U.S. Permits 3 Cancer Drugs from Cuba

U.S. Permits 3 Cancer Drugs From Cuba
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By Andrew Pollack
New York Times
July 15, 2004

The federal government is permitting a California
biotechnology company to license three experimental
cancer drugs from Cuba, making an exception to the
policy of tightly restricting trade with that country.

The company, CancerVax, had said late last year that it
was trying to license the drugs and had been awaiting
needed permission from the Treasury Department's Office
of Foreign Assets Control. That permission has been
granted, and CancerVax is expected to announce it
today.

CancerVax executives said that it was the first time an
American biotechnology company had obtained permission
to license a drug from Cuba, a country that some
industry executives and scientists say is surprisingly
strong in biotechnology for a developing nation. In
1999, SmithKline Beecham, a large conventional
pharmaceutical company now known as GlaxoSmithKline,
licensed a Cuban vaccine for meningitis B that it is
testing in clinical trials.

"I think there are other product candidates and
technology in Cuba that could be helpful to the
American people, not just the American people but
people around the world," said David F. Hale, chief
executive of CancerVax, a newly public company that
does not yet have any drugs on the market. Mr. Hale
said that he had been pursuing the Cuban drugs since he
first saw a poster about the work at an American cancer
conference three years ago.

A spokesman for the State Department, which helps rule
on such licenses, said that the exception had been made
because of the life-saving potential of the
experimental Cuban drugs and that the license approval
did not represent a relaxation of the trade policy.

"These three drugs are claimed to be revolutionary
life-saving medications," said the spokesman, who
agreed to comment only if not identified by name. "As
such, upon review it was decided that the company
should have an opportunity to further research and
verify the claims about these drugs."

CancerVax, which is based in Carlsbad, Calif., plans to
test the drugs in clinical trials and bring them to
market if they pass muster. The first one, Mr. Hale
said, which has already shown some promise in small
trials, could reach the market in 2008 or 2009.

The licensing deal calls for CancerVax to pay $6
million over the next three years, during the
development stage. If products reach the market, the
company would pay up to $35 million more.

As a government condition of allowing the license,
payments to Cuba during the developmental phase would
be in goods like food or medical supplies, to avoid
providing the Cuban government with currency. Any
payments after drugs reach the market, Mr. Hale said,
could be half in cash.

The agreement comes shortly after the Bush
administration put into effect new restrictions on
visits to Cuba and cash remittances by Americans.

The administration has also stated that it believes
Cuba has at least a limited biological weapons research
effort and that it has provided biotechnology to other
"rogue states" that might be used either for medical
purposes or in development of biological weapons. The
Cuban government has denied it is developing such
weapons.

Representatives from both parties had sent letters to
Secretary of State Colin L. Powell urging that
permission be granted on medical grounds.

One letter writer, Senator Christopher J. Dodd, the
Democrat from Connecticut, hailed the government
decision as good news in a statement issued yesterday.
"Saving lives shouldn't be a political issue," he said.

H. P. Goldfield and Richard A. Popkin, Washington
lawyers hired by CancerVax to help win approval, said
there had been no real opposition.

"At the worst, some officials in Congress did not
support us but they did not in any way try to oppose
the license," said Mr. Goldfield, who is with the firm
Hogan & Hartson.

But Mr. Goldfield and Mr. Popkin, who is with the firm
of Swidler Berlin Shereff Friedman, said the CancerVax
approval was more difficult to obtain than SmithKline's
license because of the Bush administration's tougher
policy toward Cuba.

Cuba already sells some biotechnology drugs in
countries other than the United States, said José de la
Fuente, the former head of research and development at
the Center for Genetic Engineering and Biotechnology in
Havana. The drugs include a hepatitis B vaccine and a
treatment for heart attacks called streptokinase.

Dr. de la Fuente, who is now a research professor at
Oklahoma State University, said the move into
biotechnology began in the early 1980's after Fidel
Castro heard about interferons - immune system proteins
that were viewed back then as potential cancer cures -
during a visit to Cuba by the president of M. D.
Anderson Cancer Center in Houston.

More than $1 billion was spent over the years to build
and operate research institutes on the west side of
Havana staffed by Cuban scientists, many of them
educated in Europe, Dr. de la Fuente said. But he said
that the Cuban program has become weaker because the
government had started to exercise more control over
the scientists and because of economic pressures.

Still, John S. Kavulich II, the president of the U.S.-
Cuba Trade and Economic Council, a nonprofit
organization in New York, said Cuba had a few drugs
that have interested other American companies.

He said one other drug-licensing deal had already been
approved by Washington. An American company, that he
said he was not at liberty to identify, had licensed a
drug called PPG, derived from sugar cane, that was used
to lower cholesterol and was also reputed to be the
Cuban equivalent of Viagra for erectile dysfunction.
The Treasury Department does not confirm or deny
licensing approvals.

The Cuban drugs that CancerVax is obtaining were
developed by the Center of Molecular Immunology in
Havana. They were first licensed to YM Biosciences, a
Canadian company. YM Biosciences is transferring those
rights to CancerVax. Mr. Hale said YM Biosciences had
apparently decided to concentrate on some drugs that
were further along in development. David G. P. Allan,
YM's chief executive, did not return a call seeking
comment.

The Cuban drugs in question are so-called cancer
vaccines, which attempt to harness the body's immune
system to fight tumors.

While the concept of cancer vaccines have excited
researchers, the field has been littered with
disappointments. CancerVax's own main drug is a
melanoma vaccine that has been in development by an
academic scientist for 40 years and is only now in the
final phase of clinical trials.

The lead drug from Cuba aims to thwart epidermal growth
factor, a protein in the body that can spur the growth
of cancer cells when it binds to them.

The approach is different from the new cancer drug
Erbitux, developed by ImClone Systems, which blocks the
epidermal growth factor receptor, the docking port on
cancer cells to which the growth factor binds.

The Cuban vaccine, instead of trying to block the
receptor, links the growth factor to a bacterial
protein, which is injected into the body. Doing so is
supposed to stimulate the immune system to make
antibodies that attack the growth factor.

The drug has already been tested in small clinical
trials outside the United States. In one trial,
according to data presented last month at the American
Society for Clinical Oncology meeting, patients with
advanced lung cancer who got the vaccine lived longer
than those who did not receive the treatment.

Mr. Hale said CancerVax planned to put the drug into
phase 2 trials, the middle stage of testing.

The second drug, which has not yet entered clinical
trials, is a similar vaccine aimed at transforming
growth factor-alpha, another protein that can stimulate
cancer cell growth by binding to the epidermal growth
factor receptor.

The third, also not in clinical trials, is aimed at
stimulating antibodies to the receptor.

Copyright 2004 The New York Times Company