E C O N O M Y

Havana. July16, 2004

First Cuban-U.S. cooperation agreement for production of anti-cancer vaccines
• President Fidel Castro attends the document’s signing

BY REYNOLD RASSÍ -Granma daily staff writer-

ON July 15, and for the first time in 40 years, a cooperation agreement was signed by Cuban and U.S. companies for the transfer of biotechnological technology directed at developing vaccines against cancer. The agreement was signed between the CancerVax Corporation and the Center for Molecular Immunology at the International Conference Center in Havana.

President Fidel Castro Ruz attended the signing, as did other leaders of state and government; Dr. David Hale and Hazel Aker, executive director and vice president and attorney for the CancerVax Corporation, respectively, as well as the directors of Cuba’s most important scientific centers and health institutes.

During the event, a video message was shown to participants, sent from Dr. Donald Morton, U.S. professor and outstanding cancer specialist and medical director and chief surgeon at the John Wayne Cancer Institute in Los Angeles, California.

The message, read by Dr. Morton himself, congratulates all those involved in this significant event for their dedication, cooperation, commitment and labor to make the day possible. He commented that the agreement signed is very important to him for many reasons: “I am a cancer surgeon and a survivor of this disease who has spent the last 40 years doing research on the use of the immune system and controlling cancer. I have dedicated my career to leading research on promising technologies, such as therapeutic cancer vaccines and the challenge to try and intimidate it.

Morton further comments that unfortunately, the incidence of this disease around the world is continuing to grow. The World Health Organization estimates that in the year 2000, more than 10 million persons throughout the world were diagnosed with cancer, and that number will grow to 15 million by the year 2020. He notes that by that time, cancer will have become the most frequent cause of death in the world, because it will have exceeded cardiovascular disease, and he adds that in his opinion, the technologies represented in the signed agreement are potentially useful for the treatment and control of cancer.

“We believe that the candidates for products that you have developed in Cuba represent new approaches. A unique, unprecedented discovery that of the development of vaccines against cancer designed to stimulate the immune system,” Morton says.

“Thank you all for your continuous support for cancer research and each one of you for your personal involvement,” he concluded.

Speaking on behalf of Cuban scientists, Dr. Agustín Lage Dávila, director of the Center for Molecular Immunology, said that dissatisfaction is a scientist’s natural state of being, and it is known that what remains to be done is much more than what we have done so far.

Lage said that it was necessary to recognize that an important point had been reached that had made the signing of the agreement possible. He recounted the history of how scientific work had begun in Cuba to search for anti-cancer vaccines, with the purpose of halting the growth of malignant tumors.

That project received a boost from Fidel Castro’s decision to develop a Center for Molecular Immunology, even in the context of the tremendous economic difficulties that the country was experiencing during the 1990s, he noted.

CancerVax, a company that was already known in Cuba for its work on melanoma vaccines, came into contact with the Center for Molecular Immunology in 2001, and its attention was caught by the first clinical results that our country had at that time for a vaccine for the treatment of advanced lung cancer, Lage explained. He recalled how Dr. Donald Morton visited the country, and that from then on, a process of contact began that took more than three years of negotiations, culminating in the signing of the current agreement.

For technical reasons, a complex negotiations process is already underway involving three different cancer vaccines, all under the protection of six patents from the Center for Molecular Immunology and the Genetic Engineering and Biotechnology Center, with different manufacturing processes, Lage noted.

“This negotiation has additional complications, and anyone could recite a long list of reasons why this agreement could have been impossible, he added.

There is not tradition of technology transfer, particularly in biotechnology, from Southern to Northern countries, generally speaking, and particularly in the case of Cuba and the United States, Lage affirmed. It is no secret that there is a 40-plus year void of a total absence of economic cooperation, a situation for which we have never blamed the U.S. people, far less the scientists of that country,” he said.

Within that complex context, CancerVax decided to set about reaching an agreement, together with Cuba, for the transfer of technology with the goal of producing anti-cancer vaccines, which has been achieved, Lage explained. “The reasons that made it possible include, among other elements, the enthusiasm and perseverance of Professor Donald Morton and Dr. David Hale, attorney Hazel Aker and her team, and the ethics of medical scientists who put the interests of the sick before any other consideration.”

He further mentioned the determination of the Cuban authorities and of the Center for Molecular Immunology, in being faithful to the idea that both Cuban and U.S. patients deserved all their efforts to overcome the obstacles and abnormal conditions surrounding these negotiations to make the project possible and open a new road forward.

From now on, a joint scientific team from both institutions are to plan and lead new clinical trials, including the United States and Europe, he explained, adding that conditions will be created to produce vaccines by CancerVax and Cuban scientific centers, as they work to make the productive processes in both countries equivalent and to obtain the vaccines’ registration in order to begin distribution.

Difficult moments will occur and will be overcome, as on other occasions; longer lives and quality of life for cancer patients depends on our ability to overcome them, Lage affirmed. “Our colleagues at CancerVax have believed in that ideal and we share it,” he stated.

For his part, Dr. David Hale, speaking for CancerVax, expressed his gratitude for the labors undertaken by all parts to make the agreement possible, and emphasized that it is the first such agreement signed between biotechnology institutions in Cuba and the United States.

Hale especially noted the support lent by scientists, congress members and other officials and figures in the United States to contribute to this achievement, and added that cancer patients are excited about the results that could be obtained through this biotechnology agreement.

Vaccines have already been created in the world to eliminate certain human diseases, and others are being developed by scientists to fight AIDS and malaria and to prevent and cure cancer, he noted.

Hale said that he was impressed by Cuban biotechnology and its scientists, and for advances achieved in the production of vaccines for controlling diverse diseases.

It is necessary to have the new products approved and registered to be able to use them throughout the world, Hale noted. In spite of the differences and challenges, joint work has been done towards both countries’ shared vision of biotechnology and its benefits for humanity. There is a ray of light in the darkness of cancer, he affirmed.

The document was signed by CancerVax, Dr. David Hale and attorney Hazel Aker, and on the Cuban side, by Dr. Agustín Lage and attorney Norkis Arteaga, president of the CIMAB distribution company.

After the signing ceremony, Fidel had a fraternal conversation with scientists from both countries and other guests.