Significant New Data on Roche's Pegasys and Hepatitis C PipelineCompounds to be Featured at 58th Annual AASLD Meeting
NUTLEY, N.J., October 30, 2007 /PRNewswire/ -- Roche today announced that new study results for PEGASYS(R) (peginterferon alfa-2a), the world's leading treatment for chronic hepatitis C virus (HCV) infection, as well as the company's robust pipeline of hepatitis C compounds in clinical development, will be presented at the upcoming 58th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), also known as The Liver Meeting, in Boston, November 2-6, 2007.
The presentations will include final efficacy and safety results from REPEAT, a major study examining retreatment with PEGASYS/COPEGUS(R) (ribavirin) in patients whose infection did not respond to prior treatment with Peg-Intron(R) (peginterferon alfa-2b) and ribavirin. Additionally, the first efficacy and safety results from a Phase IIa study with the polymerase inhibitor R1626, as well as new data on the polymerase inhibitor R7128 (being developed in partnership with Pharmasset), and the protease inhibitor R7227/ITMN-191 (being developed with InterMune), will be presented.
"As the premier meeting in the science and practice of hepatology, The Liver Meeting provides Roche with an important opportunity to demonstrate our commitment to advancing the diagnosis and treatment of this devastating disease," said Nick Cammack, Ph.D., Virology Disease Biology Area Leader, Roche. "In addition to ongoing research with PEGASYS, reinforcing its status as the leading HCV therapy, Roche is dedicated to developing new molecules that could help more patients achieve treatment success."
PEGASYS Highlights -- "Pegylated interferon alfa-2a plus ribavirin (RBV) in prior non- responders to pegylated interferon alfa-2b/RBV: final efficacy and safety outcomes of the REPEAT study," D. M. Jensen et al., Monday, November 5, 3:45 p.m. - 4:00 p.m. ET (Oral Presentation No. LB4). -- "Rapid and early virological response rates are increased with 12 week 360 Âµg/wk peginterferon alfa-2a and standard ribavirin in HCV genotype 1 treatment naive patients: efficacy and safety analysis of the induction phase of the CHARIOT study," S. Roberts et al., Sunday, November 4, 6:00 p.m. - 6:15 p.m. ET (Oral Presentation No. 54). -- "Prolonged Antiviral Therapy With Peginterferon to Prevent Complications of Advanced Liver Disease Associated With Hepatitis C: Results of the Hepatitis C Antiviral Long-term Treatment against Cirrhosis (HALT-C) Trial," A. M. Di Bisceglie et al., Monday, November 5, 3:00 p.m. - 3:15 p.m. ET (Oral Presentation No. LB1). -- "Association of Pre-Treatment and On-Treatment Factors with Rapid Virologic Response in HCV Genotype 1 Infected Patients Treated with PegIFN-2a/RBV," M. Rodriguez-Torres et al., Tuesday, November 6, 8:00 a.m. - 12:30 p.m. ET (Poster No. 1305). -- "Prophylactic Peginterferon Alfa-2a/Ribavirin vs. No Prophylaxis Following Orthotopic Liver Transplantation (OLT) for Hepatitis C: 24- Week Virologic and Safety Responses," M. R. Charlton, et al., Sunday, Nov. 4, 3:00 p.m. - 3:15 p.m. ET (Oral Presentation No. 25). Pipeline Highlights -- "Robust Synergistic Antiviral Effect of R1626 in Combination with Peginterferon alfa-2a (40KD), with or without Ribavirin - Interim Analysis Results of Phase 2a Study," P. J. Pockros, et al., Tuesday, November 6, 2007, 9:00 a.m. - 9:15 a.m. ET (Oral Presentation No. 167). -- "A high barrier to resistance may contribute to the robust antiviral effect demonstrated by R1626 in HCV genotype 1-infected treatment-naive patients," S. Le Pogam et al., Tuesday, November 6, 2007, 8:00 a.m. - 12:30 p.m. ET (Poster No. 1298). -- "Antiviral Activity, Pharmacokinetics, Safety, and Tolerability of R7128, a Novel Nucleoside HCV RNA Polymerase Inhibitor, Following Multiple, Ascending, Oral Doses in Patients with HCV Genotype 1 Infection Who have Failed Prior Interferon Therapy," R. Reddy et al., Tuesday, November 6, 2007, 8:00 a.m. - 12:00 p.m. ET (Poster No. LB9). -- "Genotype Coverage of the HCV NS3/4A Protease Inhibitor ITMN-191 (R7227): Biochemical Data Reveals Potent Inhibition and Slow Dissociation with Genotype 1-6 Proteases," P. Rajagopalan et al., Tuesday, November 6, 2007, 8:00 a.m. - 12:30 p.m. ET (Poster No. 1386).
PEGASYS, in combination with COPEGUS (ribavirin), are indicated for the treatment of adults with chronic hepatitis C who have compensated liver disease and have not previously been treated with interferon alpha. Efficacy has been demonstrated in patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A) and patients with HIV disease that are clinically stable (e.g., antiretroviral therapy not required or receiving stable antiretroviral therapy). In addition, PEGASYS in combination with COPEGUS is the first and only FDA-approved regimen for the treatment of chronic hepatitis C in patients coinfected with hepatitis C and HIV. PEGASYS is the only pegylated interferon indicated for the treatment of adult patients with chronic hepatitis B (HBeAg positive and HBeAg negative chronic hepatitis B who have compensated liver disease and evidence of viral replication and liver inflammation).
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.
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).
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. During treatment, patients' clinical status and hepatic function should be closely monitored, and PEGASYS treatment should be immediately discontinued if decompensation (Child-Pugh score .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%). Serious adverse events in hepatitis C trials included neuropsychiatric disorders (homicidal ideation, suicidal ideation, suicide attempt, suicide, psychotic disorder and hallucinations), 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). Adverse reactions reported during post-approval use of PEGASYS therapy, with and without ribavirin, include hearing impairment, hearing loss, serious skin reactions, including erythema multiforme major, and infections (bacterial, viral and fungal).
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 in the U.S., Roche 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 2007 Roche was named Top Company of the Year by Med Ad News and one of the Top 20 Employers (Science magazine). In 2006, Roche was ranked the No. 1 Company to Sell For (Selling Power), and one of AARP's Top Companies for Older Workers, and in 2005, Roche was named one of Fortune magazine's Best Companies to Work For in America. For additional information about the U.S. pharmaceuticals business, visit our website: www.roche.us.
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Posted: October 2007