U.S. Permits 3 Cancer Drugs From Cuba
By ANDREW POLLACK
Published: 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.
http://www.nytimes.com/2004/07/15/busine...tner=ALTAVISTA1
