Pfizer - zu Unrecht im Keller

When asked about a Vioxx market return, Robert Hazlett, analyst for Suntrust Robinson Humphrey, said, "There is a chance that could occur. It is an outside chance, but there is a chance."

The NSAID trouble began with Merck's (down $0.42 to $33.92, Research) Vioxx, which totaled $2.5 billion sales in 2003, its last full year on the market. Merck, based in Whitehouse Station, N.J., pulled the drug off the market in September, 2004, after a study showed increased risk of heart attacks and strokes in patients taking the drug for at least 18 months. Since then, nearly 10,000 lawsuits have been filed against Merck by plaintiffs who blame the drug for heart attacks, fatal and non-fatal. So far, Merck has lost one case, won two, is retrying another case that ended in a hung jury, and has another case ongoing.

The future of Bextra
The trouble for Pfizer (down $0.62 to $25.72, Research) came to light a few months later, in April of 2005, when the FDA asked the New York-based drug giant to take Bextra, which totaled $1.3 billion in 2004 sales, off the market. Pfizer's Celebrex remains on the market to this day, but sales have been cut in half, to $1.7 billion in 2005 from $3.3 billion in 2004. In July of 2005, the FDA had Pfizer add a "black box," the most severe type of warning, to its Celebrex label to reflect risks of heart attacks, strokes and gastrointestinal bleeding.

Analysts weren't so rosy about a market return for Bextra. While Vioxx has a wealth of data, positive and negative, Bextra does not, so Pfizer would have to invest in expensive studies to demonstrate the drug's safety to regulators.

"Pfizer would have to run more clinical studies for [Bextra's return to market,] and the market has really shrunk to the point where it's doubtful that Pfizer would ever return the product to market," said Moskowitz of FBR.

The future of Celebrex
Celebrex remains on the market with a black box that warns of possibly fatal heart attacks, strokes and gastrointestinal bleeding. Analysts are mixed as to whether the warning is a permanent or temporary.

Rubin of Morgan Stanley said that not only will Celebrex always have that black box, but that someday all NSAIDs will carry it, including the over-the-counter ibuprofen. But Moskowitz of FBR believes that Pfizer might shake the warning by tapping its wealth of safety data concerning Celebrex, particularly with regard to the gastrointestinal risks.

Dr. Eric Matteson, NSAID expert and professor of medicine at the Mayo Clinic College of Medicine in Rochester, Minn., said that of all the major NSAIDs, Celebrex is definitely the safest and the only one that should still be available for patients.

"The concerns that led to Vioxx and Bextra being pulled from the market are grave concerns," said Matteson. "In my opinion, Celebrex is still on the market because the degree of cardiovascular events from Celebrex is not as high as Bextra and Vioxx. A drug like Celebrex is in a good position to remain on the market."

Dr. Mark Fendrick, NSAID expert and professor of internal medicine at the University of Michigan, said that Vioxx, Bextra and Celebrex were initially developed as alternatives to other NSAIDs like ibuprofen because they're easier, or intended to be easier, on the stomach. He said this fact is often overlooked amid the hype surrounding the fallen-from-grace blockbusters.

"If you have gastro-intestinal concerns, and you don't have heart concerns, and you're not taking aspirin, then that's where COX-2 inhibitors – Vioxx, Bextra, Celebrex – have a safety advantage," said Fendrick. "I do believe that in the absence of aspirin, Celebrex is safer for those with gastro-intestinal risk. They're no better in terms of pain relief, but they have an advantage for gastro-intestinal safety. If only we gave them to people to get the gastro-intestinal advantage, we wouldn't have this trouble."

To read about a study on NSAIDs and heart disease, click here.

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The New York-based pharmaceutical giant said it sees reporting 2006 earnings of $1.52 to $1.56 a share.

On an adjusted basis, earnings will amount to $2 a share. Pfizer reported adjusted earnings of $2.02 a share in 2005, down from $2.12 in 2004.

Likewise, revenue will be relatively flat with 2005's top line of $51.3 billion, executives said during the company's annual analyst day.

A poll of analysts by Thomson First Call pegged the drugmaker's 2006 adjusted earnings at $2.04 a share, on revenue of $51.6 billion.

Lower sales from products that have lost their market exclusivity due to patent expirations should be offset by revenue from newer products, Pfizer said.
Executives added that Pfizer should return to revenue growth in 2007.

The company's plans call for launching six new drugs in 2006, including inhaled insulin product Exubera, a smoking-cessation aid called Champix and oncology drug Sutent.

"While near-term results will be tempered by loss of exclusivity of older medicines, we see a bright, long-term future driven by growth of current and new medicines, productivity enhancements and new initiatives to enhance shareholder value," said David Shedlarz, Pfizer's vice chairman, in a statement.

For 2006, sales of Lipitor -- the cholesterol agent that's the company's top-selling drug -- are expected to total upwards of $13 billion. The drug took in $12.2 billion in 2005.

[Vor allem diese Erwartung Pfizers ist mir schleierhaft, wenn ab Juni die Zocor- und Prachavol-Generika kommen. ICH erwarte, dass die Lipitor-Verkäufe im 2. Halbjahr zurückgehen und insgesamt deutlich unter 12 Mrd. - dem Wert von 2005 - bleiben werden. Ich kann mir auch schon vorstellen, wie Pfizer im Herbst argumentieren wird: "Zahlen leider verfehlt, weil Fettsenker-Generika UNERWARTET STARK den Lipitor-Umsatz reduzierten." Für mich ist das nicht unerwartet, sondern JETZT schon zu erwarten. Pfizer scheint seine Aktionäre für dumm verkaufen zu wollen. - A. L.]

According to Natexis Bleichroeder analyst Jon LeCroy, those projections for Lipitor, the world's best-selling medicine, were a bit light. Lipitor sales grew by 12% in 2005, whereas the new forecast sees sales growing by only 7%.
One looming threat to Lipitor's growth has been the expected launch of cheaper, generic versions of Merck's popular cholesterol drug Zocor, which it loses patent protection later this year.

In December, Pfizer scored a major victory against generic drugmaker Ranbaxy Laboratories when a federal court upheld its patents for Lipitor, which are due to expire in June 2011. Ranbaxy, which has sought to put out a generic version of the drug, plans to appeal the decision.

On its conference call with analysts, Pfizer management talked about their plan to unveil a "new and improved" Lipitor. The new product, which has yet to be named, would include the drug torcetrapib, which can boost levels of "good" HDL cholesterol levels in the bloodstream. Higher HDL levels are believed to help combat heart disease.

The new Lipitor would follow in the footsteps of Merck and Schering-Plough's Vytorin, which is really a combination of two older products -- Zocor and Zetia. Just as Merck has worked to move Zocor users over the Vytorin, Pfizer would try to lure Lipitor users over to Lipitor/torcetrapib. "But the new Lipitor would be a much bigger product than Vytorin," said LeCroy, noting that Vytorin doesn't raise HDL levels.

Pfizer hopes to file for regulatory approval of the new Lipitor in 2007, making a 2008 launch is likely. If the drug makes it to market in 2008, LeCroy said it could have sales of $5 billion by 2010, on top of sales of original Lipitor.

Pfizer also said sales of the pain reliever Celebrex should be more than $2 billion in 2006, compared with $2.4 billion in 2005. Sales of Lyrica, Pfizer's new pain medication, will be around $900 million, a dramatic jump from its 2005 sales of $291 million.

[Das ist positiv: Es gibt also auch organisches Wachstum in der bestehenden Pipeline - A. L.]

Medicare Part D as growth catalyst

Vice-Chairman Karen Katen said that Pfizer has also repositioned its mammoth sales force in response to the new Medicare Part D program, which provides increased drug benefits to many seniors. The program went into effect on Jan. 1.

Pfizer said that Part D will account for about 20% of U.S. sales in 2006, and almost 40% in 2008.

"We restructured our U.S. field force to mirror the new regional structure under Medicare," Katen said. "This has resulted in our representatives spending more time in the field with less duplication, enabling us to build even stronger relationships with physicians and Medicare prescription-drug plans."

Pfizer also said its ongoing cost-cutting plan should reap about $3.5 billion in savings by 2007 and $4 billion by 2008.

[Das ist ebenfalls positiv, FALLS es eingehalten wird. - A. L.]

The company also plans to buy back $1 billion in stock over during 2006. By comparison, Pfizer bought back $4 billion in stock during 2005.

Pfizer reiterated that it has raised its dividend by 26%, 24 cents a share for the first quarter.

Earlier this week, Pfizer confirmed rumors that it was considering selling or spinning off its consumer products division, which markets such popular brands as Lubriderm, Sudafed and Listerine.

On a call with analysts Friday, Shedlarz said the division, whose 2005 revenue totaled nearly $4 billion, could have a market value of more than $10 billion. He added that the company would make a decision on what to do about the unit during the third quarter of 2006

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Und hier noch MEIN Ausblick für 2006:

Das Schlafmittel Indiplon, das Pfizer gemeinsam mit Neurocrine Biosciences entwickelte, soll in wenigen Monaten auf den Markt gelangen. Auch hier ein hohes Potenzial: Indiplon soll das Ein- und Durchschlafen verbessern. Pfizer nahm frühere Gewinnschätzungen für 2006 / 07 zur Überarbeitung wieder zurück. Wenn am 10. Februar weitere Zahlen zu 2005 genannt werden, erwarten wir auch neue mehrjährige Planungsdaten.

Fazit: Die Pharma-Spekulation absolviert die spektakulärste Branchensanierung, die es jemals gab. Sämtliche großen Firmen der Pharmazeutik mußten in den vergangenen Jahren empfindliche Rückschläge in der Forschung, in der Zulassung und der Wettbewerbsfähigkeit ihrer Produkte hinnehmen, nebst Schadensersatzleistungen aller Art. Die neue Aufstellung geht in Richtung delegierter Forschung oder Lizenzproduktion von reinen Forschungsunternehen, bei reduzierter Eigenforschung und mithin einem neuen Geschäftsmodell.