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New
HIVID� Combination Indication
Approved in the European Union

Basel, Switzerland (December 1, 1997) -- F. Hoffmann-La Roche, Ltd. announced today that HIVID� (zalcitabine, or ddC), a proven nucleoside analogue therapy for the treatment of HIV/AIDS, has received clearance in the European Union to be marketed for use in combination with other antiretroviral therapies. This new indication confirms the continued value of ddC, an established therapy with a long history of successful "real-world" use, in the rapidly evolving arena of HIV/AIDS treatment.

The new indication was granted based on data from numerous studies demonstrating the benefits of ddC in combination with other agents. These studies include four large controlled clinical endpoint studies: Delta, ACTG 175, CPCRA007 and NV 14256. The benefits of ddC were recently confirmed in the largest HIV trial to date (PISCES) which studied ddC in combination with AZT and INVIRASE� and demonstrated a significant clinical benefit for ddC as part of a state-of-the-art 3-drug regimen.

"ddC�s value in first-line combination anti-HIV regimens is supported by numerous clinical trials," said Professor Brian Gazzard of the Chelsea and Westminster Hospital, London. "These trials have shown that ddC works in synergy with other antiretroviral agents, and first-line use of ddC may maximize future therapeutic options."

The value of ddC as a component of combination therapy is significantly enhanced by its excellent cross-resistance profile. ddC has been shown to induce resistance/cross-resistance at a very low frequency relative to other antiretroviral agents.

ddC has been an integral component of HIV/AIDS treatment regimens in Europe since receiving marketing clearance in Austria in 1992. Since ddC was cleared for marketing, physicians and people with HIV/AIDS have had over 90,000 patient/years experience in clinical practice with ddC. Previously, ddC was indicated for use as monotherapy for persons with HIV / AIDS unable to benefit from AZT.

The new indication was granted through a mutual recognition process in which Germany served as Reference Member State. The indication will be implemented in all E.U. member states by January 1, 1998.

ddC is marketed by F. Hoffmann-La Roche, Ltd. Roche also markets three protease inhibitor therapies for HIV/AIDS: INVIRASE (saquinavir mesylate), the world�s first protease inhibitor; FORTOVASE� (saquinavir), a new formulation of saquinavir that is currently being evaluated for use in the E.U.; and VIRACEPT� (nelfinavir), which has received a positive opinion from E.U. regulatory authorities. Both FORTOVASE and VIRACEPT are currently marketed in the U.S.

The Roche Group is a research-based health care company with principal businesses in pharmaceuticals, diagnostics, vitamins, and fragrances and flavors. Roche discovers, develops, and markets prescription drugs in key therapeutic areas such as virology, infectious diseases, cardiology, oncology, transplantation, and obesity.

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