Extending a powerful statin franchise, Pfizer readies dual-use marketing plan

Drug Store News, March 1, 2004 by Michael Johnsen

NEW YORK -- The Food and Drug Administration s approval last month of Pfizer's Caduet--a product developed to treat two separate conditions in one pill--could give the pharmaceutical giant a blockbuster sequel to its No. 2 best-selling treatment, Norvasc.

A treatment for hypertension, Norvasc faces patent expiration as early as 2006.

"Caduet is a life-cycle management story," remarked David Moskowitz, an analyst, with Friedman, Billings, Ramsey & Co. The lifecycle that Pfizer is attempting, to extend here is the Norvasc franchise, he said.

Caduet is a combination of Pfizer's two leading prescription drug franchises, Lipitor and Norvasc, and as such is indicated as a treatment both for high blood pressure and high cholesterol--both risk factors for heart disease.

Analysts have predicted Caduet worldwide sales will reach $1.1 billion by 2008. Currently, according to Pfizer figures, 2003 Lipitor sales worldwide total $9.2 billion and Norvasc $4.3 billion.

"Franchise rotation strategies are very important strategies these days, given the patent challenges that we re seeing from generic companies," Moskowitz noted. Other than coming up with new and novel products, he noted, the only way to really protect against the rapid erosion of large franchises to generic competition is to move them into other drug regimens that make sense.

"Any cannibalization on Norvasc is well-intended," Moskowitz continued. "And any cannibalization on Lipitor is an unfortunate consequence, but the company still captures those sales."

But as demonstrated by the introduction of AstraZeneca's Crestor to the statin scene last year, there is still plenty of room for growth in the high-cholesterol treatment arena, so Lipitor sales may not actually be cannibalized to any great extent. As many as 65 percent of people suffering from high cholesterol don t treat their condition, said David Shedlarz, Pfizer's executive vice president and chief financial officer, in a presentation he gave last month.

"What we're doing with Caduet [is] really focusing on a different, unique piece of the population," observed Patrick Holmes, vice president of Pfizer's cardiovascular franchises.

With 63 million Americans now estimated to have dyslipidemia and 47 million with hypertension, some 30 million Americans shake out as at risk for both high cholesterol and high blood pressure. Roughly 500,000 people are at risk for both disease states are currently on a combined regimen of Lipitor and Norvasc, Holmes estimated.

Consequently, those patients are at a significantly higher risk for end-stage cardiovascular disease, Pfizer research has found. "We think that that patient population is not recognized as an important entity," Holmes suggested. Physicians are not necessarily targeting this patient population."

Approved in February, Caduet will be available this spring in multiple dosage combinations. Getting the word out to physicians on the importance of aggressively treating the combination of risk factors won't be a hurdle for Pfizer, however. "Pfizer's sales force is very well-entrenched, probably the most well-entrenched sales force in the cardiovascular area," Moskowitz noted.

Already, the company has an advertorial that's been placed in a number of cardiology journals, Holmes said. "It's an underappreciated patient population that's certainly going to be a focus of our efforts."

Although patents protecting Lipitor aren't expected to expire before 2009, Pfizer may already be lining up a successor for the most prescribed, best-selling pharmaceutical. The company in December offered $1.3 billion for Esperion Therapeutics in a deal that's expected to close some time this quarter. Esperion is currently researching a HDL-heightening drug regimen that has shown initial promise.

And Pfizer already has the ball in motion for another combination therapy, this time combining Lipitor with torce-trapib to make a drug that simultaneously lowers LDL levels, or the "bad" cholesterol and raises "good cholesterol HDL levels. The drug, currently in late-stage trials, is expected to hit the market by 2006, has the potential of pulling in $2 billion in sales annually. "That will be the product rotation strategy for the Lipitor franchise," Moskowitz commented.

Top pharmaceuticals
by U.S. prescriptions dispensed

              Prescriptions
Drug           dispensed *     % change

Lipitor           68.3             6%
Synthroid         48.8             6
HYCD/APAP         41.3            25
Norvasc           36.3             2

Top drugs by U.S. sales

Drug           $ sales **      % change
Lipitor           $6.6            11%
Zocor              4.3             5
Prevacid           3.9            11
Procrit            3.3             5
Zyprexa            3.2            11
Epogen             3.0             8
Nexium             2.8            73
Z01oft             2.8            10
Celebrex           2.5            -2
Neurontin          2.4            20
Norvasc            2.1             4

* In millions ** In billions
Source: IMS Health for the 12 months ended in September