[Marxism] CancerVax wins rare OK from U.S.

Walter Lippmann walterlx at earthlink.net
Thu Jul 15 15:15:49 MDT 2004


(Exceptionally interesting and significant deal between a US firm
and a Cuban biotech firm. Demonstrates the extremely high level
of accomplishments of Cuba's biotech sector, so high that regime
in Washington finds it to its interest to permit this specific deal to
be struck. Notice the peculiar method of payment to Cuba for its
precious technological accomplishments. All the while, however,
Washington is working feverishly to try to overthrow the Cuban
system under which these important products were brought out..

(Congratulations to CancerVax for its committment to fighting the
cancer plague, and for doing what needed to be done to make
the legal arrangements required within US blockade legislation.

(From this we can begin to see, in microcosm, the potentional for
much greater mutually-advantagous medical and economic links if
only the massive web of blockade legislation were to be dismantled.
Truly the cynicism of Washington knows no limits, does it?)
==============================================================

CancerVax wins rare OK from U.S.
By Penni Crabtree
UNION-TRIBUNE STAFF WRITER
July 15, 2004 

CancerVax Corp. has received a rare U.S. government
approval to license three experimental cancer drugs from
Cuba - a deal believed to be a first for a U.S. biotech and
the communist country.

The Carlsbad biotech got permission to make the deal late
last week from the U.S. Treasury's Office of Foreign Assets
Control, which enforces a 40-year-old trade embargo against
Fidel Castro's government.

The agreement with Cuban biotechnology company CIMAB was
signed this week, CancerVax chief executive David Hale said
yesterday.

Since May 2001, when CancerVax officials heard a
presentation by Cuban scientists at a major U.S. oncology
meeting, the company has been tenaciously negotiating a way
through scientific and political hurdles to forge the
unusual agreement.

Along the way, CancerVax won bipartisan support in Congress
and the endorsement of top oncology researchers for the
Cuban deal, Hale said.

And the deal went through despite a crackdown by the Bush
administration, which last month tightened restrictions on
travel and money sent to Cuba. The move was seen by some as
an election-year concession to Florida's conservative
Cuban-American community.

"This for us is not political, it is just something we've
been working on because we think it will have potential
benefits for cancer patients," said Hale, whose company has
a therapeutic skin cancer vaccine in final-stage, Phase 3
testing.

"Our objective is to get these products developed and get
them to the American people, as well as other people, as
quickly as we can.

"I think most people felt it was pretty much impossible to
make all this happen," Hale said. "I can't say it hasn't
been difficult, but we are very excited about the potential
of these products."

The CancerVax-Cuba deal involves the three experimental
drugs, known as immunotherapies, that are designed to teach
the body's immune system to recognize and kill cancer
cells.

The treatments target the epidermal growth factor receptor,
a member of a larger family of related receptors involved
in the regulation of cell growth. The overproduction of EGF
has been linked to the development of many solid tumor
cancers.

The most advanced of the three experimental Cuban drugs,
SAI-EGF, has been tested in humans in combination Phase 1-2
studies as a treatment for non-small-cell lung cancer.

Early data suggest that the drug may significantly increase
survival for patients with the deadly disease.

AstraZeneca's Iressa for lung cancer has been approved by
the FDA, and ImClone Systems' Erbitux for colorectal cancer
has won European approval. Both use a related approach.

"The EGFR pathway is one of the most important in the
treatment of cancer, and all three of these therapies are
novel approaches," Hale said.

Hale said CancerVax is now developing a clinical plan for
SAI-EGF that it hopes to put in place within the next six
to nine months.

Because of the federal rules governing the U.S. trade
embargo against Cuba, the CancerVax deal is a complex one.

CancerVax will pay $6 million in upfront fees over the next
three years, Hale said, but the Cuban biotech can't receive
the money in hard cash.

Instead, CancerVax will pay the money in goods, such as
medical supplies and food, that are allowed to be exported
to Cuba by the United States.

If the drugs are successfully developed and commercialized
in the United States, Europe and Japan, the Cuban company
can receive up to an additional $35 million, part of it in
bartered goods and part in cash. CIMAB will also earn
royalties on sales of the drugs, if they are approved.

While the licensing agreement for SAI-EGF is between
CancerVax and CIMAB, CancerVax did a three-way deal with
CIMAB and Canada's YM Biosciences, which has rights to the
two earlier-stage treatments.

Cuba has spent hundreds of millions of dollars to develop
its biotech industry, largely as a way to produce medicines
and vaccines for its people and to export them to Latin
American countries, according to the Cuban government.

For instance, Cuba has developed a topical cream to treat
vitiligo, a disfiguring depigmentation of the skin, and
also a cholesterol-lowering drug made from sugar cane
derivatives.

In 1999, a U.S. division of Smith Kline Beecham, now
GlaxoSmithKline, was allowed to license an experimental
Cuban vaccine to treat meningitis B.

Penni Crabtree: (619) 293-1237;
penni.crabtree at uniontrib.com






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