Roche Licenses Potential Second-Generation Drug From ICN to Set New
Standards In Hepatitis C Treatment
Roche and ICN Pharmaceuticals, Inc. announced today that Roche has licensed in the rights to the developmental compound Levovirin, a promising second-generation drug for the treatment of hepatitis C from ICN.
Roche is currently developing Pegasys, its pegylated version of interferon alpha 2a, which on its own represents a major improvement in the treatment of hepatitis C. Its use in combination with Levovirin is expected to set new standards of care in this therapeutic area.
Levovirin is an L-isomer of ribavirin, which is part of current treatment regimes for hepatitis C. In preclinical studies, Levovirin shows immuno-modulatory activity similar to ribavirin but a better tolerability profile. Most importantly, the compound has not shown genotoxic effects in animals and cell-line studies and it does not seem to cause hemolytic anemia which is the major dose limiting side effect of ribavirin. Phase I clinical trials for the treatment of hepatitis C including Levovirin have been initiated in February 2001.
Levovirin will represent an important addition to Pegasys. The highest sustained virological response to therapy ever recorded for chronic hepatitis C patients has been achieved with combination therapy of Pegasys (40 kDa branched peginterferon alfa-2a) and ribavirin. The results from Phase III clinical trials were reported at the Digestive Disease Week in Atlanta, USA, in May this year. ICN also presented Levovirin's preclinical and development data at the same meeting.
"The incidence of hepatitis C is growing worldwide and physicians will require a range of highly effective therapies to treat this disease," said William M. Burns, head of the Pharmaceutical Division of Roche. "We believe that Roche is strongly suited to meet the current and future demands of the marketplace and we see Levovirin as another important addition to our growing virology portfolio."
Milan Panic, chairman and chief executive officer of ICN, said: "We are pleased that Roche, a leading pharmaceutical company with its reputation for high-quality and innovative products, will assume responsibility for the development of Levovirin. Roche's worldwide marketing and distribution capabilities will enable physicians and their patients access to what we hope will prove to be a significant addition to the hepatitis C therapeutic arsenal."
About the licensing agreement Roche will pay a one-time licensing fee, milestone payments, and, after Levovirin has been successfully developed and received regulatory marketing clearance, royalties to ICN. Roche will be in charge of all future development activities and will have global marketing rights except for some Eastern European countries. Roche will also offer to ICN a compound at a similar stage of development.
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