NUTLEY, N.J., Jan. 13 /PRNewswire/ -- Roche today announced that Copegus(TM) (ribavirin, USP), the medication used in combination with Pegasys® (peginterferon alfa-2a) for the treatment of chronic hepatitis C, is being introduced with a list price or wholesale acquisition cost that is 43 percent less per milligram than the other available brand of ribavirin. Copegus will be available in U.S. pharmacies beginning the week of January 13. The list price or wholesale acquisition cost for Copegus is $5.06 per 200mg tablet.
Pegasys and Copegus combination therapy was approved by the U.S. Food and Drug Administration (F.D.A.) on December 3, 2002, for adults who have compensated liver disease and have not previously been treated with interferon alpha. An estimated 2.7 million Americans are chronically infected with hepatitis C.
"Roche is very proud of the steps the company has taken to drastically reduce the cost of combination therapy for the millions of Americans chronically infected with hepatitis C," said George B. Abercrombie, Roche President and Chief Executive Officer. "With Pegasys and Copegus, physicians and patients can have confidence knowing that this therapy is backed by an unprecedented development program -- the most extensive ever conducted in hepatitis C."
A Visible Difference in Price
Roche has rolled back the list price or wholesale acquisition cost of Copegus to that of branded ribavirin in August 1998.* For patients prescribed 1200mg of ribavirin per day, there is a list price or wholesale acquisition cost savings with Copegus of approximately $7,600 for 48 weeks of therapy.
Backed By Most Extensive Development Program
Pegasys is backed by the most extensive development program ever undertaken in hepatitis C. As part of its clinical development program, Roche conducted five pivotal studies (three for the Pegasys monotherapy indication and two for the Pegasys and Copegus combination therapy indication). Included was a study to evaluate Pegasys monotherapy in patients with cirrhosis and a study to evaluate shorter durations of therapy and lower doses of Copegus for patients with certain genotypes (strains) of the hepatitis C virus. As a result of the combination therapy study, the following dosing regimens are recommended for Pegasys and Copegus combination therapy:
* Genotype 1 and 4: 48 week duration with 180mcg Pegasys weekly and
1000 - 1200mg of Copegus daily
* Genotype 2 and 3: 24 week duration with 180mcg Pegasys weekly and
800mg Copegus daily
Pegasys is available as a premixed solution and administered as a subcutaneous injection once a week. Copegus is available as a 200mg tablet, and is administered orally two times a day as a split dose.
Please see attached Facts About Pegasys in Combination with Copegus... |
