Schering-Plough Announces Peg-Intron(R) And Rebetol(R) Surpasses 150,000 Patients Treated Mark In United States

Schering-Plough Corporation (NYSE:SGP) today announced that the U.S. launch of PEG-INTRON(R) (peginterferon alfa-2b) Powder for Injection and REBETOL(R) (ribavirin, USP) Capsules combination therapy represents the most successful new product introduction in the company's history, measured in terms of product sales. Since its introduction in October 2001, more than 150,000 hepatitis C patients in the United States have been treated with the combination therapy.

"As a result of the advances we have made in hepatitis C treatment in the last 10 years, we are providing a therapy that was effective in the majority (52 percent) of patients studied. We are extremely pleased with the rapid acceptance by physicians and patients of PEG-INTRON and REBETOL combination therapy," said Richard W. Zahn, president of Schering Laboratories. "We believe this combination therapy has transformed the treatment of hepatitis C, providing established therapeutic value to patients as well as economic value to the U.S. health care system. The proven safety and efficacy of PEG-INTRON, along with its convenient once-weekly dosing, has resulted in more U.S. patients starting treatment in the past year than during any previous period."

An estimated 4 million Americans are infected with the hepatitis C virus (HCV), which contributes to approximately 8,000 to 10,000 deaths each year, according to the Centers for Disease Control (CDC). This toll is expected to triple by the year 2010. 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.

"Along with our extensive clinical development program involving U.S. studies, the real-world treatment experience we've gained with PEG-INTRON and REBETOL in U.S. patients allows physicians to prescribe this combination therapy with confidence," said Robert J. Spiegel, M.D., senior vice president of medical affairs and chief medical officer, Schering-Plough Research Institute. "This deep knowledge base is especially significant given that U.S. patients often have disease characteristics that make them a more difficult group to treat successfully than patients in other countries."

American patients with hepatitis C have a higher incidence of genotype 1 virus, which is the most difficult to treat, and typically are older, more cirrhotic and generally have greater body weight, all factors known to negatively affect treatment outcome.

"We designed the clinical study program for PEG-INTRON and REBETOL combination therapy to be consistent with the demographics of the U.S. hepatitis C patient population," Spiegel said. "You can't change a patient's viral genotype, age or degree of cirrhosis, but one factor that a physician can address during treatment is patient body weight, by adjusting dosing accordingly. This gives physicians the flexibility to tailor the appropriate dose of PEG-INTRON to the patient to remove the impact of patient weight on sustained virologic response rates and help achieve consistent treatment outcomes."

PEG-INTRON is approved by FDA for dosing according to body weight, whether used as monotherapy or in combination therapy with REBETOL for up to 48 weeks. Data from a large, randomized, controlled clinical study, which served as the basis for U.S. approval of PEG-INTRON and REBETOL combination therapy (Manns et al., Lancet 2001), demonstrated that once weekly administration of weight-based PEG-INTRON (1.5 mcg/kg) in combination with daily REBETOL (800 mg) achieved consistent sustained viral response (SVR) rates across all patient weights. In this study, 68 percent were U.S. patients and, of these, 73 percent weighed more than 75 kg (165 lbs.). Among U.S. patients weighing more than 75 kg, those treated with weight-based PEG-INTRON and REBETOL achieved a 47 percent SVR versus 39 percent of patients who received standard INTRON(R) A (interferon alfa-2b, recombinant) Injection three times weekly in combination with daily REBETOL (1,000-1,200 mg). These results were consistent with the overall SVR rates seen in U.S. patients in this study (49 vs. 39 percent, respectively).

PEG-INTRON, the only weight-based alpha interferon product, is approved for use in the United States as monotherapy or in combination therapy with REBETOL 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.

Continuing Clinical Research

Schering-Plough is conducting a comprehensive investigational clinical study program with PEG-INTRON and REBETOL involving more than 10,000 U.S. patients that is designed to maximize treatment benefits and improve outcomes for a variety of patient populations with HCV. Ongoing studies include defining the optimal dose and duration of PEG-INTRON and REBETOL combination therapy in all HCV virus genotypes; evaluating the safety and efficacy of this combination therapy in African-American patients, patients on methadone and HIV/HCV co-infected patients; the effect of treatment on liver cirrhosis; and long-term maintenance therapy in patients who are non-responders to previous combination therapy.