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FDA Approves Pegasys(R) (Peginterferon alfa-2a) Pre-filled Syringes for the Treatment of Hepatitis C
  - Roche continues effort to enhance hepatitis C treatment options -
NUTLEY, N.J., Jan. 8 /PRNewswire/ -- Roche announced today that the U.S. Food and Drug Administration (FDA) has approved pre-filled syringes of Pegasys(R) (Peginterferon alfa-2a) for the treatment of chronic hepatitis C.
Pegasys, a pegylated alpha interferon, and Copegus(R) (ribavirin, USP) were approved by the FDA in December 2002 for use in combination 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.
Pegasys is the most prescribed interferon therapy in the United States for the treatment of chronic hepatitis C.* Roche expects Pegasys pre-filled syringes to be available in pharmacies by the end of the month. Pre-filled syringes will be packaged four per box. Pegasys is currently available in vials as a pre-mixed solution.
"Taking a medication by self-injection can be challenging for some people," said Dr. David Bernstein, Director of Hepatology, North Shore University Hospital. "Reducing the number of steps involved can make the process less intimidating for patients and reduce the risk of errors."
The introduction of pre-filled syringes is yet another way in which Roche is working to add value to the management of hepatitis C, including:
* developing approaches to reduce the duration of treatment with Pegasys and Copegus and the dose of Copegus therapy for certain patients
* introducing Copegus with a list price or wholesale acquisition cost that is 43 percent less per milligram than the other available brand of ribavirin
* backing Pegasys with the most extensive development program ever undertaken in hepatitis C
* formulating Pegasys as a pre-mixed solution requiring no reconstitution prior to self-injection
Hepatitis C is a blood-borne infectious disease of the liver and the leading cause of cirrhosis and liver cancer and the number one reason for liver transplants in the U.S. An estimated 2.7 million Americans are chronically infected with hepatitis C.
Pegasys is dosed at 180mcg as a subcutaneous injection taken 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 web site at: http://www.rocheusa.com
* IMS weekly data for the week ending December 26, 2003.
Facts About Pegasys (Peginterferon alfa-2a) in Combination with Copegus
* Pegasys(R), a pegylated alpha interferon, alone or in combination with Copegus(R) (ribavirin, USP) 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.
Physicians and patients are strongly encouraged to report any pregnancies that do occur to Roche 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.
CO: Roche; Hoffmann-La Roche Inc.
ST: New Jersey
Web site: http://www.rocheusa.com
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