RESEARCH TRIANGLE PARK, N.C., Oct. 12, 1995 - A new therapy for shingles (herpes zoster), a painful and potentially debilitating disease that affects hundreds of thousands of older Americans each year, has been released for marketing by the Food & Drug Administration.

Valtrex(R) brand valacyclovir HC1, indicated for the treatment of shingles in otherwise healthy (immunocompetent) patients, becomes the newest treatment option for this disease. Valtrex represents the next generation of antiherpetic medication to be developed and marketed by Glaxo Wellcome Inc. The company also developed and markets Zovirax(R) brand acyclovir, the world's most widely prescribed antiherpetic medication and still the only therapy in the U.S. indicated for the treatment of genital herpes.

"Valtrex offers us an important new treatment for managing patients with shingles, and it provides a more convenient dosing regimen when compared to Zovirax," said Karl Beutner, M.D., Ph.D., associate clinical professor of Dermatology at the University of California, San Francisco, and a lead clinical investigator for Valtrex.

The efficacy of Valtrex was studied in the largest controlled study for antiviral treatment of herpes zoster to date. The study, involving 1,141 immunocompetent patients over 50 years of age (median age of 68), showed that the time to cessation of new lesion formation in patients receiving Valtrex was comparable to those receiving Zovirax. Data from the clinical trial of immunocompetent patients over 50 years of age also suggest that Valtrex may shorten the duration of postherpetic neuralgia (PHN), the severe pain which often persists after the shingles rash has healed. Although the trend was not statistically significant, Valtrex shortened the median duration of PHN by 19 days compared to Zovirax.

In a separate clinical trial which compared Valtrex to placebo in patients 18 to 49 years of age (mean age of 35), the median time to cessation of new lesion formation was two days for those treated with Valtrex compared to three days for those treated with placebo.

Valtrex delivers three to five times higher blood levels of acyclovir than oral Zovirax and therefore offers substantial dosing convenience when compared to Zovirax. Labeled dosing of Valtrex for the treatment of shingles is two 500 mg caplets three times daily for seven days. By comparison, Zovirax is dosed at 800 mg five times daily for the treatment of shingles.

"Improving on a drug that has been as phenomenally successful and well received as Zovirax was a challenge, but we feel we have done that with Valtrex," said Richard S. Kent, M.D., director of worldwide clinical research and chief medical officer for Glaxo Wellcome. "I expect Glaxo Wellcome to continue to expand upon Wellcome's reputation as the leader in antiviral research."

In clinical trials, Valtrex was shown to be effective when administered within 72 hours of the onset of the shingles rash. Valtrex, like Zovirax, was generally well tolerated by study participants in the shingles trials. The most common adverse events experienced by patients over 50 years of age consisted of nausea (16%), headache (13%), vomiting (7%), diarrhea (5%), constipation (5%), asthenia (4%), dizziness (4%), abdominal pain (3%) and anorexia (3%). The incidence of these adverse events was comparable to the incidence in patients taking Zovirax.

Valtrex is not indicated for the treatment of patients with compromised, or weakened, immune systems (immunocompromised). Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), in some cases resulting in death, has been reported in patients with advanced HIV disease and also in bone marrow transplant and renal transplant recipients participating in clinical trials of Valtrex. This syndrome has not been observed in immunocompetent (otherwise healthy) patients treated with Valtrex in clinical trials.

Shingles is a painful viral disease that affects as many as 750,000 people each year in the United States. The condition is most commonly experienced by older Americans and is caused by a reactivation of the varicella-zoster virus, the same herpes virus which causes chickenpox. A major challenge for physicians in managing patients with shingles is alleviating the severe pain associated with an active shingles rash, as well as postherpetic neuralgia (long-term debilitating pain) which may occur following rash healing.

Valtrex has already been approved as a therapy for shingles in 19 other countries including the United Kingdom, France, Ireland, Sweden and South Africa.

Valtrex caplets became available by prescription to consumers in the U.S, in early October. The Glaxo Wellcome price to wholesalers for a seven-day course of therapy with Valtrex to treat shingles is $96.60. This price represents a cost-of-therapy savings compared to treatment with Zovirax, which can range from approximately $107 to $154 depending on the duration of therapy. These figures reflect prices to wholesalers and may not be the price actually paid by pharmacies or patients.

Glaxo plc recently acquired and has merged with Wellcome plc to create the leading pharmaceutical company in the world. A strength of the new company is the pharmaceutical industry's leading antiviral research program. The efforts of scientists at Glaxo Wellcome have resulted in treatments for smallpox, herpes eye infections, HIV infection and AIDS, shingles, chickenpox, genital herpes, herpes encephalitis and hepatitis.

CONTACT: Ramona Jones of Glaxo Wellcome, 919-248-2839