Executive Summary

UCB DEVELOPING NON-SEDATING CETIRIZINE FOR POLLEN-ASSOCIATED ASTHMA as well as an antihistamine allergy treatment. According to a recent scientific seminar presentation by Christine De Vos of the Belgian company UCB Pharmaceutical Sector, cetirizine is in human studies in Europe for the additional antiasthma indication. Cetirizine (Zyrtec), is licensed by UCB in the U.S. to Pfizer, which is reportedly conducting clinicals in the U.S. for the asthma indication. The product is currently awaiting an NDA for treatment of chronic urticaria and seasonal and allergic rhinitis. At an Oct. 3 conference on "New Approaches to the Treatment of Allergic Diseases," sponsored by International Business Communications, De Vos said that cetirizine has greater H[1] selectivity than other antihistamines. "No affinity has been found for any other agonist-receptor other than the H[1] receptor," De Vos stated. She claimed the selectivity makes cetirizine "an exquisitely precise tool" with less potential for side effects. In contrast, according to the UCB presentation, terfenadine (Marion-Merrell-Dow's leading non-sedating Seldane) is active in blocking serotonin as well as H[1] receptors. De Vos described several European studies suggesting cetirizine could be effective against asthma. One study was a six week, 39-patient trial in the Netherlands in 1987 which compared the prophylactic effectiveness of 10 mg cetirizine versus 60 mg terfenadine in preventing the appearance of pollen asthma. Also cited by De Vos was a 20-patient, double-blind study of patients with severe birch pollen-associated asthma, which was published in The Lancet in March 1989 and also compared cetirizine to terfenadine. Both studies "demonstrated a protective effect of cetirizine . . . statistically superior to terfenadine," De Vos said. A third study of 80 asthmatic patients during the 1988 grass-pollen season in France compared cetirizine 15 mg, cetirizine 10 mg and terfenadine 60 mg in a twice-daily regimen. "Asthma symptoms disappeared in 58% of C15 patients," compared to 21% of the terfenadine patients, De Vos reported. Therefore, she concluded, "cetirizine should have a place in the treatment of asthma, as well as seasonal pollen allergies."