Valeant Reports Encouraging End of Treatment Results with Taribavirin

[Guest guest]

Valeant Reports Encouraging End of Treatment Results with Taribavirin

PharmaLive News Archive - 23-Nov-2008

Similar to the treatment week 12 results reported earlier this year, the 48-week

viral response (EOT) data continue to show comparable reductions in viral load

for weight-based doses of taribavirin and ribavirin. The incidence rates among

treatment arms were generally comparable except with respect to diarrhea, where

diarrhea was approximately twice as common in taribavirin patients as ribavirin

patients.

Summary

• ALISO VIEJO, Calif.--(BUSINESS WIRE)--Nov 24, 2008 - Valeant Pharmaceuticals

(NYSE:VRX) today reported results at end of treatment, week 48 analysis point in

the Phase IIb clinical trial for its antiviral compound, taribavirin, a prodrug

of ribavirin in development for the treatment of chronic hepatitis C in

conjunction with a pegylated interferon.

• Similar to the treatment week 12 results reported earlier this year, the

48-week viral response (EOT) data continue to show comparable reductions in

viral load for weight-based doses of taribavirin and ribavirin.

• The anemia rate was statistically significantly lower for patients receiving

taribavirin in the 20mg/kg and 25mg/kg arms versus the ribavirin control arm.

• In the Phase IIb study, 278 treatment naïve, genotype 1 patients were

randomized with the following patient demographics: mean age 48.8 yr, 61.1%

male, 30% African-American or Latino, 80.7% viral load ‰¥400,000 IU/mL and 82.1

kg mean weight.

• Treatment week (TW) 48 efficacy and safety results for the intention-to-treat

(ITT) population are shown in the table below.

• “The results of this phase II study are encouraging, and suggest that

comparable efficacy on therapy can be achieved when compared to ribavirin,”

stated Fred Poordad, M.D., Chief of Hepatology at the Center for Liver Disease

and Transplantation, Cedars-Sinai Medical Center, Los Angeles, CA.

• “If the sustained response rates are also similar with less anemia, this will

be a significant step forward in the development of taribavirin.”

• “We are pleased that the 48-week data continues to demonstrate sustained

comparable efficacy between taribavirin and ribavirin given that the genotype 1

group is a difficult to treat population and a third of the patients in this

study were either African-American or Latino,” said J. Pearson, chairman

and chief executive officer.

[Guest guest]

Valeant Reports Encouraging End of Treatment Results with Taribavirin

PharmaLive News Archive - 23-Nov-2008

Similar to the treatment week 12 results reported earlier this year, the 48-week

viral response (EOT) data continue to show comparable reductions in viral load

for weight-based doses of taribavirin and ribavirin. The incidence rates among

treatment arms were generally comparable except with respect to diarrhea, where

diarrhea was approximately twice as common in taribavirin patients as ribavirin

patients.

Summary

• ALISO VIEJO, Calif.--(BUSINESS WIRE)--Nov 24, 2008 - Valeant Pharmaceuticals

(NYSE:VRX) today reported results at end of treatment, week 48 analysis point in

the Phase IIb clinical trial for its antiviral compound, taribavirin, a prodrug

of ribavirin in development for the treatment of chronic hepatitis C in

conjunction with a pegylated interferon.

• Similar to the treatment week 12 results reported earlier this year, the

48-week viral response (EOT) data continue to show comparable reductions in

viral load for weight-based doses of taribavirin and ribavirin.

• The anemia rate was statistically significantly lower for patients receiving

taribavirin in the 20mg/kg and 25mg/kg arms versus the ribavirin control arm.

• In the Phase IIb study, 278 treatment naïve, genotype 1 patients were

randomized with the following patient demographics: mean age 48.8 yr, 61.1%

male, 30% African-American or Latino, 80.7% viral load ‰¥400,000 IU/mL and 82.1

kg mean weight.

• Treatment week (TW) 48 efficacy and safety results for the intention-to-treat

(ITT) population are shown in the table below.

• “The results of this phase II study are encouraging, and suggest that

comparable efficacy on therapy can be achieved when compared to ribavirin,”

stated Fred Poordad, M.D., Chief of Hepatology at the Center for Liver Disease

and Transplantation, Cedars-Sinai Medical Center, Los Angeles, CA.

• “If the sustained response rates are also similar with less anemia, this will

be a significant step forward in the development of taribavirin.”

• “We are pleased that the 48-week data continues to demonstrate sustained

comparable efficacy between taribavirin and ribavirin given that the genotype 1

group is a difficult to treat population and a third of the patients in this

study were either African-American or Latino,” said J. Pearson, chairman

and chief executive officer.