Astra Merck and P&G form Alliance to Develop OTC Version of Prilosec

Astra Merck Inc. and the Procter & Gamble Company have formed a strategic alliance to develop and market an over-the-counter version of Astra Merck's antisecretory drug Prilosec. Prilosec is the brand name in the United States for omeprazole, which is currently the world's best-selling prescription medication, generating worldwide net sales of $3.7 billion and U.S. sales of $1.7 billion in 1996.

The companies are pursuing indications for an OTC version of Prilosec for occasional heartburn. Physicians will still have the opportunity to prescribe Prilosec for acid-related disorders including heartburn and other symptoms associated with gastroesophageal reflux disease (GERD).

"We've seen a tremendous amount of excitement generated by the Rx-to-OTC switches of H2 antagonists in recent years," said Susan Lavine Coleman, an expert on Rx-to-OTC switches with NCI Consulting in Princeton, N.J. "However, when the switch of Prilosec does occur, we can expect to see a high level of interest, given the increasing consumer demand for effective heartburn medicines."

Based on sales of OTC stomach remedies, a higher awareness of heartburn and available treatment options may be contributing factors to the 50 percent increase in sales of OTC acid reducers and antacids from 1994 to 1996, reaching more than $1.2 billion in 1996. In fact, antacids and anti-gas products are the third largest category in OTC medicines, behind pain relief and vitamin products.

Prilosec was the first in a class of drugs called proton (acid) pump inhibitors. Rather than selectively blocking H2 receptor sites on the stomach's parietal cells, as H2 antagonists do, Prilosec works on parietal cells at the final step of acid production by inhibiting the proton pumps. A single dose can provide 24-hour acid control.

In 1996, Rx-to-OTC switches accounted for more than 30 percent of the total U.S. OTC market, estimated at $15 billion in annual sales, based on industry data. Since 1995, there have been 16 Rx-to-OTC switches. Since 1975, the FDA has cleared 70 ingredients or dosages of ingredients for OTC status. Of the 16 best-selling OTC brands since 1975, 15 of them were previously prescription products rather than branded products introduced for sale directly to consumers.

Astra Merck will continue to market prescription Prilosec to healthcare professionals in the U.S. One of Astra Merck's owners, Astra AB of Sweden, will maintain responsibility for marketing the drug internationally under the brand name Losec. Losec is currently sold in more than 100 countries, and is the antisecretory market leader in 17 of the 27 countries where prescription data is available.