Schering-Plough
Corporation (NYSE: SGP) today announced that PEGINTRON(TM) (peginterferon
alfa-2b) has been approved by the Chinese State Food and Drug
Administration (SFDA) for the treatment of patients with chronic hepatitis
B, the most prevalent infectious disease in China and one of the country's
leading causes of death. There are 120 million chronic carriers of the
hepatitis B virus in China and each year more than 330,000 people die in
China due to hepatitis B-related complications, including cirrhosis and
liver cancer.
PEGINTRON is administered once weekly at an individualized dose
according to a patient's weight and is the only pegylated interferon
indicated in China for a 24 week treatment duration in the hepatitis B
patient population. The SFDA approval is based in part on a multicenter
clinical trial in e-antigen positive chronic hepatitis B patients in China
showing that PEGINTRON achieved a sustained response with 24 weeks of
therapy when used as a first-line treatment.(1) PEGINTRON has been
available in China since 2004 for the treatment of chronic hepatitis C.
"Schering-Plough is pleased to offer this effective new treatment
option for Chinese patients with chronic hepatitis B, a major public health
problem in China," said Robert J. Spiegel, M.D., chief medical officer and
senior vice president, Schering-Plough Research Institute. "We applaud the
SFDA and Chinese healthcare professionals for their ongoing efforts in
fighting hepatitis B, and we are committed to continuing our work with them
and to educating patients on the importance of effective antiviral
treatment."
Schering-Plough has been working together with Chinese healthcare
professionals and patients for nearly 15 years on hepatitis B education for
INTRON(R) A, which was approved in China for hepatitis B and C in 1993. In
addition, the company offers ongoing educational programs in China to help
support patients on PEGINTRON and INTRON A therapy.
PEGINTRON
PEGINTRON is not approved in the United States for treatment of chronic
hepatitis B. 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
WARNING
Alpha interferons, including PEGINTRON, 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
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/PEGINTRON 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/PEGINTRON 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.
PEGINTRON
There are no new adverse events specific to PEGINTRON as compared to
INTRON 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 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.
PEGINTRON/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 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.
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 approximately 33,500
people around the world. The company is based in Kenilworth, N.J., and its
Web site is schering-plough.
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. 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 of these and other risks and uncertainties that may impact
forward-looking statements, see Schering-Plough's Securities and Exchange
Commission filings, including Part I, Item 1A, "Risk Factors" in the
company's 2006 10-K.
Reference
(1) Zhao H, Si CW, Wei L, Wan MB, Ying YK, Hou JL, Niu JQ. A multicenter,
randomized, open-label study of the safety and effectiveness of
pegylated interferon alfa-2b and interferon alfa-2b in treating HBeAg
positive chronic hepatitis B patients. Zhonghua Gan Zang Bing Za Zhi.
2006 May;14(5):323-6.
Schering-Plough Corporation
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