A slowdown in the growth rate for Lipitor reflects the softness in overall prescription demand during the first quarter, Pfizer suggested during an April 22 earnings conference call.

Lipitor (atorvastatin) posted U.S. sales of $1.38 bil. for the quarter, an increase of 6%. The relatively slow growth by historical trends (Lipitor grew by 21% in the U.S. in 2002) "reflects what's going on in the overall market," Global Pharmaceuticals President Karen Katen said.

IMS Health prescription data showed a marked slowdown in the overall volume growth of the pharmaceutical market during the opening months of 2003.

IMS is still predicting double-digit growth in prescription dollar sales for the full year but at a slower rate than in the past several years (¹ Also see "Rx Market Starts Slow In 2003; IMS Still Confident Of Double-Digit Growth" - Pink Sheet, 24 March, 2003., p. 3).

"Clearly there has been a slowdown in script growth" industry wide, Pfizer CEO Henry McKinnell said. "It is not just the first quarter; you can trace it back earlier than that."

Pfizer reported first quarter U.S. pharmaceutical sales of $4.88 bil., an 8% increase. That is half the rate of increase in 2002. On a volume basis, the decline was even sharper. Pfizer reported worldwide volume gains of 11.9% in 2002 (and 13.1% in the fourth quarter); for the first quarter of 2003, volume was up just 4.7%, Pfizer said.

As the largest pharmaceutical company, Pfizer would be unlikely to escape a broad market slowdown unscathed.

However, Pfizer's bulk also poses a chicken-and-egg dilemma: the company is big enough that a lackluster showing on its part would likely show up as a slowdown in the overall market growth rates.

With the closing of the Pharmacia acquisition April 16, Pfizer now represents 11% of the global pharmaceutical market (preceding story).

Other pharmaceutical and distribution companies offered a different take on the IMS data during their quarterly calls.

Merck, for example, noted that it can speak definitively only about its own products but claimed its results "belie" IMS' overall volume results. Merck reported first quarter U.S. pharma sales of $3.59 bil., up 14%, with the majority of the growth (11%) coming from volume gains.

Cardinal Health CEO Robert Walter, speaking during an April 23 call, suggested that the "slowdown" may reflect "a little slower prescription same-store growth in some of the chains." However, "we can't reconcile" the strong growth recorded by wholesalers with the extremely low rate reported by IMS.

"It is not a major perceivable slowdown," Walter maintained. While growth rates may be down "a point or two...we're not seeing a weakness that's really worth talking about."

McKinnell suggested that the slowdown reflects a combination of factors, "like weather, war, the economy, Claritin going OTC, Premarin script growth changes, imports from Canada, few new products, increased copays, and maybe just bad data."

"I've not seen any good analysis of how much of that is accounting for what," McKinnell said. "I suspect it is cumulative and all of that is having some kind of an effect."

"Something is going on, which I don't think anybody has adequately analyzed or explained yet," McKinnell said. However, "I don't think there is any fundamental change here."

"Pharmaceutical markets will continue to grow at high rates into the future," McKinnell said. He pointed to the "major markets" where industry estimates suggest there are still large numbers of untreated or under-treated patients. "If you add demographics on top of that, I don't think we are seeing any fundamental change."

McKinnell also offered a breakdown of the IMS data by therapeutic category to suggest that Pfizer should not be broadly affected by the slowdown.

"We are still seeing 8%-10% or better growth in lipid-lowering, Alzheimer's, antidepressants, anti-epileptics, antipsychotics [and] HIV," McKinnell said. "We're in all those markets."

The "rapidly declining" categories are allergy and menopause, McKinnell noted. Pfizer has divested its women's health line, and, in the allergy category, Zyrtec (cetirizine), is "gaining both growth and share," although "it is probably too early to tell." Zyrtec sales were up 33% in the U.S. to $293 mil.

"Why the cardiovascular market is only growing 4% in the first quarter, or oral hypoglycemics, is kind of a mystery to me," McKinnell acknowledged. The cardiovascular market, where Pfizer markets Norvasc (amlodipine) and Accupril (quinapril), "is a big one for us," he noted.

Norvasc sales declined 3% in the U.S. to $436 mil.; Accupril sales fell 7% to $113 mil.

One possible explanation for the impact in that category is the publicity surrounding the ALLHAT trial. The National Institutes of Health reported results in December, emphasizing its conclusion that diuretics outperformed a calcium channel blocker (Norvasc) and an ACE inhibitor (lisinopril) (² [A#00640510008], p. 11).

Pfizer has launched an aggressive campaign to counter the ALLHAT study report, claiming that the data in fact support first-line use of Norvasc (³ Also see "ALLHAT Supports First-Line Norvasc Use, Pfizer Claims" - Pink Sheet, 27 January, 2003., p. 20).

For Lipitor, Katen indicated that Pfizer is counting on the ASCOT trial, presented during the American College of Cardiology meeting, to spur a turnaround in growth rates. The study showed a significant benefit in patients with normal or mildly elevated lipid levels who took Lipitor in combination with an antihypertensive, Pfizer said.

The study further expands the patient population eligible for statin therapy, Katen said.

Pfizer is pursuing a Lipitor/Norvasc combination that could help capitalize on the ASCOT results (provided that the company is successful in reassuring physicians about Norvasc's role in light of ALLHAT). Pfizer filed an NDA for the dual therapy in March.

Pfizer has not seen any lingering impact from the withdrawal of Bayer/GlaxoSmithKline's Baycol on Lipitor in the U.S., Katen added. She noted that all Lipitor doses are now approved as starting doses, suggesting that there are no undue safety concerns even at high doses with the drug.

Lipitor Sales Slowdown Reflects Overall Rx Market Trend, Pfizer Says

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