Cingles Info

Roche Dramatically Reduces Cost of Combination Therapy for Millions of Americans
Chronically Infected with Hepatitis C
Copegus, used in combination with Pegasys, rolls ribavirin cost per milligram
back 43 percent to 1998 price
NUTLEY, N.J., Jan. 13 /PRNewswire/ -- Roche today announced that Copegus(TM)
(ribavirin, USP), the medication used in combination with Pegasys(R)
(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.
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
http://www.pegasys.com , or by calling 1-877-PEGASYS.
SOURCE: Roche
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