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Tylenol to go on sale in Japan

By Kate Fodor

NEW YORK, Jul 19 (Reuters Health) - Johnson & Johnson's McNeil Consumer division announced on Tuesday that it plans to launch Tylenol into Japan's US$10 billion over-the-counter (OTC) healthcare market later this year. But US tourists should not look for the red-and-white box familiar to American shoppers. Market research involving about 3,500 Japanese consumers led to a decision to market the acetaminophen product in Japan in certain forms not sold in the US and in significantly different packaging.

"The Japanese consumer looks at analgesic products very differently than here in the US," McNeil Global Franchise Director Peter Bell said. "They don't treat headaches as much as they'd like because of worries about upset stomach (and) there's a certain belief that you only take pain medication at the time that you're eating (because) products available there have the potential to upset the stomach."

Tylenol, which will be the only 100% acetaminophen OTC product available in Japan, is unlikely to cause the gastrointestinal side effects that can be associated with other types of painkillers, J&J claims. "Hopefully, that will come through in our marketing," Bell said.

In addition, Japanese consumers indicated that the US packaging for the product was confusing, Bell noted. In Japan, red packaging generally signals an upper respiratory product; as a result, adult Tylenol products will get new blue bottles and cartons for the Japanese market, while the children's packaging will be pink.

J&J will launch Tylenol in the third quarter as a family of four products: gelcaps, quick-dissolve granules, chewable tablets designed for children aged 5 to 14 and junior strength caplets for children 11 to 14. The company has been strategizing about the launch with its marketing partner, Japan's Takeda Chemical Industries, for 3 years, Bell told Reuters Health.

Under the agreement between the firms, Johnson & Johnson KK, the Japanese subsidiary of Johnson & Johnson, will be responsible for product development, manufacturing, regulatory issues, importation and marketing. Takeda Chemical Industries' consumer division will handle distribution and sales. Tylenol's main competition in the Japanese market will be Bristol-Myers Squibb's Bufferin, which has been available in Japan for many years, Bell said. According to Bristol-Myers, Bufferin features a special coating to help protect against stomach upset.

Johnson & Johnson also reported on Tuesday that its second quarter earnings beat analysts' estimates, driven by strong sales in the pharmaceutical segment. The New Brunswick, New Jersey-based company's net earnings rose 14.3% over the same quarter in 1999 to a record $1.3 billion. Earnings per share of 94 cents came in slightly ahead of the 92 cents consensus forecast by analysts surveyed by First Call/Thomson Financial. Revenues for the quarter were up 7.7% year-over-year at $7.5 billion.

Because the company "did moderately outpace expectations in the quarter," J&J is "comfortable with closer to the top end" of Wall Street's $3.35 to $3.40 earnings per share range for the year, J&J CFO Robert Darretta said during a conference call with investors on Tuesday morning.

Despite taking a hit related to the withdrawal of the heartburn remedy Propulsid (cisapride), the company's pharmaceutical sales rose 13.9% to $3.2 billion, Robert Wilson, vice chairman of the board, said during the call. Propulsid, which analysts have estimated to be about a $1 billion drug, was taken off the market by J&J earlier this year in response to reports linking the product to cardiac adverse events and deaths. Johnson & Johnson announced the market withdrawal at the end of March but established a "limited access" program for patients who had not been helped by other therapies. The limited access program was scheduled to conclude last Friday.

Despite the loss of revenues from the Propulsid withdrawal, strong sales of other drugs helped to compensate for the loss, Wilson said. J&J's over-the-counter segment experienced a "modest decline" of 3% compared with second quarter 1999, in part reflecting a spike in sales last year related to the launch of the cholesterol-lowering spread Benecol and other products. This year, product launches including Motrin Migraine "helped to offset lower sales in other products," he noted. Sales of Mylanta, driven up by the introduction of a nighttime formula of the drug, also helped. However, "inroads made by private label H2 antagonists contributed to a decrease" in sales of the company's blockbuster OTC heartburn treatment, Pepcid AC.

Looking forward, Wilson said that the company "expects to hear from the FDA shortly" with a decision on Reminyl; the company filed a New Drug Application for the drug, a treatment for moderate to severe Alzheimer's disease, in September.

Final labeling approval for a new indication for Remicade should be granted within 6 to 8 weeks, he added. An FDA advisory committee recommended this month that the drug, which is manufactured by J&J's Centocor unit, be approved for use in slowing progression of joint damage in rheumatoid arthritis patients under certain conditions.


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