Pfizer - zu Unrecht im Keller

In an article in the October 7 New England Journal of Medicine, one expert makes a case for the same harmful effects. Pfizer's president of worldwide development disputes this perspective, stating, "The data we've accumulated over time demonstrate that Celebrex does not increase the risk of serious cardiovascular events in patients with arthritis and pain, even at higher-than-recommended doses." He is backed up by the acting director of the Food and Drug Administration's Center for Drug Evaluation and Research, who pointed out that Vioxx and other Cox-2 inhibitors did not show the same incidence of heart attack and stroke in clinical trials.

Who's right? Who's wrong? Are there hidden agendas? For now, it's impossible to say. But the lesson is that investors should not throw the baby out with the bathwater just because the baby next door is a demon seed. Do you sell Chico's FAS (NYSE: CHS) just because same-store sales at the Gap (NYSE: GAP) went down last month? Not necessarily.

There are four things to do before you panic. Watch. Wait. Research. Act. Until then, take some Cox-2 inhibitor and call me in the morning.

Pfizer Bextra, ebenfalls ein COX-2-Schmerzmittel, hat eine ähnliche Mortalitätsrate wie Mercks Vioxx. Es deckt jedoch nur eine Nischenmarkt ab (687 Mio. Umsatz), Celebrex hat einen mehr als doppelt so hohen Umsatz, der durch Umsteiger von Vioxx weiter wachsen wird. Bextra wird vermutlich nicht vom Markt genommen, erhält aber eine Black-Box-Warnung, was Werbung für das Medikament verbietet. Die Umsatzsteigerungen bei Celebrex dürften etwaigen Schwund bei Bextra überkompensieren.

Es gibt erste Klagen wegen Bextra, und es könnten auch Sammelklagen kommen. Doch anders als bei Merck, wo die Vioxx-Risiken lange bekannt waren und "böswillig" verschwiegen wurden, zeigten sich die Probleme bei Bextra erst kürzlich, so dass PFE keine vorsätzliche Täuschung der Kunden vorgeworfen werden kann. Das niedrige Verkaufsvolumen von Bextra macht Klagen auch weit weniger bedrohlich als bei Merck. Merck muss bei der Regulierung der Vioxx-Klagen mit Kosten bis zu 12 Mrd. Dollar rechnen. Bei PFE ist schon der Umsatz mit Bextra viermal niedriger als der Vioxx-Umsatz von Merck. Außerdem hat PFE 18 Mrd. Cash für etwaige Regulierungen.

- Lipitor (Patentklage - mögliche generische Konkurrenz)

eine indische Firma versucht am 30. November, vor einem US-Gericht das Patentrecht für den Fettsenker Lipitor - Pfizers Hauptumsatzbringer - anzufechten. Die Inder sind aber die einzigen Kläger, andere halten den Fall wohl für zu aussichtslos. Normalerweise treten bei solchen Klagen immer mehrere Kläger auf. Der Prozess wird sich in jedem Fall noch lange hinziehen. Die Patente für Lipitor laufen bis 2009/2011.

"We have long understood that we are facing significant patent expirations in
the 2005-07 period that will impact $14 billion of current Pfizer revenue,"
Chairman Hank McKinnell told an audience of investors and analysts at its
central research facility in Groton, Conn.

"We are in a much different situation than those companies that failed to
anticipate or lacked the means to respond to these challenges," McKinnell
added in remarks that were carried via a live Webcast.

Additionally, Pfizer, the industry leader in annual sales, reaffirmed its
existing financial forecast to earn $1.58 to $1.60 a share this year. Shares of
Pfizer, a component of the Dow Jones Industrial Average, closed up 44 cents, or
1.6 percent, at $27.77.

Pfizer highlighted its lucrative anti-cholesterol franchise from drugs like
Lipitor, the world's most prescribed brand-name pharmaceutical, which is due to
lose its patent exclusivity in 2010.

Pfizer has been working to promote a new combination therapy called Caduet,
which contains both Lipitor and Norvasc, a treatment for high blood-pressure.
Pfizer researchers said they believe combining Lipitor, which had 2003 sales of
$10.3 billion, with Norvasc, which took in $4.5 billion, could be a new
comprehensive approach to battling cardiovascular disease.

Pfizer is also developing a combination therapy of Lipitor, which reduces so-
called "bad" cholesterol, with Trorcetrapib, its drug that boosts "good"
cholesterol in the blood stream. The company plans to spend $800 million on a
massive clinical trial program as part of its effort to garner regulatory
approval for the new treatment.

Pfizer also focused on its Cox-2 inhibitors Celebrex and Bextra, which have
faced harsh scrutiny since Merck & Co. was forced to pull the painkiller
Vioxx, another Cox-2 inhibitor, from the market because it was linked to cardiac
problems. Pfizer said that it is on track to initiate a major clinical study
geared to study not only whether Celebrex may cause cardiac problems but
also whether it may actually be protective to the heart. Pfizer has
emphatically maintained that Celebrex, which generated about $2.5 billion last
year, poses no cardiac threat because its molecular makeup is different from
Vioxx and Bextra.

Kommentar: Schon frech, wie Pfizer den Spieß umdreht! Aber dies zeigt:
Celebrex bleibt am Markt und kann für Mercks zurückgezogenes Vioxx in die
Bresche springen.

The company also plans to file by the end of the year to have a liquid form of
Bextra approved for use as a painkiller following surgery.

Bextra scheint daher auch auf dem Markt zu bleiben.

Executives went on to discuss the progress of other drug candidates.
Of particular interest to investors was Pfizer's announcement that its inhaled
insulin drug Exubera, developed with Nektar Therapeutics and Sanofi-Aventis,
appears to be on track for receiving regulatory approval in Europe to treat
diabetes. Reports had circulated earlier this year that the regulators were
reluctant to approve the drug amid concerns that long-term use could harm the
lungs. Pfizer said it expects to file its application for U.S. approval of
Exubera early next year.

The company is also awaiting U.S. approval for two other promising drugs --
Macugen, a treatment for macular degeneration, a leading cause of blindness,
and Indiplon, a next-generation sleep aid. Pfizer aims to get Macugen approved
to treat other eye disorders such as blindness caused by diabetes.