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| |  Helidac Ulcer Therapy Receives FDA Clearance CINCINNATI, Aug. 22, 1996-- The Procter & Gamble Company (NYSE: PG) has received U.S. Food and Drug Administration (FDA) clearance to market a prescription duodenal ulcer drug therapy in the U.S. that eradicates the bacterium "Helicobacter pylori (H. pylori)" from the stomach and small intestine and, in combination with an H2 antagonist, helps heal the ulcer. These bacteria cause about 90% of duodenal ulcers, which afflict about 1 in 12 people during their lifetime. P&G's patented drug therapy, called Helidac(TM) Therapy, combines three drugs -- bismuth subsalicylate, metronidazole and tetracycline hydrochloride -- in a consumer-tested, patient-friendly kit. P&G expects to begin selling Helidac Therapy in November. P&G's Helidac Therapy, when used with an H2 antagonist, not only heals the ulcer, but is effective in eradicating bacteria and reducing the chance of ulcer recurrence. Helidac Therapy achieved eradication rates of up to 82%. Additionally, 91% of Helidac Therapy patients did not have an ulcer recurrence one year after treatment. "There's no doubt, 'H. pylori' is one tough bug," said Dr. Barry Marshall, a University of Virginia researcher who discovered the connection between 'H. pylori' infection and ulcer disease, as well as the medical benefit of using bismuth salts and anti-infectives to treat the infection. "We now know that eradicating the bacteria is important in curing someone with duodenal ulcer disease. P&G's Helidac Therapy is clinically proven to deliver effective 'H. pylori' bacterial eradication rates, making it an important ulcer therapy option." As part of its long-term research on gastrointestinal diseases, P&G collaborated with Dr. Marshall in the mid-1980s. Dr. Marshall continues to focus his research on further understanding how the "H. pylori" bacterium is associated with gastrointestinal diseases. In 1995, Dr. Marshall won the Lasker Award, considered one of medicine's highest honors, for his work in ulcer disease. Helidac is also well-tolerated; the most common side effects include nausea (10%), diarrhea (5%) and abdominal pain (3%). As with any prescription drug, however, Helidac is not for all patients. Helidac is contraindicated in pregnant or nursing women, pediatric patients and patients with renal or hepatic impairment. It is recommended that all patients not eradicated of 'H. pylori' following Helidac Therapy plus an H2 antagonist should be considered to have 'H. pylori' resistant to metronidazole. Patients who fail therapy should not be retreated with a regimen containing metronidazole. The attached full prescribing information has additional information about contraindications, warnings, precautions and adverse reactions. Not Your Ordinary Medicine Bottle Early in the development process of Helidac Therapy, P&G learned through consumer and physician research the importance of addressing patient compliance with multi-drug therapies. To address this, P&G began evaluating strategies to improve patient compliance for its 14-day ulcer therapy. During this process, P&G learned that patients often don't take their medicine because they don't fully understand their illness. This insight led P&G to focus on educating patients about their disease and motivating and reminding them of the benefit of taking their medicine correctly. P&G then developed a unique cube-shaped "kit" for Helidac Therapy, incorporating the most successful ideas from its research in improving patient compliance. For convenience, each single day's supply of medicine (14 days in total) is individually packaged in a special push-through, senior-friendly, child-resistant packaging. There is also a patient booklet which provides information about duodenal ulcers and Helidac Therapy. In addition, the kit contains reminder devices (e.g., pre-printed sticky notes) to help patients remember to take their medicine. In addition to the clinical trials, P&G's market research confirmed that ulcer patients preferred the convenient packaging. The kit was also well-received in testing with health care professionals because they believe it will help patients take this medication appropriately. Available This Fall: Lowest Cost Ulcer Eradication Therapy P&G plans to launch Helidac Therapy nationally by mid-November, backed by a marketing effort directed to health care professionals and managed care organizations. As part of this effort, P&G plans to communicate that Helidac Therapy provides good patient outcomes while being the lowest priced approved duodenal ulcer eradication therapy available. Prices are based on average wholesale prices; the final price paid by pharmacists and patients may vary. "In the new world of health care, delivering therapeutic options which are not only effective but also give the patient a good value is what it takes to win," said Bruce L. Byrnes, president of P&G's health care business. "We believe we've struck the right balance with Helidac Therapy: it's effective, designed to help patients take their medication appropriately and is competitively priced." Byrnes also noted that P&G relied on an infrequently used new drug approval method called a literature-based new drug application (NDA). A literature-based NDA relies on clinical studies reported in the medical literature. In addition to saving time, a literature-based NDA reduces costs associated with traditional drug development which are estimated to average about $350 million over 12 years. In prescription drugs, P&G is focusing on cardiovascular, bone health and anti-infective therapies. In over-the-counter health care, P&G's leading brands include Metamucil(R), Pepto-Bismol(R), Crest(R), Scope(R) and the Vicks(R) line of cold/flu/cough and allergy medicines.
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