Allegra® Launched in Japan

World's Second Largest Allergy Market Receives Widely Used Treatment Option

20-Nov-2000

The world's fastest growing prescription medicine for the safe and effective treatment of seasonal allergy symptoms was launched today in Japan, the second largest allergy medication market in the world. Allegra® (fexofenadine hydrochloride) was approved for use by the Japanese Ministry of Health on September 22, 2000, and is now available by prescription only.

Allegra is a non-sedating antihistamine that has been shown in clinical trials and in clinical practice to safely provide relief from symptoms associated with seasonal allergies, in as little as one hour after dosing. Allegra was approved in Japan with recommended dosing of one 60 mg tablet, twice daily.

"Allegra has become one of the most widely used antihistamines in the world today, and will become an important new treatment option for millions of people in Japan who are seeking safe, non-sedating relief from disruptive and uncomfortable allergy symptoms," said Richard Markham, Chief Executive Officer of Aventis Pharma, the company that discovered, developed and markets Allegra.

Reports estimate that as much as USD $1. billion (source: IMS, MAT August 2000) is spent each year in Japan on allergy medications. It is also estimated that Japan represents 20% of the overall global allergy market, and is second only to the United States in the use of antihistamine treatments.

"We believe the Japanese market represents a considerable opportunity for Allegra and we are pleased that allergy sufferers there now have this option," said Mr. Markham.

Allegra is currently available in 50 countries worldwide and is backed by more than 1.5 billion patient days of experience. Allegra was first approved for use in the United States in July of 1996 and is considered the 7th most successful new product launched in the past five years (source: IMS, 1999).

Clinical Data In clinical trials of Allegra, the onset of action of the drug was observed within one hour after dosing. Additional studies have shown that allergy sufferers continued feeling relief throughout the dosing period. Also, Allegra was shown to relieve symptoms among allergy sufferers in a study in which those sufferers were exposed for five hours to extremely high pollen challenges in a pollen chamber. This exposure is typically much greater than what most patients would experience in "very high" pollen season.

Other clinical trials have demonstrated that Allegra provides effective symptom relief without sedating side effects or impairment of performance. Consequently, unlike other antihistamines in Japan, such as Zyrtec

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