Pepcid AC, a joint venture of Johnson & Johnson and Merck & Co., got federal approval in April. By mid-July, J&J was boasting of a 14% share in the antacid market after a single month on drugstore shelves.
Yet Pepcid AC's claim as the only H2-blocker over-the-counter stomach remedy was short-lived. SmithKline Beecham won approval to take its Tagamet OTC in a fall launch, and Glaxo Wellcome won preliminary approval to sell an OTC version of Zantac, the No. 1 selling drug worldwide, for entry possibly as soon as 1996.
An H2-blocker blocks the histamine stimulation of gastric acid production.
Not to be overlooked is Axid, a joint venture of Eli Lilly & Co. and American Home Products Corp., also in stepped-up FDA review channels, and a new-drug application from Procter & Gamble Co.
The P&G petition is for a triple-antibiotic therapy for ulcers that includes bismuth subsalicylate, the active ingredient in its Pepto-Bismol antacid, the third best-selling brand among antacids with a 9.5% share, according to Information Resources Inc.
There seems room for Pepcid AC and Tagamet among other heartburn remedies, including OTC antacids such as Mylanta and Tums, note industry executives. After all, heartburn and acid indigestion affect an estimated 95 million Americans a month.
Consumers spent $1.12 billion on heartburn, acid indigestion and sour stomach remedies during the year ending this June, up 4.7% from the comparable prior-year period, reports IRI.
Analysts expect J&J/Merck, SmithKline and Glaxo to spend a combined $300 million in introductory campaigns to tout the new breed of stomach remedies. They spent more than $166 million in media on digestive aids in 1994, according to Competitive Media Reporting.
What might be more durable than ad largess, however, is brand loyalty. Tagamet, although second to the marketplace, was a billion-dollar ulcer prescription drug in the U.S. before being extended to OTC.
"It's not so important to be first or even second to market; it comes down to who has the strongest prescription recognition," notes David Williams, a consultant with New England Consulting Group. "I could see Tagamet surpassing Pepcid purely on awareness."
Pepcid and Tagamet already have locked horns. SmithKline last month sued J&J/Merck for making false claims in its advertising of Pepcid AC.
Pepcid AC is promoting its better safety profile, as well as one-dose and extended relief (up to 12 hours). Tagamet interacts adversely with some asthma, seizure and blood-thinning medications and requires two caplets for a similar extended relief period.
Pepcid AC can be used as an aid to prevent heartburn, but Tagamet can only be cited as a heartburn treatment. Both can be billed as ulcer remedies.
Yet these H2-blockers won't drive antacids out of business. Antacids neutralize stomach acids, while H2s keep the stomach from making acid. Both antacids and H2s are equally effective in relieving heartburn, and therein lies a problem for H2s. If a consumer doesn't take an H2 in anticipation of a problem, the antacid may get the nod because it takes an H2 one hour to kick in.
And, H2s need antacids if the bottom lines of pharmaceutical companies are consulted.
"Both SmithKline and J&J have a substantial interest in keeping Tagamet and Pepcid from cannibalizing Tums and Mylanta, since those OTC brands are the antacid leaders," says Michael Perlmutter, senior consultant-pharmaceutical group, Kline & Co.
J&J/Merck's Mylanta tops the stomach remedies list at 16.4% share, on sales of $184.3 million, up 7.5%, for the year ended this June. Next is SmithKline's Tums at 14.5% share on sales of $163.3 million, up 7.2%, notes IRI.
SmithKline has moved in recent years to reposition Tums as being more than an antacid. It brought out Tums Ultra, a calcium supplement that has twice the acid neutralizing power of regular Tums, and Tums 500, with 500mg calcium. Ads via Jordan, McGrath, Case & Taylor, New York, position Tums as effective against heartburn while providing "something your body needs," calcium.
Maalox is the brand showing vulnerability. Sold at year-end by Rhone-Poulenc Rorer to Ciba-Geigy, Maalox has been busy adding flavors the last few years: mint, lemon, cherry. Yet its share has slipped from 10.2% the end of '93 to 9.4% last year to 8.8% at mid-year '95. This could be a Maalox moment for Ciba.