Schering-Plough Announces FDA Approval of PEG-INTRON REDIPEN(TM) for the Treatment of Chronic Hepatitis C

Market Wire, 20050229

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 at Cedars-Sinai Medical Center. "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.