KENILWORTH, N.J., Oct. 30 /PRNewswire-FirstCall/ -- Schering-Plough
Corp. (NYSE:SGP) announced today the U.S. Food and Drug
Administration (FDA) has issued a complete response letter to the
company's supplemental Biologics License Application regarding
PEGINTRON® (pegylated interferon alfa-2b) for the adjuvant
treatment of patients with stage III malignant melanoma after
complete lymphadenectomy. Schering-Plough will work closely with
FDA to respond to outstanding concerns related to the PEGINTRON
melanoma filing. In early October, the FDA's Oncologic Drugs
Advisory Committee recommended approval of PEGINTRON in this
indication by a vote of 6 to 4. Schering-Plough had sought approval
for this indication based on data from the largest positive
adjuvant trial in subjects with stage III melanoma. Introducing new
drugs to treat malignant melanoma remains a challenge, and
Schering-Plough is committed to the treatment of this aggressive
form of cancer. Full U.S. prescribing information may be found at.
http://www.spfiles.com/pipeg-intron.pdf U.S. Indications for
PEGINTRON PEGINTRON is indicated in the U.S. for use in combination
with REBETOL® (ribavirin) for the treatment of chronic hepatitis C
in patients 3 years of age and older with compensated liver
disease. The following points should be considered when initiating
therapy with PEGINTRON in combination with REBETOL: (1) These
indications are based on achieving undetectable HCV RNA after
treatment for 24 or 48 weeks and maintaining a Sustained Virologic
Response (SVR) 24 weeks after the last dose. (2) Patients with the
following characteristics are less likely to benefit from
re-treatment after failing a course of therapy: previous
nonresponse, previous pegylated interferon treatment, significant
bridging fibrosis or cirrhosis, and genotype 1 infection. (3) No
safety and efficacy data are available for treatment of longer than
one year. PEGINTRON is also indicated in the U.S. for use alone for
the treatment of chronic hepatitis C in patients with compensated
liver disease previously untreated with interferon alpha and who
are at least 18 years of age. The following points should be
considered when initiating therapy with PEGINTRON alone:
Combination therapy with REBETOL is preferred over PEGINTRON
monotherapy unless there are contraindications to, or significant
intolerance of, REBETOL. Combination therapy provides substantially
better response rates than monotherapy. Important U.S. Safety
Information on PEGINTRON WARNING: RISK OF SERIOUS DISORDERS AND
RIBAVIRIN-ASSOCIATED EFFECTS 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. Use with Ribavirin: Ribavirin may
cause birth defects and 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 known hypersensitivity reactions
such as urticaria, angioedema, bronchoconstriction, anaphylaxis;
Stevens-Johnson syndrome and toxic epidermal necrolysis to
interferon alpha or any other component of the product; autoimmune
hepatitis, and hepatic decompensation (Child-Pugh score >6
[class B and C]) in cirrhotic CHC patients before or during
treatment. PEGINTRON/REBETOL combination therapy is additionally
contraindicated in women who are pregnant or may become pregnant
(see Boxed Warning and Pregnancy section); men whose female
partners are pregnant; patients with hemoglobinopathies (eg,
thalassemia major, sickle-cell anemia); and patients with
creatinine clearance < 50 mL per min. 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 posttreatment. 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. If this drug
is used during pregnancy or if a patient becomes pregnant, the
patient should be apprised of the potential hazard to a fetus. 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 Most common
adverse reactions (>40%) in adult patients receiving either
PEGINTRON or PEGINTRON/REBETOL are injection site
inflammation/reaction, fatigue/asthenia, headache, rigors, fevers,
nausea, myalgia, and anxiety/emotional lability/irritability. Most
common adverse reactions (>25%) in pediatric patients receiving
PEGINTRON/REBETOL are pyrexia, headache, neutropenia, fatigue,
anorexia, injection site erythema, and vomiting. In a study with
PEGINTRON/REBETOL (weight-based) combination therapy in adult
patients, anemia with weight-based dosing was 29%; however, the
majority of these cases were mild and responded to dose reductions.
The incidence of serious adverse reactions reported for the
weight-based REBETOL group was 12%. In many but not all cases,
adverse reactions resolved after dose reduction or discontinuation
of therapy. Some patients experienced ongoing or new serious
adverse reactions during the 6-month follow-up period.
Discontinuations for adverse events were 15% and were related to
known interferon effects of psychiatric, systemic (eg, fatigue,
headache), or gastrointestinal adverse reactions. Dose
modifications due to adverse reactions occurred in 29% of patients.
Most common adverse reactions with PEGINTRON/REBETOL (weight-based)
combination therapy were psychiatric, which occurred among 68-69%
of patients. These psychiatric adverse reactions included most
commonly depression, irritability, and insomnia, each reported by
approximately 30-40% of subjects in all treatment groups. Suicidal
behavior (ideation, attempts, and suicides) occurred in 2% of all
patients during treatment or during follow-up after treatment
cessation. PEGINTRON induced fatigue or headache in approximately
two-thirds of patients, with fever or rigors in approximately half
of the patients. The severity of some of these systemic symptoms
(eg, fever and headache) tends to decrease as treatment continues.
There was a 23-24% incidence overall for injection site reactions
or inflammation. Individual serious adverse reactions occurred at a
frequency less than or equal to 1% and included suicide attempt,
suicidal ideation, severe depression; psychosis, aggressive
reaction, relapse of drug addiction/overdose; nerve palsy (facial,
oculomotor); cardiomyopathy, myocardial infarction, angina,
pericardial effusion, retinal ischemia, retinal artery or vein
thrombosis, blindness, decreased visual acuity, optic neuritis,
transient ischemic attack, supraventricular arrhythmias, loss of
consciousness; neutropenia, infection (sepsis, pneumonia, abscess,
cellulitis); emphysema, bronchiolitis obliterans, pleural effusion,
gastroenteritis, pancreatitis, gout, hyperglycemia, hyperthyroidism
and hypothyroidism, autoimmune thrombocytopenia with or without
purpura, rheumatoid arthritis, interstitial nephritis, lupus-like
syndrome, sarcoidosis, aggravated psoriasis, urticaria, injection
site necrosis, vasculitis, and phototoxicity. Additional serious
adverse events included suicide, homicidal ideation, aggressive
behavior sometimes directed towards others, hallucinations, bipolar
disorders, mania, encephalopathy (usually elderly treated with
higher doses of PEGINTRON), hypotension, tachycardia, retinopathy
including macular edema, retinal hemorrhage, cotton wool spots,
papilledema, serous retinal detachment, ischemic and hemorrhagic
cerebrovascular events, bone marrow toxicity (cytopenia and very
rarely aplastic anemia), thyroiditis, dental and periodontal
disorders, hemorrhagic/ischemic colitis, dyspnea, pulmonary
infiltrates, pneumonia, interstitial pneumonitis, pulmonary
hypertension, hepatic failure, increases in serum creatinine in
patients with renal insufficiency, acute hypersensitivity
(angioedema, bronchoconstriction, anaphylaxis and cutaneous
eruptions), hypertriglyceridemia, and peripheral neuropathy. During
the course of therapy lasting up to 48 weeks in patients ages 3
through 17 years receiving PEGINTRON/REBETOL combination therapy,
weight loss and growth inhibition were common. About
Schering-Plough 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, animal health and consumer health
care products. Schering-Plough's vision is to "Earn Trust, Every
Day" with the doctors, patients, customers and other stakeholders
served by its colleagues 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 media alert includes certain
"forward-looking statements" within the meaning of the Securities
Litigation Reform Act of 1995, including statements relating to
clinical development of investigational oncology compounds.
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 about these and other factors
that may impact the 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 2009 10-Q, filed October 29, 2009. DATASOURCE:
Schering-Plough Corporation CONTACT: Mary-Frances Faraji,
+1-908-298-7109, or cell, +1 908 432 2404, ; Investor Contacts,
Joseph Romanelli, or Janet Barth, +1-908-298 7436 Web Site:
http://www.schering-plough.com/
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