Schering-Plough Highlights Boceprevir, Narlaprevir (SCH 900518) and Pegintron Data at the American Association for the Study of Liver Diseases (AASLD) 2009 Annual Meeting
KENILWORTH, N.J., Oct. 15 /PRNewswire-FirstCall/ --
Schering-Plough (NYSE: SGP) today announced that data on
boceprevir, an investigational hepatitis C virus (HCV) protease
inhibitor, will be reported in an oral presentation at the American
Association for the Study of Liver Diseases (AASLD) Annual Meeting
in Boston, Oct. 30-Nov. 3. Researchers will present sustained
virologic response (SVR) data on boceprevir triple combination
therapy in treatment-naive HCV genotype 1 patients who had a null
response to peginterferon and ribavirin (defined as <1 log
decrease in hcv viral load) the 4-week lead-in arms of phase
ii sprint-1 study. patients with null response to peginterferon and
ribavirin are considered be among most difficult treat
successfully.
Phase III registration studies with boceprevir in
treatment-naive HCV patients and those who failed prior treatment
have been fully enrolled and are expected to be completed in
mid-2010.
In addition, a late-breaker oral presentation on narlaprevir
(SCH 900518), a next-generation once-daily HCV protease inhibitor,
will report week-4 rapid virologic response (RVR) and week-12 early
virologic response (EVR) data in treatment-naive HCV genotype 1
patients from the ongoing NEXT-1 study. Narlaprevir is currently in
Phase II clinical development.
Several presentations will report results with PEGINTRON(R)
(peginterferon alfa-2b) and REBETOL(R) (ribavirin, USP) combination
therapy, an approved treatment regimen for chronic hepatitis C.
These include a late-breaker oral presentation on a genome-wide
analysis of patients from the IDEAL study that identified the first
genetic marker that may predict a patient's response to
peginterferon and ribavirin combination therapy for hepatitis C.
Peginterferon and ribavirin are expected to remain the backbone of
HCV treatment regimens for the next several years. Schering-Plough
is in the process of analyzing options for the development of a
genetic test based on this marker and for making it widely
accessible to providers, patients and diagnostic companies for the
advancement of science and for helping physicians and patients make
more informed treatment decisions.
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. It is the leading cause of cirrhosis and liver cancer,
and the number one reason for liver transplants in the United
States and Europe.
For program information, please visit the AASLD Web site at
www.aasld.org.
This document is intended for trade media attending AASLD for
their planning purposes.
Key Data Presentations at AASLD 2009 Boceprevir Oral Presentation
High Sustained Virologic Response (SVR) in Genotype 1 (G1) Null
Responders to Peg-Interferon alfa-2b plus Ribavirin When Treated
with Boceprevir Combination Therapy; P.Y. Kwo et al. Abstract 62.
Sunday, Nov. 1, 5:00 pm to 5:15 pm, Hynes Auditorium
Boceprevir Poster Presentations
Response-Guided Therapy (RGT) for Boceprevir Combination
Treatment - Results from HCV SPRINT-1; P.Y. Kwo et al. Abstract
1582. Tuesday, Nov. 3, 8:00 am to 1:00 pm, Hynes Exhibit Hall
C
Clonal analysis of mutations selected in the HCV NS3 protease
domain of genotype 1 non-responders sequentially treated with
boceprevir and/or pegylated interferon alfa-2b; J. Vermehren et al.
Abstract 1592. Tuesday, Nov. 3, 8:00 am to 1:00 pm, Hynes Exhibit
Hall C
Narlaprevir (SCH 900518) Late-Breaker Oral Presentation
Once-Daily Narlaprevir (SCH 900518) in Combination with PEGINTRON
(Peginterferon alfa-2b)/ Ribavirin) for Treatment-Naive Subjects
with Genotype-1 CHC: Interim Results from NEXT-1, a Phase 2a Study;
J.M. Vierling et al. Abstract LB4. Monday, Nov. 2, 5:30 pm to 5:45
pm, Hynes Auditorium
Narlaprevir (SCH 900518) Poster Presentation
SVR Results in Chronic Hepatitis C Genotype 1 Patients Dosed
with SCH 900518 and Peginterferon Alfa-2b for 2 Weeks, Followed by
Peginterferon Alfa-2b and Ribavirin for 24/48 Weeks: An Interim
Analysis; J. de Bruijne et al. Abstract 1555. Tuesday, Nov. 3, 8:00
am to 1:00 pm, Hynes Exhibit Hall C
IDEAL Study Late-Breaker Oral Presentation
Genome-wide analysis of patients from the IDEAL study identifies
a polymorphism upstream of the IL28B gene that is strongly
associated with SVR in patients with HCV-1; A.J. Thompson et al.
Abstract LB5. Monday, Nov. 2, 5:45 pm to 6:00 pm, Hynes
Auditorium
IDEAL Study Oral Presentation
Relationship of the Use of Statins and Elevated Low-Density
Lipoprotein (LDL) or Total Cholesterol (TC) to Virologic Response
in Patients Treated for Hepatitis C Virus (HCV) in the IDEAL Study;
S.A. Harrison et al. Abstract 120. Monday, Nov. 2, 4:15 pm to 4:30
pm, Hynes Ballroom B
IDEAL Study Poster Presentation
Analysis of Reasons for Treatment Ineligibility in the IDEAL
study: African Americans (AA) vs. non-African Americans (non-AA);
M. Melia et al. Abstract 848. Sunday, Nov. 1, 8:00 am to 5:30 pm,
Hynes Exhibit Hall C
PEGINTRON Oral Presentation
Interim analysis of a controlled trial of pre-transplant
peginterferon alfa-2b/ribavirin (PEG/RBV) to prevent recurrent
hepatitis C virus (HCV) infection after liver transplantation (LT)
in the Adult-to-Adult Liver Transplantation (A2ALL) Study; G.T.
Everson et al. Abstract 1. Sunday, Nov 1, 8:00 am to 8:15 am, Hynes
Auditorium
About PEGINTRON
PEGINTRON is indicated 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 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 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 (e.g.,
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 six months post-treatment. Patients
should use at least two effective forms of contraception and have
monthly pregnancy tests during therapy and for six 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 six 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 (e.g., 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 (e.g., 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
equal to or less than 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.
Please see full prescribing information at http://www.spfiles.com/pipeg-intron.pdf.
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 www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this news
release includes certain "forward-looking statements" within the
meaning of the Securities Litigation Reform Act of 1995, including
statements relating to the Company's marketed products and
investigational agents for hepatitis C. 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 second quarter 2009 10-Q, filed July 24, 2009.
Source: Schering-Plough
CONTACT: Media, Robert Consalvo, +1-908-298-7409, or Investors,
Janet
Barth, +1-908-298-7436, or Joe Romanelli, +1-908-298-7436, all
for
Schering-Plough
Web Site: 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. Schering-Plough press releases are also available on PRNewswire's Web site at http://www.prnewswire.com/comp/777050.html/
Posted: October 2009
