TORONTO, Ontario and NEW YORK, NY ‐ November 1, 2010 /PRNewswire via COMTEX/ --
Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) and Kadmon Pharmaceuticals LLC have concluded two strategic agreements for the development and commercialization of taribavirin and the commercial marketing of ribavirin in the treatment of viral diseases, including hepatitis C virus (HCV). Under the terms of the first agreement, Valeant grants Kadmon an exclusive, worldwide license to taribavirin, excluding the territory of Japan, in exchange for an upfront payment of $5 million, other development milestones, and royalty payments in the range of 8‐12% of future net sales. Under a separate agreement, Valeant has paid Kadmon $7.5M for exclusive rights to all Kadmon dosage forms of ribavirin, including 200mg, 400mg, and 600mg tablets and capsules, in Poland, Hungary, Czech Republic, Slovakia, Romania and Bulgaria.
Valeant will source these products from Kadmon.
J. Michael Pearson, CEO of Valeant Pharmaceuticals, said: “We are pleased to find a strong partner for a compound that we believe has potential to help patients in need of improved treatment. While participating in product development in the overall hepatitis C market no longer fits within our corporate development strategy, ribavirin should be a significant product for our branded generics portfolio in Central Europe.”
Samuel D. Waksal, CEO of Kadmon Pharmaceuticals, said: “Kadmon is building upon its commercial platform in hepatitis C through expanded global distribution and the addition of complementary products. Our agreements with Valeant achieve milestones for both of these objectives. Taribavirin completes our ribavirin franchise and will ensure its future sustainability and growth. We have also expanded our global distribution network for ribavirin into markets in which Valeant is a leading provider.”
Taribavirin and ribavirin are both nucleoside antimetabolite drugs that interfere with duplication of viral genetic material. Ribavirin is currently indicated, either alone or in combination with other therapies, for hepatitis C infection and other viral infections. Ribasphere® and Ribapak®, proprietary formulations of ribavirin, are currently marketed by Kadmon’s Three Rivers Pharmaceuticals division for the treatment of hepatitis C in territories around the world.
Taribavirin is a prodrug of ribavirin currently in development for the treatment of chronic hepatitis C. Data from a Phase IIb weight‐based dosing study presented at the American Association for the Study of Liver Disease 2009 Annual Meeting demonstrated similar efficacy to ribavirin but with significantly less anemia, which is the main treatment‐limiting toxicity associated with ribavirin.
About Valeant Pharmaceuticals International, Inc.
Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of neurology, dermatology and branded generics. More information about Valeant Pharmaceuticals International, Inc. can be found at www.valeant.com.
Caution Regarding Forward-Looking Information and "Safe Harbor" Statement
To the extent any statements made in this document contain information that is not historical, these statements are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and may be forward-looking information as defined under applicable Canadian securities legislation (collectively, "forward-looking statements").
These forward-looking statements relate to, among other things, the strength of our partner, the impact of ribavirin on our branded
generic portfolio in Central Europe and the ability of a taribavirin product, if approved, to provide patients with improved treatment.
Forward-looking statements can generally be identified by the use of words such as "believe", "anticipate", "expect", "estimate",
"intend", "continue", "plan", "project", "will", "may", "should", "could", "would", "target", "potential" and other similar expressions. In
addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are
forward-looking statements. Actual results may differ materially from those expressed or implied in such statements. Important
factors that could cause actual results to differ materially from these expectations include, among other things, the strength of our
partner, the impact of ribavirin on our branded generic portfolio in Central Europe and the ability of a taribavirin product, if approved,
to provide patients with improved treatment, and the risk factors as detailed from time to time in Valeant's reports filed with the
Securities and Exchange Commission ("SEC") and the Canadian Securities Administrators ("CSA").
Additional information about these factors and about the material factors or assumptions underlying such forward-looking statements may be found in the body of this filing, as well as under Item 1.A. in each of Valeant’s and Biovail’s Annual Report on Form 10-K for the fiscal
year ended December 31, 2009, and Item 1.A in each of Valeant’s and Biovail’s most recent Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2010. Valeant cautions that the foregoing list of important factors that may affect future results is not exhaustive. When
relying on forward-looking statements to make decisions with respect to Valeant, investors and others should carefully consider the foregoing factors and other uncertainties and potential events. Valeant does not undertake any obligation to update or revise any forward-looking
statement, except as may be required by law.
Contact for Valeant
Laurie W. Little
Contact for Kadmon