Perrigo 2012 targets: Prevacid 24HR and Align; Lipitor on the horizon?

ALLEGAN, Mich. — Perrigo is planning to launch more than 45 new products in fiscal 2012 that will translate into approximately $190 million added to annual Perrigo sales, Perrigo chairman, president and CEO Joe Papa told analysts during the company's fourth-quarter conference call Tuesday.

And while none of these new over-the-counter private-label products will help reduce cholesterol levels, Papa did set the stage for a future store-brand equivalent to Pfizer's blockbuster statin Lipitor.

Presently, Perrigo plans to introduce store-brand equivalents to Prevacid 24HR, Mucinex, Zantac Cool Mint, a cinnamon-flavored nicotine gum, Claritin D and the probiotic Align. "For the fiscal 2012 year, we expect year-over-year revenue growth in [the OTC segment, which does not include Align,] to be in the range of 12% to 14%," commented Judy Brown, Perrigo EVP and CFO. "We expect full-year fiscal 2012 adjusted gross margin in consumer health care to be between 32% and 33%, and adjusted operating margin to be between 18% and 19%."

In the company's nutritionals segment, which does include Align, Perrigo expects revenue to grow 5% to 7% over fiscal 2011 and anticipates fiscal 2012 adjusted gross margin of between 33% and 35%, with adjusted operating margin of between 17% and 19%.

The big prize, however, will be a store-brand equivalent to Lipitor if and when Pfizer successfully switches its Lipitor statin franchise from prescription-only to OTC status. "Lipitor is a phenomenal opportunity that I ultimately think could find its way into the OTC space," Papa said, expressing cautious optimism.

Papa pointed out that companies have lobbied the Food and Drug Administration to approve an OTC statin three times. And three times those companies have failed. "[Companies] have had success in moving products outside of the United States that are statins from prescription to OTC," Papa said, though those countries typically field a third class of drugs overseen by a pharmacist.

"I don’t think [a statin switch] is an event that will occur this year or next year," Papa cautioned. "I think it will take several years to ultimately see that happen, but if it does happen, certainly Perrigo will be very interested and will be available to go into that marketplace. We have a program ourselves to look at atorvastatin, or Lipitor, in terms of moving it over the counter, and we believe that that’s something that could be a very significant opportunity for Perrigo if indeed it does happen."

According to industry executives consulted by Drug Store News, the industry may soften its stance against a traditional third-class of drugs so long as it's a de facto third class as opposed to a codified third class created by way of legislation.

There already is at least one example of a de facto third class OTC — emergency contraceptives like Plan B One Step. As part of the approval process, companies that supply nonprescription emergency contraceptives have agreed to restrict those sales to pharmacies that position the products behind the counter, Drug Store News has been told.

The FDA had last hosted public meetings around a proposed third class of drugs in 2007, when Andrew von Eschenbach was still at the helm of the agency. The American Pharmacists Association has long supported a third class of drugs so long as pharmacists are reimbursed for the increased consultation role they would play.

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