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Subject:   ROCHE DRAMATICALLY REDUCES COST OF COMBINATION THERAPY
Name:   WIZofWAZ
Date Posted:   Jul 18, 03 - 2:51 PM
IP Address:   68.173.145.85
Message:   ROCHE DRAMATICALLY REDUCES COST OF COMBINATION THERAPY
FOR MILLIONS OF AMERICANS CHRONICALLY INFECTED
WITH HEPATITIS C


-- Copegusä, used in combination with PegasysÒ, rolls ribavirin cost
per milligram back 43 percent to 1998 price --


Roche today announced that Copegusä (ribavirin, USP), the medication used in combination with PegasysÒ (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.

About Roche

Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. prescription drug unit of the Roche Group, a leading research-based health care enterprise that ranks among the world’s leaders in pharmaceuticals and diagnostics.

Roche discovers, develops, manufactures and markets numerous important prescription drugs that enhance people's health, well-being and quality of life. Among the company’s areas of therapeutic interest are: dermatology; genitourinary disease; infectious diseases, including influenza; inflammation, including arthritis and osteoporosis; metabolic diseases, including obesity and diabetes; neurology; oncology; transplantation; vascular diseases; and virology, including HIV/AIDS and hepatitis C.

For more information on the Roche pharmaceuticals business in the United States, visit the company’s website at: http://www.rocheusa.com.

###

* In August 1998, branded ribavirin (Rebetol) was only available in combination with Intron A, packaged as Rebetron. To extrapolate the August 1998 price of branded ribavirin, the following calculation was performed on a comparable 1200mg pack: 1998 Rebetron price ($1,200 for 4 weeks of treatment with 1200mg daily ribavirin and Intron A 3 times per week) minus the 1998 Intron A price ($349.30 for 4 weeks of treatment with Intron A 3 times per week) = $850.70 for 4 weeks of treatment with 1200mg per day of branded ribavirin. Pricing is based on published wholesale acquisition costs by First Data Bank in August 1998. The current price of Rebetol was obtained from First Data Bank on January 6, 2003.



Facts About Pegasys in Combination with Copegus

Indication

Pegasys, a pegylated interferon, in combination with Copegus is indicated for the treatment of adults with chronic hepatitis C who have compensated liver disease and have not previously been treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated
   


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