Pubdate: Thu, 6 Nov 2008
Source: San Jose Mercury News (CA)
Copyright: 2008 San Jose Mercury News
Contact:  http://www.mercurynews.com/
Details: http://www.mapinc.org/media/390
Author: Linda A. Johnson, AP Business Writer

SANOFI-AVENTIS, PFIZER END STUDIES ON 2 DIET DRUGS

TRENTON, N.J.--French drugmaker Sanofi-Aventis said Wednesday it is
halting all research on a diet drug sold in Europe, Acomplia, and
rival Pfizer Inc. hours later said it is ending research on an
experimental weight-loss drug in the same class.

Both drugs work by blocking the pleasure centers that give marijuana
smokers the "munchies"--the cannabinoid type 1, or CB1, receptors.

Given that obesity and related complications are arguably the world's
biggest public health problem, the demise of both drugs will be a big
disappointment for patients and doctors, and possibly for investors.
The decisions leave New York-based Pfizer, the world's top drugmaker
by sales, and Paris-based Sanofi-Aventis, ranked No. 4, suddenly
without drugs in a category all but guaranteed as a
blockbuster.

"This will significantly affect the perception of their (future)
revenues," but the companies could overcome that with replacement
drugs down the road, said analyst Steve Brozak of WBB Securities.

Just four years ago, scientists were touting Acomplia as a Holy Grail
of medical research, saying it showed promise in helping people lose
weight, control blood sugar and other aspects of diabetes, lower
cholesterol, quit smoking and stop abusing alcohol, marijuana and cocaine.

Some researchers predicted that once Acomplia got approval for weight
loss or smoking cessation, research would ramp up in those other
areas. But that early promise didn't materialize, it didn't win
approval for smoking cessation and problems began piling up as
psychiatric side effects--now a huge red flag for regulators--emerged in
various studies of Acomplia as a diet drug.

Sanofi-Aventis said in a brief statement it was stopping ongoing human
testing ofAcomplia, known chemically as rimonabant, for all uses, "in
light of recent demands by certain national health
authorities."

Two weeks ago, Sanofi-Aventis temporarily stopped sales in Europe,
where the pill had been marketed in 18 European Union countries since
2006. That move came after the European Medicines Agency recommended
the European Commission temporarily suspend sales of Acomplia, saying
its risks--depression, anxiety and stress disorders--outweighed its benefits.

At the time, Sanofi-Aventis said it "remains committed to Acomplia to
bring an important therapeutic approach to obese and overweight
patients," about 700,000 of whom it said had used Acomplia and gained
health benefits. The company said it planned to provide additional
evidence for health officials to re-evaluate its risks and benefits in
patients with diabetes and heart disease.

In the U.S., a Food and Drug Administration advisory panel unanimously
rejected the drug on June 13, 2007, citing psychiatric problems
including increased risk of suicidal thoughts. Two weeks later,
Sanofi-Aventis withdrew its application for U.S. approval.

For the first nine months of this year, Accomplia had sales of only 81
euros, about $113 million, not even making the company's top 15 products.

On Wednesday, Pfizer said it ended final-stage human testing of a drug
known only by the designation CP-945,598--not explicitly for safety
concerns but because of "changing regulatory perspectives on the
risk/benefit profile of the CB1 class and likely new regulatory
requirements for approval."

"While confident in the safety of the compound, we believe that this
is the appropriate decision based on all available information
regarding this class of agents, as well as recent discussions with
regulatory authorities," Martin Mackay, president of Pfizer Global
Research and Development, said in a statement.

The statement said the company believes the compound "has the
potential to be a safe and effective treatment for weight
management."

Brozak, the analyst, said that Pfizer is technically correct in
stating that even if the drug is safe, it's not certain that it could
make it onto the U.S. market because the FDA "has almost become
paralyzed with caution in its approval process."

Sanofi-Aventis said its decision would not affect its profit forecast.
The company would not say whether it has any plans to try to resume
sales, which never approached the levels anticipated. Past statements
from Sanofi-Aventis indicate the drug at one point was approved for
sale in 37 countries, yet was marketed in only 18.

In trading Wednesday, Pfizer shares fell $1.09, or 6 percent, to $17,
while U.S.-traded Sanofi-Aventis shares fell $2.40, or 7.5 percent, to
$29.69, on a day in which the broader market fell about 5 percent.
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MAP posted-by: Richard Lake