Skip to NavigationSkip to content

OTC omeprazole to become Glaxo's next generation Zantac

Published on 28/10/03 at 03:01pm

GlaxoSmithKline is poised to launch omeprazole, AstraZeneca's former prescription-only blockbuster Losec as part of its leading over the counter Zantac brand range.

Launched in 1989, the gastro oesphagal reflux disease treatment Losec transformed the gastrointestinal market, becoming the biggest selling prescription drug ever, and turned AstraZeneca into one of the industry's major players.

But the Anglo-Swedish company has no consumer marketing division and has not pursued an OTC licence in the UK following Losec's patent expiry in 2002. The picture is quite different in the US where AstraZeneca has collaborated with one of the world's leading consumer products companies Procter & Gamble on Prilose's US OTC launch. The drug was launched to huge fanfare in September, and is set to be one of the biggest consumer drug launches for many years.

OTC Prilosec is selling about 1,800 packs an hour in the US, and annual sales are expected to reach about $400 million based on a price of 70 cents per capsule.

GlaxoSmithKline and its partner, generic firm Galpharm, which holds a licence to market omeprazole are now  awaiting final regulatory approval from the MHRA to launch the drug over the counter in the coming months.

Galpharm's application for OTC status has been public knowledge for some time, being subject to a MHRA public consultation, but Pharmafocus is the first to reveal that GSK will mastermind the drug transformation into a major consumer brand.

A source close to the deal, who wishes to remain anonymous, told Pharmafocus: "Galpharm have been the stalking horse as they have a track record in POM to P switches but GSK are waiting in the wings."

Galpharm are understood to be developing its generic versions of omeprazole for outlets like Boots and Moss, while GSK will bring out a fully-fledged brand, probably under the Zantac umbrella.

"This means all the money will go to Galpharm and GSK, and not a penny to AstraZeneca," the source commented, "which doesn make sense when you consider how successful the US launch of Prilosec has been."

AstraZeneca UK are understood to have rejected the idea of launching an OTC version of Losec, with concern that it might cannibalise prescription sales of its follow-up drug Nexium.

"Personally, I think AZ simply missed a business opportunity and have now woken up to the fact by starting to think about developing a global OTC medicine capability - however, it too late this time as the horse has already bolted!" the source said.

The switch will be one of the most significant ever for the UK consumer medicines market, and has been supported by bodies such as the Royal Pharmaceutical Society and the government, which is keen to see consumers take greater control of their health and medicines.

GlaxoSmithKline declined to comment on any plans for omeprazole.

Meanwhile, an even bigger POM-P switch is also thought to be in the pipeline - that of simvastatin, Merck Sharp & Dohme's recently off-patent statin Zocor.

Mission Statement is a leading portal for the pharmaceutical industry, providing industry professionals with pharma news, pharma events, pharma service company listings and pharma jobs,
Site content is produced by our editorial team exclusively for and our industry newspaper Pharmafocus. Service company profiles and listings are taken from our pharmaceutical industry directory, Pharmafile, and presented in a unique Find and Compare format to ensure the most relevant matches