Basel, 27 September 2001 - Roche today announced that Valcyte received regulatory approval for the treatment of AIDS-related cytomegalovirus (CMV) retinitis in the Netherlands. This decision by the Dutch Medicines Evaluation Board marks the first approval of Valcyte for CMV retinitis in the EU and the Dutch approval will be used to initiate a mutual recognition procedure* with pan-European approval of Valcyte expected by mid-2002.

Valcyte (valganciclovir) is a new version of Roche’s existing anti-CMV treatment, Cymevene (ganciclovir), with a much better bioavailability. It was developed in response to the need for more convenient and patient-friendly administration of ganciclovir. The introduction of Valcyte means that patients with acute CMV retinitis will only have to take two Valcyte tablets twice-daily rather than receive two IV infusions a day. For patients receiving maintenance treatment aimed at preventing relapse or progression of CMV retinitis, two Valcyte tablets once-daily will replace a daily Cymevene IV infusion or up to 12 Cymevene capsules daily on a three times daily basis. Cymevene is currently the most widely prescribed anti-CMV medication worldwide.

"We are delighted with the first European regulatory approval of Valycte," said William M. Burns, Head of Pharmaceuticals, Roche. "The approval of Valcyte is the first step to giving patients and physicians throughout Europe a much more convenient and practical anti-CMV medication."

The approval was supported by clinical studies that show Valcyte tablets have comparable efficacy for induction therapy when compared to intravenous Cymevene. In the U.S. Valcyte received approval following priority review from the Federal Drug Administration, a designation reserved for treatments deemed to represent potentially major advances in healthcare.

Cytomegalovirus (CMV) is a member of the herpes family of viruses. In individuals with healthy immune systems, CMV exists in the body in a dormant state. Among individuals with compromised immune systems, such as those with HIV/AIDS or patients taking post-transplant immunosuppressants, the virus can become active and cause disease. In people with AIDS, the most common manifestation of CMV is CMV retinitis, a sight-threatening form of this disease. Although retinitis may develop without symptoms, when symptoms do occur they include visual problems, such as blind spots, distorted vision and noticeable blurring. Since other conditions can also cause these clinical symptoms to appear, it is recommended that the physician diagnose CMV as causal to the retinitis.

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 innovative products and services address needs for the prevention, diagnosis and treatment of disease, thus enhancing people’s well-being and quality of life.

* For further information about the Mutual Recognition Procedure see: http://www.cbg-meb.nl/uk/reghoudr/index.htm

All trademarks used or mentioned in this release are legally protected.