First of Two Global Phase III Studies Initiated for Viramidine in Hepatitis C

[Guest guest]

First of Two Global Phase III Studies Initiated for Viramidine in Hepatitis

C

COSTA MESA, Calif., Jan 28, 2004 /PRNewswire-FirstCall via COMTEX/ --

Valeant Pharmaceuticals (NYSE: VRX) today provided an update on its clinical

program for the development of its antiviral compound, Viramidine, a

nucleoside (guanisine) analog, in oral form for the treatment of hepatitis

C. In addition, the company announced that it will increase its investment

in research and development to support an accelerated schedule for

progressing development of Viramidine.

W. O'Leary, Valeant Pharmaceuticals' Chairman and Chief Executive

Officer, commented, " Our clinical data have allowed us to begin Phase 3

clinical trials for Viramidine after 12 weeks of our 72-week Phase 2

program. Our evaluation has led us to decide to further increase our total

research and development expenditures in 2004 to between $85 million and $95

million to accelerate the clinical trials for Viramidine while continuing to

support other discovery and development programs. "

Valeant Pharmaceuticals has initiated the first of two global Phase 3

studies for Viramidine that will be conducted at approximately 80 sites with

approximately 1,000 patients in each study. Global patient enrollment in the

first study, known as VISER1 (VIramidine's Safety and Efficacy vs.

Ribavirin), has commenced, and the company expects to complete enrollment in

2004.

The second Viramidine Phase 3 study, known as VISER2, is now scheduled to

commence by mid-2004 with investigator meetings in the U.S., Europe and

Australia. Patient enrollment in the second study is expected to begin

shortly thereafter. Valeant also noted that the accelerated schedule for

Viramidine may or may not accelerate the timetable for submission for

approval.

The studies will compare Viramidine and ribavirin, each in conjunction with

a pegylated interferon. The company has selected PEG-INTRON, a pegylated

interferon marketed by Schering-Plough, for use in its first study, and has

now added Pegasys, marketed by F. Hoffmann-La Roche, for use in its second

study.

The Phase 3 studies are designed to treat patients for either 24 or 48

weeks, depending on viral genotypes, take patients off therapy for an

additional 24 weeks, and then determine the percentage of patients with

undetectable virus in their blood, as well as the incidence of anemia during

the course of the entire 72-week study period.

Valeant Pharmaceuticals is continuing its Phase 2 study of Viramidine and

has completed that study's 24-week treatment evaluation of safety and

efficacy. Valeant intends to present the 24-week data from the Phase 2 study

at the 39th Annual Meeting of the European Association for the Study of the

Liver (EASL) in Berlin, Germany in April 2004, and additional data at the

Digestive Disease Week (DDW) Conference in New Orleans in May 2004.

Source: Valeant Pharmaceuticals

[Guest guest]

First of Two Global Phase III Studies Initiated for Viramidine in Hepatitis

C

COSTA MESA, Calif., Jan 28, 2004 /PRNewswire-FirstCall via COMTEX/ --

Valeant Pharmaceuticals (NYSE: VRX) today provided an update on its clinical

program for the development of its antiviral compound, Viramidine, a

nucleoside (guanisine) analog, in oral form for the treatment of hepatitis

C. In addition, the company announced that it will increase its investment

in research and development to support an accelerated schedule for

progressing development of Viramidine.

W. O'Leary, Valeant Pharmaceuticals' Chairman and Chief Executive

Officer, commented, " Our clinical data have allowed us to begin Phase 3

clinical trials for Viramidine after 12 weeks of our 72-week Phase 2

program. Our evaluation has led us to decide to further increase our total

research and development expenditures in 2004 to between $85 million and $95

million to accelerate the clinical trials for Viramidine while continuing to

support other discovery and development programs. "

Valeant Pharmaceuticals has initiated the first of two global Phase 3

studies for Viramidine that will be conducted at approximately 80 sites with

approximately 1,000 patients in each study. Global patient enrollment in the

first study, known as VISER1 (VIramidine's Safety and Efficacy vs.

Ribavirin), has commenced, and the company expects to complete enrollment in

2004.

The second Viramidine Phase 3 study, known as VISER2, is now scheduled to

commence by mid-2004 with investigator meetings in the U.S., Europe and

Australia. Patient enrollment in the second study is expected to begin

shortly thereafter. Valeant also noted that the accelerated schedule for

Viramidine may or may not accelerate the timetable for submission for

approval.

The studies will compare Viramidine and ribavirin, each in conjunction with

a pegylated interferon. The company has selected PEG-INTRON, a pegylated

interferon marketed by Schering-Plough, for use in its first study, and has

now added Pegasys, marketed by F. Hoffmann-La Roche, for use in its second

study.

The Phase 3 studies are designed to treat patients for either 24 or 48

weeks, depending on viral genotypes, take patients off therapy for an

additional 24 weeks, and then determine the percentage of patients with

undetectable virus in their blood, as well as the incidence of anemia during

the course of the entire 72-week study period.

Valeant Pharmaceuticals is continuing its Phase 2 study of Viramidine and

has completed that study's 24-week treatment evaluation of safety and

efficacy. Valeant intends to present the 24-week data from the Phase 2 study

at the 39th Annual Meeting of the European Association for the Study of the

Liver (EASL) in Berlin, Germany in April 2004, and additional data at the

Digestive Disease Week (DDW) Conference in New Orleans in May 2004.

Source: Valeant Pharmaceuticals

[Guest guest]

First of Two Global Phase III Studies Initiated for Viramidine in Hepatitis

C

COSTA MESA, Calif., Jan 28, 2004 /PRNewswire-FirstCall via COMTEX/ --

Valeant Pharmaceuticals (NYSE: VRX) today provided an update on its clinical

program for the development of its antiviral compound, Viramidine, a

nucleoside (guanisine) analog, in oral form for the treatment of hepatitis

C. In addition, the company announced that it will increase its investment

in research and development to support an accelerated schedule for

progressing development of Viramidine.

W. O'Leary, Valeant Pharmaceuticals' Chairman and Chief Executive

Officer, commented, " Our clinical data have allowed us to begin Phase 3

clinical trials for Viramidine after 12 weeks of our 72-week Phase 2

program. Our evaluation has led us to decide to further increase our total

research and development expenditures in 2004 to between $85 million and $95

million to accelerate the clinical trials for Viramidine while continuing to

support other discovery and development programs. "

Valeant Pharmaceuticals has initiated the first of two global Phase 3

studies for Viramidine that will be conducted at approximately 80 sites with

approximately 1,000 patients in each study. Global patient enrollment in the

first study, known as VISER1 (VIramidine's Safety and Efficacy vs.

Ribavirin), has commenced, and the company expects to complete enrollment in

2004.

The second Viramidine Phase 3 study, known as VISER2, is now scheduled to

commence by mid-2004 with investigator meetings in the U.S., Europe and

Australia. Patient enrollment in the second study is expected to begin

shortly thereafter. Valeant also noted that the accelerated schedule for

Viramidine may or may not accelerate the timetable for submission for

approval.

The studies will compare Viramidine and ribavirin, each in conjunction with

a pegylated interferon. The company has selected PEG-INTRON, a pegylated

interferon marketed by Schering-Plough, for use in its first study, and has

now added Pegasys, marketed by F. Hoffmann-La Roche, for use in its second

study.

The Phase 3 studies are designed to treat patients for either 24 or 48

weeks, depending on viral genotypes, take patients off therapy for an

additional 24 weeks, and then determine the percentage of patients with

undetectable virus in their blood, as well as the incidence of anemia during

the course of the entire 72-week study period.

Valeant Pharmaceuticals is continuing its Phase 2 study of Viramidine and

has completed that study's 24-week treatment evaluation of safety and

efficacy. Valeant intends to present the 24-week data from the Phase 2 study

at the 39th Annual Meeting of the European Association for the Study of the

Liver (EASL) in Berlin, Germany in April 2004, and additional data at the

Digestive Disease Week (DDW) Conference in New Orleans in May 2004.

Source: Valeant Pharmaceuticals

[Guest guest]

First of Two Global Phase III Studies Initiated for Viramidine in Hepatitis

C

COSTA MESA, Calif., Jan 28, 2004 /PRNewswire-FirstCall via COMTEX/ --

Valeant Pharmaceuticals (NYSE: VRX) today provided an update on its clinical

program for the development of its antiviral compound, Viramidine, a

nucleoside (guanisine) analog, in oral form for the treatment of hepatitis

C. In addition, the company announced that it will increase its investment

in research and development to support an accelerated schedule for

progressing development of Viramidine.

W. O'Leary, Valeant Pharmaceuticals' Chairman and Chief Executive

Officer, commented, " Our clinical data have allowed us to begin Phase 3

clinical trials for Viramidine after 12 weeks of our 72-week Phase 2

program. Our evaluation has led us to decide to further increase our total

research and development expenditures in 2004 to between $85 million and $95

million to accelerate the clinical trials for Viramidine while continuing to

support other discovery and development programs. "

Valeant Pharmaceuticals has initiated the first of two global Phase 3

studies for Viramidine that will be conducted at approximately 80 sites with

approximately 1,000 patients in each study. Global patient enrollment in the

first study, known as VISER1 (VIramidine's Safety and Efficacy vs.

Ribavirin), has commenced, and the company expects to complete enrollment in

2004.

The second Viramidine Phase 3 study, known as VISER2, is now scheduled to

commence by mid-2004 with investigator meetings in the U.S., Europe and

Australia. Patient enrollment in the second study is expected to begin

shortly thereafter. Valeant also noted that the accelerated schedule for

Viramidine may or may not accelerate the timetable for submission for

approval.

The studies will compare Viramidine and ribavirin, each in conjunction with

a pegylated interferon. The company has selected PEG-INTRON, a pegylated

interferon marketed by Schering-Plough, for use in its first study, and has

now added Pegasys, marketed by F. Hoffmann-La Roche, for use in its second

study.

The Phase 3 studies are designed to treat patients for either 24 or 48

weeks, depending on viral genotypes, take patients off therapy for an

additional 24 weeks, and then determine the percentage of patients with

undetectable virus in their blood, as well as the incidence of anemia during

the course of the entire 72-week study period.

Valeant Pharmaceuticals is continuing its Phase 2 study of Viramidine and

has completed that study's 24-week treatment evaluation of safety and

efficacy. Valeant intends to present the 24-week data from the Phase 2 study

at the 39th Annual Meeting of the European Association for the Study of the

Liver (EASL) in Berlin, Germany in April 2004, and additional data at the

Digestive Disease Week (DDW) Conference in New Orleans in May 2004.

Source: Valeant Pharmaceuticals