Valeant Grants Schering-Plough Exclusive Option in Japan for Taribavirin in Exchange...
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Valeant Grants Schering-Plough Exclusive Option in Japan for Taribavirin in
Exchange for Release of Last Right of Refusal
ALISO VIEJO, Calif., June 1 /PRNewswire-FirstCall/ -- Valeant Pharmaceuticals
International (NYSE: VRX) announced today that it has entered into an
exclusive option agreement with Schering-Plough (NYSE: SGP) for taribavirin in
Japan. In exchange for the exclusive option, Schering-Plough has agreed to
waive and release its last right of refusal on taribavirin under a 2000
agreement, providing more flexibility for Valeant to actively pursue
partnering arrangements for the rest of the world.
Under the terms of the option agreement, Valeant granted Schering-Plough the
option to enter into an exclusive license agreement for the development and
commercialization of taribavirin in Japan. Upon exercising the option and
entering into the exclusive license agreement, Schering-Plough would provide a
$2 million upfront payment to Valeant and pay mid-single digit royalties on
net sales of taribavirin in Japan.
Taribavirin, a prodrug of ribavirin, is in Phase II development for the
treatment of chronic hepatitis C in conjunction with a pegylated interferon.
"This agreement with Schering-Plough releases our company from the last right
of refusal and provides us more flexibility to pursue partnering opportunities
with other companies," said J. Michael Pearson, Valeant's chairman and chief
executive officer. "With the data we have seen so far from the Phase IIb
trial, we believe that taribavirin presents an attractive licensing
opportunity."
About Taribavirin
Taribavirin is an investigational compound that has not been approved by the
U.S. Food and Drug Administration (FDA) or any other regulatory agency for 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 the FDA has
approved a New Drug Application. Similar restrictions apply in other
countries.
Recent data from the Phase IIb study demonstrates that the 60-week viral
response data continues to show comparable reductions in viral load for
weight-based doses of taribavirin and ribavirin in a difficult-to-treat
population of patients chronically infected with hepatitis C genotype 1. At
the end of week 60, a statistically significantly lower anemia rate for
patients receiving taribavirin in the 20mg/kg and 25mg/kg arms versus the
ribavirin control arm was maintained at a rate similar to that seen at the end
of treatment (week 48).
About Valeant
Valeant Pharmaceuticals International (NYSE:VRX) is a multinational specialty
pharmaceutical company that develops, manufactures and markets a broad range
of 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 may contain forward-looking statements, including, but not
limited to, statements regarding the potential efficacy and safety of
taribavirin in the treatment of hepatitis C, and the continuing role of
ribavirin or taribavirin in the treatment of hepatitis C. These statements
are based upon the current expectations and beliefs of 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, but are not limited to, risks and
uncertainties related to relating to the clinical development of new products,
regulatory approval processes, that interim results from a Phase IIb clinical
trial are not necessarily predictive of the entire Phase IIb trial or a Phase
III trial, and other risks and uncertainties discussed in the company's most
recent annual or quarterly report filed with the SEC, which factors are
incorporated herein by reference. These risks are among the factors that
could cause actual results to differ materially from the expectations
described in the forward-looking statements and undue reliance should not be
placed on any of these forward-looking statements. Valeant undertakes no
obligation 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.
Contact:
Laurie W. Little
Valeant Pharmaceuticals
949-461-6002
laurie.little@valeant.com
(Logo: http://www.newscom.com/cgi-bin/prnh/20081125/VALEANTLOGO)
SOURCE Valeant Pharmaceuticals International
Laurie W. Little of Valeant Pharmaceuticals, +1-949-461-6002,
laurie.little@valeant.com
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