Biovail Corporation has received approval from the United States Food and Drug Administration (FDA) for Zovirax (acyclovir) Cream, a topical medication used for the treatment of recurrent herpes labialis (cold sores) in adults and adolescents 12 years of age and older.
"The sooner-than-expected FDA approval of Zovirax Cream is certainly good news for Biovail," commented Eugene Melnyk, Chairman and CEO of Biovail. "This will allow us additional time for pre-launch marketing activities and puts us in an excellent position for our trade launch of this product in the first half of 2003."
Cold sores are the result of a virus, which causes painful lesions that range from mere redness, to pimple-like sores, to blisters. It is estimated that 20-40 percent of the U.S. adult population has had a cold sore at some point. Market research shows that, when asked to choose among products applied directly to the sore, many patients prefer a cream-based topical medication to ointments when treating cold sores. Zovirax Cream is not a cure for cold sores. In studies, the most common skin-related side effects with Zovirax Cream were local application site reactions, occurring in five percent of patients on Zovirax Cream. These reactions included dry or cracked lips, flakiness or dryness of skin, a burning or stinging feeling or itching of the skin. Each event occurred in fewer than one percent of patients.
Biovail acquired the exclusive rights for U.S. promotion and distribution of Zovirax Cream from GlaxoSmithKline (GSK) in the fourth quarter of 2001 with an effective date of January 1, 2002. According to the terms of this agreement, GSK will manufacture and supply this topical cream to Biovail. Biovail intends to launch Zovirax Cream in 2003.