Pfizer - zu Unrecht im Keller

Pfizer, which is based in New York, said that in addition to its cox-2 problems, results this year would be affected by the loss of United States exclusivity on four major drugs: Diflucan, Neurontin and Accupril during 2004 and Zithromax in 2005.

But the picture was not all gloomy, thanks largely to continuing double-digit growth of the cholesterol-lowering drug Lipitor, one of the world's top-selling medicines. Sales of the drug increased 23 percent, to $3.08 billion in the first quarter. Pfizer's overall sales rose nearly 5 percent to $13.09 billion.

Without one-time charges, Pfizer's earnings were $4 billion, or 54 cents a share, exceeding Wall Street expectations by one penny.

In a statement, Pfizer's chief executive, Henry A. McKinnell Jr., characterized the company's performance as steady, but he said 2005 would be a transitional year. Dr. McKinnell said the company's size, as well as the breadth of its portfolio and pipeline, would permit it to "marshal and refocus resources."

Bextra was withdrawn from the market early this month, but negative publicity surrounding the cox-2 inhibitors had already led to a sales decline in the first quarter. Bextra revenue dropped to $56 million, 79 percent less than the $270 million in the first quarter of 2004. The Food and Drug Administration asked Pfizer to stop selling Bextra because of evidence linking it to a rare but serious skin disorder. Pfizer said it disagreed with the F.D.A.'s risk-benefit analysis of Bextra and was meeting with regulators in an effort to resume sales of the drug.

Celebrex remains on the market, but its sales were down to $411 million, the company said, as consumers and physicians focused on reports about heart risks associated with drugs in the cox-2 class. In the first quarter of 2004, Pfizer sold $769 million worth of Celebrex.

Johnson & Johnson's record sales of $12.83 billion, up 11 percent, reflected stronger sales of medical devices as well as continued growth in some of its pharmaceutical products. Net income was $2.93 billion, or 97 cents a share, compared with $2.49 billion, or 83 cents, a year earlier, an increase of 17.7 percent.

Sales of Remicade, which is used to treat autoimmune disorders, were up 22 percent, to $501 million. Sales of the antipsychotic drug Risperdal also increased, by 16 percent, to $844 million. Revenue from the epilepsy drug Topamax increased 24 percent, to $406 million, partly because it has been approved to treat migraines.

The company, based in New Brunswick, N.J., said generic competition hurt sales for some big drugs, including contraceptives and the painkiller patch Duragesic.

The company also said that it was talking with the F.D.A. about revised labeling for Natrecor, an intravenous drug that is used to treat severe heart failure. Articles in the medical publications Circulation and The Journal of the American Medical Association have raised questions about the drug's safety.  

Damit fällt Sortis auf den 18. Platz der deutschen Arzneimittelrangliste zurück. Von den Veränderungen profitiert unter anderem der Hersteller des neuen Marktführers bei Cholesterinsenkern. Die Firma Hexal, die das Sortis-Konkurrenzprodukt Simvahexal verkauft, wurde kürzlich von Novartis übernommen und wird derzeit mit Sandoz, der Generika-Tochter des Konzerns, verschmolzen. Die Simvahexal-Umsätze legten im ersten Quartal 2005 gegenüber den ersten drei Monaten 2004 um 40 Prozent auf rund 25 Mio. Euro zu, so IMS. Diese Zahl spiegelt allerdings nicht den wahren Firmenumsatz wider, da Generikahersteller den Apothekern Rabatt-Packungen schenken, die den geldwerten Umsatz mindern.

Bei den gesetzlichen Krankenkassen sackte Sortis in der Gruppe der Cholesterinsenker von einem Marktanteil von über 30 Prozent auf nur noch sieben Prozent ab. Der Marktanteil von Sortis bei den Verordnungen privat Versicherter liegt bei 50 Prozent. "Das ist ein klarer Fall von Zwei-Klassen-Medizin", so die Pfizer-Sprecherin. Sortis hat laut Pfizer therapeutische Vorteile gegenüber anderen Produkten aus der Jumbo-Gruppe. Diese würden nun vielen Patienten nicht mehr ohne weiteres zugute kommen.

In the weeks since Bextra's withdrawal, Abramson said he has switched patients to a variety of drugs including Celebrex, Mobic and naproxen. He said overall, doctors are prescribing lower doses of all the drugs and limiting the time patients take the medications.

While the FDA's decision on Bextra and the other pain relievers created confusion for doctors and patients, it certainly roiled Pfizer. Just two days before it pulled Bextra off the market, Pfizer executives told analysts and journalists it believed it could revitalize sales of both Celebrex and Bextra as part of a strategy to return the company to double-digit growth by next year. It hasn't backed away from that projection. However, the company did lower its after-charges earnings projection for this year to $1.98 from $2 as it took a $766 million charge during the first quarter for halting Bextra sales.

Analysts had noted that Celebrex would pick up some Bextra sales, so the loss wouldn't be a total disaster.

For the week ended May 6, Celebrex picked up 34 percent of Bextra's prescriptions, according to Verispan, which tracks prescription data. A week earlier, it grabbed 32 percent. For the week ended May 6, Celebrex's new prescriptions totaled 228,898, while new prescription reached 92,674 - its best showing in at least three months.

Analyst Jason Napodano said Celebrex was performing better than he imagined but believed the results were likely below but Pfizer's expectations.

"I think 30 percent (of the Bextra prescriptions) would be good," said Napodano, of Zacks Investment Research Inc.

Pfizer wouldn't comment on its projections.

Last year, Celebrex generated $3.3 billion in sales while Bextra revenues totaled $1.3 billion. Bert Hazlett, an analyst at Suntrust Robinson Humphrey, had thought Celebrex sales would total $1.8 billion this year. He lowered his projection after Bextra was withdrawn to $1.75 billion because he felt Celebrex would be hurt in the fallout.

Hazlett was predicting flat sales growth for Celebrex in the next two years but said the gains from Bextra suggest Pfizer may be able to grow revenues. Now he thinks revenues next year could hit $1.825 billion and increase to $1.9 billion in 2007. But he said for Celebrex to get anywhere near its 2004 revenues it would need a host of new studies proving its usefulness in other areas and attesting to its safety.

Shares of Pfizer fell 4 cents to $28.19 in afternoon trading on the New York Stock E
xchange, where they have traded in a 52-week range of $21.99 to $36.60.  

In the weeks since Bextra's withdrawal, Abramson said he has switched patients to a variety of drugs including Celebrex, Mobic and naproxen. He said overall, doctors are prescribing lower doses of all the drugs and limiting the time patients take the medications.

While the FDA's decision on Bextra and the other pain relievers created confusion for doctors and patients, it certainly roiled Pfizer. Just two days before it pulled Bextra off the market, Pfizer executives told analysts and journalists it believed it could revitalize sales of both Celebrex and Bextra as part of a strategy to return the company to double-digit growth by next year. It hasn't backed away from that projection. However, the company did lower its after-charges earnings projection for this year to $1.98 from $2 as it took a $766 million charge during the first quarter for halting Bextra sales.

Analysts had noted that Celebrex would pick up some Bextra sales, so the loss wouldn't be a total disaster.

For the week ended May 6, Celebrex picked up 34 percent of Bextra's prescriptions, according to Verispan, which tracks prescription data. A week earlier, it grabbed 32 percent. For the week ended May 6, Celebrex's new prescriptions totaled 228,898, while new prescription reached 92,674 - its best showing in at least three months.

Analyst Jason Napodano said Celebrex was performing better than he imagined but believed the results were likely below but Pfizer's expectations.

"I think 30 percent (of the Bextra prescriptions) would be good," said Napodano, of Zacks Investment Research Inc.

Pfizer wouldn't comment on its projections.

Last year, Celebrex generated $3.3 billion in sales while Bextra revenues totaled $1.3 billion. Bert Hazlett, an analyst at Suntrust Robinson Humphrey, had thought Celebrex sales would total $1.8 billion this year. He lowered his projection after Bextra was withdrawn to $1.75 billion because he felt Celebrex would be hurt in the fallout.

Hazlett was predicting flat sales growth for Celebrex in the next two years but said the gains from Bextra suggest Pfizer may be able to grow revenues. Now he thinks revenues next year could hit $1.825 billion and increase to $1.9 billion in 2007. But he said for Celebrex to get anywhere near its 2004 revenues it would need a host of new studies proving its usefulness in other areas and attesting to its safety.

Shares of Pfizer fell 3 cents to close at $28.20 in Tuesday trading on the New York Stock Exchange, where they have traded in a 52-week range of $21.99 to $36.60.

Ein Sprecher der Herstellerfirma Pfizer bestätigte, dass Gespräche mit der FDA darüber geführt würden, einen Hinweis auf derartige Fälle im Beipackzettel aufzunehmen. Er sagte aber, dass es keinen Beweis dafür gebe, dass Viagra die Erblindung verursacht habe. Männer, die Viagra nähmen, hätten häufig auch einen hohen Blutdruck und einen hohen Cholesterinspiegel - auch dies gelte als Risikofaktor für eine Erblindung. Zu den häufigsten Nebenwirkungen der Potenzpille zählen laut dem Pharmaunternehmen Kopfschmerzen, Gesichtsröte und Übelkeit. Weniger häufig träten kurzzeitige Blausichtigkeit, eine verschwommene Wahrnehmung oder Lichtempfindlichkeit auf.

Anleger lassen Pfizer-Kurs straucheln

Die Pfizer-Aktie büßte an der Wall Street 2,7 Prozent auf 28,11 $ ein. Händler äußerten die Befürchtung, dass auf Pfizer millionenschwere Schadenersatzforderungen zukämen, wenn sie der Verdacht der FDA bestätige.

Im ersten Quartal hatte Pfizer mit dem Potenzmittel einen Umsatz von 438 Mio. $ erwirtschaftet, ein Plus von fünf Prozent binnen Jahresfrist. Das Mittel steht im Wettbewerb mit den Potenzpillen Cialis von Eli Lilly und Levitra von Bayer.  

Vicuron had about 60.86 million shares outstanding as of March 31. The deal is expected to close in the third quarter of 2005.


VICURON PHARMACEUTICALS  - Nasdaq National Market: MICU
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Associated Press
Pfizer Gets Lyrica FDA OK for Epilepsy
06.13.2005, 10:55 AM

Drug maker Pfizer Inc. said Monday that the Food and Drug Administration approved Lyrica as an adjunctive treatment of partial onset seizures in adults with epilepsy.

The company said that the approval was based on clinical trials that followed a total of 1,052 patients. Subjects treated in the trials had about 10 seizures a month despite taking one to three other antiepileptic medications. Pfizer said that patients who were also given Lyrica had an up to 51 percent decrease in the frequency of partial seizures.

The FDA approved the drug in December as a treatment for diabetic peripheral neuropathy, a nerve condition caused by diabetes leading to a loss of feeling in the extremities, and postherpetic neuralgia, or nerve damaged caused by shingles.

Lyrica is a type of drug known as an alpha-2-delta ligand that is believed to work by calming hyper-excited neurons.

Pfizer shares rose 2 cents to $27.70 in morning trading on the New York Stock Exchange.

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Bei Üfizer tut sich was!