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P&G Begins Selling New Ulcer Drug

 Helidac Therapy wins first-ever award

CINCINNATI, Nov. 25 /PRNewswire/ -- On the eve of the Holiday season, duodenal ulcer sufferers nationwide now have yet another reason to celebrate: Helidac(TM) Therapy, P&G's newest prescription drug, is now being stocked in pharmacies nationwide.

"To millions of ulcer sufferers, this is great news," said Bruce L. Byrnes, president of P&G's health care business. "Now, instead of spending up to $400 or more each year on prescription medicines to just relieve duodenal ulcer symptoms, patients may rid themselves of the Helicobacter pylori (H. pylori) infection in two weeks and get on with their lives."

In December, P&G will kick off a national marketing campaign to make health care professionals aware of Helidac Therapy's ulcer-causing bacterial eradication benefits, unique packaging designed for compliance and low price -- up to 50% less than competitive ulcer medicines.

P&G's Helidac Therapy, which is patented, combines three drugs: bismuth subsalicylate, metronidazole and tetracycline hydrochloride in a unique cube- shaped kit designed for patient compliance.

The components of Helidac Therapy (bismuth subsalicylate, metronidazole and tetracycline hydrochloride), in combination with an H2 acid suppression medication are indicated for the treatment of patients with an active duodenal ulcer associated with H. pylori infection. The eradication of H. pylori has been demonstrated to reduce the risk of duodenal ulcer recurrence. Appropriate doses of H2 antagonists for the treatment of active duodenal ulcers should be prescribed for ulcer healing. Helidac Therapy is highly effective in eradicating H. pylori bacteria, which live in the stomach and upper intestine.

These bacteria are associated with most cases of duodenal ulcers, which afflict three million Americans. P&G's Helidac Therapy, when used with an H2 antagonist for an active duodenal ulcer, not only heals the ulcer, but is effective in eradicating H. pylori bacteria and reducing the chance of ulcer recurrence. In pivotal clinical trials, among all evaluable patients, Helidac Therapy in conjunction with an H2 acid suppression medication, achieved eradication rates of up to 82%. Additionally, 91% of all evaluable patients did not have an ulcer recurrence one year after treatment.

P&G plans to promote Helidac Therapy, which has an average wholesale price of $77.70, through health care professional magazine advertising and direct mail campaigns to physicians. In addition, P&G's health care sales force will call on health care professionals, including managed care executives, to make them aware of Helidac Therapy's benefits.

Packaging Designed For Patient Compliance

P&G's Helidac Therapy is the only duodenal ulcer therapy with packaging designed for patient compliance -- with features like blister card dosing and easy-to-read patient information literature. Some health care professionals believe this packaging is a critically-important addition. In fact, P&G filed a patent application for Helidac Therapy's unique compliance-friendly packaging.

Alan Cutler, M.D., one of the nation's leading H. pylori researchers and director of gastroenterology research at Sinai Hospital in Detroit, said physicians often find some patients have a hard time complying with multi-drug regimens. All ulcer bacterial eradication therapies, including Helidac Therapy, require multiple drugs, some of which need to be taken up to four times each day.

"Medication only works if it's taken properly. Not only are the medicines in Helidac Therapy effective against eradicating the H. pylori bacteria, it's packaged in a way to help patients take it correctly," said Cutler.

A study conducted in 1984 by the U.S. Chamber of Commerce estimated than $15 billion are lost each year due to patient non-compliance with prescribed medicines. This study also identified that up to 10 percent of hospital admissions and 20 percent of nursing home patient admissions are associated with non-compliance.

Helidac Wins First Seal from Healthcare Compliance Packaging Council

"We believe Helidac Therapy's packaging is important in helping ulcer patients take their medicine just as the doctor ordered," said Dan Gerner, chairman of the Healthcare Compliance Packaging Council (HCPC). "We hope that by recognizing the special packaging P&G developed for Helidac, we'll encourage a greater focus on patient compliance."

Early in the development process for Helidac, P&G learned many patients struggle with the task of taking prescription medicines properly. Confusing directions, hard-to-open packages and poor understanding among patients of how the medicine is working are key reasons inhibiting patient compliance.

Through its research into patient compliance, P&G developed a unique cube -shaped "kit" for Helidac Therapy. This kit incorporated the most successful ideas from its patient, physician and pharmacist research.

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.

To earn the HCPC Seal of Approval, P&G was required to submit Helidac Therapy through a series of tests by an independent test lab to certify that it meets rigorous criteria for compliance packaging. Helidac Therapy was also tested to gauge patient understanding of usage directions and assess its packaging against child-resistant and senior-friendly packaging guidelines established by the U.S. Consumer Product Safety Commission.

Additional medical information about Helidac Therapy

Helidac Therapy 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 Therapy is not for all patients.

Helidac Therapy is contraindicated in pregnant or nursing women, pediatric patients and patients with renal or hepatic impairment, and in those with known hypersensitivity to bismuth subsalicylate, metronidazole or other nitromidazole derivatives, or any of the tetracyclines. 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.

For more information about Helidac Therapy and duodenal ulcers, call 1-888-4HELIDAC to receive free literature.

Background information: HCPC, P&G

The HCPC was formed in 1990 as a not-for-profit corporation to educate consumers, health professionals and policy makers about the important role that unit dose blister packaging can play in improving pharmaceutical compliance.

P&G makes and markets prescription and over-the-counter products in 60 countries. P&G's focus for prescription drugs is on cardiac, anti- infective and bone health therapies. In OTC health care, P&G's leading brands include Vicks(R) cough/cold/flu and allergy products, Crest(R), Scope(R), Metamucil(R) and Pepto-Bismol(R).

P&G is also actively partnering with a range of leading pharmaceutical and biotechnology companies to develop and market innovative therapies. P&G had sales of $35 billion in fiscal 1995-96.

SOURCE The Procter & Gamble Company
 -0- 11/25/96

/CONTACT: James J. Schwartz of P&G, 513-945-8055, or Peter Mayberry of HCPC, 202-434-4268/


CO: The Procter & Gamble Company ST: Ohio IN: HOU MTC SU:

BG-TC -- CLM014 -- 3569 11/25/96 09:42 EST
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Date:Nov 25, 1996
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