEGINTRON. The following serious or
clinically significant adverse events have been reported at a
frequency less than 1% with PEGINTRON 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 PEGINTRON/REBETOL combination trial,
the incidence of serious adverse events was 17% in the
PEGINTRON/REBETOL groups compared to 14% in the INTRON A/ REBETOL
group. The incidence of severe adverse events in the
PEGINTRON/REBETOL combination therapy trial was 23% in the INTRON
A/REBETOL group and 31-34% in the PEGINTRON/REBETOL groups. Dose
reductions due to adverse reactions occurred in 42% of patients
receiving PEGINTRON (1.5 mcg/kg)/REBETOL and in 34% of those
receiving INTRON A/REBETOL. Additional Safety Information Relapse
of drug addiction/overdose has occurred in patients on PEGINTRON
therapy. Aggressive behavior sometimes directed towards others has
occurred in patients with and without a previous psychiatric
disorder during PEGINTRON and/or INTRON A treatment and follow-up.
If patients develop psychiatric problems, including clinical
depression, it is recommended that patients be carefully monitored
during treatment and in the 6-month follow-up period. If
psychiatric symptoms persist or worsen, or suicidal ideation or
aggressive behavior towards others is identified, it is recommended
that treatment with PEGINTRON and/or INTRON A be discontinued, and
the patient be carefully followed with psychiatric intervention, as
appropriate. Cases of encephalopathy have been observed in some
patients, usually elderly, treated with higher doses of PEGINTRON
and/or INTRON A. Ischemic and hemorrhagic cerebrovascular events
have been observed in patients treated with interferon alpha
therapies, including PEGINTRON and INTRON A. Dental and periodontal
disorders have been reported in patients receiving PEGINTRON or
INTRON A in combination with REBETOL therapy. For full prescribing
information, please see the PEGINTRON Package Insert at
http://www.pegintron.com/. About Schering-Plough 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 approximately 33,500 people around the world. The
company is based in Kenilworth, N.J., and its Web site is
http://www.schering-plough.com/. SCHERING-PLOUGH DISCLOSURE NOTICE:
The information in this press release includes certain
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995, including statements
relating to the potential market for PEGINTRON and REBETOL.
Forward-looking statements relate to expectations or forecasts of
future events. Schering- Plough does not assume the obligation to
update any forward-looking statement. Many factors could cause
actual results to differ materially from Schering- Plough's
forward-looking statements, including market forces, economic
factors, product availability, patent and other intellectual
property protection, current and future branded, generic or
over-the-counter competition, the regulatory process, and any
developments following regulatory approval, among other
uncertainties. For further details and a discussion of risks and
uncertainties that may impact forward-looking statements, see
Schering-Plough's Securities and Exchange Commission filings,
including Part II, Item 1A, "Risk Factors" in the company's third
quarter 2007 10-Q. DATASOURCE: Schering-Plough CONTACT: Media,
Robert J. Consalvo, +1-908-298-7409, or Investors, Alex Kelly,
+1-908-298-7436, Robyn Brown, +1-908-298-7436, all for
Schering-Plough Web site: http://www.schering-plough.com/
http://www.pegintron.com/ http://www.aasld.org/ Company News
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