The early returns in the Lipitor versus Crestor marketing battle are running heavily in favor of Pfizer.

U.S. sales of Pfizer's market-leading cholesterol brand Lipitor (atorvastatin) grew 17% in the third quarter to $1.58 bil. The product was not "appreciably" affected by the launch of AstraZeneca's Crestor (rosuvastatin) in August (¹ Also see "AstraZeneca Crestor 10 Mg Starting Dose Priced At 12% Discount To Lipitor" - Pink Sheet, 18 August, 2003., p. 3).

AstraZeneca reported $56 mil. in Crestor sales for the quarter, including initial wholesaler stocking.

Pfizer cited two data points to suggest that the launch will not live up to blockbuster expectations. "The uptake on Crestor...is significantly less than the uptake seen for Lipitor when it launched several years ago," U.S. Pharmaceuticals President Pat Kelly told an Oct. 22 conference call.

In addition, Kelly said, the uptake is slower than the rate achieved by Schering-Plough/Merck's Zetia (ezetimibe) earlier in the year. Pfizer maintains that Zetia is having trouble moving above a 5% share of the cholesterol category (see ² Also see "Merck/Schering Zetia Early Use Is In High-Risk Patients; New Rx Share At 5%" - Pink Sheet, 3 November, 2003.).

Crestor's performance in the U.S. is "very similar to what we've seen in the international markets," Pfizer CEO Hank McKinnell said. "The growth is very slow and not overwhelming," Global Pharmaceuticals President Karen Katen added.

AstraZeneca acknowledged during an Oct. 23 conference call that early prescription trends are tracking below some of the all-time best launches. However, AstraZeneca maintained that there are more encouraging signs in "softer" data points.

"What we are really more interested in is some of the softer feedback," CFO Jonathan Symonds said. "What are the patients telling us? What experiences are they having on Crestor as opposed to other statins? What are doctors seeing?"

Symonds pointed to the "very, very rapid uptake in managed care" as another encouraging sign. AstraZeneca announced Oct. 2 that the product is covered by managed care plans representing 50% of the market (³ Also see "Crestor Flat Pricing Helps AstraZeneca Secure Coverage For 50% Of Lives" - Pink Sheet, 6 October, 2003., p. 39).

There has been one prominent non-coverage decision, announced by Wellpoint, citing potential safety issues. "I'm not aware of anyone else who has publicly come out in the way that Wellpoint has." There "will always be some managed care organizations that are more conservative and will wait to come in," Symonds said.

"Clearly it takes time for all of those things to flow through in the IMS data," he added. "A single data view of progress of a launch of this scale on daily prescriptions, weekly prescriptions or monthly prescriptions simply isn't going to give you the full richness in what we are achieving to date."

Symonds noted that sampling for Crestor is "significantly greater than anything we've done before," including the launch of Nexium . "Clearly that will suppress the data."

Pfizer's Kelly, however, suggested a different interpretation. The slow pace of the launch "reflects a marketplace reality that is setting in, which is that Crestor might or might not offer some efficacy benefits, but there is way too much baggage that comes along with the product to inspire all the trials that would be necessary to generate greater movement in the new prescriptions."

Pfizer's argument that Crestor carries too much "baggage" received support from an editorial published by The Lancet Oct. 24. The editorial noted the lack of outcomes data for Crestor, the safety issues in the statin category and what it called the "unusually acute commercial pressure" on AstraZeneca.

"AstraZeneca has pushed its marketing machine too hard and too fast," the editorial declared, calling on AstraZeneca CEO Tom McKillop by name "to desist from this unprincipled campaign." [Editor's Note: The Lancet and F-D-C Reports, publisher of "The Pink Sheet," are both divisions of Elsevier.]

The Lancet also published a response from McKillop, characterizing the editorial as "outrageous." McKillop noted the extensive data set included in the Crestor NDA, the lack of outcomes data for other statins at the time of launch and the fact that approval was supported by an FDA advisory committee. "Over 200,000 patients worldwide have now been treated with Crestor," McKillop noted. "Post-marketing surveillance confirms its safety profile to be similar to that of other marketed products in the statin class," he maintained.

Lipitor Weathers Crestor Launch; Lancet Weighs In On Pfizer’s Side

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