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Gut-Wrenching Battle Begins for New-Antacid Market

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From Associated Press

It’s shaping up as the battle of the bellyache.

Three of the world’s most popular prescription drugs--ulcer medicines called Zantac, Tagamet and Pepcid--are being or are expected to be introduced as powerful over-the-counter ways to block stomach acids.

Experts believe the drugs have the potential to revolutionize the $1-billion-per-year market for antacids, which has not seen a major innovation since the 19th Century. And the fight for market supremacy promises to be one of the industry’s most tenacious.

Because the drugs block the production of stomach acid, they can offer all-day relief from heartburn and sour stomach.

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That will be welcome news for any of the millions of Americans who have spent a day popping Tums or slugging Mylanta after hefty servings of spicy meatballs.

Industry analysts predict that by late this year or early next, the three products will be common sights on TV, billboards and in magazines as their manufacturers roll out ad campaigns expected to cost as much as $100 million each.

“I think we will be blitzed,” said Mariola Haggar of C.J. Lawrence-Deutsche Bank in New York.

“We’re talking about three gladiators here,” said David Saks of Gruntal & Co. “It would be a major disappointment if they, as a combined group, didn’t double the size of the gastrointestinal therapy market” within three years.

Drug companies’ latest over-the-counter products often come from the ranks of their prescription medicines. But these entries, assuming they are all approved, as is expected, are the biggest ever to make the switch.

Tagamet, introduced by Britain’s SmithKline Beecham in 1977, became the first drug ever to reach $1 billion a year in sales.

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Zantac, made by Britain’s Glaxo Wellcome, with annual sales of about $3.6 billion, is the best-selling drug in the world. Those drugs, along with Pepcid, are the best-known members of a family called H2 blockers. As prescriptions, these pills have treated hundreds of millions of patients with gastric ulcers or other gastrointestinal diseases. They work quite differently from antacids.

Antacids are typically made from chemicals such as calcium carbonate or magnesium hydroxide. They neutralize stomach acid that has already been produced. They work quickly, but the effects typically last only about two hours--the amount of time they are in the stomach.

H2 blockers, by contrast, must be absorbed into the bloodstream. They take longer to work--perhaps up to an hour--but once they do, they slow or stop acid from being produced for six to 12 hours, doctors say.

The blockers act by blocking proteins called H2 receptors in the stomach’s acid-producing cells from setting off a chemical reaction that causes the cells to secrete acid.

Although the potencies of Tagamet, Pepcid and Zantac vary widely, the non-prescription dosages will be structured so that all three will have about the same effectiveness, doctors say.

Their success, therefore, will depend largely on timing and promotion.

On that score, Pepcid has an obvious lead. The drug’s creator, Merck & Co., in partnership with its New Jersey neighbor Johnson & Johnson, persuaded the Food and Drug Administration to approve non-prescription Pepcid AC (for acid controller) in April and rushed it to market by early June.

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The two companies have begun saturation advertising, hoping to imprint the Pepcid name in consumers’ minds before competitors hit the market.

SmithKline Beecham got approval for Tagamet HB (for heartburn) in June, and it expects to begin selling it in the early fall.

As for Glaxo Wellcome’s Zantac, an FDA advisory committee will take up consideration of the drug today. It is expected to recommend approval, with final approval anticipated by late this year at the earliest.

However, the time involved may be irrelevant once Zantac arrives because it has been such a strong seller as a prescription drug. Nonetheless, Pepcid enjoys other advantages. J&J-Merck; did extra studies on its effects in humans and received permission to sell Pepcid for an added use-- preventing indigestion, not just treating it.

Although doctors say Zantac and Tagamet will do the same, Glaxo and SmithKline never sought permission for their drugs to be marketed for that use.

It’s a decision that SmithKline Vice President Jack Ziegler, for one, said he does not regret. “Very few consumers can actually predict when they’re going to get heartburn,” he said.

Despite their blockbuster potential, analysts point out that profits from these drugs probably won’t come for two years. The biggest reason is the tremendous start-up and promotional costs.

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In addition, Stephen Gerber, an analyst for Oppenheimer & Co., expects some consumers may be turned off by the drugs’ slow-acting nature.

Further, if the drugs do sell well, they will take away from sales of antacids made by the same companies. SmithKline, for instance, makes Tums, and J&J-Merck; makes Mylanta.

And in coming years, there will be other competitors, including cheaper generic versions and perhaps other brand names such as Eli Lilly & Co.’s H2 blocker, Axid.

The drugs will also be expensive. A box of 12 Pepcid was selling for $5.50 at a discount drug chain in New York City, whereas 75 Tums go for $2.39.

Analyst Haggar doubts, however, that consumers will be bothered by sticker shock when they see the drugs on store shelves.

“Pepcid costs about 45 cents a pill, but it may provide relief for a whole day. That’s less than a cup of coffee,” she said.

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