Roche Licenses Potential Second-Generation Drug From ICN to Set New Standards In Hepatitis C Treatment
BASEL, Switzerland, July 2 /PRNewswire

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.

About Hepatitis C
Hepatitis C is a potentially life-threatening viral infection that can lead to liver inflammation, liver disease, cirrhosis or liver cancer. Transmitted primarily through infected blood, approximately three percent of the world's population, or 170 million, is infected with the hepatitis C virus, making hepatitis C more common than the HIV virus. Chronic hepatitis C is the leading cause of liver transplantation today.

About ICN
ICN, headquartered in Costa Mesa, California, is an innovative-research focused global pharmaceutical company that manufacturers, markets and distributes a broad range of prescription and non-prescription pharmaceuticals under the ICN brand name. Its therapeutic focus is in anti-infectives, including anti-virals, dermatology and oncology.

About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-oriented healthcare groups in the fields of pharmaceuticals, diagnostics and vitamins. Roche's products and services address prevention, diagnosis and treatment of diseases, thus enhancing well-being and quality of life. Roche has approximately 64,000 employees and sells its products in over 170 countries. In 2000 the Roche Group posted sales of 28,7 billion Swiss francs and an adjusted net income of 5,0 billion Swiss francs.

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SOURCE ICN Pharmaceuticals, Inc.
CO: ICN Pharmaceuticals, Inc.; Roche Group ST: Switzerland, California