Valeant reports encouraging results from Phase IIb hepatitis study

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Valeant reports encouraging results from Phase IIb hepatitis study

25th November 2008

By Staff Writer

Valeant Pharmaceuticals, a multinational specialty pharmaceutical company, has

reported promising 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 in 2008, the 48-week

viral response 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.

The Phase IIb trial is a US multi-center, randomized, parallel, open-label study

in 278 treatment-naive, genotype 1 patients evaluating taribavirin at 20 mg/kg,

25 mg/kg, and 30 mg/kg per day in combination with pegylated interferon alfa-2b.

The control group is being administered weight-based dose ribavirin

(800/1000/1200/1400mg daily) and pegylated interferon alfa-2b. Overall treatment

duration is 48 weeks with a post-treatment follow-up period of 24 weeks.

Pearson, chairman and CEO of Valeant, said: " We believe that taribavirin

will be a promising alternative to ribavirin in the treatment of chronic

hepatitis C and, with Valeant's strategic shift away from the infectious disease

market, we plan to out-license this compound in order to maximize its potential

for these patients. "

[Guest guest]

http://www.pharmaceutical-business-review.com/article_news.asp?guid=02C2D191-166\

C-4F5C-AA9E-CAEE307BE5B6

Valeant reports encouraging results from Phase IIb hepatitis study

25th November 2008

By Staff Writer

Valeant Pharmaceuticals, a multinational specialty pharmaceutical company, has

reported promising 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 in 2008, the 48-week

viral response 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.

The Phase IIb trial is a US multi-center, randomized, parallel, open-label study

in 278 treatment-naive, genotype 1 patients evaluating taribavirin at 20 mg/kg,

25 mg/kg, and 30 mg/kg per day in combination with pegylated interferon alfa-2b.

The control group is being administered weight-based dose ribavirin

(800/1000/1200/1400mg daily) and pegylated interferon alfa-2b. Overall treatment

duration is 48 weeks with a post-treatment follow-up period of 24 weeks.

Pearson, chairman and CEO of Valeant, said: " We believe that taribavirin

will be a promising alternative to ribavirin in the treatment of chronic

hepatitis C and, with Valeant's strategic shift away from the infectious disease

market, we plan to out-license this compound in order to maximize its potential

for these patients. "