..auf Grund generischer Konkurrenz. Wie schon im Forbes-Artikel (siehe oben im Thread) konzentriert sich der WSJ-Artikel zu sehr auf Lipitor und mögliche Verkaufseinbußen durch Generika, obwohl Lipitor im jetzigen PFE-Kurs fast "ausgepreist" ist (d. h. selbst ohne Lipitor wäre die Bewertung günstig). Neue Entwicklungen wie Sutent, Exubera und Champix (Raucherentwöhnung) werden IMHO nicht genug gewürdigt - ebensowenig wie die im Text zitierte Aussage von CEO McKinnell, dass Pfizer von allen US-Pharmafirmen die beste Pipeline an neuen Produkten hat (siehe unten, fett unterstrichen).
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Wall Street Journal
4.1.06
Pfizer Faces Uncertain FuturePfizer Inc., the world's largest drug company, is struggling with a big problem: an escalating campaign by employers and insurers to drive patients toward cheap generics.
Investors and the company have long known that generic copies would pummel several of Pfizer's top drugs that are losing patent protection. But in a new twist, generic versions of competitors' drugs are hurting sales of Pfizer drugs that are still patent-protected. Licensing deals, acquisitions and the company's own research have failed to produce enough products to pick up the slack.
[und was ist mit den 6 neuen Medikamenten, die im ersten Halbjahr 2006 kommen? - A.L.]
Most critically, U.S. prescriptions for Pfizer's cholesterol buster Lipitor have stagnated, even though five years remain on the key patent covering the medicine. At Kaiser Permanente, a California health-maintenance organization, fewer than 10% of patients on cholesterol-lowering drugs are getting Lipitor.
The result is trouble for the company that defined an era of heavily marketed pills for masses of patients. In October, Pfizer withdrew projections for 2006 and 2007, saying it lost a reasonable basis to make predictions.
[Dies geschah IMHO auf Grund der Unsicherheit vor dem US-Lipitor-Urteil, ohne das keine verlässliche Guidance gegeben werden kann - A.L.]
Its share price hit an eight-year low last month before recovering somewhat after a court ruling affirmed Lipitor's patent.
For years, even as some rivals hedged their bets by developing high-priced specialty medicines and vaccines free from generic competition, Pfizer threw its energy into remedies for common ailments. Among them were Celebrex for pain, Zoloft for depression and Viagra for impotence. Its key weapon was marketing: television ads for the public and an army of sales representatives urging doctors to prescribe Pfizer pills.
Today, insurers and drug benefit managers are becoming adept at overcoming Pfizer's marketing might. Massachusetts requires 131,000 state employees, retirees and dependents to try two other cholesterol pills before it will pay for Lipitor. Even if patients get Lipitor, they have to pay $40 a month as their share of the cost -- compared with just $7 a month for a generic competitor.
Lipitor sales in the U.S. rose only 1% in the third quarter from the year-earlier period even though prices were 5% higher. For the first two months of the fourth quarter, U.S. Lipitor prescriptions fell 2.3% compared with the same period a year earlier, according to NDCHealth, an Atlanta health-care information firm. It remains the world's best-selling drug with $12 billion in annual sales.
Lipitor's performance has put pressure on Pfizer's chief executive, Henry McKinnell. "Our strategy is to survive this period, and survival is the right word," says Mr. McKinnell in an interview. Regarding Lipitor's malaise, he says: "We think that's a temporary slowdown, but we would like some confirmation of that."
Pfizer's board is keeping a close eye on Mr. McKinnell, 62 years old, who has been chief executive since 2001. About a half-dozen members listened in during his latest earnings conference call with analysts, according to one person familiar with the situation. And at every board meeting, directors discuss where Pfizer will find new drugs, according to this person.
At the moment, however, the board isn't ready to ax Mr. McKinnell before his planned 2008 exit date or order a major change of course, people familiar with the situation say. "The board has known and management has known and the investment community has known for a long time that 2005 would be a challenging year," says Pfizer's lead director, Stanley O. Ikenberry, a former president of the University of Illinois. He says the board is confident that Pfizer's long-term investments in research will pay off.
Pfizer is responding to the immediate threat in the way it knows best: with lots of marketing. It is spending more to advertise Lipitor and courting employers with discounts on its drugs. While other drug companies are slashing sales staff, Pfizer has made only small cuts through attrition and still has 9,000 salespeople in the U.S. It says they'll be needed later this year with a slew of expected approvals of new products by the Food and Drug Administration, including a potential breakthrough pill to help smokers kick the habit.
Pfizer's pipeline has never looked better, says Mr. McKinnell. Still, he concedes, "we are not a growth company in the next couple of years."
Pharmaceuticals became one of America's biggest and most profitable industries thanks largely to a series of huge sellers introduced in the late 1980s and 1990s. Now many of those drugs are losing patent protection. Once that happens, brand-name pills eventually lose nearly all of their sales to generics, which are chemically identical. Pfizer itself lost patent protection on its huge-selling antibiotic Zithromax in November, and will lose its antidepressant Zoloft this year and blood-pressure pill Norvasc in 2007.
Generics now are building a critical mass. It's possible to treat a broad range of common conditions without any brand-name drugs. Some 60% of prescriptions in the U.S. are filled with generics, compared with less than half in 2000, according to IMS Health.
Historic Shift
As health-care costs continue to climb and take a bite out of corporate profits, employers and insurers are seizing on this historic shift. They are increasingly demanding that patients start with a generic and switch to a brand only if they need to. That approach damages brands that still have patent protection in addition to those that have lost it. Some 45% of employer-based insurance plans used this "step therapy" for at least one drug category in 2004, up from 22% five years ago, according to a survey by the Pharmacy Benefit Management Institute.
The agency that administers benefits for Massachusetts state employees estimates that the use of step therapy in 11 disease categories saved $3.9 million on its $158 million prescription-drug bill in 2004.
The trend afflicts all of Pfizer's top competitors, and the share prices of several are languishing far below peaks set in 1999-2001. Almost every company has had trouble discovering new mass-market pills to replace those going off-patent. Among the factors blamed for the research drought are the difficulty of topping existing drugs, tighter approval standards and big-company bureaucracy.
But Pfizer is in a particularly tough position because of its failure so far to develop new hits for specialty markets such as cancer, where rivals such as Novartis AG and Roche Holding AG are making big inroads.
[Das ist schlicht FALSCH. Spätestens im Februar 06 kommt Pfizers hochwirksames Krebsmedikament Sutent. Außerdem kursieren Gerüchte, dass PFE die US-Pharma-Firma Bristol-Myers kauft, die an Imclone beteiligt ist und einer der führenden amerikanischen Krebsmedikamente-Hersteller ist - A.L.]
Insurers have a tougher time restricting use of these specialty drugs because there are fewer generics and the drugs often treat life-threatening conditions.
Pfizer has also taken a hit from questions about painkillers that arose after Merck & Co. withdrew Vioxx from the market in September 2004 over heart risks. Sales of Pfizer's Celebrex painkiller have fallen by more than half, and Pfizer had to withdraw a related drug, Bextra, from the market last April at the FDA's request. Although Celebrex works similarly to Vioxx, studies haven't shown that it shares the same degree of heart-attack risk.
It was Mr. McKinnell who placed a huge bet on Celebrex by buying the drug's developer, Pharmacia Corp., in 2003 for $56 billion. Now some analysts are beginning to gripe. Barbara Ryan of Deutsche Bank wrote in an October report that Mr. McKinnell seemed "far too smug" and hasn't been transparent enough.
Mr. McKinnell, who has worked at Pfizer since 1971 and served as chief financial officer, says he understands the dissatisfaction of shareholders. "We need to go out and demonstrate that we heard the concerns" by quickly offering a new forecast for 2006 and 2007, he says. The company expects to do so next month.
As a salve for investors, Pfizer raised its quarterly dividend effective in the first quarter to 24 cents a share from 19 cents.
Pfizer's new TV spots promote cholesterol awareness, and print ads for Lipitor highlight the drug's ability to reduce risk of stroke. The company has redrawn sales territories to match the geographic boundaries of insurers offering the new drug benefit in the federal Medicare program for seniors. Pfizer blames the third-quarter slowdown in Lipitor sales in part on the demands of the reorganization during the quarter. It notes that foreign sales of Lipitor and some other top drugs continue to grow strongly.
Pfizer is seeking to counter managed care's efforts to downgrade Lipitor. The company's message: Insurers are hurting patients' health with their cost-cutting efforts. Dolores Mitchell, executive director of the Massachusetts agency overseeing health benefits for state employees, admits the higher co-payments for some branded drugs can be unpopular. "My husband, for one, is on Lipitor, and he's not a happy camper," she says.
Express Scripts, which manages pharmacy benefits for health plans and employers including Ms. Mitchell's agency, has recommended that its customers remove Lipitor from their lists of preferred drugs, or formularies. As a substitute Express Scripts is recommending Merck's Zocor, which will be available in generic form in June.
No. 1 Target
Pfizer contends it has lured back many employers who normally follow Express Scripts' advice. It is offering better prices on Lipitor directly to those employers. "We're in the trenches fighting it out," says J. Patrick Kelly, president of the company's U.S. pharmaceuticals unit. Lipitor, he says, "is No. 1 in market share. It's also the No. 1 target. People are getting really excited about taking on that No. 1 target."
Express Scripts says Pfizer's counterattack is failing. "The overwhelming majority of our clients have accepted our 2006 formulary recommendations," says spokesman Steve Littlejohn.
In California, where managed care's influence is strong, the generic drug lovastatin claims 15% of prescriptions for cholesterol-reducing drugs -- nearly double its national share of 8%, according to NDCHealth. Lovastatin is the second-most prescribed cholesterol drug in California, despite having no sales force or advertising behind it.
At Kaiser Permanente, 95% of patients prescribed a cholesterol-lowering "statin" drug start with lovastatin. Three-quarters eventually reach their goals with that drug and fewer than 10% get Lipitor, says Sharon Levine, associate executive director of Kaiser's medical group in Northern California. Kaiser similarly encourages use of generic antidepressants instead of Pfizer's Zoloft and older painkillers such as naproxen instead of Celebrex.
Nationwide, Zoloft, still patent-protected until the end of this year, has seen its 25% share of prescriptions flatten and recently start to slip under increasing pressure from generic versions of rival brands, including Celexa, Paxil and Prozac.
Testing Ground
The latest testing ground for Pfizer is the new Medicare drug benefit, under which seniors can sign up with private insurers for coverage and Uncle Sam pays part of the bill. Mr. Kelly says Lipitor has landed an unrestricted position on 85% of Medicare formularies, about 20 percentage points higher than on non-Medicare plans. That means these patients don't have to pay extra to get Lipitor instead of another brand.
But an analysis by a drug-industry newsletter, the Pink Sheet, found that Lipitor held an inferior position on formularies of five of nine nationwide Medicare plans, compared with only one for soon-to-go-generic Zocor. Depending on the plan, that means patients might have to pay an extra $25 or more each month out of their own pockets for Lipitor. Pfizer says its figures don't conflict with those from the Pink Sheet because there are many regional Medicare plans that the Pink Sheet didn't examine.
Pfizer's always been able to prove clinical benefit to the physician who wasn't paying for it," says Mason Tenaglia, an industry consultant at Amundsen Group. "But am I as a consumer willing to pay a premium over generics in the same class?"
Although Pfizer spends nearly $8 billion a year on research and development, its recent rollout of new products to supplement Lipitor is thin. With the antibiotic Zithromax now facing generic competition, Pfizer is trying to plug the gap with Zmax, a one-dose form of Zithromax protected by patent until 2017. Similarly it is trying to replace the older drug Neurontin, which treats epilepsy and nerve pain, with patent-protected Lyrica.
Mr. McKinnell agrees that the age of the blockbuster mass-market pill may be ebbing. He says Pfizer will shift to a portfolio that includes some biotechnology medicines for serious conditions and larger number of smaller sellers.
Since late 2001, Pfizer has sought approval from regulators to market 17 new drugs. Two of the drugs, Oporia for osteoporosis and Dynastat for pain, were rejected by the FDA last year. Of the nine drugs approved for marketing, none has become a billion-dollar-a-year seller.
This year the FDA may approve Sutent, a drug for kidney cancer that Pfizer acquired when it bought Pharmacia. Other drugs that may win approval this year include an inhaled form of insulin for diabetics called Exubera and a smoking cessation pill called Champix. Pfizer is also spending $800 million on studies of a potential blockbuster combining Lipitor, which lowers LDL or "bad" cholesterol, with another medicine.
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