LONDON -- The anticipated switch of Prilosec, an ulcer remedy, from prescription to over-the-counter in the second quarter of 2001 could change the landscape of the crowded stomach remedy market, industry observers believe.
Produced by AstraZeneca here, the drug captured higher sales -- $2.85 billion -- than any other prescription medication for the first half of 1999, according to the F-D-C Report.
Competition in the $1.6 billion remedies business, however, will be stiff from well-established OTC brands -- important for the grocery industry, which, of late, has the greatest share of sales in a category where share points run neck-and-neck. The three mass-market channels are separated by less than 2 points when it comes to share of total sales.
Prilosec displays clinical test results on its prescription label that compares it to similar competitor drugs and claims superiority to category leaders. The clinical data compares it to the agent ranitidine (in Warner-Lambert's Zantac 75, the No. 4 stomach remedy, according to IRI) and says that, in a 392 patient trial, both 10mg and 20mg Prilosec (omeprazole) taken daily had better results than ranitidine twice daily.
Additionally, the labeling claims that, in people suffering from certain grades of esophagitis, "complete daytime and nighttime heartburn relief occurred faster than in those taking placebo or histamine H2-receptor antagonists." Drugs in this class include Pepcid AC, Zantac 75 and the No. 9 seller, according to IRI, Tagamet HB (SmithKline Beecham).
In accordance with a deal struck in December 1997, Cincinnati-based Procter & Gamble, which is sharing in the development of an OTC version of Prilosec, will market the drug if and when it becomes approved. A spokesman at one of AstraZeneca's two U.S. facilities was guarded when discussing the switch. Speaking only briefly about the joint development agreement with P&G, he declined comment on when the drug might hit the market and a possible price point.
Indeed, superiority claims could set Prilosec apart from category leaders but one thing that might impede a potential upsurge, observers say, is the fact that - although it treats active duodenal ulcers, benign gastric ulcers and erosive esophagitis - the drug contains no prevention indications as it does for Pepcid AC, Zantac 75 and Tagamet HB.
Other obstacles include potential drug interactions with a number of agents listed on Prilosec's Rx label, which also states that tests on laboratory rats produced gastric cancer cells in large doses.