PFPC Daily - December 18, 2004

NOTE: A few of the readers might remember the PFPC Health Alerts from
2002 and 2003 concerning the fluorinated drug Iressa. The drug had
been fast-tracked for approval in Japan, and within a few months had
caused more than 160 deaths, as well as serious lung disease (it was
approved for lung cancer treatment). The article below reports on a
new study that the drug does not prolong survival for lung cancer
patients. It also states that there are 'no safety concerns'
regarding this drug. How soon we forget...

SEE:
http://64.177.90.157/pfpc/html/iressa.html

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"Third AstraZeneca drug found wanting"

Management on the defensive as trials show pharmaceutical company's
lung cancer medicine does not prolong survival

The Guardian - Saturday December 18, 2004

By Simon Bowers

AstraZeneca faced its third major setback in as many months yesterday
after clinical trials dashed expectations that its lung cancer drug
Iressa would develop into a blockbuster product that would dominate
treatment around the world.

A run of disappointing news for the UK's second largest drugs group
has left a question mark over the future of the chief executive, Sir
Tom McKillop, analysts said last night.

The study of 1,692 patients showed the lung cancer drug - hailed
until yesterday as a breakthrough medicine - appears to have no
significant life-prolonging effects. However, there are no concerns
on safety grounds. The US Food and Drug Administration said last
night that it would review the information and issue a statement
about Iressa in the next few days.

The announcement about the trial data, which wiped £2.8bn off the
company's market value, comes three months after AstraZeneca's
anti-stroke drug Exanta was in effect blocked by US regulators.

The company has also faced questions about the safety of its
anti-cholesterol drug Crestor from a veteran FDA official.

"It's obviously terrible for them," said Nick Turner, an analyst at
Jefferies. "This would be two of the three blockbuster drugs that
were meant to power the company forward failing - and we've got risks
on Crestor."

Mark Brewer, of Dresdner Kleinwort Wasserstein, added: "The
likelihood of [Crestor] being withdrawn from the US market is high."

Some analysts said yesterday's announcement fuelled already mounting
concerns over management competence at AstraZeneca. "They always talk
big numbers but we have been questioning their competence for a
while," said one.

Prior to yesterday's disappointing trial data, bullish analysts had
forecast that Iressa sales could reach up to $2bn (£1bn). These
forecasts have now been torn up.

Sir Tom conceded yesterday that AstraZeneca "could have managed
[research] risks better" in relation to developing Exanta and Iressa,
adding that lessons had been learned.

Asked if he would resign, he said: "I will continue to vigorously
work for the company, its shareholders and patients as long as the
board wants me to. My ego would never get in the way of doing the
right thing."

Sir Tom warned, however, that there was a risk that an over-reaction
from investors after disappointing news could curb the drive to
pursue ground-breaking medicines.

"There needs to be a balance between retaining that creative
innovation and at the same time optimising the chances of bringing
[new drugs] through the pipeline to patients. There is a danger
pharmaceutical companies will feel punished for taking risks."

Shares in AstraZeneca closed down 170p at £18.86, against
£28.68 in October last year.

Sir Tom tried to assuage investor concerns over development
competency by promoting John Patterson to a new boardroom seat in
charge of managing risks. "He is charged with delivering really
high-quality clinical programmes, designed very carefully and
risk-managed to a very high degree," said Sir Tom.

Iressa is on sale in 35 countries and is being used by about 20,000
patients, half of whom are in the US and a third in Japan. European
regulators have not approved it.

AstraZeneca has had to concede that a rival treatment, Tarceva, has
won a marketing battle after it showed marked benefits in patient
studies.

SOURCE:
http://www.guardian.co.uk/medicine/story/0,11381,1376563,00.html