Kadmon and Valeant ink global deal on ribavirn and taribavirin....

Valeant Pharmaceuticals and Kadmon Pharmaceuticals inked two separate agreements, worth a combined $12.5 million up front, covering the development and/or marketing of the hepatitis C drug ribavirin and the clinical-stage ribavirin prodrug candidate taribavirin. The deals come within a few days of Kadmon buying out Three Rivers Pharmaceuticals, which already markets the hepatitis C drugs Infergen™ (consensus interferon), Ribasphere® (ribavirin, USP), and RibaPak® (ribavirin).

The first new deal gives Kadmon an exclusive, worldwide license (excluding Japan) to taribavirin, which has successfully completed a Phase IIb trial for the treatment of chronic hepatitis C. Under terms of this agreement Kadmon will pay Valeant $5 million up front in addition to development milestones and future sales royalties.

The second agreement gives Valeant exclusive rights to all Kadmon dosage forms of ribavirin, including its 200 mg, 400 mg, and 600 mg capsules and tablets, in Poland, Hungary, the Czech Republic, Slovakia, Romania, and Bulgaria. Valeant paid Kadmon $7.5 million for the ribavirin portfolio and will source the products from Kadmon.

At first glance the combination of these two deals may seem counterintuitive. Valeant is passing further development of its ribavirin prodrug candidate virtually worldwide to Kadmon but is instead taking on rights to a marketed ribavirin portfolio in central Europe. However, as Valeant’s CEO, J. Michael Pearson, points out, while further development of taribavirin in house was halted in 2009 until a partner could be found, the firm wants to keep its hand in the branded generics market for hepatitis C drugs in some territories. “While participating in product development in the overall hepatitis C market no longer fits within our corporate development strategy, ribavirin could be a significant product for our branded generics portfolio in Central Europe.”

Kadmon, meanwhile, is making a more obvious push into the hepatitis C market globally, both through its deal with Valeant and with its recent acquisition of Three Rivers. “Kadmon is building upon its commercial platform in hepatitis C through expanded global distribution and the addition of complementary products,” notes Samuel D. Kalsal, CEO. “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.”

Expanded label for Infergen - too little too late?

New Labeling Provides Alternative for Hepatitis C Patients Who Need Retreatment

WARRENDALE, Pa.--(BUSINESS WIRE)--Three Rivers Pharmaceuticals, LLC, today received expanded labeling from the U.S. Food and Drug Administration (FDA) to include daily use of INFERGEN (Consensus Interferon) in combination with ribavirin (RBV) for retreatment of chronic hepatitis C patients. The expanded labeling targets hepatitis C patients who need retreatment. In the clinical trial leading to the expanded labeling, the primary endpoint of increased sustained virological response (SVR) was achieved demonstrating that INFERGEN provides a second chance for patients to clear their hepatitis C virus.


“Approximately 50 percent of patients with chronic hepatitis C do not respond to their initial course of therapy,” stated Dr. Bruce Bacon, the lead investigator for the registration trial. “The FDA’s recognition of this expanded label allows patients failing therapy a safe and efficacious retreatment strategy. The results from this study legitimize how we properly treat these patients helping them to achieve SVR.”

The data reported and published in Hepatology (2009) from the U.S.-based, randomized, DIRECT clinical trial (Daily-Dose Consensus Interferon and Ribavirin: Efficacy of Combined Therapy) led to the approval of the expanded label. Results from the DIRECT trial had shown that the use of INFERGEN and RBV is a safe and effective retreatment strategy for patients failing initial therapy with PEG-IFN/RBV. This was especially apparent with interferon-sensitive patients with lower baseline fibrosis scores. In fact, up to 38 percent of non-cirrhotic patients (in the 15mcg arm) who were sensitive to Peg-IFN/RBV and who did not modify their INFERGEN and RBV dosages achieved an SVR. Additionally, patients with cirrhosis were less likely to benefit from retreatment with INFERGEN and RBV unless they displayed previous interferon sensitivity or at least 1-log₁₀ drop in viral levels on prior therapy.

“The expanded labeling for INFERGEN is a significant step forward for retreatment of hepatitis C patients who deserve a second chance to overcome their HCV,” stated Patrick Kerrish, R.Ph, M.B.A., President of Three Rivers Pharmaceuticals, LLC. “Our hope is that INFERGEN will become the standard of care for the retreatment of chronic hepatitis C patients.”

Three Rivers Pharmaceuticals, LLC is expanding its INFERGEN and hepatitis C education efforts via physician outreach and online patient support programs. An instructional video and guide about proper at-home injections of INFERGEN, tips for patient compliance, access to reimbursement specialists and a hotline staffed by nurse counselors are available at www.infergen.com.