Pfizer is reportedly weighing an attempt at an over-the-counter (OTC) switch for Lipitor – a move that could help the company recoup some of its losses when the $11 billion drug loses US exclusivity in November — but the reception from analysts has been muted so far.
The company is keeping mum on the scheme, first reported in yesterday’s Wall Street Journal, saying in a statement only that “We can confirm that we have strategic plans in place for Lipitor’s loss of exclusivity and will comment no further at this time.”
The New York Times reported that Pfizer is exploring the possibility of a branded generic as well as an OTC switch. Both options would put the company’s marketing prowess to use, but to win FDA approval for an OTC version, Pfizer would have to succeed where Merck and Bristol-Myers Squibb have failed.
Deutsche Bank analyst Barbara Ryan splashed cold water on Pfizer’s prospects.
“I do not think that an OTC Lipitor is likely over the next few years,” Ryan told MM&M. “Merck tried with Mevacor for better than five years, and finally gave up. The issue is the asymptomatic nature of the disease, that has not changed.”
Mary Tinetti, MD, chair of the FDA’s non-prescription drugs advisory committee, wrote in a 2008 journal article that the reasons advisory committees rejected a Mevacor OTC switch for a third time in 2007 included: “insufficient data on benefits and risks in the target population with over-the-counter sales, the inability of consumers to make appropriate self-selection decisions, a lack of evidence that there will be appropriate monitoring, and inadequate FDA authority over advertising and marketing.”
Because high cholesterol is an asymptomatic condition, the panels were concerned, in part, that at-risk consumers would stop taking the drug because they felt fine. They also worried about consumers’ inability to determine which drug was best for them, and about the benefits versus risks of neuropathy, depression, muscle weakness and possibly, stroke, associated with the drug.
“Existing FDA procedures and rules governing the switch from prescription to nonprescription sales simply are inadequate for long-term treatment of asymptomatic conditions,” wrote Dr. Tinetti. “As a start, in studies of real-world use over several years (not just a few months) and in settings reproducing the over-the-counter environment, pharmaceutical companies must be required to show that consumers make accurate selection and monitoring decisions.”
In an analyst note touting OTC and generics distributor Perrigio as a “buy,” Collins Stewart’s Louise Chen and Swati Kumar predicted that if Pfizer were successful, an OTC Lipitor would likely be sold “Behind the counter,” as simvastatin (Zocor) is in the UK. Pfizer announced last month that it would hold on to its Established Products and Consumer Health businesses, backing away from talk of selling those units in hopes of wringing as much as possible out of mature and OTC brands.