MORRIS PLAINS, N.J., -- Warner Wellcome Consumer Healthcare announced today that Zantac 75(TM) (ranitidine hydrochloride), the over-the-counter version of Glaxo Wellcome's Zantac(TM), received marketing clearance from the Food and Drug Administration. Zantac has been the most-prescribed medicine of its kind worldwide for the last five years. Zantac 75 is indicated for the relief of heartburn, acid indigestion and sour stomach in adults and children 12 years of age and older.
With more than 200 million Zantac prescriptions written in the U.S. since 1983, Zantac 75 is one of the most exciting Rx-to-OTC switches of all time. The benefits of Zantac 75 include: wide acceptance among physicians and pharmacists; an enviable safety profile with no clinically significant drug interaction warnings; and impressive efficacy that will make it easy for pharmacists to recommend it to their customers.
"The world's leading prescription H2 antagonist over the last five years is now poised to take its rightful place in the over-the-counter heartburn market," said Robert Casale, Vice President, Gastrointestinal Marketing. Beginning in 1988, more prescriptions were written each year in the U.S. for Zantac than any other H2 antagonist. In fact, over the last five years in the U.S., Zantac has been prescribed more than all other H2 antagonists combined.
In the United Kingdom, Zantac 75 surpassed both Tagamet(TM) 100 and Pepcid(TM) AC, despite being third into the marketplace. By its fifth month on the market, Zantac 75 had earned a 50 percent share of the OTC H2 market. "We fully expect to repeat the prescription success of Zantac and the U.K. OTC success of Zantac 75 in the U.S. OTC marketplace," said Casale.
Impressive Efficacy, Safety Profile
One tablet of Zantac 75 (containing 75 mg of the active ingredient ranitidine HCl) gives patients clinically proven relief from heartburn, acid indigestion and sour stomach day or night. And, unlike antacid remedies which neutralize existing gastric acid, Zantac 75 works by reducing the production of stomach acid.
The prescription dosage forms of Zantac remain available for use in conditions that require a physician's diagnosis.
The medicine in Zantac 75 is widely accepted by physicians and pharmacists. During Zantac's 12-year history in the U.S., prescriptions have averaged at a rate of one every two seconds, totaling more than 200 million scripts. According to David Thueson, Ph.D., a pharmacologist and author of Thueson's Guide to Over-the-Counter Drugs, "Occasional heartburn sufferers -- and there are millions of them -- can feel comfortable choosing Zantac 75, which has an enviable efficacy and safety profile."
Retail Excitement Anticipated
According to Casale, pharmacies, supermarkets and mass merchandisers are very excited about Zantac 75. "Our research has shown that heartburn sufferers are looking forward to buying a product with the characteristics of Zantac 75: wide acceptance, prescription heritage and familiarity. We expect that high consumer expectation will translate into even higher retailer excitement." Casale added that U.S. sales of OTC stomach remedies over a 22-week period are up nearly 27 percent since the availability of OTC H2s. "We expect that growth will continue with the introduction of Zantac 75."
Marketing to Jump-Start Sales
The ascent of Zantac 75 will be supported by the largest marketing campaign in Warner Wellcome Consumer Healthcare's history. A high-profile advertising campaign will debut on national television, radio and print media, and will focus on the product's heritage and clinical benefits in relieving heartburn. "As the world's most-prescribed medicine of its kind for the last five years, Zantac 75 will enter the consumer marketplace from an enviable position of leadership," said Casale.
For many consumers, Zantac is already a household name. "To be a leader in the name game is one of the greatest strengths a product can have, and Zantac should be the champion," added Susan Lavine Coleman, an expert in Rx-to-OTC switches, and managing partner of NCI Consulting in Princeton, New Jersey.
Zantac 75 is a five-sided tablet, which initially will be sold in 4-, 10-, and 20-tablet packs. The recommended dose for adults and children 12 years of age and older is one tablet swallowed whole with water, not to exceed two tablets in 24 hours. Zantac 75 will have no drug interaction warnings and, when used as directed, can be taken at the maximum daily dose for up to two weeks. Zantac 75 will be available early in 1996 wherever OTC products are sold.
In addition to the United States, Zantac is approved for OTC use in Denmark and the United Kingdom. Glaxo Wellcome has filed regulatory submissions in major markets worldwide.
Warner Wellcome Consumer Healthcare is the joint venture established by Warner-Lambert and Glaxo Wellcome to market selected OTC products of both companies and identify and switch certain prescription products that have OTC potential. Joint ventures between the two companies are established in the U.S., Canada, Europe, New Zealand and Australia.
NOTE: Tagamet(TM) is a registered trademark of SmithKline Beecham. Pepcid(TM) is a registered trademark of Merck & Co., Inc.
CONTACT: media -- Jennifer Mann, 201-540-4268, or investors -- George Shields, 201-540-6916, or Cary Rosansky, 201-540-4874, all of Warner-Lambert; or media -- Lisa Stockman or Mary Sofield of The Chandler Chicco Agency, 212-274-1110/ (GLX)
All contents Copyright (c) 1995 P\S\L Consulting Group Inc. All rights reserved.