Simvastatin now has OTC status in the UK.

The UK Department of Health has announced that, starting this month, it will permit over-the-counter (OTC) sales of a low-dose, 10-mg formulation of simvastatin (Zocor Heart Pro; Merck) to people at moderate risk of coronary heart disease.

This is the first time such a move has been sanctioned for a statin. It follows earlier, unsuccessful applications by Bristol-Myers Squibb and by Merck to the US FDA in 2000 to gain OTC status for pravastatin (Pravachol) and lovastatin (Mevacor), respectively.

Merck's recent move is interpreted by one analyst as a response to the threat from generics — simvastatin lost its patent protection in the UK last year — rather than an attempt to gain market share from its main rivals. “If they did £20 million in [OTC sales in] the UK, I'd be amazed,” says Anthony Colletta, head of pharmaceuticals equity research at Dresdner Kleinwort Wasserstein in London. (Statins cost the UK's National Health Service around £700 million a year.) “It's really draining the last few drops out of it.”

BMS faces a similar issue, as pravastatin will come off-patent in the US in April 2006. “We are continuing to explore the potential of Pravachol as an over-the-counter therapy for patients in whom treatment is appropriate,” says BMS spokeswoman Julie Keenan, although she declines to comment on the status of that process, or on whether it extends to markets outside the United States. The FDA is also remaining tight-lipped, and the UK Department of Health says it has received no additional applications for an OTC switch for a statin.

Neither Pfizer nor AstraZeneca intends to react should BMS and Merck succeed in gaining OTC status in the United States for their respective statins. “We would only look at it if agencies asked us to. We are not dependent on what our competitors do,” says Pfizer Associate Medical Director Michael Zaiac. AstraZeneca's rosuvastatin (Crestor) is not a candidate for an OTC switch any time soon, given its recent market launch. “Our key focus is to go after those patients who should be treated under the care of their general practitioners,” says Neil Brickel, UK physician for Crestor at AstraZeneca.

Any further statin OTC approvals, according to a research note written by Frazer Hall, a London-based analyst at Credit Suisse First Boston, are also likely to be at low doses and would be aimed at patients with a relatively low risk of developing cardiovascular disease. “Also, given recent clinical data, the market may polarize in the future, with the more efficacious products, such as Lipitor [atorvastatin; Pfizer] and Crestor left largely unaffected by the OTC availability of other products,” Hall wrote. “Overall, we see no major threat to other prescription category brands from possible OTC moves.”

Pfizer and AstraZeneca are critical of a switch to OTC statin therapy in the absence of any obligation to monitor clinical parameters such as blood pressure, low-density lipoprotein and total cholesterol. “If you work on lipids you must measure your success,” says Zaiac.

Another concern is the lack of trial data for OTC statins for primary prevention of heart disease. Insufficient safety and efficacy data for statins in an OTC setting was the reason the FDA rejected the applications for pravastatin and lovastatin.

OTC status could potentially contribute to a greater incidence of adverse events, says Beatrice Golomb of the University of California at San Diego (UCSD), principal investigator of the UCSD statin study, although it is not the most crucial issue. “My own concerns are less about OTC versus prescription status than about awareness of the spectrum of effects, so that when possible adverse effects arise, appropriate decisions can be made about whether to continue the drug.”