Schering-Plough Corporation announced that the PEG-Intron pre-filled pen (peginterferon alfa-2b) Single-dose Delivery System for the treatment of hepatitis C is being launched in Europe. The introduction of the PEG-Intron pre-filled pen marks a major advancement in helping patients manage their disease. Each pre-filled pen Single-dose Delivery System will contain PEG-Intron at one of five different dosing strengths for a single use - 50 mcg, 80 mcg, 100 mcg, 120 mcg or 150 mcg. Maximum injection volume is 0.5 ml delivered through a very fine 30-gauge needle specifically designed to reduce patient discomfort often associated with needles utilized for subcutaneous injection.
"Schering-Plough is dedicated to providing innovative treatment options to patients with hepatitis C," said Roch Doliveux, president of Schering-Plough International. "We are very pleased to offer patients in Europe the PEG-Intron pre-filled pen, which offers a convenient method for administering PEG-Intron. This may help patients adhere to their treatment regimens."
Combination therapy with PEG-Intron and Rebetol (ribavirin) Capsules for hepatitis C was approved in the European Union (EU) in March 2001. PEG-Intron had previously received centralized marketing authorization in the EU and is marketed as a monotherapy in cases of intolerance or contraindication to ribavirin for the treatment of adult patients with histologically proven chronic hepatitis C.
PEG-Intron is a longer-acting form of Intron A (interferon alfa-2b, recombinant) Injection that uses proprietary PEG technology developed by Enzon Inc of Piscataway, N.J. PEG-Intron, recombinant interferon alfa-2b linked to a 12,000 dalton polyethylene glycol (PEG) molecule, is a once-weekly therapy designed to optimize the 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 with broad-spectrum antiviral activity. Schering-Plough has exclusive rights to market oral ribavirin for hepatitis C in all major world markets through a licensing agreement with Ribapharm Inc of Costa Mesa, Calif.