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Valeant Pharmaceuticals Presents Details of 24-Week Data for Viramidine

Phase 2 Clinical Trials

- Data Shows a Sustained Reduction in Viral Titre for All Three Doses of

Viramidine, Comparable to Ribavirin -

COSTA MESA, Calif., April 19 /PRNewswire-FirstCall/ -- Valeant

Pharmaceuticals (NYSE: VRX) presented 24-week data from Phase 2 clinical

trials of Viramidine, a nucleoside (guanosine) analog Valeant is developing

in

oral form for the treatment of chronic hepatitis C (HCV) in conjunction with

a

pegylated interferon. Valeant presented its data at the European

Association

for the Study of the Liver (EASL) Conference in Berlin, Germany.

The Viramidine Phase 2 study consists of 180 treatment-naive subjects

with

chronic HCV. The on-going study was an open-label, randomized, active

control

trial, being conducted at multiple centers in the United States and with

patients stratified by genotype. The study consists of four demographically

comparable treatment groups: Viramidine 400 mg BID, Viramidine 600 mg BID,

Viramidine 800 mg BID and ribavirin 1000/1200 mg daily all in combination

with

peginterferon alfa-2a. Treatment duration was based on genotype, with

genotypes two and three receiving 24 weeks of treatment and genotype one

receiving 48 weeks of treatment, each with a post-treatment follow-up period

of 24 weeks.

The interim 24-week data shows that Viramidine demonstrates antiviral

activity comparable to that of ribavirin, when used in combination with

peginterferon alfa-2a in treatment naive patients, but with a lower

incidence

of anemia.

The data demonstrates a sustained reduction in HCV RNA of approximately

two-and-a-half log10 for all three doses of Viramidine, comparable to the

ribavirin group in the same study. The proportion of patients with greater

than or equal to 2 log(10) reduction or non-detectable HCV RNA was 83

percent

for both Viramidine (800-1600 mg/day) and ribavirin at 24 weeks. The

results

also show the percent of patients with non-detectable HCV RNA at 12 weeks

and

24 weeks were similar between all treatment groups.

There were also fewer patients in the Viramidine groups with anemia

(defined as hemoglobin < 10g/dL) when compared with the ribavirin arm

(2 percent versus 24 percent; p < 0.001). In the Viramidine 400 mg BID and

600 mg BID dosage groups, defined anemia (hemoglobin < 10g/dL) did not

occur,

while there were only two occurrences of anemia in the 800 mg BID group.

Other adverse events were similar among treatment groups.

Data was presented by Gish, M.D., the lead investigator on the

Viramidine Phase 2 study and Medical Director of the Liver Transplant

Program

at California Pacific Medical Center in San Francisco.

A Phase 3 clinical trial of Viramidine compared to ribavirin in

combination with pegylated interferon was initiated in the fourth quarter of

2003 and is ongoing. The Phase 3 trial compares the 600 mg BID dose of

Viramidine to ribavirin, each in conjunction with pegylated interferon alpha

2b.

About Valeant

Valeant Pharmaceuticals International (NYSE: VRX) is a global, publicly

traded, research-based specialty pharmaceutical company that discovers,

develops, manufactures and markets a broad range of pharmaceutical products.

More information about Valeant can be found at http://www.valeant.com.

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements within the

meaning

of the federal securities laws relating to expectations, plans or prospects

for Valeant Pharmaceuticals, including funding and conducting clinical

trials

and expected research and development expenses. These statements are based

upon the current expectations and beliefs of Valeant Pharmaceuticals'

management and are subject to certain risks and uncertainties that could

cause

actual results to differ materially from those described in the forward-

looking statements. These risks and uncertainties include market conditions

and other factors beyond Valeant Pharmaceuticals' control, the company's

success in identifying and enrolling patients in the clinical trials

program,

the absence of adverse events that would require the clinical trials to be

prematurely terminated, clinical results that indicate continuing clinical

and

commercial pursuit of Viramidine is advisable, and the risk factors and

other

cautionary statements discussed in Valeant Pharmaceuticals' filings with the

U.S. Securities and Exchange Commission.

SOURCE Valeant Pharmaceuticals International

Web Site: http://www.valeant.com

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Valeant Pharmaceuticals Presents Details of 24-Week Data for Viramidine

Phase 2 Clinical Trials

- Data Shows a Sustained Reduction in Viral Titre for All Three Doses of

Viramidine, Comparable to Ribavirin -

COSTA MESA, Calif., April 19 /PRNewswire-FirstCall/ -- Valeant

Pharmaceuticals (NYSE: VRX) presented 24-week data from Phase 2 clinical

trials of Viramidine, a nucleoside (guanosine) analog Valeant is developing

in

oral form for the treatment of chronic hepatitis C (HCV) in conjunction with

a

pegylated interferon. Valeant presented its data at the European

Association

for the Study of the Liver (EASL) Conference in Berlin, Germany.

The Viramidine Phase 2 study consists of 180 treatment-naive subjects

with

chronic HCV. The on-going study was an open-label, randomized, active

control

trial, being conducted at multiple centers in the United States and with

patients stratified by genotype. The study consists of four demographically

comparable treatment groups: Viramidine 400 mg BID, Viramidine 600 mg BID,

Viramidine 800 mg BID and ribavirin 1000/1200 mg daily all in combination

with

peginterferon alfa-2a. Treatment duration was based on genotype, with

genotypes two and three receiving 24 weeks of treatment and genotype one

receiving 48 weeks of treatment, each with a post-treatment follow-up period

of 24 weeks.

The interim 24-week data shows that Viramidine demonstrates antiviral

activity comparable to that of ribavirin, when used in combination with

peginterferon alfa-2a in treatment naive patients, but with a lower

incidence

of anemia.

The data demonstrates a sustained reduction in HCV RNA of approximately

two-and-a-half log10 for all three doses of Viramidine, comparable to the

ribavirin group in the same study. The proportion of patients with greater

than or equal to 2 log(10) reduction or non-detectable HCV RNA was 83

percent

for both Viramidine (800-1600 mg/day) and ribavirin at 24 weeks. The

results

also show the percent of patients with non-detectable HCV RNA at 12 weeks

and

24 weeks were similar between all treatment groups.

There were also fewer patients in the Viramidine groups with anemia

(defined as hemoglobin < 10g/dL) when compared with the ribavirin arm

(2 percent versus 24 percent; p < 0.001). In the Viramidine 400 mg BID and

600 mg BID dosage groups, defined anemia (hemoglobin < 10g/dL) did not

occur,

while there were only two occurrences of anemia in the 800 mg BID group.

Other adverse events were similar among treatment groups.

Data was presented by Gish, M.D., the lead investigator on the

Viramidine Phase 2 study and Medical Director of the Liver Transplant

Program

at California Pacific Medical Center in San Francisco.

A Phase 3 clinical trial of Viramidine compared to ribavirin in

combination with pegylated interferon was initiated in the fourth quarter of

2003 and is ongoing. The Phase 3 trial compares the 600 mg BID dose of

Viramidine to ribavirin, each in conjunction with pegylated interferon alpha

2b.

About Valeant

Valeant Pharmaceuticals International (NYSE: VRX) is a global, publicly

traded, research-based specialty pharmaceutical company that discovers,

develops, manufactures and markets a broad range of pharmaceutical products.

More information about Valeant can be found at http://www.valeant.com.

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements within the

meaning

of the federal securities laws relating to expectations, plans or prospects

for Valeant Pharmaceuticals, including funding and conducting clinical

trials

and expected research and development expenses. These statements are based

upon the current expectations and beliefs of Valeant Pharmaceuticals'

management and are subject to certain risks and uncertainties that could

cause

actual results to differ materially from those described in the forward-

looking statements. These risks and uncertainties include market conditions

and other factors beyond Valeant Pharmaceuticals' control, the company's

success in identifying and enrolling patients in the clinical trials

program,

the absence of adverse events that would require the clinical trials to be

prematurely terminated, clinical results that indicate continuing clinical

and

commercial pursuit of Viramidine is advisable, and the risk factors and

other

cautionary statements discussed in Valeant Pharmaceuticals' filings with the

U.S. Securities and Exchange Commission.

SOURCE Valeant Pharmaceuticals International

Web Site: http://www.valeant.com

Link to comment
Share on other sites

Guest guest

Valeant Pharmaceuticals Presents Details of 24-Week Data for Viramidine

Phase 2 Clinical Trials

- Data Shows a Sustained Reduction in Viral Titre for All Three Doses of

Viramidine, Comparable to Ribavirin -

COSTA MESA, Calif., April 19 /PRNewswire-FirstCall/ -- Valeant

Pharmaceuticals (NYSE: VRX) presented 24-week data from Phase 2 clinical

trials of Viramidine, a nucleoside (guanosine) analog Valeant is developing

in

oral form for the treatment of chronic hepatitis C (HCV) in conjunction with

a

pegylated interferon. Valeant presented its data at the European

Association

for the Study of the Liver (EASL) Conference in Berlin, Germany.

The Viramidine Phase 2 study consists of 180 treatment-naive subjects

with

chronic HCV. The on-going study was an open-label, randomized, active

control

trial, being conducted at multiple centers in the United States and with

patients stratified by genotype. The study consists of four demographically

comparable treatment groups: Viramidine 400 mg BID, Viramidine 600 mg BID,

Viramidine 800 mg BID and ribavirin 1000/1200 mg daily all in combination

with

peginterferon alfa-2a. Treatment duration was based on genotype, with

genotypes two and three receiving 24 weeks of treatment and genotype one

receiving 48 weeks of treatment, each with a post-treatment follow-up period

of 24 weeks.

The interim 24-week data shows that Viramidine demonstrates antiviral

activity comparable to that of ribavirin, when used in combination with

peginterferon alfa-2a in treatment naive patients, but with a lower

incidence

of anemia.

The data demonstrates a sustained reduction in HCV RNA of approximately

two-and-a-half log10 for all three doses of Viramidine, comparable to the

ribavirin group in the same study. The proportion of patients with greater

than or equal to 2 log(10) reduction or non-detectable HCV RNA was 83

percent

for both Viramidine (800-1600 mg/day) and ribavirin at 24 weeks. The

results

also show the percent of patients with non-detectable HCV RNA at 12 weeks

and

24 weeks were similar between all treatment groups.

There were also fewer patients in the Viramidine groups with anemia

(defined as hemoglobin < 10g/dL) when compared with the ribavirin arm

(2 percent versus 24 percent; p < 0.001). In the Viramidine 400 mg BID and

600 mg BID dosage groups, defined anemia (hemoglobin < 10g/dL) did not

occur,

while there were only two occurrences of anemia in the 800 mg BID group.

Other adverse events were similar among treatment groups.

Data was presented by Gish, M.D., the lead investigator on the

Viramidine Phase 2 study and Medical Director of the Liver Transplant

Program

at California Pacific Medical Center in San Francisco.

A Phase 3 clinical trial of Viramidine compared to ribavirin in

combination with pegylated interferon was initiated in the fourth quarter of

2003 and is ongoing. The Phase 3 trial compares the 600 mg BID dose of

Viramidine to ribavirin, each in conjunction with pegylated interferon alpha

2b.

About Valeant

Valeant Pharmaceuticals International (NYSE: VRX) is a global, publicly

traded, research-based specialty pharmaceutical company that discovers,

develops, manufactures and markets a broad range of pharmaceutical products.

More information about Valeant can be found at http://www.valeant.com.

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements within the

meaning

of the federal securities laws relating to expectations, plans or prospects

for Valeant Pharmaceuticals, including funding and conducting clinical

trials

and expected research and development expenses. These statements are based

upon the current expectations and beliefs of Valeant Pharmaceuticals'

management and are subject to certain risks and uncertainties that could

cause

actual results to differ materially from those described in the forward-

looking statements. These risks and uncertainties include market conditions

and other factors beyond Valeant Pharmaceuticals' control, the company's

success in identifying and enrolling patients in the clinical trials

program,

the absence of adverse events that would require the clinical trials to be

prematurely terminated, clinical results that indicate continuing clinical

and

commercial pursuit of Viramidine is advisable, and the risk factors and

other

cautionary statements discussed in Valeant Pharmaceuticals' filings with the

U.S. Securities and Exchange Commission.

SOURCE Valeant Pharmaceuticals International

Web Site: http://www.valeant.com

Link to comment
Share on other sites

Guest guest

Valeant Pharmaceuticals Presents Details of 24-Week Data for Viramidine

Phase 2 Clinical Trials

- Data Shows a Sustained Reduction in Viral Titre for All Three Doses of

Viramidine, Comparable to Ribavirin -

COSTA MESA, Calif., April 19 /PRNewswire-FirstCall/ -- Valeant

Pharmaceuticals (NYSE: VRX) presented 24-week data from Phase 2 clinical

trials of Viramidine, a nucleoside (guanosine) analog Valeant is developing

in

oral form for the treatment of chronic hepatitis C (HCV) in conjunction with

a

pegylated interferon. Valeant presented its data at the European

Association

for the Study of the Liver (EASL) Conference in Berlin, Germany.

The Viramidine Phase 2 study consists of 180 treatment-naive subjects

with

chronic HCV. The on-going study was an open-label, randomized, active

control

trial, being conducted at multiple centers in the United States and with

patients stratified by genotype. The study consists of four demographically

comparable treatment groups: Viramidine 400 mg BID, Viramidine 600 mg BID,

Viramidine 800 mg BID and ribavirin 1000/1200 mg daily all in combination

with

peginterferon alfa-2a. Treatment duration was based on genotype, with

genotypes two and three receiving 24 weeks of treatment and genotype one

receiving 48 weeks of treatment, each with a post-treatment follow-up period

of 24 weeks.

The interim 24-week data shows that Viramidine demonstrates antiviral

activity comparable to that of ribavirin, when used in combination with

peginterferon alfa-2a in treatment naive patients, but with a lower

incidence

of anemia.

The data demonstrates a sustained reduction in HCV RNA of approximately

two-and-a-half log10 for all three doses of Viramidine, comparable to the

ribavirin group in the same study. The proportion of patients with greater

than or equal to 2 log(10) reduction or non-detectable HCV RNA was 83

percent

for both Viramidine (800-1600 mg/day) and ribavirin at 24 weeks. The

results

also show the percent of patients with non-detectable HCV RNA at 12 weeks

and

24 weeks were similar between all treatment groups.

There were also fewer patients in the Viramidine groups with anemia

(defined as hemoglobin < 10g/dL) when compared with the ribavirin arm

(2 percent versus 24 percent; p < 0.001). In the Viramidine 400 mg BID and

600 mg BID dosage groups, defined anemia (hemoglobin < 10g/dL) did not

occur,

while there were only two occurrences of anemia in the 800 mg BID group.

Other adverse events were similar among treatment groups.

Data was presented by Gish, M.D., the lead investigator on the

Viramidine Phase 2 study and Medical Director of the Liver Transplant

Program

at California Pacific Medical Center in San Francisco.

A Phase 3 clinical trial of Viramidine compared to ribavirin in

combination with pegylated interferon was initiated in the fourth quarter of

2003 and is ongoing. The Phase 3 trial compares the 600 mg BID dose of

Viramidine to ribavirin, each in conjunction with pegylated interferon alpha

2b.

About Valeant

Valeant Pharmaceuticals International (NYSE: VRX) is a global, publicly

traded, research-based specialty pharmaceutical company that discovers,

develops, manufactures and markets a broad range of pharmaceutical products.

More information about Valeant can be found at http://www.valeant.com.

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements within the

meaning

of the federal securities laws relating to expectations, plans or prospects

for Valeant Pharmaceuticals, including funding and conducting clinical

trials

and expected research and development expenses. These statements are based

upon the current expectations and beliefs of Valeant Pharmaceuticals'

management and are subject to certain risks and uncertainties that could

cause

actual results to differ materially from those described in the forward-

looking statements. These risks and uncertainties include market conditions

and other factors beyond Valeant Pharmaceuticals' control, the company's

success in identifying and enrolling patients in the clinical trials

program,

the absence of adverse events that would require the clinical trials to be

prematurely terminated, clinical results that indicate continuing clinical

and

commercial pursuit of Viramidine is advisable, and the risk factors and

other

cautionary statements discussed in Valeant Pharmaceuticals' filings with the

U.S. Securities and Exchange Commission.

SOURCE Valeant Pharmaceuticals International

Web Site: http://www.valeant.com

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