Rx-Strength Pepcid Could Join Prilosec OTC In Consumer Market

Johnson & Johnson/Merck is preparing to introduce a prescription strength version of Pepcid (famotidine) for over-the-counter sale.

The firm reportedly filed an NDA months ago with the intent of launching the new strength of OTC Pepcid in late 2003. The new product apparently is part of J&J/Merck's strategy to shore up its position in the heartburn treatment category against the imminent introduction of Procter & Gamble/AstraZeneca's Prilosec OTC .

J&J/Merck declined to comment on an NDA or on plans to extend the OTC Pepcid line.

FDA approved a nonprescription form of Prilosec (omeprazole) for the treatment of "frequent heartburn (occurs two or more days in a week)" on June 20 (¹ (Also see "Prilosec OTC Approved In 28-, 42-Count Multiple Regimen Sizes" - Pink Sheet, 23 Jun, 2003.), p. 3).

J&J/Merck launched its 10 mg strength Pepcid AC in 1995 (² (Also see "OTC Zantac name recognition will help overcome late market entry, consultant predicts." - Pink Sheet, 22 May, 1995.), p. 3). Merck still sells 20 mg and 40 mg famotidine as Rx drugs for short-term treatment of duodenal ulcer and short-term treatment of gastroesophageal reflux disease.

The NDA reportedly focuses on the 20 mg dose, which would allow a prescription version to remain available.

J&J/Merck also plans to bolster its pharmacist education programs with regard to heartburn therapies in 2004.

According to the firm, Pepcid Complete is the number one pharmacist recommended OTC heartburn medication. J&J/Merck added that maintaining this position is important for the drug's sales, as data show pharmacists are asked to recommend heartburn treatments 19 times per week and that consumers follow the advice 80% of the time.

J&J/Merck additionally said it has completed studies comparing Prilosec with its Pepcid Complete famotidine/antacid combination. The firm noted, however, that it has not yet decided how to leverage the studies' results.

For the 52 weeks ended May 18, Pepcid AC and Pepcid Complete were first and fourth, respectively, in retail sales among branded heartburn remedies in food, drug and mass merchandise outlets excluding Wal-Mart, according to Information Resources, Inc. (Chicago).

Sales for Pepcid AC and Pepcid Complete were $82.8 mil. and $45.7 mil., respectively. Pfizer's Zantac 75 was a close second among branded heartburn remedies with sales of $82.1 mil. in the period, the IRI data show.

Pfizer also is gearing up to compete with Prilosec OTC. In a June 21 press release, the company commented on the Prilosec OTC approval by saying "the difference between Zantac 75 and Prilosec OTC is simple: Zantac 75 relieves heartburn fast. Prilosec OTC doesn't."

Pfizer then emphasized that Prilosec OTC "has to be taken continuously for two weeks and can take one to four days for full effect."

According to Pfizer Consumer Healthcare Gastrointestinal R&D VP Mark Gelbert, PhD, "consumers tend to resist continuous, daily dosing of OTC medicines where treating the onset of symptoms is readily available." Zantac 75 better satisfies "the typical OTC consumer who suffers from heartburn [and] is looking for immediate relief," he maintained.

P&G said it plans to begin airing TV and print ads for Prilosec OTC in October; the ad agency of record is New York-based Publicis.

P&G also said Prilosec OTC will cost consumers "noticeably less than $1 per pill" and less than the co-pays charged by many health plans for the drug. Pepcid AC currently costs consumers about 25¢ per pill, according to J&J/Merck.

Wal-Mart said it met with P&G June 25 to discuss plans for in-store Prilosec promotions, which will include point-of-purchase signs. The launch was termed as "huge" by a Wal-Mart spokesperson. The rep added that the retailer expects Prilosec sales to double those of OTC Claritin in its stores.

P&G and AstraZeneca anticipate Prilosec OTC will generate $200 mil. to $400 mil. in sales during its first year on the market.