SCHERING-PLOUGH ANNOUNCES FDA APPROVAL OF PEG-INTRON REDIPEN FOR THE TREATMENT OF CHRONIC HEPATITIS C
PRE-FILLED PEN DESIGNED TO ENHANCE CONFIDENCE IN DOSING, SIMPLIFY USE
Press release from Schering-Plough
KENILWORTH, N.J., Oct. 13, 2003 — Schering-Plough Corporation (NYSE: SGP) today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval to PEG-INTRON REDIPEN, a pre-filled pen for administering PEG-INTRON (peginterferon alfa-2b) Powder for Injection, the most-prescribed interferon treatment for patients with chronic hepatitis C.
PEG-INTRON REDIPEN is the first and only pen delivery system approved for administering pegylated interferon therapy. Pegylated interferon in combination with ribavirin is the standard of care in treating chronic hepatitis C. The REDIPEN is designed to be simpler to use than a traditional vial and syringe, thus enhancing patient confidence with dosing of their PEG-INTRON regimen.
“Individualized, weight-based dosing of PEG-INTRON used in combination with REBETOL Capsules has proven effective in patients with chronic hepatitis C,” said Fred Poordad, M.D., associate director of hepatology and liver transplantation, Cedars-Sinai Medical Center, Los Angeles. “The simplicity of the PEG-INTRON REDIPEN may enhance patients’ confidence in dosing and make treatment administration easier for some patients.”
The PEG-INTRON REDIPEN is a disposable, single-dose delivery system that allows patients to administer PEG-INTRON in three easy steps: Mix, Dial and Deliver. Mixing occurs by simply pushing down on the pen to combine the PEG-INTRON powder with sterile water, both of which are stored in the pen; Dialing allows the patient to accurately select their predetermined individualized dose; and Delivery allows the patient to inject their individualized dose of the medication. The REDIPEN will be available in four different strengths: 50, 80, 120 and 150 mcg, each indicated by a color-coded label and dosing button. An instructional videotape and brochure for use by patients and healthcare professionals will also be available.
“The REDIPEN is a high-tech pen delivery system for injecting peginterferon therapy and offers an easy-to-use alternative for people who may be put off by using a traditional vial and syringe,” said Alan P. Brownstein, president and chief executive officer of the American Liver Foundation. “Development of the PEG-INTRON REDIPEN is consistent with Schering-Plough’s continuing role as an industry leader in providing innovative products and patient services to people with chronic hepatitis C,” said Robert J. Spiegel, M.D., senior vice president of medical affairs and chief medical officer, Schering-Plough Research Institute. “We are very pleased to bring forward this latest advance in meeting the needs of the hepatitis C patient community,” he said.
The PEG-INTRON REDIPEN is expected to be available in the United States in early 2004. It is currently available in the European Union (EU) and several other international markets.
Commitment to Hepatitis C Patients
As the leading innovator of interferon-based treatments for hepatitis C, Schering-Plough on Sept. 23, 2003, announced plans to initiate the IDEAL trial, a major clinical study involving 2,880 patients that for the first time will directly compare the two approved forms of pegylated interferon therapy for chronic hepatitis C: PEG-INTRON versus PEGASYS (peginterferon alfa-2a/Hoffmann-La Roche, Inc.), both used in combination with ribavirin. Schering-Plough Research Institute, in collaboration with leading medical centers, will conduct the comparative study in response to requests by the hepatitis C medical and patient communities, and to clear up misperceptions in the marketplace about these two treatments.
In addition to its ongoing commitment to research and development, 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 more than 55,000 U.S. patients to date, with more than 25,000 patients enrolling in 2002 alone. 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.
Twenty-five percent of all U.S. patients currently treated with PEG-INTRON and REBETOL (ribavirin, USP) combination therapy are enrolled in the company’s Commitment to Care program, which provides medication and/or reimbursement assistance to eligible patients. The market value of assistance and treatment provided to hepatitis C patients through this program exceeded $100 million in 2002.
PEG-INTRON and REBETOL combination therapy is indicated for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon alpha and are at least 18 years of age.
PEG-INTRON is a long-acting, pegylated form of INTRON A (interferon alfa-2b, recombinant) Injection that is taken once weekly for 48 weeks in an individualized dosing regimen based on a patient’s body weight. PEG-INTRON (1.5 ug/kg/week) in combination with REBETOL (800 mg/day) is the market-leading hepatitis C therapy in the United States. More than 300,000 hepatitis C patients worldwide, including 175,000 U.S. patients, have received this combination therapy since its introduction in 2001.
PEG-INTRON, the only interferon product for hepatitis C approved for dosing according to body weight, uses proprietary PEG technology developed by Enzon, Inc. (NASDAQ: ENZN) of Bridgewater, N.J. PEG-INTRON, recombinant interferon alfa-2b linked to a 12,000 dalton polyethylene glycol (PEG) molecule, is a once-weekly therapy that is designed to achieve an effective balance between antiviral activity and elimination half-life. Schering-Plough holds an exclusive worldwide license to PEG-INTRON. REBETOL is an oral formulation of the antiviral agent ribavirin, a synthetic nucleoside analog.
- 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 led 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.)
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.
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, among other things, the future prospects of the company and its products, which the reader of this release should understand are subject to substantial risks and uncertainties. The company’s business prospects and the prospects of its products may be adversely affected by general market and economic factors, competitive product development, product availability, current and future branded, generic and OTC competition, market acceptance of new products, federal and state regulations and legislation, the regulatory review process in the United States and foreign countries for new products and indications, existing manufacturing issues and new manufacturing issues that may arise, timing of trade buying, patent positions, litigation and investigations, and instability or destruction in a geographic area important to the company due to reasons such as war or SARS. For further details and a discussion of these and other risks and uncertainties, see the company’s Securities and Exchange Commission filings, including the company’s 8-K filed Aug. 22, 2003.
Schering-Plough Research Institute is the pharmaceutical research and development arm of Schering-Plough Corporation, a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical products worldwide. # # #
For more information about Schering-Plough, visit the company’s website at www.schering-plough.com. For information about hepatitis and for full prescribing information regarding PEG-INTRON and REBETOL, visit www.hepatitisinnovations.com.
PEGASYS is a trademark of Hoffmann-La Roche Inc. See the PEGASYS product insert for information on this product.