Valeant Pharmaceuticals to Present Viramidine(TM) End-of-Treatment Data From Pha

[Guest guest]

Valeant Pharmaceuticals to Present Viramidine End-of-Treatment Data From

Phase 2 Clinical Trial

Source: PRNewswire

COSTA MESA, Calif.,-- Valeant Pharmaceuticals (NYSE:VRX) announced that an

abstract based on Viramidine 48-week end-of-treatment study data will be

posted to the American Association for the Study of the Liver Conference

(AASLD) Web site. Valeant submitted the abstract for presentation at AASLD

based on data from a Phase 2 clinical trial 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 will present the data at AASLD in Boston in October 2004.

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

chronic HCV. The on-going study is 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 (800 mg daily),

Viramidine 600 mg BID (1200 mg daily), Viramidine 800 mg BID (1600 mg daily)

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

24-week follow-up period is considered the medically therapeutic standard

evaluation of efficacy.

The end-of-treatment analysis was conducted to determine the incidence of

anemia (hemoglobin<10g/dL) and also assessed HCV RNA levels (Bayer TMA

assay; sensitivity to 5 IU/mL, 25 copies/mL).

At end of treatment, fewer patients developed anemia in the Viramidine arms

than in the ribavirin arm (4 percent versus 27 percent; p<0.001). Among

patients receiving the 400 mg BID dosage of Viramidine, there were no cases

of defined anemia and among patients receiving the 600 mg BID dosage there

was only one case of defined anemia (2 percent). In contrast, there was an

11 percent incidence of defined anemia in the 800 mg BID arm and a 27

percent incidence in the ribavirin arm. Other types of adverse events were

similar between treatment arms. (The most common adverse events associated

with combination therapy are fatigue, headache, insomnia, depression and

myalgia.) Differences noted in efficacy were not statistically significant

between the Viramidine arms versus ribavirin (Viramidine 400 mg BID - 55

percent, 600 mg BID - 63 percent, 800 mg BID - 56 percent, versus ribavirin

- 62 percent; p=NS), all in combination with pegylated interferon alfa-2a,

in the proportion of patients with undetectable HCV RNA levels.

Two Phase 3 clinical trials of Viramidine 600mg BID, known as VISER1 and

VISER2 (VIramidine's Safety and Efficacy vs. Ribavirin), are being conducted

with approximately 100 sites and approximately 1,000 patients in each study.

VISER1 compares Viramidine to ribavirin, in combination with

Schering-Plough's Peg-Intron®, and completed enrollment in July. VISER2

compares Viramidine to ribavirin, in combination with Roche's Pegasys®,

and is currently enrolling patients. Phase 3 is the last phase in a

multi-phase clinical evaluation that may lead to the filing of a New Drug

Application.

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 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.

For further information please contact: Jeff Misakian of Valeant

Pharmaceuticals, +1-714-545-0100 ext. 3309

Source: Valeant Pharmaceuticals

CONTACT: Jeff Misakian of Valeant Pharmaceuticals,

+1-714-545-0100 ext. 3309

[Guest guest]

Valeant Pharmaceuticals to Present Viramidine End-of-Treatment Data From

Phase 2 Clinical Trial

Source: PRNewswire

COSTA MESA, Calif.,-- Valeant Pharmaceuticals (NYSE:VRX) announced that an

abstract based on Viramidine 48-week end-of-treatment study data will be

posted to the American Association for the Study of the Liver Conference

(AASLD) Web site. Valeant submitted the abstract for presentation at AASLD

based on data from a Phase 2 clinical trial 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 will present the data at AASLD in Boston in October 2004.

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

chronic HCV. The on-going study is 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 (800 mg daily),

Viramidine 600 mg BID (1200 mg daily), Viramidine 800 mg BID (1600 mg daily)

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

24-week follow-up period is considered the medically therapeutic standard

evaluation of efficacy.

The end-of-treatment analysis was conducted to determine the incidence of

anemia (hemoglobin<10g/dL) and also assessed HCV RNA levels (Bayer TMA

assay; sensitivity to 5 IU/mL, 25 copies/mL).

At end of treatment, fewer patients developed anemia in the Viramidine arms

than in the ribavirin arm (4 percent versus 27 percent; p<0.001). Among

patients receiving the 400 mg BID dosage of Viramidine, there were no cases

of defined anemia and among patients receiving the 600 mg BID dosage there

was only one case of defined anemia (2 percent). In contrast, there was an

11 percent incidence of defined anemia in the 800 mg BID arm and a 27

percent incidence in the ribavirin arm. Other types of adverse events were

similar between treatment arms. (The most common adverse events associated

with combination therapy are fatigue, headache, insomnia, depression and

myalgia.) Differences noted in efficacy were not statistically significant

between the Viramidine arms versus ribavirin (Viramidine 400 mg BID - 55

percent, 600 mg BID - 63 percent, 800 mg BID - 56 percent, versus ribavirin

- 62 percent; p=NS), all in combination with pegylated interferon alfa-2a,

in the proportion of patients with undetectable HCV RNA levels.

Two Phase 3 clinical trials of Viramidine 600mg BID, known as VISER1 and

VISER2 (VIramidine's Safety and Efficacy vs. Ribavirin), are being conducted

with approximately 100 sites and approximately 1,000 patients in each study.

VISER1 compares Viramidine to ribavirin, in combination with

Schering-Plough's Peg-Intron®, and completed enrollment in July. VISER2

compares Viramidine to ribavirin, in combination with Roche's Pegasys®,

and is currently enrolling patients. Phase 3 is the last phase in a

multi-phase clinical evaluation that may lead to the filing of a New Drug

Application.

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 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.

For further information please contact: Jeff Misakian of Valeant

Pharmaceuticals, +1-714-545-0100 ext. 3309

Source: Valeant Pharmaceuticals

CONTACT: Jeff Misakian of Valeant Pharmaceuticals,

+1-714-545-0100 ext. 3309

[Guest guest]

Valeant Pharmaceuticals to Present Viramidine End-of-Treatment Data From

Phase 2 Clinical Trial

Source: PRNewswire

COSTA MESA, Calif.,-- Valeant Pharmaceuticals (NYSE:VRX) announced that an

abstract based on Viramidine 48-week end-of-treatment study data will be

posted to the American Association for the Study of the Liver Conference

(AASLD) Web site. Valeant submitted the abstract for presentation at AASLD

based on data from a Phase 2 clinical trial 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 will present the data at AASLD in Boston in October 2004.

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

chronic HCV. The on-going study is 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 (800 mg daily),

Viramidine 600 mg BID (1200 mg daily), Viramidine 800 mg BID (1600 mg daily)

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

24-week follow-up period is considered the medically therapeutic standard

evaluation of efficacy.

The end-of-treatment analysis was conducted to determine the incidence of

anemia (hemoglobin<10g/dL) and also assessed HCV RNA levels (Bayer TMA

assay; sensitivity to 5 IU/mL, 25 copies/mL).

At end of treatment, fewer patients developed anemia in the Viramidine arms

than in the ribavirin arm (4 percent versus 27 percent; p<0.001). Among

patients receiving the 400 mg BID dosage of Viramidine, there were no cases

of defined anemia and among patients receiving the 600 mg BID dosage there

was only one case of defined anemia (2 percent). In contrast, there was an

11 percent incidence of defined anemia in the 800 mg BID arm and a 27

percent incidence in the ribavirin arm. Other types of adverse events were

similar between treatment arms. (The most common adverse events associated

with combination therapy are fatigue, headache, insomnia, depression and

myalgia.) Differences noted in efficacy were not statistically significant

between the Viramidine arms versus ribavirin (Viramidine 400 mg BID - 55

percent, 600 mg BID - 63 percent, 800 mg BID - 56 percent, versus ribavirin

- 62 percent; p=NS), all in combination with pegylated interferon alfa-2a,

in the proportion of patients with undetectable HCV RNA levels.

Two Phase 3 clinical trials of Viramidine 600mg BID, known as VISER1 and

VISER2 (VIramidine's Safety and Efficacy vs. Ribavirin), are being conducted

with approximately 100 sites and approximately 1,000 patients in each study.

VISER1 compares Viramidine to ribavirin, in combination with

Schering-Plough's Peg-Intron®, and completed enrollment in July. VISER2

compares Viramidine to ribavirin, in combination with Roche's Pegasys®,

and is currently enrolling patients. Phase 3 is the last phase in a

multi-phase clinical evaluation that may lead to the filing of a New Drug

Application.

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 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.

For further information please contact: Jeff Misakian of Valeant

Pharmaceuticals, +1-714-545-0100 ext. 3309

Source: Valeant Pharmaceuticals

CONTACT: Jeff Misakian of Valeant Pharmaceuticals,

+1-714-545-0100 ext. 3309

[Guest guest]

Valeant Pharmaceuticals to Present Viramidine End-of-Treatment Data From

Phase 2 Clinical Trial

Source: PRNewswire

COSTA MESA, Calif.,-- Valeant Pharmaceuticals (NYSE:VRX) announced that an

abstract based on Viramidine 48-week end-of-treatment study data will be

posted to the American Association for the Study of the Liver Conference

(AASLD) Web site. Valeant submitted the abstract for presentation at AASLD

based on data from a Phase 2 clinical trial 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 will present the data at AASLD in Boston in October 2004.

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

chronic HCV. The on-going study is 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 (800 mg daily),

Viramidine 600 mg BID (1200 mg daily), Viramidine 800 mg BID (1600 mg daily)

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

24-week follow-up period is considered the medically therapeutic standard

evaluation of efficacy.

The end-of-treatment analysis was conducted to determine the incidence of

anemia (hemoglobin<10g/dL) and also assessed HCV RNA levels (Bayer TMA

assay; sensitivity to 5 IU/mL, 25 copies/mL).

At end of treatment, fewer patients developed anemia in the Viramidine arms

than in the ribavirin arm (4 percent versus 27 percent; p<0.001). Among

patients receiving the 400 mg BID dosage of Viramidine, there were no cases

of defined anemia and among patients receiving the 600 mg BID dosage there

was only one case of defined anemia (2 percent). In contrast, there was an

11 percent incidence of defined anemia in the 800 mg BID arm and a 27

percent incidence in the ribavirin arm. Other types of adverse events were

similar between treatment arms. (The most common adverse events associated

with combination therapy are fatigue, headache, insomnia, depression and

myalgia.) Differences noted in efficacy were not statistically significant

between the Viramidine arms versus ribavirin (Viramidine 400 mg BID - 55

percent, 600 mg BID - 63 percent, 800 mg BID - 56 percent, versus ribavirin

- 62 percent; p=NS), all in combination with pegylated interferon alfa-2a,

in the proportion of patients with undetectable HCV RNA levels.

Two Phase 3 clinical trials of Viramidine 600mg BID, known as VISER1 and

VISER2 (VIramidine's Safety and Efficacy vs. Ribavirin), are being conducted

with approximately 100 sites and approximately 1,000 patients in each study.

VISER1 compares Viramidine to ribavirin, in combination with

Schering-Plough's Peg-Intron®, and completed enrollment in July. VISER2

compares Viramidine to ribavirin, in combination with Roche's Pegasys®,

and is currently enrolling patients. Phase 3 is the last phase in a

multi-phase clinical evaluation that may lead to the filing of a New Drug

Application.

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 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.

For further information please contact: Jeff Misakian of Valeant

Pharmaceuticals, +1-714-545-0100 ext. 3309

Source: Valeant Pharmaceuticals

CONTACT: Jeff Misakian of Valeant Pharmaceuticals,

+1-714-545-0100 ext. 3309