Oral Dosing Form Provides Comparable Efficacy to Cytovene-IV

NUTLEY, N.J., April 2, 2001 – Roche announced today that the U.S. Food and Drug Administration (FDA) has approved Valcyte (valganciclovir) for the treatment of cytomegalovirus (CMV) retinitis in AIDS patients. Valcyte is the oral pro-drug of Roche’s existing anti-CMV treatment, Cytovene (outside the US: Cymevene; ganciclovir) which is currently the most widely prescribed anti-CMV medication worldwide.

In a clinical study, Valcyte tablets were found to have comparable efficacy for induction therapy when compared to Cytovene-IV. The application for Valcyte received a priority review from the FDA, a designation reserved for treatments deemed to represent potentially major advances in healthcare.

"Since Cytovene was introduced in 1989, it has become the mainstay of anti-CMV treatment in patients with HIV/AIDS," said Nick Coppard, Valcyte Project Leader, Roche. "We expect that Valcyte will replace and build upon Cytovene in the marketplace, because it offers comparable efficacy in a much more convenient dosing regimen for induction therapy."

"CMV retinitis, which can lead to blindness, affects between 10 and 25 percent of people with the late stages of AIDS," said Terje Anderson, executive director, National Association for People with AIDS, US. "It’s devastating to these patients to lose their eyesight at the same time they are fighting to survive. During the past few years, advances in treatments for HIV/AIDS have decreased the prevalence of opportunistic infections like CMV; however, there is still a need for convenient treatment regimens versus drugs currently available for CMV retinitis," Anderson added.

Valganciclovir was discovered in 1994 in Palo Alto. "Following the introduction of Ganciclovir into the market the lack of an oral induction treatment regiment was considered to be limiting and inconvenient for the patient," said Hans Maag, director of Medicinal Chemistry and lead scientist for the initial pre-clinical development efforts. "This provided a challenge for research, which took up renewed efforts to either improve the formulation or to identify a prodrug," he said. Maag, along with principal research scientists, Scott Womble and Charles Dvorak, are Roche Palo Alto inventors listed on the patent.

Development work for Valcyte was carried out by a global project team, with functional representation at several Roche development sites. "The Palo Alto team is particularly proud of this medicine because ganciclovir was developed in Palo Alto and Valcyte was discovered here," said Mary Jean Jean Stempien, clinical science leader for Roche Palo Alto Global Development.

Studies in the prevention of CMV disease in solid organ transplantation recipients are underway and it is anticipated that applications for marketing authorizations for this indication will be filed in the second quarter, 2002.

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 HIV/AIDS, the most common manifestation of CMV is CMV retinitis, a sight-threatening form of this disease.

About Hoffmann-La Roche Inc.
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. prescription drug unit of the Roche Group, a leading research-based health care enterprise that ranks among the world’s leaders in pharmaceuticals, diagnostics and vitamins. Roche discovers, develops, manufactures and markets numerous important prescription drugs that enhance people's health, well-being and quality of life. Among the company’s areas of therapeutic interest are: virology, including HIV/AIDS and hepatitis C; infectious diseases, including influenza; cardiology; neurology; oncology; transplantation; dermatology; and metabolic diseases, including obesity and diabetes.

About Roche Pharmaceuticals - Palo Alto
The Roche pharmaceutical operations in Palo Alto include Roche Bioscience and Roche Global Development. Roche Bioscience is focused on the discovery and early clinical development of innovative new medicines to treat diseases including arthritis, asthma and other respiratory diseases; anxiety, depression, schizophrenia and other neuropsychiatric diseases; genitourinary diseases and osteoporosis. The Roche Global Development organization in Palo Alto manages human clinical studies and works to achieve worldwide regulatory approvals for compounds from the Roche research pipeline. Located in the Stanford Research Park, Roche employs approximately 1,200 men and women in Palo Alto as part of the Roche Group, headquartered in Basel, Switzerland. More information about the Roche campus in Palo Alto is available at http://paloalto.roche.com.

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