FDA Approves Pegasys (Peginterferon alfa-2a) Pre-filled Syringes for the Treatment of Hepatitis C

[Guest guest]

FDA Approves Pegasys (Peginterferon alfa-2a) Pre-filled Syringes for the

Treatment of Hepatitis C

Posted on: 01/09/2004

NUTLEY, N.J. -- Roche announced today that the U.S. Food and Drug

Administration (FDA) has approved pre-filled syringes of Pegasys

(Peginterferon alfa-2a) for the treatment of chronic hepatitis C.

Pegasys, a pegylated alpha interferon, and Copegus (ribavirin, USP) were

approved by the FDA in December 2002 for use in combination 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 liver

disease and histological evidence of cirrhosis.

Pegasys is the most prescribed interferon therapy in the United States for

the treatment of chronic hepatitis C.* Roche expects Pegasys pre-filled

syringes to be available in pharmacies by the end of the month. Pre-filled

syringes will be packaged four per box. Pegasys is currently available in

vials as a pre-mixed solution.

" Taking a medication by self-injection can be challenging for some people, "

said Dr. Bernstein, director of hepatology at North Shore University

Hospital. " Reducing the number of steps involved can make the process less

intimidating for patients and reduce the risk of errors. "

The introduction of pre-filled syringes is yet another way in which Roche is

working to add value to the management of hepatitis C, including:

* developing approaches to reduce the duration of treatment with Pegasys

and Copegus and the dose of Copegus therapy for certain patients

* introducing Copegus with a list price or wholesale acquisition cost

that is 43 percent less per milligram than the other available brand of

ribavirin

* backing Pegasys with the most extensive development program ever

undertaken in hepatitis C

* formulating Pegasys as a pre-mixed solution requiring no reconstitution

prior to self-injection

Hepatitis C is a bloodborne infectious disease of the liver and the leading

cause of cirrhosis and liver cancer and the number one reason for liver

transplants in the U.S. An estimated 2.7 million Americans are chronically

infected with hepatitis C.

Pegasys is dosed at 180mcg as a subcutaneous injection taken once a week.

Copegus is available as a 200mg tablet, and is administered orally two times

a day as a split dose.

Hoffmann-La Roche Inc. (Roche), is the U.S. prescription drug unit of the

Roche Group, a leading research-based healthcare 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.

* IMS weekly data for the week ending Dec. 26, 2003.

[Guest guest]

FDA Approves Pegasys (Peginterferon alfa-2a) Pre-filled Syringes for the

Treatment of Hepatitis C

Posted on: 01/09/2004

NUTLEY, N.J. -- Roche announced today that the U.S. Food and Drug

Administration (FDA) has approved pre-filled syringes of Pegasys

(Peginterferon alfa-2a) for the treatment of chronic hepatitis C.

Pegasys, a pegylated alpha interferon, and Copegus (ribavirin, USP) were

approved by the FDA in December 2002 for use in combination 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 liver

disease and histological evidence of cirrhosis.

Pegasys is the most prescribed interferon therapy in the United States for

the treatment of chronic hepatitis C.* Roche expects Pegasys pre-filled

syringes to be available in pharmacies by the end of the month. Pre-filled

syringes will be packaged four per box. Pegasys is currently available in

vials as a pre-mixed solution.

" Taking a medication by self-injection can be challenging for some people, "

said Dr. Bernstein, director of hepatology at North Shore University

Hospital. " Reducing the number of steps involved can make the process less

intimidating for patients and reduce the risk of errors. "

The introduction of pre-filled syringes is yet another way in which Roche is

working to add value to the management of hepatitis C, including:

* developing approaches to reduce the duration of treatment with Pegasys

and Copegus and the dose of Copegus therapy for certain patients

* introducing Copegus with a list price or wholesale acquisition cost

that is 43 percent less per milligram than the other available brand of

ribavirin

* backing Pegasys with the most extensive development program ever

undertaken in hepatitis C

* formulating Pegasys as a pre-mixed solution requiring no reconstitution

prior to self-injection

Hepatitis C is a bloodborne infectious disease of the liver and the leading

cause of cirrhosis and liver cancer and the number one reason for liver

transplants in the U.S. An estimated 2.7 million Americans are chronically

infected with hepatitis C.

Pegasys is dosed at 180mcg as a subcutaneous injection taken once a week.

Copegus is available as a 200mg tablet, and is administered orally two times

a day as a split dose.

Hoffmann-La Roche Inc. (Roche), is the U.S. prescription drug unit of the

Roche Group, a leading research-based healthcare 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.

* IMS weekly data for the week ending Dec. 26, 2003.

[Guest guest]

FDA Approves Pegasys (Peginterferon alfa-2a) Pre-filled Syringes for the

Treatment of Hepatitis C

Posted on: 01/09/2004

NUTLEY, N.J. -- Roche announced today that the U.S. Food and Drug

Administration (FDA) has approved pre-filled syringes of Pegasys

(Peginterferon alfa-2a) for the treatment of chronic hepatitis C.

Pegasys, a pegylated alpha interferon, and Copegus (ribavirin, USP) were

approved by the FDA in December 2002 for use in combination 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 liver

disease and histological evidence of cirrhosis.

Pegasys is the most prescribed interferon therapy in the United States for

the treatment of chronic hepatitis C.* Roche expects Pegasys pre-filled

syringes to be available in pharmacies by the end of the month. Pre-filled

syringes will be packaged four per box. Pegasys is currently available in

vials as a pre-mixed solution.

" Taking a medication by self-injection can be challenging for some people, "

said Dr. Bernstein, director of hepatology at North Shore University

Hospital. " Reducing the number of steps involved can make the process less

intimidating for patients and reduce the risk of errors. "

The introduction of pre-filled syringes is yet another way in which Roche is

working to add value to the management of hepatitis C, including:

* developing approaches to reduce the duration of treatment with Pegasys

and Copegus and the dose of Copegus therapy for certain patients

* introducing Copegus with a list price or wholesale acquisition cost

that is 43 percent less per milligram than the other available brand of

ribavirin

* backing Pegasys with the most extensive development program ever

undertaken in hepatitis C

* formulating Pegasys as a pre-mixed solution requiring no reconstitution

prior to self-injection

Hepatitis C is a bloodborne infectious disease of the liver and the leading

cause of cirrhosis and liver cancer and the number one reason for liver

transplants in the U.S. An estimated 2.7 million Americans are chronically

infected with hepatitis C.

Pegasys is dosed at 180mcg as a subcutaneous injection taken once a week.

Copegus is available as a 200mg tablet, and is administered orally two times

a day as a split dose.

Hoffmann-La Roche Inc. (Roche), is the U.S. prescription drug unit of the

Roche Group, a leading research-based healthcare 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.

* IMS weekly data for the week ending Dec. 26, 2003.

[Guest guest]

FDA Approves Pegasys (Peginterferon alfa-2a) Pre-filled Syringes for the

Treatment of Hepatitis C

Posted on: 01/09/2004

NUTLEY, N.J. -- Roche announced today that the U.S. Food and Drug

Administration (FDA) has approved pre-filled syringes of Pegasys

(Peginterferon alfa-2a) for the treatment of chronic hepatitis C.

Pegasys, a pegylated alpha interferon, and Copegus (ribavirin, USP) were

approved by the FDA in December 2002 for use in combination 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 liver

disease and histological evidence of cirrhosis.

Pegasys is the most prescribed interferon therapy in the United States for

the treatment of chronic hepatitis C.* Roche expects Pegasys pre-filled

syringes to be available in pharmacies by the end of the month. Pre-filled

syringes will be packaged four per box. Pegasys is currently available in

vials as a pre-mixed solution.

" Taking a medication by self-injection can be challenging for some people, "

said Dr. Bernstein, director of hepatology at North Shore University

Hospital. " Reducing the number of steps involved can make the process less

intimidating for patients and reduce the risk of errors. "

The introduction of pre-filled syringes is yet another way in which Roche is

working to add value to the management of hepatitis C, including:

* developing approaches to reduce the duration of treatment with Pegasys

and Copegus and the dose of Copegus therapy for certain patients

* introducing Copegus with a list price or wholesale acquisition cost

that is 43 percent less per milligram than the other available brand of

ribavirin

* backing Pegasys with the most extensive development program ever

undertaken in hepatitis C

* formulating Pegasys as a pre-mixed solution requiring no reconstitution

prior to self-injection

Hepatitis C is a bloodborne infectious disease of the liver and the leading

cause of cirrhosis and liver cancer and the number one reason for liver

transplants in the U.S. An estimated 2.7 million Americans are chronically

infected with hepatitis C.

Pegasys is dosed at 180mcg as a subcutaneous injection taken once a week.

Copegus is available as a 200mg tablet, and is administered orally two times

a day as a split dose.

Hoffmann-La Roche Inc. (Roche), is the U.S. prescription drug unit of the

Roche Group, a leading research-based healthcare 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.

* IMS weekly data for the week ending Dec. 26, 2003.