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March 30, 2001 -- Nutley, N.J.

VALCYTE (VALGANCICLOVIR) IS APPROVED BY U.S. FOOD

AND DRUG ADMINISTRATION FOR TREATMENT OF AIDS-RELATED CMV RETINITIS

-- Oral Drug with IV Potency --

Hoffmann-La Roche today announced 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®

(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. The product is expected to be available in

pharmacies in late Spring 2001.

" Since CYTOVENE was introduced in 1989, it has become the mainstay of

anti-CMV treatment in patients with HIV/AIDS, " said s Gemayel, vice

president, marketing, Roche Laboratories. " 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 ,

executive director, National Association for People with AIDS. " 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 induction therapy for CMV retinitis, "

added.

For patients with active CMV retinitis, the recommended induction dose

of Valcyte is two 450mg tablets twice a day for 21 days. Following induction

treatment, or for patients with inactive CMV retinitis who require

maintenance therapy, the recommended dose is two 450mg tablets once daily.

Clinical Data

The safety and efficacy of Valcyte has been demonstrated in a

controlled study involving 160 patients with AIDS and newly diagnosed CMV

retinitis who were randomized evenly to receive Valcyte or CYTOVENE-IV for a

4-week induction treatment phase. The pivotal trial compared treatment with

Valcyte (900 mg twice daily for 21 days, then 900 mg once daily for 7 days)

or with CYTOVENE-IV (5 mg/kg twice daily for 21 days, then 5 mg/kg once

daily for 7 days). After week four, the 154 patients continuing therapy

received open-label Valcyte (900 mg once daily) for maintenance.

Analysis of the primary CMV progression endpoint revealed that after 4

weeks of therapy, the proportion of patients with progression as measured by

retinal photography was the same in both treatment groups. In the

CYTOVENE-IV arm, 7 progressed, 63 did not progress and 10 were unevaluable.

In the Valcyte arm, 7 progressed, 64 did not progress, and 9 were

unevaluable. After week four, all patients were allowed to continue to

receive maintenance treatment with 900 mg of Valcyte once daily.

Safety Information

Safety data were submitted for 370 patients who received

valganciclovir for an average of 320 days. In clinical studies, the toxicity

of Valcyte, which is metabolized to ganciclovir, includes low blood cell

counts (granulocytopenia (27%), anemia (26%), and thrombocytopenia (6%)) as

well as diarrhea (41%), nausea (30%), vomiting (21%), abdominal pain (15%),

fever (31%), headache (22%), insomnia (16%), peripheral neuropathy (9%),

paresthesia (8%) and retinal detachment (15%). In animal studies,

ganciclovir was carcinogenic, teratogenic and caused aspermatogenesis.

Valcyte tablets cannot be substituted for CYTOVENE capsules on a one-to-one

basis. If renal function is impaired, dosage adjustments are required.

Valcyte must be taken with food. Because it is an oral formulation, Valcyte

eliminates the risk of catheter-related sepsis.

As a pro-drug of ganciclovir, Valcyte is rapidly converted to

ganciclovir in the body. Pharmacokinetic studies have demonstrated the

bioavailability of ganciclovir from Valcyte is increased 10-fold compared to

the oral formulation of CYTOVENE, and two 450 mg Valcyte tablets one or two

times daily achieved systemic exposure of ganciclovir comparable to that

achieved with the recommended doses of intravenous CYTOVENE of 5mg/kg once

or twice daily, respectively.

A Phase 3 CMV prophylaxis study of Valcyte in solid organ transplant

recipients is ongoing.

About CMV

Cytomegalovirus (CMV), a member of the herpes family of viruses,

infects approximately 50 to 75 percent of the U.S. adult population. 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. Although retinitis may develop without symptoms, when symptoms

do occur they include visual problems, such as blind spots, distorted vision

and noticeable blurring. Because these problems can happen in diseases other

than CMV retinitis, a physician must make the diagnosis of CMV retinitis.

About Hoffmann-a 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.

For more information on the Roche pharmaceuticals business in the

United States, visit the company’s web site at: http://www.rocheusa.com

Editors’ Note: Full prescribing information available upon request.

# # #

Contact: Kellie McLaughlin

Hoffmann-La Roche Inc.

(973) 562-2231

Pager: (800) 946-4645

PIN# 6438692

na Sussman

Manning Selvage & Lee

(212) 213-7129

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