Valeant Pharmaceuticals Reports Encouraging Final Results With Taribavirin Phase...

Valeant Pharmaceuticals Reports Encouraging Final Results With Taribavirin
Phase IIb Study

ALISO VIEJO, Calif., June 1 /PRNewswire-FirstCall/ -- Valeant Pharmaceuticals
International (NYSE: VRX) today reported final results for its Phase IIb
dose-finding clinical trial for taribavirin, a prodrug of ribavirin which is
in development for the treatment of chronic hepatitis C in conjunction with a
pegylated interferon. The study in treatment naive genotype 1 infected
subjects was of standard design, consisting of 48 weeks of treatment with a
24-week follow-up period. It explored three weight-based doses of
taribavirin: 20 mg/kg, 25 mg/kg and 30 mg/kg vs. ribavirin 800-1400 mg/day.
Throughout the 72-week trial, all doses of taribavirin demonstrated comparable
efficacy (sustained virologic response (SVR)) to ribavirin with consistently
lower levels of anemia. In addition, relapse rates in the 25 mg/kg and 30
mg/kg arms were comparable with the ribavirin arm; supporting the premise that
higher dose weight-based taribavirin may be as effective as weight based
ribavirin. Valeant plans to present the full final data at the American
Association for the Study of Liver Disease (AASLD) later this year.

"The final results of this Phase II study are promising and imply that
comparable efficacy with taribavirin 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. "As is known for ribavirin, low doses are associated with a high relapse
rate and, except for the lowest dose with taribavirin, relapse rates are also
comparable to ribavirin. The safety of this ribavirin analog is of particular
relevance in the evolving era of small molecule therapies as anemia appears to
be more problematic."

"We are very pleased with the results from this dose finding study which
confirms that taribavirin could replace ribavirin as a cornerstone in the
treatment of hepatitis C, but with the advantage of less anemia," said J.
Michael Pearson, chairman and chief executive officer. "These encouraging
results, coupled with Schering-Plough's option agreement for a license in
Japan, could offer new alternatives for patients suffering from this disease
and we will continue to pursue additional licensing and partnering
opportunities in order to maximize this compound's potential."

The most common adverse events during treatment were fatigue, nausea, flu-like
symptoms, headache and diarrhea. The incidence rates for these adverse events
among treatment arms were generally comparable except with respect to
diarrhea, where incidence of diarrhea was approximately twice as common in
patients receiving taribavirin compared to patients receiving ribavirin.
However, the diarrhea was generally mild and not treatment limiting for
taribavirin or ribavirin patients.

About Taribavirin
Taribavirin is an investigational compound that has not been found by the Food
and Drug Administration (FDA) or any other regulatory agency to be safe or
effective in the diagnosis, mitigation, treatment or cure of any disease or
illness. It may not be sold or promoted in the United States unless and until
approved for marketing by the FDA. Similar restrictions apply in other
countries.

About Study 204
The Phase IIb trial is a U.S. multi-center, randomized, parallel, open-label
study in 278 treatment-naive, genotype 1 patients evaluating taribavirin at
weight-based doses of 20 mg/kg, 25 mg/kg, and 30 mg/kg per day in combination
with pegylated interferon alfa-2b. The control group was 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.

In the Phase IIb study (previously disclosed as Study 204), 278 treatment
naive, genotype 1 patients were randomized with the following patient
demographics: mean age 48.8 yrs, 61.1% male, 30% African-American or Latino,
80.7% viral load >=400,000 IU/mL and 82.1 kg mean weight.

About Valeant
Valeant Pharmaceuticals International (NYSE: VRX) is a multinational specialty
pharmaceutical company that develops, manufactures and markets a broad range
of pharmaceutical products primarily in the areas of neurology and
dermatology. More information about Valeant can be found at www.valeant.com.

FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements, including, but not
limited to, statements regarding the potential for taribavirin in the
treatment of hepatitis C, the continuing role of ribavirin or taribavirin in
the treatment of hepatitis C and our ability to successfully pursue partnering
opportunities for taribavirin, that are based on management's current
expectations and involve risks and uncertainties, including, but not limited
to, risks and uncertainties relating to the clinical development of new
products, regulatory approval processes, that results from week 72 in the
phase IIb clinical trial are not necessarily predictive of results in a phase
III trial, our ability to successfully pursue partnering opportunities for
taribavirin, and other risks as set forth under the caption Risk Factors in
the company's most recent annual or quarterly report filed with the SEC, which
factors are incorporated herein by reference. The company cautions the reader
that these factors, as well as other factors described in its SEC filings, are
among the factors that could cause actual results to differ materially from
the expectations described in the forward-looking statements. The company also
cautions the reader that undue reliance should not be placed on any of the
forward-looking statements, which speak only as of the date of this press
release. The company undertakes no responsibility to update any of these
forward-looking statements to reflect events or circumstances after the date
of this press release or to reflect actual outcomes.

(Logo: http://www.newscom.com/cgi-bin/prnh/20081125/VALEANTLOGO)

Contact:
Laurie W. Little, Valeant Pharmaceuticals
949-461-6002
laurie.little@valeant.com

SOURCE Valeant Pharmaceuticals International

Laurie W. Little, Valeant Pharmaceuticals, +1-949-461-6002,
laurie.little@valeant.com