【推荐】**级新闻－pfizer一最重磅新药临床试验失败

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呵呵，应该算旧闻了，pfizer上周六公布的消息，但引起众多媒体的关注。

torcetrapib，pfize的重磅新药，被认为是用以代替即将到期的全球销售额最高的药物 Lipitor的战略武器，Lipitor 去年销售额约为120亿美元。Torcetrapib一直被业界认为，极有可能取代 Lipitor成为制药行业的销售老大。临床试验失败消息公布后，pfizer股价下跌了15%。
下面是一篇摘自纽约时报的报道。

December 3, 2006, The New York Times
Pfizer Ends Studies on Drug for Heart Disease
By ALEX BERENSON

Pfizer announced last night that it had discontinued research on its most important experimental drug, a treatment for heart disease. The decision is a stunning deelopment that is likely to seriously damage the company’s prospects through the next decades.

Preliminary research found that the drug, torcetrapib, appeared to be linked with deaths and heart problems in the patients who were taking it.

For people with heart disease, Pfizer’s decision to stop the trial represents the failure of a drug that many cardiologists had iewed as a potentially major adance in efforts to reduce heart attacks and strokes.

Torcetrapib is designed to raise leels of so-called good cholesterol. It was to be used in combination with older drugs called statins, like Lipitor and Zocor, which reduce so-called bad cholesterol.

As recently as Thursday, Pfizer executies had hailed the drug at a meeting with inestors and analysts at the company’s research center in Groton, Conn.

“This will be one of the most important compounds of our generation,” said Jeffrey B. Kindler, Pfizer’s chief executie.

Pfizer is the world’s biggest drug company, with 106,000 employees and $51 billion in sales in 2005.

In a news release issued yesterday, the company said that it would immediately halt clinical trials of the drug and end its deelopment.

The decision was based on interim results from a 15,000-patient clinical trial. The trial, called Illuminate, was scheduled to be completed in 2009. Pfizer had hoped it would proe that the combination of the two drugs was significantly more likely to reduce heart attacks and strokes than Lipitor alone does.

Een before yesterday’s announcement, some cardiologists had raised concerns about torcetrapib, noting that the drug raised blood pressure in many patients, a serious side effect for a heart medicine. But Pfizer said those concerns would proe to be unfounded, arguing that torcetrapib’s effects on good cholesterol would oerwhelm its negatie impact on blood pressure.

At this point, it is unclear whether the drug’s failure was due to a specific problem with its chemistry or whether other drugs to raise good cholesterol will also face unexpected problems in clinical trials. Pfizer has other drugs similar to torcetrapib in its pipeline, but they are in much earlier stages of deelopment.

For Pfizer, the end of the torcetrapib program is an enormous blow. Drugs for heart disease are among the most widely used prescription medicines. Lipitor, another Pfizer drug, is the best-selling drug in the world, with sales of $13 billion this year.

The company and inestors had expected that torcetrapib would be another big seller, making up for sales that Pfizer will lose when Lipitor loses patent protection in the United States in 2010.

Despite a research budget of $7 billion annually, Pfizer has had difficulty bringing important new drugs to market this decade and its near-term pipeline of new drugs is also thin. On Tuesday, the company said it would cut 20 percent of its American sales force, almost 2,400 employees. Yesterday, it said it intended to accelerate its restructuring because of torcetrapib’s failure.

Pfizer had planned to sell the drug both as a stand-alone drug and in combination with Lipitor. The company had said it expected to file for federal approal in 2007 based on data from other clinical trials that will also be halted.

值得关注！

espicom邮件：

On 2nd December, the independent Data Safety Monitoring Board (DSM
monitoring the ILLUMINATE morbidity and mortality study for torcetrapib
recommended terminating the trial due to an imbalance of mortality and
cardioascular (C) eents. Pfizer has confirmed that it is stopping
all
torcetrapib clinical trials, has informed the FDA and is in the process
of
notifying all clinical inestigators in the programme, as well as other
regulatory authorities.

At the end of October, the cholesterol ester transfer protein (CETP)
inhibitor attracted attention due to a negatie outcome from the
preliminary results of Phase III heterozygous familial
hypercholesterolaemia trials in combination with the company's
established
statin, Lipitor (atorastatin), with patients in the combination
therapy
group experiencing an increase in systolic blood pressure ersus those
taking atorastatin alone. The company stated at the time its belief
that
this would not alter the faourable clinical profile of
torcetrapib+atorastatin (T/A) in the treatment of C disease and
underscored that the studies were far from complete. Oerall lipid
results
from all the completed trials were positie, generally showing that T/A
significantly increased HDL cholesterol by 55 to 60 per cent and
lowered
LDL cholesterol by 10 to 15 per cent oer atorastatin alone (leading
to a
combined reduction in LDL-C of 50 to 60 per cent).

At its recent research and deelopment meeting, Pfizer highlighted T/A
and
CETP research as the most important new deelopment in C medicine in
years. Dr John LaMattina, President of Pfizer Global Research and
Deelopment, commented that the category "has the potential to change
the
face of cardioascular medicine" and that at the end of its
comprehensie
programme, the company expected to hae a medicine with "unparalleled
efficacy in raising HDL, lowering LDL and with an anti-atherosclerosis
indication". The top-line results of the three piotal imaging trials
were
expected during the first quarter of 2007, in addition to results of
some
additional Phase III lipid studies.

Pfizer has, howeer, terminated ILLUMINATE and in fact, ended the
deelopment programme for this compound, with participating patients
being
adised to stop taking the study medication immediately. According to
Espicom's latest Pharmaceutical Companies Analysis report, Pfizer was
inesting approximately US$800 million in the deelopment of T/A.

Dr Philip Barter, Director of the Heart Research Institute in Australia
and
Chairman of the Steering Committee oerseeing the ILLUMINATE study,
clarified how surprised those blinded to the safety data were by the
DSMB's
information, stating that it was "totally unexpected and
disappointing." At
1.40pm CET on 4th December, Pfizer's share price was EUR 18.00 in
Frankfurt, down by 12.83 per cent from the preious day. The company's
CEO,
Jeffrey B Kindler, confirmed that despite the setback, Pfizer's
financial
guidance for 2006 is unchanged and that its preiously-announced plan
for
transforming the company will now be accelerated, with a focus on core
R&D,
manufacturing and commercial operations, as well as procurement and
other
areas.

Espicom's Cardioascular Drug Discoeries had predicted that this CT
had
the potential to become the new gold standard treatment by 2010, and
that
by 2012, sales could hae reached around US$6.8 billion.
Source: Cardioascular Drug News

For further information on this and other articles featured in
Cardioascular Drug News isit:
http://www.espicom.com/prodcat.nsf/structure/SourceLanding?EditDocument&Referer=FM02EB&ProductCode=00000032

For further information and to order your copy of Cardioascular Drug
Discoeries go to:
http://www.espicom.com/prodcat.nsf/structure/SourceLanding?EditDocument&Referer=FM02EB&ProductCode=00001315

******************************************************************************
JUST PUBLISHED:

PFIZER: PROSPECTS TO 2010

Headquartered in New York, Pfizer has been the world's largest
research-based pharmaceutical company since it stole Merck & Co's Crown
in
1998. The subsequent acquisition of Warner-Lambert (and with it
Agouron)
in June 2000 and the merger with Pharmacia in April 2003 (which
included
the former Monsanto diision GD Searle) cemented this position and
looks
unlikely to be toppled in the near future.

Pfizer has a broad portfolio, with strengths in the areas of
cardioascular
disease, central nerous system disorders, inflammatory disease,
metabolic
disorders, infectious disease and oncology.

Employing around 115,000 people worldwide, it has more than 100
oerseas
subsidiaries and operations in around 150 countries.

Pfizer beliees it has one of the broadest product portfolios of all
the
major pharmaceutical companies. In 2004, Pfizer set an industry record
with ten of its products (including Celebrex) generating reenues of
more
than US$1 billion each; 2005 saw a decline in sales of Neurotin and the
oluntary withdrawal of Bextra, reducing this total to eight.

During 2005, Pfizer filed an NDA with the FDA for marketing approal of
Exubera (inhaled insulin) and it was finally approed in the US in
January
2006. Pfizer submitted a reised label to the FDA for the add-on
epilepsy
indication for Lyrica, which was approed in 2004 for the treatment of
diabetic peripheral neuropathy and post-herpetic neuralgia.

Pfizer also submitted seeral important sNDAs for new indications for
existing products including the noel antibiotic, Zyox, and the
antifungal, fend. Pfizer's medicine depo-subQ proera 104 receied
FDA
approal for contraception and endometriosis.

Espicom Business Intelligence has just published a strategic report
which
includes a full reiew of the Pfizer's actiities together with a
fie-year
sales forecast for its key products, in-depth coerage of the
company’s
financial performance and an outlook for the future. More information
on
this report can be found on the Espicom website.

To iew the full table of contents for this report please isit
Espicom's
website by following the link below or copying and pasting it into your
browser window:

Pfizer: Prospects to 2010
http://www.espicom.com/prodcat.nsf/structure/SourceLanding?EditDocument&Referer=FM02EB&ProductCode=00000136

* Please note: This report is included in Espicom's premium serice:
Pharma
Online. Pharma Online users should contact their information centre, or
their Espicom Account Manager, with any questions.

别老看到人家赚钱的时候，也要看到大公司也有倒霉的时候。