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SCHERING-PLOUGH ANNOUNCES AVAILABILITY OF PEG-INTRON REDIPEN
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FIRST PRECISION DOSING PEN FOR ADMINISTERING PEGINTERFERON THERAPY FOR CHRONIC HEPATITIS C.
ROCHE IS EXPECTED TO ALSO ANNOUNCE THE AVAILABILITY OF A SIMILAR DEVICE SOON TO BE USED WITH PEGASYS.
Press Release from Schering Plough
KENILWORTH, N.J., Feb. 17, 2004 — Schering-Plough Corporation today announced the U.S. launch of PEG-INTRON REDIPEN, which provides the proven efficacy of PEG-INTRON (peginterferon alfa-2b) Powder for Injection in an easy-to-use pen. The PEG-INTRON REDIPEN is the first and only pen delivery system approved for administering pegylated interferon therapy for chronic hepatitis C, a potentially lethal virus that has overtaken HIV as the most common blood-borne infectious disease in the United States. An estimated 2.7 million Americans are chronically infected with hepatitis C. (edit note: as I say above Roche is expected soon to be making a similar device available for Pegasys, the Roche pegylated interferon).
PEG-INTRON REDIPEN is designed to be patient-friendly with features such as an easy-to-read dial-up dosing button for precise, individualized weight-based dosing of PEG-INTRON, a self-priming action that automatically removes air bubbles from the pen prior to patient self-administration and a small needle size (30-gauge) to minimize patient discomfort.
"For successful treatment of patients with hepatitis C, it is important that they take their medicine consistently and get the appropriate dose for their individualized therapy," said Bruce R. Bacon, M.D., professor of internal medicine, director, division of gastroenterology and hepatology, Saint Louis University School of Medicine. "With the small needle, self-priming feature and large, easy-to-read dosing knob, PEG-INTRON REDIPEN is designed to help patients feel confident that they are getting an accurate dose and offers an easy-to-use alternative for people who may be intimidated by a traditional needle and syringe system."
PEG-INTRON used in combination with REBETOL (ribavirin, USP) has proven effective in treating patients with chronic HCV infection, including American patients infected with genotype 1 virus, the most common and difficult to treat form of the disease.
The PEG-INTRON REDIPEN is a disposable, one-time use precision dosing 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 body of the pen; Dialing allows patients to accurately select their predetermined individualized dose; and Delivery allows patients to inject their individualized dose of the medication. The PEG-INTRON REDIPEN is 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 are available for use by patients and healthcare professionals.
"Schering-Plough is committed to 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 pleased to introduce PEG-INTRON REDIPEN to further help meet the needs of the hepatitis C patient community," he said. 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.
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 (Individualized Dosing Efficacy vs. flat dosing to Assess optimaL pegylated interferon therapy), 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 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 $150 million in 2003.
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 longer-acting form of INTRON A (interferon alfa-2b, recombinant) Injection that 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.
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.
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.
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 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.)
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 PEG-INTRON REDIPEN 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.
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