Pfizer sees signs of a rebound in Lipitor (atorvastatin) prescriptions over the past six weeks, U.S. Pharmaceuticals President Pat Kelly said during Pfizer's June 17 analysts meeting in New York.

"We are beginning what is hopefully a significant rebound in Lipitor prescribing," Kelly said.

Asked about what an analyst described as a "slight uptick" in Lipitor prescriptions in recent weeks, Kelly characterized it as a reflection of "the fact that we've mobilized a significant portion of our field sales and marketing organization to increase support of the product."

Lipitor sales in the U.S. for the first quarter were $1.38 bil., an increase of 6%, slow growth compared to the 21% Lipitor grew in the U.S. in 2002. When Pfizer reported its quarterly numbers in April, the company speculated that Lipitor's performance may reflect an overall softening in prescription demand (¹ Also see "Lipitor Sales Slowdown Reflects Overall Rx Market Trend, Pfizer Says" - Pink Sheet, 28 April, 2003., p. 24).

During the June 17 analysts meeting, Pfizer talked at length about what it sees as a more specific softening in the overall cholesterol market, which the company believes reflects: (1) the limited attention paid to treatment guidelines; (2) cost-containment pressures, and (3) "lingering" safety issues associated with the Baycol withdrawal.

According to Pfizer, Lipitor continues to deliver above-market growth, with a 4% increase in new prescriptions through April, compared to a 5% decline for Merck's Zocor , a 1% decline for Bristol's Pravachol and a 5% decline for Reliant's Lescol XL .

There is "significant upside potential in the cholesterol category," Pfizer Global Pharmaceuticals President Karen Katen maintained.

While worldwide Lipitor growth is twice that of the market, Pfizer would like to see a return to historical, double-digit trends. "Four percent growth is absolutely not enough; we need to drive this higher and we have the data to do it," Katen stated.

"Treatment guidelines continue to evolve encouraging the use of statin therapy to lower levels of cholesterol," Katen said. "Underdiagnosis and undertreatment remain significant and we see consistent new clinical and exciting clinical data that supports the early use of statin therapy."

Pfizer is underscoring that message with new outcome studies of Lipitor.

"The data we now have provides a platform for even more growth as it shows Lipitor benefits in expanded populations," Katen said. "That's where we're targeting our educational and promotional efforts."

Katen pointed to the Anglo-Scandinavian Cardiac Outcomes trial (ASCOT), presented during the American College of Cardiology meeting, as an example of how data will drive Lipitor growth.

The study involved untreated patients with hypertension and normal to moderately elevated cholesterol. "ASCOT results showed that by taking Lipitor, these patients had significantly...fewer strokes, fewer cardiac events than non-treated patients....This benefit was obtained with the lowest dose of Lipitor," Katen stated.

ASCOT showed a 39% reduction in events in three years with patients taking Lipitor 10 mg. Katen compared the findings to Merck's 4S trial of Zocor (simvastatin), which showed 34% event reduction in five years for patients taking Zocor 20 mg or 40 mg.

A Lipitor study in diabetic patients was halted June 16 because the drug demonstrated superiority to placebo. "When Lipitor is used in diabetic patients as seen in the CARD study this week...it improved cardiac outcome. We are really excited about these studies; they are the platform for growth and for our future educational efforts," Katen stated.

The studies will help underscore the message that Lipitor has "power you can trust."

The message plays up Lipitor's reputation for potency while acknowledging the safety concerns in the category following the withdrawal of Baycol.

"In an extensive meta-analysis of the entire Lipitor database, which is well over 8,500 patients across the dosing range, we found that myalgia is not an issue. The incidence is same as that of placebo. Myopathy or muscle damage was zero, and again was not an issue. That's trust," Katen said.

The recent introduction of the first generic into the category (lovastatin) and the launch of the non-statin Zetia (ezetimibe) have not expanded the category, Katen said.

"The growth of generic lovastatin is moderating and, while Zetia's growth is not moderating, neither of these launches are market expanding events; products are just capturing share from other products on the market," Katen said.

Katen does not expect Lipitor growth to be affected by the launch of other statins, particularly AstraZeneca's Crestor (rosuvastatin).

Crestor has an advisory committee review set for July 9. [To watch a ² webcast or video of the meeting, go to FDAAdvisoryCommittee.com.]

"Crestor was recently launched in the U.K. and Canada....So far, this launch as been underwhelming, I would say. We are confident that Lipitor will continue to grow in these and other markets despite new competition," Katen stated.

Pfizer is also counting on the Lipitor/ Norvasc combination therapy to boost the product. An NDA was submitted in March, under the tradename Caduet .

The dual therapy will be targeted at an estimated population of 27 mil. patients with both dyslipidemia and hypertension. Katen noted that the ASCOT trial will be particularly useful in launching Caduet.

"Only 2% of these patients are currently treated for both conditions, and 43% are treated for neither one," Katen said.

Also, Pfizer is developing the HDL-elevating agent torcetrapib (CP-529,414) for concomitant use with Lipitor to treat dyslipidemia and atherosclerosis. The treatment will allow patients to raise HDL cholesterol and lower LDL cholesterol simultaneously. Phase III studies for torcetrapib will commence this year.

Lipitor Scripts Rebounding, Pfizer Says; Cholesterol Category Still Has Life

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