Healthcare Industry News:  pancreatitis 

Biopharmaceuticals

 News Release - April 29, 2006

PEGASYS(R) ACCELERATE Trial Shows Six Months of Treatment Is Optimal for Achieving Success in Category of Hepatitis C Patients

Interim Analyses Results from a Second Study, REPEAT, for Hepatitis C Patients Who Have Failed on Peg-Intron(R)

VIENNA, Austria, April 29 (HSMN NewsFeed) -- Roche announced today that results from a new trial have shown that 24 weeks of therapy with PEGASYSŪ (peginterferon alfa-2a) combined with ribavirin is more effective than 16 weeks for patients infected with hepatitis C genotypes 2 and 3. The additional eight weeks gave patients a greater chance of being successfully treated for chronic hepatitis C and also lowered the relapse rate after treatment. The results of the ACCELERATE trial, the only randomized controlled study specifically designed to examine a shorter treatment duration versus standard duration in patients with genotypes 2 and 3, were presented at the 41st Annual Meeting of the European Association for the Study of the Liver (EASL).

"There has been a trend toward treating patients for shorter durations, but this study shows that genotypes 2 and 3 patients really do need 24 weeks of treatment for optimal results," said Mitchell Shiffman, M.D., Professor of Medicine, Chief of the Hepatology Section and Medical Director of the Liver Transplant Program at the Medical College of Virginia, Commonwealth University and MCV Hospitals and lead investigator of the study. "With these results, doctors can be confident that they are treating their patients for the correct period of time to give them the best chance for success."

A total of 1,469 patients from eight countries took part in the trial. Patients were randomized to receive PEGASYS 180mcg once weekly plus COPEGUSŪ (ribavirin) 800mg daily for either 16 or 24 weeks, followed by 24 weeks of treatment-free follow-up. The trial included patients from the United States, Australia, Canada, France, Germany, Italy, New Zealand and Spain.

The key findings of the trial were:

* More patients achieved a sustained virological response (SVR) after 24 weeks (n=679) of therapy compared with 16 weeks (n=630) of therapy (76 percent vs. 65 percent).

* Ninety percent of rapid viral responders (a drop in the amount of virus in their blood to below the limits of detection after just four weeks of therapy) achieved a SVR after 24 weeks of therapy.

* The incidence of adverse events was similar in the two groups. However, more patients in the 24-week group had their dose of PEGASYS and ribavirin modified or discontinued.

"This trial underscores Roche's continuing scientific commitment to optimizing treatment in people with hepatitis C," said James A. Thommes, M.D., Senior Medical Director, Roche. "ACCELERATE joins a large number of other PEGASYS trials that provide physicians with the most current scientific information to guide treatment decisions."

About the REPEAT Trial

In addition to ACCELERATE, results were announced from the REPEAT (REtreatment with PEgasys in PATients Not Responding to Peg-Intron Therapy) trial, which focuses on patients who did not respond to previous therapy with Peg-Intron. Data presented from this study include a 12-week interim efficacy and safety analysis of standard-dose (180mcg) and fixed-dose induction (360mcg) therapy as well as similar outcomes for patients with cirrhosis and/or advanced fibrosis. After the initial 12-week treatment period, all patients are being treated with the standard dose of PEGASYS and COPEGUS for a total treatment duration of either 48 or 72 weeks.

Interim results showed:

* Forty-five percent of patients treated with the standard dose of PEGASYS with COPEGUS had an early viral response (EVR), defined as having a greater than or equal to 2 log drop in viral load or having no detectable virus after 12 weeks of treatment (n=469).

* An EVR rate of 62 percent was achieved in the group of patients who were treated with the higher fixed-dose induction of PEGASYS with standard COPEGUS for the first 12 weeks of therapy (n=473).

* The adverse event profiles were similar for patients taking the higher fixed-dose induction of PEGASYS with COPEGUS for 12 weeks compared to those taking the standard dose. However, more patients in the higher fixed-dose induction group had their dose of PEGASYS and ribavirin modified or were discontinued.

About Hepatitis C

Hepatitis C, a blood-borne infectious disease of the liver, is transmitted through body fluids, primarily blood or blood products, and by sharing needles. Hepatitis C chronically infects an estimated 2.7 million Americans and 170 million people worldwide and is the leading cause of cirrhosis and liver cancer and the number one reason for liver transplants in the United States.

About Pegasys

Pegasys, a pegylated alpha interferon, and Copegus 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 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. Roche has backed Pegasys with the most extensive clinical research program ever undertaken in hepatitis C, with major studies initiated to advance treatment for hepatitis C patients with unmet needs, including patients co-infected with HIV and HCV, African Americans, patients with cirrhosis, and patients who have failed to respond to previous therapy.

Please see attached additional information about Pegasys indication and safety.

About Roche

Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. pharmaceuticals headquarters of the Roche Group, one of the world's leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics. For more than 100 years, the Roche Group has been committed to developing innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people's health and quality of life. An employer of choice, in 2005, Roche was named one of Fortune magazine's Best Companies to Work For in America, one of the Top 20 Employers (Science magazine), ranked as the No. 3 Best Company to Work For in NJ (NJ Biz magazine), the No. 1 Company to Sell For (Selling Power), and one of AARP's Top Companies for Older Workers. For additional information about the U.S. pharmaceuticals business, visit our websites: http://www.rocheusa.com or http://www.roche.us.

IMPORTANT SAFETY INFORMATION

PEGASYS, alone or in combination with COPEGUS, 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 PEGASYSŪ (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 COPEGUSŪ, 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 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 (homicidal ideation, suicidal ideation, suicide attempt and suicide), serious and severe bacterial infections (sepsis), bone marrow toxicity (cytopenia and rarely, aplastic anemia), cardiovascular disorders (hypertension, supraventricular arrhythmias and myocardial infarction), hypersensitivity (including anaphylaxis), endocrine disorders (including thyroid disorders and diabetes mellitus), autoimmune disorders (including idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura, psoriasis, lupus, rheumatoid arthritis and interstitial nephritis), 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).


Source: Roche

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