Astra Merck And P&G To Market OTC Prilosec

The 50/50 joint venture Astra Merck and Procter & Gamble have formed astrategic alliance to develop and market an over-the-counter version of the antisecretory drug Prilosec (omeprazole) in the USA. Under the agreement, the companies say they will work together to generate the clinical data needed for clearance of the prescription-to-OTC switch by the US Food and Drug Administration. They hope to establish Prilosec in the OTC market before it begins to lose its patent protection after 2000.

The two groups are pursuing indications for an OTC version of Prilosec for occasional heartburn which, with acid indigestion, afflicts six out of 10 people at least once a year. Sales of OTC acid reducers and antacids increased 50% from 1994 to 1996, when they reached more than $1.2 billion. Furthermore, in 1996, Rx-to-OTC switches accounted for more than 30% of the total US OTC market.

Once cleared by the FDA, P&G will be responsible for marketing, selling and distributing the OTC version of Prilosec and will make undisclosed upfront payments to Astra Merck, as well as royalties based on US net sales, though it will not be available over the counter for several years.