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Roche (RHHBY) New Data On Most Prescribed Hepatitis C Therapy Pegasys(R) Presented At European Association For The Study Of The Liver Conference



10/19/2005 5:12:42 PM

PARIS, April 15 /PRNewswire/ -- New Pegasys(R) (peginterferon alfa-2a) data, including exploration of factors associated with treatment response in hepatitis C patients, were revealed in 33 oral and poster presentations at the 40th Annual Meeting of The European Association for the Study of the Liver, April 13 - 17, in Paris, France.

Pegasys and Copegus(R) (ribavirin, USP), are approved by the U.S. Food and Drug Administration for the treatment of chronic hepatitis C and are the only combination regimen FDA-approved for the treatment of chronic hepatitis C in patients coinfected with hepatitis C and HIV.

Hepatitis C is a blood-borne virus that chronically infects an estimated 2.7 million Americans. The virus is a leading cause of cirrhosis and liver cancer and is the number-one reason for liver transplants in the U.S.

According to the Centers for Disease Control, approximately 1.25 million Americans are chronically infected with hepatitis B, a virus that can be transmitted through sexual contact and contact with infected blood.

Data from several Pegasys studies will be presented and discussed at the meeting, including:

Hepatitis C 1. The Influence of Cumulative Peginterferon Alfa-2a (40 KD) and Ribavirin (RBV) Exposure on Sustained Virological Response (SVR) Rates in Patients with Genotype 1 Chronic Hepatitis C (Viral Hepatitis: Hepatitis C Clinical Poster Session; 4/15/05) This analysis of pooled data from two phase III trials looked at the relationship between cumulative ribavirin exposure (total drug administered) and the desired outcome (sustained virological response, or SVR) in 569 chronic hepatitis C patients treated with Pegasys and ribavirin. The analysis found that as the cumulative dose of ribavirin decreased, SVR rates also decreased. Sixty-six percent of patients who took greater than 97 percent of the recommended ribavirin dose achieved an SVR compared to only 33 percent in patients who took less than 60 percent of the recommended ribavirin dose. 2. Age and Sustained Virological Response in Patients With Persistently 'Normal' ALT and Chronic Hepatitis C Treated With Peginterferon Alfa- 2a (40KD) Plus Ribavirin (Viral Hepatitis: Hepatitis C Clinical Poster Session; 4/15/05) A retrospective analysis of 422 chronic hepatitis C patients with persistently 'normal' ALT levels showed that younger patients had higher response rates to Pegasys and Copegus treatment compared to older patients. In the study, patients were divided into two groups based on age (<40 or >40), and were treated for 24 or 48 weeks. The study found that 54 percent of patients in the younger group achieved an SVR compared to 34 percent of those in the older group. 3. Clustering of Poor Prognostic Factors in Patients with Chronic Hepatitis C (Viral Hepatitis: Hepatitis C Clinical Poster Session; 4/15/05) An analysis of 2,404 patients from two multinational, randomized, controlled phase III studies showed that a cluster of poor prognostic characteristics, and not weight alone, may explain why lower response rates to therapy are observed in heavier patients, irrespective of the pegylated interferon therapy used. Patients were divided into three weight categories: <65 kg, <65-<85 kg, >85 kg. As previous studies with both pegylated interferons have shown, the patients in the highest weight category experienced lower SVR rates than lighter weight patients. The heaviest patients were also more likely to be male, black, cirrhotic, and infected through intravenous drug use, which are characteristics that are typically associated with lower treatment response rates. About Pegasys

Pegasys, a pegylated alpha interferon, and Copegus, an oral antiviral medication, 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. In addition, Pegasys is the only pegylated interferon approved by the FDA for use alone and in combination with Copegus for the treatment of chronic hepatitis C in patients coinfected with hepatitis C and HIV who are clinically stable (e.g., antiretroviral therapy not required or receiving stable antiretroviral therapy).

Roche filed a submission with the U.S. Food and Drug Administration in 2004 to market Pegasys for the treatment of hepatitis B. Action on the submission is expected in 2005.

About Roche - More Than a Century in the U.S. and the World

Founded in 1896 and headquartered in Basel, Switzerland, Roche is one of the world's leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is one of the world's leaders in diagnostics, the leading supplier of pharmaceuticals for cancer, as well as a leader in virology and transplantation. As a supplier of products and services for the prevention, diagnosis and treatment of disease, the Group contributes on many fronts to improve people's health and quality of life. Roche employs roughly 65,000 people in 150 countries, including approximately 15,000 in the United States.

Roche's U.S. operations celebrate their American Centennial in 2005. In another milestone this year, Roche was named in January to Fortune magazine's list of Best Companies to Work for in America. One of an increasingly rare breed of major healthcare companies that still bear their original name, Roche today has more than a dozen U.S. sites located in California, Colorado, Indiana, New Jersey and South Carolina, as well as in Puerto Rico. Roche has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai. Roche's Pharmaceuticals Division offers a portfolio of leading medicines in therapeutic areas including cancer, HIV/AIDS, hepatitis C, transplantation, dermatology and influenza. Roche's Diagnostics Division supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories world-wide. For further information, please visit our worldwide and U.S. websites (Global: http://www.roche.com/ and U.S.: http://www.roche.us/).

Facts About Pegasys (Peginterferon alfa-2a) in Combination with Copegus

PEGASYS, alone or in combination with COPEGUS(R), is indicated for the treatment of adults with chronic hepatitis C virus infection who have compensated liver disease and have not been previously 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) and patients with HIV disease that is clinically stable (eg, antiretroviral therapy not required or receiving stable antiretroviral therapy).

Alpha interferons, including PEGASYS(R) (Peginterferon alfa-2a), 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 REACTIONS in complete product information).

Use with Ribavirin. Ribavirin, including COPEGUS(R), 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 a worsening of cardiac disease. Ribavirin is genotoxic and mutagenic and should be considered a potential carcinogen (see CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS in complete product information).

PEGASYS is contraindicated in patients with hypersensitivity to PEGASYS or any of its components, autoimmune hepatitis, and hepatic decompensation (Child-Pugh score greater than 6; class B and C) in cirrhotic CHC monoinfected patients before or during treatment. Pegasys is also contraindicated in hepatic decompensation with Child-Pugh score greater than or equal to 6 in cirrhotic CHC patients coinfected with HIV before or during treatment. PEGASYS is also contraindicated in neonates and infants because it contains benzyl alcohol. Benzyl alcohol is 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, in 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 6 months after treatment has concluded. Routine monthly pregnancy tests must be performed during this time. If pregnancy should occur during treatment or during 6 months post-therapy, the patient must be advised of the significant teratogenic risk of COPEGUS therapy to the fetus. Healthcare providers and patients are strongly encouraged to immediately report any pregnancy in a patient or partner of a patient during treatment or during 6 months after treatment cessation to the Ribavirin Pregnancy Registry at 1-800-593-2214.

Chronic hepatitis C (CHC) patients with cirrhosis may be at risk of hepatic decompensation and death when treated with alpha interferons, including PEGASYS. Cirrhotic CHC patients coinfected with HIV receiving highly active antiretroviral therapy (HAART) and interferon alfa-2a with or without ribavirin appear to be at increased risk for the development of hepatic decompensation compared to patients not receiving HAART. During treatment, patients' clinical status and hepatic function should be closely monitored, and PEGASYS treatment should be immediately discontinued if decompensation (Child-Pugh score greater than or equal to 6) is observed.

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%). The adverse event profile of coinfected patients treated with PEGASYS and COPEGUS was generally similar to that shown for monoinfected patients. Events occurring more frequently in coinfected patients were neutropenia (40%), anemia (14%), thrombocytopenia (8%) weight decrease (16%) and mood alteration (9%).

Serious adverse events included neuropsychiatric disorders (suicidal ideation and suicide attempt), serious and severe bacterial infections (sepsis), 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/ischemic colitis), pancreatitis, and ophthalmologic disorders (decrease or loss of vision, retinopathy including macular edema and retinal thrombosis/hemorrhages, optic neuritis and papilledema).

Contacts: Pamela VanHouten Roche (973) 562-2231 pamela.vanhouten@roche.com David Freundel Manning Selvage & Lee (212) 468-3982 david.freundel@mslpr.com

Web Sites: http://www.roche.com http://www.roche.us

Roche

CONTACT: Pamela VanHouten, Roche, +1-973-562-2231, orpamela.vanhouten@roche.com; or David Freundel, Manning Selvage & Lee,+1-212 468-3982, or david.freundel@mslpr.com, for Roche


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