Glaxo to be sued, BIGTIME (LYMErix?), Pfizer joins earth (NYT)
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Subject: Glaxo to be sued, BIGTIME (LYMErix?), Pfizer joins earth
(NYT)
Date: Jan 19, 2011 6:41 AM
"The $3.4 billion charge will be used for those added product
liability claims as well as costs ***related to an investigation by a
federal prosecutor, the company said in the statement."***
http://www.nytimes.com/2011/01/18/business/18drug.html?sq=Glaxo&st=cse&scp=1&pagewanted=print
Over the "Lyme Disease" and LYMErix
false claims? Huh?
This is not science:
http://www.actionlyme.org/DICKSON_FDA_SUBMISSION_FULL.htm
The LYMErix ^^^ report.
And Pfizer (below), ready to join
the vaccines-don't-work reality of
Tb, HIV, and Lyme?
And fungal-viral synergy as the REALITY
and State of the Art in nearly every
disease?
http://www.actionlyme.org/101016.htm
They have no choice.
KMDickson
http://www.actionlyme.org
======================================
http://www.nytimes.com/2011/01/18/business/18drug.html?sq=Glaxo&st=cse&scp=1&pagewanted=print
January 17, 2011
Glaxo’s Legal Problems Lead to New $3.4 Billion Charge
By DUFF WILSON
The British drug maker GlaxoSmithKline announced Monday that it was
setting aside $3.4 billion — wiping out fourth-quarter profit — to pay
for United States government investigations and product liability
cases over its marketing of the diabetes drug Avandia.
The one-time charge is expected to exceed GlaxoSmithKline’s quarterly
profits, which are scheduled to be reported Feb. 3.
The company’s London shares fell 1.63 percent Monday, reflecting
investor surprise at the size of the charge. The New York Stock
Exchange was closed for the observance of Martin Luther King’s
Birthday.
Avandia, once the world’s top-selling diabetes medicine, was severely
restricted in September by the Food and Drug Administration and banned
by the European Medicines Agency after safety reviews.
GlaxoSmithKline took a $2.36 billion charge last summer to settle
about 10,000 of 13,000 Avandia product liability lawsuits it was
facing in the United States, as well as investigations over its
antidepressant Paxil and manufacturing problems in Puerto Rico.
But the company has received “substantial” new claims since then, it
said in a statement Monday to the London Stock Exchange. The $3.4
billion charge will be used for those added product liability claims
as well as costs related to an investigation by a federal prosecutor,
the company said in the statement.
“We recognize that this is a significant charge, but we believe the
approach we are taking to resolve longstanding legal matters is in the
company’s best interests,” P. D. Villarreal, GlaxoSmithKline’s senior
vice president for global litigation, said in the statement. “We have
closed out a number of major cases over the last year, and we remain
determined to do all we can to reduce our litigation risk.”
Avandia has been controversial since a 2007 analysis linked it with a
43 percent increase in the risk of heart attacks.
The lead author of that study, Dr. Steven Nissen, chairman of
cardiovascular medicine at the Cleveland Clinic, said Monday that he
was not surprised at the added billions of costs to GlaxoSmithKline.
“Millions of patients were exposed to Avandia during 11 years on the
market, resulting in 50,000 or more excess heart attacks,” he said in
an e-mail. “Most of these events occurred during a period of time when
GlaxoSmithKline was aware that the company’s own research demonstrated
a hazard for the drug, but they failed to warn physicians or
patients.”
GlaxoSmithKline previously disclosed in a Securities and Exchange
Commission filing that the United States attorney’s office in Colorado
had issued a subpoena for records about its off-label promotion and
payments to doctors involving nine drugs from 1997 to 2004.
Mary Anne Rhyne, a company spokeswoman, said Monday that
GlaxoSmithKline had charged a total of more than $6 billion against
2010 earnings to pay for various legal cases in the United States,
including $333 million in the first quarter, $2.3 billion in the
second, $76 million in the third and $3.4 billion in the fourth
quarter.
Avandia sales, once topping $3 billion a year, have dwindled as a
result of publicity about heart risks and government warnings.
The F.D.A. decision in September came amid a fierce internal battle
between those who wanted only to warn doctors more forcefully about
the drug’s risks and those who wanted the drug withdrawn entirely.
The agency decided that existing patients could continue taking the
medicine but that new patients could get it only if they and their
doctors attest that they have tried every other diabetes medicine and
have been informed of the drug’s substantial risks of heart attacks,
strokes and heart failure.
Nearly four months later, the government has not yet officially put
those restrictions in place. Beth Martino, an F.D.A. spokeswoman,
said, “We’re working on it.”
Gardiner Harris contributed reporting.
http://www.nytimes.com/2011/01/19/health/research/19pfizer.html?hpw=&pagewanted=print
January 18, 2011
Pfizer in Deal With Theraclone for Antibody Drug Research
By DUFF WILSON
Pfizer, the world’s largest drug company, has agreed to pay up to $632
million to Theraclone Sciences in a research collaboration on antibody
drugs for cancer and infectious disease, the companies said Tuesday.
Pfizer, based in New York, is trying to keep up with its
pharmaceutical rivals that are increasingly relying on biotechnology
for products and profits.
“This fits in the big picture of us wanting to be on the leading edge
of biotherapeutics and antibody discovery, and this is one company we
are very excited to work with,” Jose-Carlos Gutiérrez-Ramos, Pfizer’s
senior vice president and head of biotherapeutics research, said in an
interview Tuesday.
Theraclone, a small company in Seattle, is receiving a jolt of new
research financing.
Theraclone is led by Steven Gillis, a scientist and venture capitalist
who previously co-founded the biotechnology companies Immunex and
Corixa. Amgen bought Immunex for about $16 billion in 2002;
GlaxoSmithKline bought Corixa for about $300 million in 2005.
“The fact that Pfizer selected our antibody discovery technology is, I
think, a great endorsement of our science and the speed with which we
can make discoveries,” Dr. Gillis said in an interview.
Dr. Gillis, who is also managing director of Arch Venture Partners,
took over as interim chief executive of Theraclone last year after its
president and chief executive, David Fanning, died unexpectedly.
Neither company would specify the amount of initial financing for the
deal. The upfront money will take the form of technology access fees
on two unspecified targets in oncology and two unspecified goals in
infectious disease, he said.
Dr. Gillis said 30 to 40 percent of the deal, or $189 million to $252
million, was “near term money” for milestones before the Phase II
clinical trials. Theraclone could also earn royalties on any developed
products. Pfizer is responsible for preclinical and clinical
development.
The announcement follows a similar, smaller deal earlier this month
when Pfizer agreed to pay Seattle Genetics about $8 million upfront
and up to $200 million over time for work on its antibody technology
against cancer.
In a much larger deal in September, a Pfizer rival, Johnson & Johnson,
announced that it intended to buy the antibody maker Crucell for $2.3
billion. Johnson & Johnson already owned 18 percent of the Dutch
company. The final terms are still pending amid some concern about a
Crucell manufacturing problem.
Theraclone has received other investments in its antibody work
previously. That included financing from the International AIDS
Vaccine Initiative, partly financed by the Bill & Melinda Gates
Foundation, for an experimental antibody to AIDS, and money from the
Tokyo-based drug maker Zenyaku Kogyo for an antibody to influenza.
Antibodies are Y-shaped proteins that can target and bind to other
molecules. They form the body’s defense system against a bacteria,
virus or toxin.
Theraclone specializes in screening human antibodies.
“They’re selected naturally for their lack of side effects and good
expression,” Mr. Gutiérrez-Ramos of Pfizer said.
Pfizer already has 15 to 20 antibodies in clinical development, he
added. Its research in the field was previously bolstered by the
purchases of two antibody development companies, Boren in 2005 for an
undisclosed amount, and Wyeth in 2009 for $68 billion.