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Schering-Plough Announces Availability of REBETOL(R) Oral Solution For Use in Treating Pediatric Hepatitis C
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First Approved Therapy for Children With Chronic Hepatitis C Fills Unmet Medical Need
KENILWORTH, N.J., Jan. 20 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP), the leading innovator of interferon-based therapies for chronic hepatitis C, today announced the launch of REBETOL(R) (ribavirin, USP) Oral Solution for use in combination with INTRON(R) A (interferon alfa- 2b, recombinant) Injection for treating pediatric chronic hepatitis C. Previously, there was no therapy approved for children with hepatitis C. An estimated four million people in the United States are infected with the hepatitis C virus, and approximately 160,000 of these are children.
"Now for the first time, children with hepatitis C have a treatment option that has been proven effective and, importantly, the doses may be tailored to a child's individual body weight and size," said Maureen Jonas, M.D., associate professor of pediatrics at Harvard Medical School and associate in gastroenterology at Children's Hospital Boston. "Combination therapy is now available for children as young as three years of age, with the REBETOL dosing made easier by the availability of the oral solution. This is an important step forward in treating pediatric hepatitis C, a disease that can cause a myriad of medical complications and eventually lead to serious liver damage."
In a clinical study of previously untreated pediatric patients, INTRON A and REBETOL combination therapy achieved a sustained virologic response (SVR) in 46 percent of patients overall, with an SVR rate of 36 percent in genotype 1 patients and 81 percent in genotype 2 or 3 patients.
In the pediatric population, the combination of INTRON A and REBETOL is indicated for the treatment of chronic hepatitis C in patients three years of age and older with compensated liver disease previously untreated with alpha interferon. For these patients, individualized combination therapy is recommended, with REBETOL dosed according to patient body weight (15 mg/kg daily in divided a.m. and p.m. doses) and INTRON A dosed according to patient size measured in body surface area (3 MIU/m2 three times weekly). The recommended duration of therapy is 24 weeks for pediatric patients with genotype 2 or 3 virus. The recommended duration of therapy for pediatric patients with genotype 1 virus is 48 weeks. Treatment discontinuation should be considered for any patient who has not achieved a virologic response after 24 weeks of treatment.
The New Drug Application (NDA) for REBETOL for pediatric use was reviewed by the U.S. Food and Drug Administration (FDA) on a priority basis. Priority review status is granted to drugs that, if approved, would address unmet medical needs and represent significant advances over existing treatments. Schering-Plough also noted that FDA has granted orphan-drug designation to REBETOL for the treatment of chronic hepatitis C in pediatric patients.
REBETOL Oral Solution represents a new formulation of ribavirin, USP, and was developed specifically to meet the needs of pediatric patients. It has a pleasant bubble gum flavor. REBETOL Capsules also are now approved for use in combination therapy with INTRON A for the treatment of chronic hepatitis C in pediatric patients. REBETOL Capsules were previously approved for use in combination therapy with INTRON A for the treatment of chronic hepatitis C in patients 18 years of age and older with compensated liver disease previously untreated with alpha interferon or who have relapsed following alpha interferon therapy. REBETOL Capsules also are indicated in combination with PEG-INTRON(R) (peginterferon alfa-2b) Powder for Injection for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon and are at least 18 years of age.
Since the introduction of PEG-INTRON and REBETOL combination therapy in 2001, more than 300,000 hepatitis C patients worldwide have received this treatment, including more than 200,000 U.S. patients.
Approximately 70 percent of patients infected with the hepatitis C virus (HCV) go on to develop chronic liver disease, according to the Centers for Disease Control and Prevention (CDC). Hepatitis C infection contributes to the deaths of an estimated 8,000 to 10,000 Americans each year and this toll is expected to triple by the year 2010, according to the CDC. The CDC has reported that HCV-associated end-stage liver disease is the most frequent indication for liver transplantation among adults. It is predicted that direct U.S. medical costs to treat HCV-related disease will exceed $13 billion for the years 2010 through 2019, according to a study published in the American Journal of Public Health.
Commitment to Hepatitis C Patients
Schering-Plough is committed to supporting hepatitis C patients with education and service programs as well as to help locate financial assistance for patients in need. The company's programs for patients in the United States are among the most comprehensive in the industry, providing support and guidance to patients, and ensuring that all eligible patients have access to the company's hepatitis C products.
Schering-Plough's Be In Charge hepatitis C patient-support program has enrolled approximately 95,000 U.S. patients since its inception in 1997. This U.S. program is designed to support patients treated with Schering-Plough hepatitis C products through the use of educational materials and telephone contact with personal nurse counselors skilled in the management of hepatitis C.
The company's Commitment to Care program is designed to ensure that eligible U.S. patients have access to Schering-Plough's hepatitis products, either by assisting patients in obtaining the reimbursement or assistance for which they qualify, or by providing products free of charge to eligible patients. The market value of treatment provided to hepatitis C patients through this program exceeded $170 million in 2003.
REBETOL is an oral formulation of ribavirin, a synthetic nucleoside analog. Schering-Plough has worldwide rights to market oral ribavirin for hepatitis C through a licensing agreement with Valeant Pharmaceuticals International (NYSE: VRX), formally ICN Pharmaceuticals, of Costa Mesa, Calif.
PEG-INTRON is a longer-acting form of INTRON A that uses proprietary PEG technology developed by Enzon, Inc. (Nasdaq: ENZN) of Bridgewater, N.J. Schering-Plough holds an exclusive worldwide license to PEG-INTRON.
INTRON A is a recombinant version of naturally occurring alpha interferon, which has been shown to exert both antiviral and immunomodulatory effects. Schering-Plough markets INTRON A for 16 major antiviral and anticancer indications worldwide.
WARNING
- REBETOL monotherapy is not effective for the treatment of chronic hepatitis C virus infection and should not be used alone for this indication. (See WARNINGS.)
- The primary toxicity of ribavirin is hemolytic anemia. The anemia associated with REBETOL therapy may result in worsening of cardiac disease that has lead to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease should not be treated with REBETOL. (See WARNINGS, ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION.)
- Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin. In addition, ribavirin has a multiple-dose half-life of 12 days, and so it may persist in nonplasma compartments for as long as 6 months. Therefore, REBETOL therapy is contraindicated in women who are pregnant and in the male partners of women who are pregnant. Extreme care must be taken to avoid pregnancy during therapy and for 6 months after completion of treatment in both female patients and in female partners of male patients who are taking REBETOL therapy. At least two reliable forms of effective contraception must be utilized during treatment and during the 6-month post-treatment follow-up period. (See CONTRAINDICATIONS, WARNINGS, PRECAUTIONS-Information for Patients and Pregnancy Category X.)
- Alpha interferons, including PEG-INTRON and INTRON 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 therapy with PEG-INTRON or INTRON A. (See WARNINGS, ADVERSE REACTIONS.)
PEG-INTRON
There are no new adverse events specific to PEG-INTRON 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 PEG-INTRON 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 PEG-INTRON. Alopecia (thinning of the hair) is also often associated with alpha interferons including PEG-INTRON.
Psychiatric adverse events, which include insomnia, were common (57%) with PEG-INTRON, 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 PEG-INTRON. PEG-INTRON is contraindicated in patients with autoimmune hepatitis and decompensated liver disease.
The following serious or clinically significant adverse events have been reported at a frequency <1% with PEG-INTRON 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.
Renal failure patients should be closely monitored for signs and symptoms of interferon toxicity and PEG-INTRON should be used with caution in patients with creatinine clearance <50 mL/min. Patients on PEG-INTRON therapy should have hematology and blood chemistry testing before the start of treatment and then periodically thereafter.
INTRON A
All patients receiving INTRON A therapy experienced mild-to-moderate side effects. Some patients experienced more severe side effects, including neutropenia, fatigue, myalgia, headache, fever, chills and increased SGOT. Other frequently occurring side effects were nausea, vomiting, depression, alopecia, diarrhea and thrombocytopenia. DEPRESSION AND SUICIDAL BEHAVIOR, INCLUDING SUICIDAL IDEATION, SUICIDAL ATTEMPTS, AND COMPLETED SUICIDES, HAVE BEEN REPORTED IN ASSOCIATION WITH TREATMENT WITH ALFA INTERFERONS, INCLUDING INTRON A THERAPY.
DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking" statements concerning REBETOL Oral Solution and Capsules in the United States, the market for drugs to treat hepatitis C and Schering- Plough's products. Forward-looking statements are subject to risks and uncertainties, which may cause actual results to differ materially. These risks and uncertainties include product availability, current and future branded, generic and OTC competition, market acceptance of new products, timing of trade buying, and patent positions. For further details and a discussion of these and other risks and uncertainties, see the company's Securities and Exchange Commission filings, including the third quarter 2003 Form 10-Q.
Schering-Plough is a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical products worldwide.
SOURCE Schering-Plough Corporation
01/20/2004
CONTACT: Media, Robert J. Consalvo, +1-908-298-7409, or Investors, Lisa W. DeBerardine, +1-908-298-7437, or Janet M. Barth, +1-908-298-7417, all of Schering-Plough
Web site: http://www.schering-plough.com
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