Basel, Switzerland, 13 March — Roche today announced that VALCYTE™ (valganciclovir) has received European regulatory acceptance as an oral therapy for the treatment of AIDS patients with cytomegalovirus (CMV) retinitis, a condition that can potentially cause blindness in infected patients. National licenses from the 16 concerned member states are expected from April 2002.

VALCYTE provides IV performance with oral convenience. It is predicted to replace Cymevene (ganciclovir), currently the most widely prescribed anti-CMV medication worldwide which although effective, is a very unwieldy treatment to take. Treatment with Cymevene involves the use of inconvenient intravenous induction therapy followed by maintenance therapy on an high capsule count (12 capsules per day).

The introduction of VALCYTE means that patients with acute CMV retinitis will now 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 (4 capsules three times daily).

"Loss of vision can be incredibly devastating for people already fighting the HIV virus," said William M. Burns, Head of Pharmaceuticals, Roche. "We hope that VALCYTE will at least give patients and physicians throughout Europe a much more convenient and practical anti-CMV medication to help prevent the progression of this terrible condition."

Cymevene is currently the most widely prescribed anti-CMV medication worldwide. The positive opinion was supported by clinical data that show VALCYTE tablets have comparable efficacy for induction therapy when compared to intravenous Cymevene. VALCYTE was approved in September 2001 by the Dutch Medicines Evaluation Board who served as the reference country for the EU-wide procedure. In the U.S. VALCYTE received approval in 2001 following a priority review from the Food and Drug Administration (FDA). Priority reviews are given to treatments deemed to represent potentially major advances in healthcare.

About CMV
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 condition that affects 10-15 per cent of people with AIDS and leads to blindness.

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 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:

Lizz Fort, Ketchum Telephone: + 44 20 7611 3618 Email: [email protected]

Maria Vigneau, Roche Telephone: + 41 61 688 9291 Email: [email protected]

Editors’ Note:
For patients with active CMV retinitis, the recommended induction dose with VALCYTE is 900mg (two 450mg tablets) twice a day for 21 days. Following induction treatment, or for patients who are CMV virus positive but with inactive disease requiring maintenance therapy, the recommended dose is 900mg (two 450 mg tablets) once daily.

Full prescribing information available upon request.