Big Problems for Big Pharma - 500 Beiträge pro Seite

[gholzbauer]

Big Problems for Big Pharma
Matt Hougan
Thursday, October 4, 2001

Big pharma "safe"? It`s about as safe as a man standing at the edge of a cliff who just hasn`t fallen off yet.
MORE BY MATT HOUGAN

The pharmaceutical industry is supposed to be a safe haven for growth investors. When the economy stumbles and the market starts to punish risk, growth investors flock to the pharma giants with their non-discretionary products. The day after the terrorist attacks in New York, for example, GlaxoSmithKline opened up 3% on the FTSE. I can’t count the number of analyst reports I’ve read since the attacks touting the defensive nature of the pharmaceutical industry.

But this isn’t a defensive growth industry. This is an industry on the defensive.

As a trio of news events yesterday points out, this industry faces a perfect storm of secular developments attacking its margins, its market share, and its marquee position as a great defensive investment.

The Lilly Warning
The big event that got everyone’s attention yesterday was an earnings warning from Eli Lilly. To sum up, Lilly is taking a major hit to both 2001 and 2002 earnings because of the massive erosion of Prozac sales since the anti-depression drug came off patent in August. Everyone expected the generics to eat into Prozac’s $2.5 billion in annual sales, but apparently Lilly underestimated the speed and magnitude with which the generics would conquer the market. Lilly shaved 11 cents off of the top of 2001 guidance and 24 cents off of 2002. The stock is down more than 5%.

Surprise? No, not really. Prozac is incredibly expensive, and a generic replacement at a fraction of the cost from a respected company like Barr Labs would be hard to pass up .

The problem for big pharma is that Prozac is just the start. The pharmaceutical industry stands on the edge of the biggest patent expiration cliff it has ever faced. All the blockbuster drugs that made pharmaceutical companies so successful in the 1980s and 1990s are coming off patent, and as the Lilly warning shows, the effect is going to be severe.

Analysts expect $10 billion in drugs to come off patent in 2001, up from $3 billion in 1999. Pharma.frost.com, a pharmaceutical consulting group associated with Frost & Sullivan, estimates that 40 blockbuster products with total sales of $41 billion will come off patent in the next five years.

I suspect that it will be even worse, as eager politicians crack down on the generous patent-extension laws that allow pharmaceutical companies to stretch their patents long past the original expiry date. Big pharma has been desperately trying to restock their pipelines to replace these drugs, but $40 billion is a big hole to fill.

Glaxo’s Discount
The other big piece of news this morning came from GlaxoSmithKline, which broke with an unspoken agreement in the pharmaceutical industry and announced that it would offer poor American seniors a 25% discount on Glaxo drugs that they purchase at the pharmacy. Industry consultants have pondered this sort of “buyer-loyalty card” for decades, but as far as I know, Glaxo is the first company to actually do it.

In one sense, this is a brilliant move by Glaxo’s management. While it has been somewhat lost in the aftermath of the terrorist attacks, the high cost of prescription drugs remains near the top of the American political agenda. Almost everyone expected Congress to do something about prescription drug costs, and however that deal shook out, we all knew that it was going to impact the bottom line of the pharmaceutical industry.
By stepping in front of the government, Glaxo scores a public relations coup and creates a unique competitive advantage in the marketplace. If you were a poor senior buying prescription drugs, wouldn’t you take the one with the 25% discount? Glaxo has a long and proud history of stepping in front of government intervention and solving political issues internally, and we should applaud them for it.

At the same time, we should realize that they are doing this because they have no other choice. Glaxo knows that the politicians were going to enact a discount plan, and they’re hoping that by stepping in front of the government, they’ll look like "the good pharmaceutical company.” And who knows? Maybe Glaxo will win enough volume to make up for its discounts before the other pharmaceutical companies follow suit. And they will follow suit -- it’s only a matter of time. In the end, margins for the whole industry will come down.

Increasing Competition from Biotech
A run of biotech drug approvals by the Food and Drug Administration, matched against the relative quiet of the pharmaceutical pipelines, is emblematic of the fact that biotech is slowly stealing share in the pharmaceutical marketplace. For example, yesterday an FDA advisory panel recommended Gilead’s new AIDS drug, Viread, for approval. If early indications bear out, Viread will win approval and go on to play a major role in fighting AIDS. Viread will be the third $500 million-plus potential biotech drug that the FDA has approved in the past two months.

But the best example is Aranesp, an Amgen product that won approval from the FDA this summer. Back in the 1980s, when the biotech industry was strapped for cash, a little upstart biotech company called Amgen had developed a drug that was great at treating anemia. But because Amgen didn’t have enough money to market the drug successfully on its own, they sold the rights to market the drug for cancer-related anemia to Johnson & Johnson. J&J called the drug Procrit, and it’s gone on to become J&J’s biggest selling drug, with FY2000 sales of $2.7 billion. Amgen didn’t do too badly either: they kept the rights to sell the drug in kidney-dialysis related anemia, and that product, Epogen, does close to $2 billion/year in sales.

Aranesp is a longer-lasting version of Epogen, and most analysts expect Aranesp to rapidly cannibalize Epogen’s market. But because Aranesp is not subject to the same marketing agreement as Epogen, as soon as Amgen gets FDA approval to market Aranesp in cancer-related anemia (the application is filed), Aranesp will start to eat into Procrit’s market as well. In fact, I believe that Aranesp is uniquely suited to the cancer market, since its dosing schedule coincides perfectly with most chemotherapy treatments. Procrit is dosed more frequently than chemo, requiring additional hospital visits and higher costs.

J&J stands to lose a huge chunk of their Procrit franchise, not because of patent expiration, but because the biotech industry has out-researched big pharma and developed a better drug. Add Procrit’s $2.7 billion in sales to the other $10 billion in sales coming off patent this year. There are plenty of other examples: the wave of products coming out of the biotech industry in the next 18 months will steal significant market share from big pharma.

Bye-bye Golden Days
The free-ride product cycle and friendly political climate that allowed for the pharmaceutical industry’s tremendous growth in the 1980s and 1990s are over. Today, big pharma stands on the edge of massive patent expirations, increased political regulation and increased competition from the biotech industry.

It`s time to let go of the cherished faith that big pharma is a safety play for nervous growth investors. It`s anything but.

[puhvogel]

Ein sehr interessanter und wohl auch richtiger Artikel!

Pfizer ist teurer als die gesamte Biotechindustrie!

[puhvogel]

Ein sehr interessanter und wohl auch richtiger Artikel!

Pfizer ist teurer als die gesamte Biotechindustrie!

[gholzbauer]

Und jetzt "Big Problems for Biotech" ?






Wednesday January 30, 3:30 pm Eastern Time
Big Pharma`s Investments Sour
Big Pharma`s Biotechnology Investments Sour in ImClone`s Wake
By PAUL ELIAS
AP Biotechnology Writer
SAN FRANCISCO (AP) -- The mother`s milk of biotechnology -- cash from big drug makers -- may not be flowing so freely now that Bristol-Myers Squibb has had to write off most of the billion dollars it invested in ImClone Systems Inc.


Wary of troubles with that deal and other recent biotechnology setbacks, analyst think drug makers will become more miserly with their investments -- reversing a two-year trend in which biotech companies got increasingly better and more lucrative deals.

Through the first nine months of last year, biotechnology companies received $1.9 billion from drug makers, a 14 percent increase in investments over the same period in 2000, according to Recombinant Capital, which tracks drug-making alliances.

It said the average deal size jumped from $72 million in 2000 to $116 million last year.

That pace is now expected to slow dramatically.

``The biotechnology market is looking a little spooky for investors these days,`` said Jason Zhang, an analyst with Stephens Inc.

The most notable example is the $1 billion Bristol-Myers Squibb paid for 19.9 percent of ImClone Systems Inc. in September.

Bristol-Myers Squibb paid $200 million more -- and promised a further $800 million once regulatory hurdles were cleared -- to share in the future profits of ImClone`s highly anticipated colorectal cancer drug Erbitux.

It was the largest such alliance between a pharmaceutical company and a biotechnology firm; Erbitux was expected to be a blockbuster and to hit the market sometime this year.

Instead, ImClone`s stock price has dropped nearly 70 percent since December, when the Food and Drug Administration refused to review the company`s application to market Erbitux. Now, most analysts predict the drug will be approved no sooner than late 2003.

Last week, Bristol-Myers Squibb wrote off $735 million of its investment and said more write-offs might occur.

Bristol-Myers Squibb isn`t alone. Last week, Amgen Inc. [NasdaqNM:AMGN - news] decided to end several biotech deals and take a charge of $163 million, including a deal with Precious Pharmaceuticals Inc. to develop Planes, a prostate cancer drug.

Amgen walked away from the deal after the FDA demanded more data. Amgen`s investment, which analysts estimated to be about $100 million, is now worth nothing.

Last year, investments by Genentech Inc. (NYSE: DNA - news) and Novartis AG in tiny Tanox Inc. (NasdaqNM:TNOX - news) also suffered when the FDA declined to approve asthma drug Xolair without further data, which they hope to submit this year.

Tanox has received at least $18.5 million from its partners and can receive a total of $63.5 million if the drug is approved, according to Houston-based company`s latest annual report.

Xolair, administered through injection, was supposed to be the first in a new class of drugs that target a chemical in the blood, called IgE, that is involved at the start of a string of events that leads to asthma.

Biotechnology`s credibility wasn`t helped by a series of clinical trial setbacks recently, including those of Dendreon Corp. [NasdaqNM: DNDN - news], Cubist Pharmaceuticals Inc. and Inspire Pharmaceuticals Inc. The American Stock Exchange biotechnology index has dropped 11 percent since Jan. 1, compared with the Nasdaq declining about 1 percent.

Some analysts predict big drug makers will be more stingy, especially as ImClone`s woes mount. The Securities and Exchange Commission, the U.S. Department of Justice and a congressional panel have each opened investigations into ImClone`s public handling of the FDA`s rejection.

``This is going to send strong repercussions through the market,`` said John McCamant, editor of Medical Technology Stock Letter. ``This will put a chill on deals. Terms will get lowered.``

Biotechnology`s popularity with drug makers peaked in September, when Bristol-Myers Squibb announced the ImClone deal.

It followed such successful deals as American Home Product`s investment in Immunex Corp.`s (NasdaqNM:IMNX - news) blockbuster arthritis drug Enbrel and Johnson & Johnson`s strong returns on Procrit, an anemia-battling medication developed by Amgen.

In 2000, biotech firms raised a record $35 billion from venture capitalists, initial public offerings and other sources, according to Recombinant Capital. Biotechnology companies raised another $20 billion last year.

``Biotech is well-heeled. A lot better heeled than it was,`` said Mark Edwards, managing director of Recombinant Capital.

But drug makers` free-spending days may be gone, at least for the short-term. Analysts see pharmaceutical companies negotiating better deals for themselves and biotechnology firms settling for less.

``This is going to have a negative impact on biotechnology stocks and future deals,`` Stephens Inc.`s Zhang said. ``It exposed the risks of these companies.``

[gholzbauer]

11.02.2002 09:27
n.a.

Pharmabranche vor schweren Zeiten

Wenn man das Jahresende 2001 als Indiz für die zukünftige Entwicklung der großen Pharmakonzerne sehe, dann kämen schwere Zeiten auf die Branche zu. Fünf der acht weltgrößten Pharmakonzerne hätten die Anleger zum Jahresende mit Gewinnwarnungen verstimmt, so die Anlageexperten von Deka Investment in einer aktuellen Branchenanalyse. Brancheninsider würden ihren Angaben zufolge in der heiklen Situation schon die größte Herausforderung der Branche in den letzten 25 Jahren befürchten. Tatsächlich würden auch viele Probleme auf die Unternehmen zukommen. So würden beispielsweise die Patentrechte von umsatzstarken Medikamenten (Blockbustern) im Gegenwert von rund sieben Milliarden US-Dollar auslaufen. Dabei gelänge es den meisten Unternehmen vorerst nicht, die entstandenen Lücken mit neuen Produkten zu kompensieren. Immer schneller eroberten Generika (Nachahmerprodukte) den Markt, sobald der Patentschutz ende. Dazu würden laut Deka die großen US-Krankenversicherer mit beitragen, da sie immer häufiger Millionen von Mitglieder über die neuen und billigeren Alternativen informieren würden. Die Konsumenten wechselten daraufhin zu den billigeren Nachahmerprodukten, denn deren privaten Zuzahlungen für verschreibungspflichtige Medikamente seien bei rund 25 Prozent der Arzneimittelpreise angelangt. Daher benötigten die Pharmakonzerne dringend neue, umsatzstarke Präparate mit langen Patentrestlaufzeiten. Dazu würde aber eine freundliche Zulassungspolitik der US-Gesundheitsbehörde (FDA) benötigt. Gerade dies sei aber nach Angaben der Deka-Experten im Jahr 2001 nicht der Fall gewesen. Viele Anmeldungen seien zurückgewiesen und nicht selten seien Nachbesserungen von den Firmen bei Tests und Produktion gefordert worden. Lediglich 16 Medikamente hätte die FDA im Jahr 2001 zugelassen, während es 1996 noch 53 und in 2000 immerhin noch 27 gewesen seien. Erschwerend käme ihrer Ansicht nach hinzu, dass die FDA für Zulassungen im Durchschnitt 20 Monate Bedenkzeit benötige, während es vor zwei Jahren waren es durchschnittlich lediglich zwölf Monate gewesen seien. Die FDA sei vorsichtiger geworden, denn in den zurückliegenden vier Jahren habe sie zehnmal bedenkliche Präparate vom Markt nehmen müssen. Darunter auch das Medikament Lipobay von Bayer in 2001. Um zwingend notwendige, neue Medikamente zu bekommen, würden die Pharmariesen teure Vertriebsallianzen eingehen oder versuchten interessante Unternehmen mit innovativen Produktneuheiten gleich zu übernehmen. So dürfte sich Zukunft nach Meinung der Deka-Analysten der Trend zu Fusionen und Übernahmen weiter fortsetzen. Belastend dürfte sich zudem auswirken, dass zurzeit viele europäische Regierungen ihre Gesundheitsbudgets auch auf Kosten der Pharmaindustrie zusammenstreichen würden. Auch könnten die Entwicklungsländer nach den Beschlüssen der Welthandelsorganisation WTO einen " medizinischen Notstand" definieren, der es ihnen erlauben würde, die Patente der Pharmahersteller zu brechen. Allerdings, so die Deka-Experten in ihrer aktuellen Branchenanalyse, sollte man nicht zu schwarz malen, die langfristigen Aussichten trotz dieser düsteren, kurzfristigen Prognosen weiterhin positiv seien. Weltweit werde es immer mehr ältere Menschen geben, die immer mehr Arzneien brauchen. Gerade auf Investitionen in ihre Gesundheit würden auch in Zukunft die Verbraucher nicht verzichten. Umsatzrenditen von 20 bis 30 Prozent dürften ihrer Einschätzung zufolge für die großen Pharmaunternehmen in Zukunft aber nur schwierig zu erreichen sein.

Quelle: AKTIENCHECK.DE AG

[laserjet]

und wer sind die Gewinner?

Die Generica-Hersteller und
zwar die schnellen...
z.B. IVAX

gruss
laserjet

[DerHabicht]

Oder die hier