Pfizer is beginning its launch of the congestive heart failure therapy Inspra .

The Inspra launch meeting was held Jan. 21, Global Pharmaceuticals President Karen Katen said during the company's year-end conference call Jan. 22.

Inspra (eplerenone) was approved for congestive heart failure Oct. 7.

It had already cleared FDA for hypertension, but Pfizer held off on a launch until the CHF indication was approved (¹ Also see "Inspra Approved For First-Line CHF; Pfizer Expects Most Use Will Be Add-On" - Pink Sheet, 13 October, 2003., p. 19).

Pfizer's target market for Inspra is heart failure patients following a myocardial infarction, Katen said. "It's a very well-defined patient population."

The drug is of "major medical merit," having shown a "15% reduction in mortality in that patient group," CEO Hank McKinnell added. "It's a wonderful product opportunity."

"The reps were very excited about the availability of this product and their opportunity to deliver that message to their customers," Katen added.

Pfizer began selling Inspra through an early access program at the end of 2003. Pfizer reported initial sales of $13 mil. in the fourth quarter 2003.

Inspra is the first of two potential launches in the cardiovascular category for Pfizer in 2004. The company has an NDA pending for Caduet , a combination of the cholesterol agent Lipitor (atorvastatin) and the antihypertensive Norvasc (amlodipine).

Pfizer has begun to invest more heavily in low-risk "product enhancements" such as Caduet to help round out its R&D portfolio (² Also see "Pfizer Stops Swinging For The Fences; Combo Products Are Big Opportunity" - Pink Sheet, 17 November, 2003., p. 33).

Inspra is another product with combination potential. There are "opportunities for combination products obviously," McKinnell said.

Pfizer U.S. Pharmaceuticals President Pat Kelly noted that the "intellectual property protection for Inspra in the U.S. is through 2009" (³ Also see "Quarterly Call Round-Up: Pfizer, GSK, Lilly Updates" - Pink Sheet, 3 November, 2003., p. 26).

Katen declined to discuss Pfizer's planned product positioning for Caduet or project a launch date. The user fee date is in January.

McKinnell, however, offered a hint on the positioning.

"What's really interesting from a medical standpoint is it looks from the clinical trial results that patients with elevated blood pressure, almost no matter what their cholesterol level, would benefit from dual therapy."

Norvasc 2003 U.S. sales grew 9% to reach $1.9 bil. Lipitor generated $5.8 bil. in U.S. sales, up 9% for the year.

The drug had a bit of a slow start, 6% growth in the first quarter compared to its 21% growth in 2002, but it picked up later in the year (⁴ Also see "Lipitor Scripts Rebounding, Pfizer Says; Cholesterol Category Still Has Life" - Pink Sheet, 23 June, 2003., p. 8).

Kelly commented on the fluctuations over the last year in the statin market.

"Any ups and downs that have occurred over the past year reflect the kind of dynamic between generic availability of some of the older products, the increasing use of some combination products or products in combination in general," Kelly said.

Pfizer says it has been able to stave off AstraZeneca's Crestor (rosuvastatin), the most recent addition to the statin group (⁵ Also see "Lipitor Weathers Crestor Launch; Lancet Weighs In On Pfizer’s Side" - Pink Sheet, 3 November, 2003., p. 22).

"The Crestor launch is being kept at bay, which is where it belongs," Kelly declared. "We still have the agent available in Lipitor that is best able to get the largest number of patients safely to their cholesterol goals."

Kelly acknowledged that Lipitor prescriptions did not match the 9% dollar growth rate. The differences reflects a combination of price increases for Lipitor and "the movement of physicians prescribing up the dosage range of Lipitor."

"There will be some price impact this year as a result of a small inflation adjusted increase for Lipitor price," Kelly added.

"The net pricing environment for Lipitor is such that we believe that based on benefits the product provides to physicians and patients that it is priced appropriately to those benefits and that we will accrue the benefit that comes from increased use of the product and increased pool of patients."

"Beyond that we can't comment on any kind of calculation of what we offer in terms of other kinds of prices," Kelly said.

Pfizer expects to continue to expand Lipitor's cardiovascular outcomes labeling.

The company noted that, while many of the studies may feel "old" to investors, the process of getting the data into labeling takes time - and provides an opportunity to gain attention from physicians.

In addition, "we have found the market is willing to pay for that increased benefit," McKinnell said.

"We have a whole series of studies ongoing looking at stroke prevention, looking at morbidity, mortality effects in the elderly," Worldwide Development President Joe Feczko said.

"These larger morbidity, mortality studies...are geared to have filings when they complete," Feczko said.

Pfizer has filed the results of the ASCOT trial, and expects to file CARDS and REVERSAL once the data are fully analyzed.

"All of these great outcomes studies that are now beginning to come out are using higher doses of Lipitor," Kelly noted. "So we see a great benefit to patients and to physicians that treat them by using higher doses."

"We've also been able to reconfirm in the same time the safety of Lipitor used at all of those dosage ranges," Kelly said.

As a result, "we would expect a continued movement of the product usage up the dosage range as physicians find greater and greater application to greater and greater numbers of patients."

Overall, Pfizer's worldwide sales for 2003 totaled $45.2 bil., up 40% (thanks to the integration of Pharmacia). The company is on track to grow well past the $50 bil. sales mark next year.

"Our expectations for strong financial performance in 2004 remain substantially unchanged," the company said. "We are comfortable with targets for 2004 revenue of about $54 bil."

Net income was $3.9 bil. in 2003, including one-time charges.

Pfizer took a Pharmacia purchase accounting charge of $8.7 bil. and a charge for merger-related costs of $660 mil.

In addition, Pfizer took charges totaling $1.4 bil. to cover the resolution of Rezulin (troglitazone) product liability litigation and the pending investigation of off-label promotion of Neurontin (gabapentin).

Pfizer also recorded $2.29 bil. in income recorded from the gains on the sale of discontinued businesses and products.

Excluding one-time charges, Pfizer earned $12.7 bil. in 2003, compared to $9.1 bil. in 2002.

The full year numbers provide new metrics to measure Pfizer's new hold on the top spot in the pharmaceutical industry.

With $45 bil. in annual sales, Pfizer would still be nearly twice as big as a combined Sanofi/ Aventis; the French companies are the subject of merger speculation.

Worldwide sales of Lipitor reached $9.2 bil., making it the first pharmaceutical product to cross the $9 bil. annual sales mark - and making Lipitor by itself larger than all but about 15 pharmaceutical companies.

During the call, McKinnell noted that its research and development budget for 2003 was $7.9 bil., "which is approximately 15% of total industry research and development spending."

Pfizer Launches Inspra; Will Help Company Reach $54 Bil. In 2004

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