Schering-Plough Highlights PegIntron and Boceprevir DataPresentations at European Association for the Study of the Liver(EASL) Annual Meeting
KENILWORTH, N.J., April 17, 2008 /PRNewswire-FirstCall/ -- Schering-Plough Corporation , a leader in advancing the science and treatment of chronic hepatitis C virus (HCV) infection, announced today that final results of the IDEAL study as well as from several other clinical studies with PEGINTRON(TM) (peginterferon alfa-2b) and REBETOL(R) (ribavirin, USP) combination therapy will be presented at the European Association for the Study of the Liver (EASL) 43rd annual meeting in Milan, Italy, April 23-27. PEGINTRON combination therapy is a current standard of care in the treatment of chronic hepatitis C. A total of 36 data presentations, including nine oral presentations, highlighting Schering-Plough hepatitis medications will be presented at EASL 2008.
The IDEAL (Individualized Dosing Efficacy vs. flat dosing to Assess optimaL pegylated interferon therapy) study is the first large, randomized, clinical study comparing the leading therapies for chronic hepatitis C: PEGINTRON and REBETOL combination therapy vs. Pegasys (peginterferon alfa-2a) and Copegus (ribavirin, USP) combination therapy,(1) as well as a lower dose of PEGINTRON plus REBETOL in an investigational combination regimen. Pegasys and Copegus were dosed in accordance with their approved U.S. labeling in this study of more than 3,000 U.S. genotype 1 patients. Results showed that sustained virologic response (SVR), the primary endpoint of the study, was similar for all three treatment regimens. The study also showed in a secondary endpoint that fewer patients treated with both PEGINTRON regimens relapsed after the end of treatment compared to those receiving Pegasys and Copegus.
Final results will be presented for the EPIC3 study, in which more than 2,000 hepatitis C patients with moderate to severe fibrosis or cirrhosis who failed prior treatment with interferon alpha (pegylated or non-pegylated) and ribavirin combination therapy were retreated with PEGINTRON combination therapy. PEGINTRON combination therapy is the first and only pegylated interferon combination therapy approved in the European Union (EU) for retreating both hepatitis C relapsers and nonresponders.
Researchers also will present the final results of the COPILOT study, which evaluated the investigational use of low-dose PEGINTRON as maintenance therapy in chronic hepatitis C nonresponder patients with fibrosis or cirrhosis. The goal of maintenance therapy in this very hard-to-treat patient population is to prevent or delay the progression of liver disease, liver cancer or death.
Schering-Plough also is exploring novel therapeutic approaches to treating hepatitis C with boceprevir, its investigational oral HCV protease inhibitor currently in Phase II clinical development. Oral presentations of boceprevir data will include interim results from the HCV SPRINT-1 study in treatment-naive hepatitis C patients and final results of the HCV RESPOND-1 study in patients who were "null" responders to previous peginterferon and ribavirin combination therapy.
Key Data Presentations at EASL
PEGINTRON Oral Presentations
Final results of the IDEAL (Individualized Dosing Efficacy versus flat dosing to Assess optimaL pegylated interferon therapy) Phase IIIb study. Sulkowski, M. et al. Late-Breaker Parallel Session 16, Saturday, April 26, 4:45 p.m. Hall A.
Sustained viral response (SVR) is dependent on baseline characteristics in the retreatment of previous alfa interferon/ribavirin (I/R) nonresponders (NR): final results from the EPIC3 program. Poynard, T. et al. Late-Breaker Parallel Session 16, Saturday, April 26, 4:00 p.m. Hall A.
Colchicine versus peginterferon alfa 2b long term therapy: results of the 4 year COPILOT trial. Afdhal, N.H. et al. General Session 1, Thursday, April 24, 3:10 p.m., Hall A.
PEGINTRON Poster Presentations
Sustained virologic response after peginterferon alfa-2b and ribavirin treatment predicts long-term clearance of HCV at 5-year follow-up. Manns, M. et al.
Platelet count predicts sustained viral response (SVR) in the retreatment of previous interferon/ribavirin non-responders (NR): results from the EPIC3 program. Poynard, T. et. al.
Impact of viral load and cirrhosis on treatment outcome in HCV genotype 3-infected patients: results of the Canadian POWeR program. Marotta, P.J. et al.
The EASL Inaugural Poster Session and Welcome Reception will take place in the Poster Hall on Thursday, April 24, beginning at 7:00 p.m.
Boceprevir Oral Presentations
Boceprevir (B) combination therapy in null responders (NR): response dependent on interferon responsiveness. Schiff, E. et al. General Session 3, Saturday, April 26, 9:30 a.m., Hall A.
Interim results from HCV SPRINT-1: RVR/EVR from Phase II study of boceprevir plus PEGINTRON (peginterferon alfa-2b)/ribavirin in treatment-naive subjects with genotype-1 CHC. Kwo, P. et al. Late-Breaker Parallel Session 16, Saturday, April 26, 5:45 p.m. Hall A.
Clonal analysis of mutations selected in the HCV NS3 protease domain of genotype 1 non-responders treated with boceprevir (SCH503034). Susser, S. et al. Parallel Session 7, Friday April 25, 5:00 p.m., Hall 000.
Schering-Plough Media/Advocate Roundtable
Treating HCV Now and in the Future -- the Right Therapy for the Right Patient: What are the implications of the IDEAL study? Saturday, April 26, 6:30-8:00 p.m., Milan Convention Center, Room 4.
An expert panel of leading clinical investigators, key opinion leaders and advocates will lead a roundtable discussion following a review of the results of the IDEAL study and other recent clinical studies to address the implications for current therapy and future treatment regimens. Audience participation and Q&A are encouraged.
Schering-Plough Satellite Symposium at EASL
From Initial Therapy to a Second Chance: A Comprehensive Guide to HCV Treatment
Sunday, April 27, 8:30-10:00 a.m., Milan Convention Center, Hall B.
A world-renowned faculty will present and discuss emerging data that answer several of the most relevant questions in HCV treatment today and for the future: the most effective use of peginterferon in combination with ribavirin in initial therapy, the optimal approach to the retreatment of patients with chronic HCV for whom initial treatment was not effective, and the outlook for HCV treatment in the future. Following the scientific presentations, the faculty will engage in a panel discussion based on questions posed by the symposium attendees, providing an opportunity for dialogue around the most urgent issues facing HCV-treating clinicians today.
About Hepatitis C
Hepatitis C is a serious and potentially life-threatening disease. It is the most common blood-borne infection in America and Europe, and the most common form of liver disease, affecting nearly 5 million people in the United States, 5 million in Europe and some 200 million people worldwide. It is the leading cause of cirrhosis and liver cancer, and the number one reason for liver transplants in the United States and Europe.
In the United States, PEGINTRON is indicated for use alone or with ribavirin for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon alpha and who are at least 18 years of age.
Important Safety Information Regarding U.S. Labeling for PEGINTRON and REBETOL
Alpha interferons, including PEGINTRON and INTRON(R) A, 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. Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many, but not all cases, these disorders resolve after stopping PEGINTRON and/or INTRON A therapy.
Use with Ribavirin: Ribavirin may cause birth defects and/or death of the unborn child. 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 REBETOL therapy may result in a worsening of cardiac disease. Ribavirin is genotoxic and mutagenic and should be considered a potential carcinogen
PEGINTRON is contraindicated in patients with hypersensitivity to PEGINTRON or any other component of the product, autoimmune hepatitis, and hepatic decompensation (Child-Pugh score greater than 6 [class B and C]) in cirrhotic CHC patients before or during treatment. INTRON A (Interferon alfa-2b, recombinant) for Injection is contraindicated in patients with hypersensitivity to INTRON A or any component of the product, autoimmune hepatitis, and decompensated liver disease. PEGINTRON or INTRON A in combination with REBETOL therapy is additionally contraindicated in patients with hypersensitivity to ribavirin or any other component of the product, women who are pregnant, men whose female partners are pregnant, patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia), and patients with creatinine clearance less than 50 mL/min.
REBETOL therapy should not be started until a report of a negative pregnancy test has been obtained immediately prior to planned initiation of therapy. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients during therapy and 6 months post-treatment. Patients should use at least two effective forms of contraception and have monthly pregnancy tests during therapy and for 6 months after completion of therapy. A Ribavirin Pregnancy Registry has been established to monitor maternal-fetal outcomes of pregnancies in female patients and female partners of male patients exposed to ribavirin during treatment, and for 6 months following cessation of treatment. Physicians and patients are encouraged to report such cases by calling 1-800-593-2214.
Incidence of Adverse Events
There are no new adverse events specific to PEGINTRON as compared to INTRON A; however, the incidence of some (e.g., injection site reactions, fever, rigors, nausea) were higher. The most common adverse events associated with PEGINTRON were "flu-like" symptoms, occurring in approximately 50% of patients, which may decrease in severity as treatment continues. Application site disorders were common (47%), but all were mild (44%) or moderate (4%) and no patient discontinued, and included injection site inflammation and reaction (i.e., bruise, itchiness, irritation). Injection site pain was reported in 2% of patients receiving PEGINTRON. Alopecia (thinning of the hair) is also often associated with alpha interferons including PEGINTRON.
Psychiatric adverse events, which include insomnia, were common (57%) with PEGINTRON but similar to INTRON A (58%). Depression was most common at 29%. Suicidal behavior including ideation, suicidal attempts, and completed suicides occurred in 1% of patients during or shortly after completing treatment with PEGINTRON.
The following serious or clinically significant adverse events have been reported at a frequency less than 1% with PEGINTRON or interferon alpha: Severe decreases in neutrophil or platelet counts, hypothyroidism, hyperglycemia, hypotension, arrhythmia, ulcerative and hemorrhagic colitis, development or exacerbation of autoimmune disorders including thyroiditis, RA, systemic lupus erythematosus, psoriasis, pulmonary disorders (dyspnea, pulmonary infiltrates, pneumonitis and pneumonia, some resulting in patient deaths), urticaria, angioedema, bronchoconstriction, anaphylaxis, retinal hemorrhages, and cotton wool spots.
In the PEGINTRON/REBETOL combination trial, the incidence of serious adverse events was 17% in the PEGINTRON/REBETOL groups compared to 14% in the INTRON A/ REBETOL group. The incidence of severe adverse events in the PEGINTRON/REBETOL combination therapy trial was 23% in the INTRON A/REBETOL group and 31-34% in the PEGINTRON/REBETOL groups. Dose reductions due to adverse reactions occurred in 42% of patients receiving PEGINTRON (1.5 mcg/kg)/REBETOL and in 34% of those receiving INTRON A/REBETOL.
In a study with weight-based ribavirin, there was a higher rate of anemia among patients in the weight-based dosing group (29%) compared to the flat-dosing group (19%). The majority of these cases were mild and responded to dose reductions. Serious adverse events were similar between the two groups (12%), and discontinuations for adverse events (15% in weight-based dosing and 14% in flat dosing) were also similar. Dose modifications due to adverse events occurred more frequently in the weight-based dosing group (29%) compared to the flat-dosing (23%) group.
Additional Safety Information
Relapse of drug addiction/overdose has occurred in patients on PEGINTRON therapy. Aggressive behavior sometimes directed towards others has occurred in patients with and without a previous psychiatric disorder during PEGINTRON and/or INTRON A treatment and follow-up. If patients develop psychiatric problems, including clinical depression, it is recommended that patients be carefully monitored during treatment and in the 6-month follow-up period. If psychiatric symptoms persist or worsen, or suicidal ideation or aggressive behavior towards others is identified, it is recommended that treatment with PEGINTRON and/or INTRON A be discontinued, and the patient be carefully followed with psychiatric intervention, as appropriate. Cases of encephalopathy have been observed in some patients, usually elderly, treated with higher doses of PEGINTRON and/or INTRON A. Ischemic and hemorrhagic cerebrovascular events have been observed in patients treated with interferon alpha therapies, including PEGINTRON and INTRON A. Dental and periodontal disorders have been reported in patients receiving PEGINTRON or INTRON A in combination with REBETOL therapy.
Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription and consumer products as well as to animal health products. Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by its colleagues around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the potential market for PEGINTRON and REBETOL, and the clinical development and potential for boceprevir. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Part I, Item 1A. "Risk Factors" in Schering-Plough's 2007 10-K/A.
1 Pegasys and Copegus are registered trademarks of Hoffmann-La Roche Inc. Please see the Pegasys and Copegus product inserts for information on these products.
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Posted: April 2008