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| |  Schering-Plough Announces Claritin (Loratadine) Approved In Japan KENILWORTH, NJ -- July 8, 2002 -- Schering-Plough Corporation today announced that Schering-Plough K.K., the company's subsidiary in Japan, has received approval to market the nonsedating antihistamine Claritin® (loratadine) 10 mg Tablets as a prescription product for the treatment of allergic rhinitis (AR), chronic idiopathic urticaria (CIU), or hives of unknown cause, and itching associated with skin diseases in adults and children 15 years of age and above from Japan's Ministry of Health, Labor and Welfare (MHLW). Claritin, which will be co-marketed in Japan with Shionogi & Co., Ltd., will be launched upon receiving pricing approval. "With this approval, Claritin, the world's largest-selling antihistamine, can now compete in the world's second-largest pharmaceutical market," said Roch F. Doliveux, president, Schering-Plough International. "Backed by the product's proven clinical benefits and worldwide experience, we believe that we can establish Claritin as the premier antihistamine in the Japanese marketplace." With MHLW approval, Claritin is entitled to six years of data exclusivity, during which time any competitor wishing to introduce a generic version of Claritin would be required to submit an application to MHLW that contains data from their own clinical trials. Allergic rhinitis is estimated to affect some 15 million people in Japan. The market for prescription antihistamines in Japan is estimated to exceed $1 billion. Affecting an estimated 15 to 25 percent of people at least once in their lives, urticaria is a reaction to a variety of substances, including food, drugs and topical agents, and characterized by an eruption of itchy, swollen lesions on the skin. An estimated 25 percent of urticaria patients develop CIU, which is defined as a case that lasts for a period of at least six weeks and has no identifiable cause. More than 40 percent of prescription antihistamine use in Japan can be attributed to CIU and itching associated with skin diseases such as eczema. DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking" statements relating to Claritin, including its market potential in Japan and the timing of its launch. The reader of this press release should understand that the extent that Claritin will be prescribed in Japan will be determined by market factors. In addition, the forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, the extent of market acceptance of new products, current and future branded and generic competition, government regulations and legislation, the pricing process in Japan, existing and new manufacturing issues that may arise, trade buying patterns, patent protection, litigation and investigations. For further details and a discussion of these and other risks and uncertainties, see the company's SEC filings, including the company's 2001 annual report on Form 10-K and subsequent quarterly report on Form 10-Q and current report on Form 8-K. Schering-Plough K.K., based in Osaka, is a wholly owned subsidiary of Schering-Plough. Schering-Plough International is the worldwide pharmaceutical operation of Schering-Plough Corporation, a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical products worldwide.
SOURCE: Schering-Plough Corporation
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