US drug company punctures blockade
Campaign News | Friday, 16 July 2004
Fidel attends signing ceremony for cancer vaccine sale
Havana, July 15 - Cuban President Fidel Castro attended the signing of a technology transfer agreement between the US Cancer Vax
Corporation and the island?s Molecular Immunology Center.
The accord signed with the California-based biotechnology corporation, one of the world?s most prestigious firms in the field of research on cancer vaccines, will boost clinical tests and production.
This has been the first contract to have been signed between a Cuban biotechnology research center and a US company, and it was achieved after more than three years of negotiations and efforts by the Cancer Vax Corporation to obtain a license from the Treasury Department, according to a report this Thursday by Cuban Television.
Agustin Lage M.D., director of the Center for Molecular Immunology assured that conditions will be created for the production of vaccines both by the US company and the Cuban organizations in their respective
nations.
We will also work to register the production processes in the United States of America and Cuba, and to obtain the registration in several other nations in order to be able to start distributing the vaccines, Agustin Lage affirmed.
David Hale, vice-president of the Cancer Vax Corporation, considered the signing of this important agreement a motive of celebration and joy and assured that from now on the challenge will be to work closely together to guarantee the production of these vaccines.
The world will be watching us, the patients and their families are waiting for these products that mean a ray of hope amidst darkness, the US company executive added.
Donald Morton, president of the Cancer Vax Corporation sent a message apologizing for his absence at the signing ceremony and recognizing the work carried out by Cuba in the research and development of candidates vaccines against cancer.
The American executive also stated his interest in boosting joint work aimed at pushihg forwards the combat against the terrible disease which, according to the World Health Organization, affects more than 10 new persons every year, a figure that is expected to increase to 15 million by
2020.
http://www.adelante.cu/online/day/24/7/16.health.fidel.php
And from the US Press:
A California biotechnology company has managed to force the Bush regime into contradicting its policy trying to strangle Cuba economically by successfully obtaining licences to buy three experimental cancer drugs from Cuba.
The company, CancerVax, said late last year that it was trying to license the drugs and had been waiting for permission from the US Treasury Department's Office of Foreign Assets Control. That permission has been granted on July 15.
CancerVax officials said that it was the first time an American biotechnology company had obtained permission to license a drug from Cuba. the exception to the blocakde was made on humanitarian grounds because the drugs could save lives but CancerVax's lawyers said that the task had been difficult to obtain because of the Bush regime's hard line on Cuba.
In 1999, SmithKline Beecham, a large conventional pharmaceutical company now known as GlaxoSmithKline, licensed a Cuban vaccine for meningitis B that it is now 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 Hale, chief executive of CancerVax, a newly public company that does not yet have any drugs on the market.
Hale said that he had been pursuing the Cuban drugs since he 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, California, plans to test the drugs in clinical trials and bring them to market if they prove to be effective. The first one, which has already shown some promise in small trials, could reach the market in 2008 or 2009, Hale said.
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 as much as $35 million more.
As a US 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, Hale said, could be half in cash.
The agreement comes just after the Bush regime put into effect new restrictions on visits to Cuba and cash remittances by Americans.
The regime has also stated that it believes Cuba has at least a limited biological weapons research effort and that it has provided biotechnology to other alleged "rogue states" that might be used either for medical purposes or in development of biological weapons. There is no proof to such claims.
US members of Congress from both parties had sent letters to Secretary of State Colin Powell urging that permission to license the drugs be granted on medical grounds.
H.P. Goldfield and Richard Popkin, Washington lawyers hired by CancerVax to help win approval, said there had been no real opposition to the request.
But they 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, according to José de la Fuente, a former head of research and development at the Center for Genetic Engineering and Biotechnology in Havana.
These drugs include a hepatitis B vaccine and a treatment for heart attacks called streptokinase.
De la Fuente, who is now a research professor at Oklahoma State University, said the move into biotechnology began in the early 1980s 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 then-president of M.D. Anderson Cancer Center in Houston.
More than $1 billion was spent over the years to build and operate research institutes in Havana staffed by Cuban scientists, many of them educated in Europe, de la Fuente said.
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.
The drugs are so-called cancer vaccines, which attempt to harness the body's own 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 Cuban drug has already been tested in small clinical trials outside the United States.
In one trial, according to data presented last month at an 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.
http://www.iht.com/articles/529616.html
