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Roche Dramatically Reduces Cost of Combination Therapy for Millions of
Americans Chronically Infected with Hepatitis C
Press Release from Roche
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Copegus, used in combination with Pegasys, rolls ribavirin cost per milligram
back 43 percent
to 1998 price
NUTLEY, N.J. (January 13, 2003) - Roche today announced that Copegusä
(ribavirin, USP), the medication used in combination with PegasysŌ
(peginterferon alfa-2a) for the treatment of chronic hepatitis C, is being
introduced with a list price or wholesale acquisition cost that is 43 percent
less per milligram than the other available brand of ribavirin. Copegus will
be available in U.S. pharmacies beginning the week of January 13. The list
price or wholesale acquisition cost for Copegus is $5.06 per 200mg tablet.
Pegasys and Copegus combination therapy was approved by the U.S. Food and
Drug Administration (F.D.A.) on December 3, 2002, for adults who have
compensated liver disease and have not previously been treated with
interferon alpha. An estimated 2.7 million Americans are chronically
infected with hepatitis C.
"Roche is very proud of the steps the company has taken to drastically reduce
the cost of
combination therapy for the millions of Americans chronically infected with
hepatitis C," said George B. Abercrombie, Roche President and Chief Executive
Officer. "With Pegasys and Copegus, physicians and patients can have
confidence knowing that this therapy is backed by an unprecedented
development program--the most extensive ever conducted in hepatitis C."
A Visible Difference in Price
Roche has rolled back the list price or wholesale acquisition cost of Copegus
to that of branded ribavirin in August 1998.* For patients prescribed 1200mg
of ribavirin per day, there is a list price or wholesale acquisition cost
savings with Copegus of approximately $7,600 for 48 weeks of therapy.
Backed By Most Extensive Development Program
Pegasys is backed by the most extensive development program ever undertaken
in hepatitis C. As part of its clinical development program, Roche conducted
five pivotal studies (three for the Pegasys monotherapy indication and two
for the Pegasys and Copegus combination therapy indication). Included was a
study to evaluate Pegasys monotherapy in patients with cirrhosis and a study
to evaluate shorter durations of therapy and lower doses of Copegus for
patients with certain genotypes (strains) of the hepatitis C virus.
As a result of the combination therapy study, the following dosing regimens
are recommended for Pegasys and Copegus combination therapy:
--Genotype 1 and 4: 48 week duration with 180mcg Pegasys weekly and 1000 -
1200mg of Copegus daily
--Genotype 2 and 3: 24 week duration with 180mcg Pegasys weekly and 800mg
Copegus daily
Pegasys is available as a premixed solution and administered as a
subcutaneous injection once a week. Copegus is available as a 200mg tablet,
and is administered orally two times a day as a split dose.
Please see attached Facts About Pegasys in Combination with Copegus (below)
About Roche
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S.
prescription drug unit of the Roche Group, a leading research-based health
care enterprise that ranks among the world's leaders in pharmaceuticals and
diagnostics.
Roche discovers, develops, manufactures and markets numerous important
prescription drugs that enhance people's health, well-being and quality of
life. Among the company's areas of therapeutic interest are: dermatology;
genitourinary disease; infectious diseases, including influenza;
inflammation, including arthritis and osteoporosis; metabolic diseases,
including obesity and diabetes; neurology; oncology; transplantation;
vascular diseases; and virology, including HIV/AIDS and hepatitis C.
For more information on the Roche pharmaceuticals business in the United
States, visit the company's website at: http://www.rocheusa.com.
* In August 1998, branded ribavirin (Rebetol) was only available in
combination with Intron A, packaged as Rebetron. To extrapolate the August
1998 price of branded ribavirin, the following calculation was performed on a
comparable 1200mg pack: 1998 Rebetron price ($1,200 for 4 weeks of treatment
with 1200mg daily ribavirin and Intron A 3 times per week) minus the 1998
Intron A price ($349.30 for 4 weeks of treatment with Intron A 3 times per
week) = $850.70 for 4 weeks of treatment with 1200mg per day of branded
ribavirin. Pricing is based on published wholesale acquisition costs by
First Data Bank in August 1998. The current price of Rebetol was obtained
from First Data Bank on January 6, 2003.
Facts About Pegasys in Combination with Copegus
Indication
--Pegasys, a pegylated interferon, in combination with Copegus is indicated
for the treatment of adults with chronic hepatitis C who have compensated
liver disease and have not previously been treated with interferon alpha.
Patients in whom efficacy was demonstrated included patients with compensated
liver disease and histological evidence of cirrhosis (Child-Pugh class A).
Dosing and Administration
--Pegasys, a premixed solution, is dosed at 180mcg as a subcutaneous
injection once a week. Copegus, available as a 200mg tablet, is administered
at 800 to 1200mg taken twice daily as a split dose. The two products are
sold separately.
Combination Therapy Clinical Studies
The two combination therapy pivotal study findings:
Study 5, including 1,284 patients receiving medication, showed that patients
with certain genotypes (strains) of the hepatitis C virus should be treated
with different dosing regimens of Pegasys and Copegus. The treatment
regimens and resulting sustained virological response rates for these groups
treated with Pegasys and Copegus therapy were:
--Genotype 1: 48 week duration with 1000 - 1200mg Copegus: 51 percent
--Genotype non-1: 24 week duration with 800mg Copegus: 82 percent
Study 4, published in the September 26, 2002 New England Journal of Medicine,
including 1,121 patients receiving medication, showed that Pegasys and
Copegus combination therapy is a more effective treatment for chronic
hepatitis C than interferon alfa-2b and ribavirin. The sustained virological
response rate in the Pegasys and Copegus treated patients was 53 percent
compared to 44 percent in the interferon alfa-2b and ribavirin group.
Sustained virological response refers to a patient's continued undetectable
serum hepatitis C RNA levels 24 weeks after finishing a course of treatment.
The Future - Special Populations, HIV/HCV Co-infection
Pegasys and Copegus studies are underway to evaluate the therapy for the
treatment of African-Americans, who have a substantially higher prevalence of
hepatitis C infection and typically have lower response rates to hepatitis C
therapy than Caucasian Americans.
--Trials also are being conducted to evaluate Pegasys and Copegus treatment
in patients co-infected with hepatitis C and HIV and in patients with
hepatitis C who failed to achieve a sustained virological response to
standard interferon and ribavirin.
Adverse Events
Alpha interferons, including Pegasys, 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. Therapy should be withdrawn in patients with
persistently severe or worsening signs or symptoms of these conditions. In
many, but not all cases, these disorders resolve after stopping Pegasys
therapy (see CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE EVENTS in
complete product information).
USE with Ribavirin. Ribavirin, including Copegus may cause birth defects
and/or death of the fetus. 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 ribavirin therapy may result in
worsening of cardiac disease. Ribavirin is genotoxic, mutagenic, and should
be considered a potential carcinogen (see CONTRAINDICATIONS, WARNINGS,
PRECAUTIONS and ADVERSE EVENTS in complete product information).
Pegasys is contraindicated in patients with hypersensitivity to Pegasys or
any of its components, autoimmune hepatitis, and decompensated hepatic
disease (Child-Pugh class B and C) before or during treatment with Pegasys.
Pegasys is also contraindicated in neonates and infants because it contains
benzyl alcohol. Benzyl alcohol has been reported to be associated with an
increased incidence of neurological and other complications in neonates and
infants, which are sometimes fatal. Pegasys and Copegus therapy is
additionally contraindicated in patients with a hypersensitivity to Copegus
or any of its components, women who are pregnant, men whose female partners
are pregnant, and patients with hemoglobinopathies (eg, thalassemia major,
sickle-cell anemia).
COPEGUS THERAPY SHOULD NOT BE STARTED UNLESS A REPORT OF A NEGATIVE PREGNANCY
TEST HAS BEEN OBTAINED IMMEDIATELY PRIOR TO INITIATION OF THERAPY. Women of
childbearing potential and men must use two forms of effective contraception
during treatment and during the six months after treatment has concluded.
Routine monthly pregnancy test must be performed during this time. If
pregnancy should occur during treatment or during six months post-therapy,
the patient must be advised of the significant teratogenic risk of Copegus
therapy to the fetus. To monitor maternal-fetal outcomes of pregnant women
exposed to Copegus, the Copegus Pregnancy Registry has been established.
Physicians and patients are strongly encouraged to register by calling
1-800-526-6367.
The most common adverse events reported for Pegasys and Copegus combination
therapy, observed in clinical trials (n=451), were fatigue/asthenia (65%),
headache (43%), pyrexia (41%), myalgia (40%),
irritability/anxiety/nervousness (33%), insomnia (30%), alopecia (28%),
neutropenia (27%), nausea/vomiting (25%), rigors (25%), anorexia (24%),
injection site reaction (23%), arthralgia (22%), depression (20%), pruritus
(19%) and dermatitis (16%).
Serious adverse events include neuropsychiatric disorders (suicidal ideation
and suicide attempt), serious and severe bacterial infections, bone marrow
toxicity (cytopenia and rarely, aplastic anemia), cardiovascular disorders
(hypertension, arrhythmias and myocardial infarction), hypersensitivity
(including anaphylaxis), endocrine disorders (including thyroid disorders and
diabetes mellitus), autoimmune disorders (including psoriasis and lupus),
pulmonary disorders (dyspnea, pneumonia, bronchiolitis obliterans,
interstitial pneumonitis and sarcoidosis), colitis (ulcerative and
hemorrhagic/ischemiccolitis), pancreatitis, and opthalmologic disorders
(decrease or loss of vision, retinopathy including macular edema and retinal
thrombosis/hemorrhages, optic neuritis and papilledema).
The complete package inserts for Pegasys and Copegus are available at
www.pegasys.com, or by calling 1-877-PEGASYS.
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