World Class Pharma Puts People First

Patricia Grogg

HAVANA TIMES, Dec 1 (IPS)  – Cuban biotechnology and pharmaceutical products are already among the country’s major exports and the industry is on course to continue developing while maintaining a firm focus on making a real difference to the health of all Cubans and of people in the numerous countries where Cuba provides medical assistance.

The existence of market forces is a reality that has to be reckoned with because of production costs, but health decisions cannot be governed by business considerations alone, said Agustín Lage, head of the Centre for Molecular Immunology (CIM), whose anti-cancer product Nimotuzumab is currently undergoing clinical trials in the United States.

Lage and other Cuban scientists presented the strategy and results obtained by Cuba’s biotechnology industry at the Global Forum for Health Research, held mid-November in Havana. The biotech industry, which began to develop in Cuba in the 1980s, now holds some 1,200 international patents.

Cuban pharmaceutical research centers had to adopt policies on intellectual property and protect their inventions with patents in order to generate export revenues, as otherwise a high-tech sector like this could not exist, Lage explained. “At the CIM, about 60 percent of the patents are used commercially in some way,” he added.

According to official reports delivered at parliamentary sessions in late 2008, biotech export sales increased by 20 percent last year compared with 2007.

Export sales totaled 340 million dollars in 2008, according to estimates by academics.

Luis Herrera, head of the Centre for Genetic Engineering and Biotechnology (CIGB), said the development and sustainability of the industry is based on its “closed circle” approach, which deals with the full life cycle of its products, from research to production and marketing. “Without this approach, we would not have got the same results,” he said.

Another key element is cooperation and exchange between all the institutions. “From the start we realized that we were too poor to indulge in competition with each other,” said Herrera, who added that as well as integration, the industry is characterized by a “vocation” for applied research in line with national interests. “A result is not a result until it has a positive impact on the health system,” he said.

The CIGB, the leading institution of Cuba’s biotech industry, founded over 20 years ago, has recently produced a vaccine against hepatitis B, a synthetic vaccine against Homophiles influenza type B, and Heberprot-P, regarded as the only effective treatment in the world for diabetic foot ulcers.

CIGB scientists take pride in showing how all Cubans have benefited from their research, one way or another. Eight years after the hepatitis B vaccine came into use, there has not been a single case of the illness in children under five on the island, Herrera said.

When this Caribbean island nation plunged into economic crisis in 1990, triggered by the collapse of the Soviet Union and the East European socialist bloc, the government decided to carry on developing the biotechnology and pharmaceutical industries, creating new facilities in what is known as the West Havana Scientific Pole.

The Carlos J. Finlay Institute for vaccine development opened in 1991, the National Biopreparations Centre, which ramps up production for the biotech institutions, in 1992, and in 1994 the CIM was established, for research and development and production of monoclonal antibodies.

Monoclonal antibodies are produced in laboratories and bind to specific target molecules (like proteins) on the surface of, for instance, cancer cells.

Each monoclonal antibody preparation recognizes only one target protein or antigen.

Later on, biotech research spread throughout the country and at present 12 provinces have so-called “scientific poles”, which integrate the efforts of researchers, university professors, business experts and innovators, among others, according to Cuban academics Betsy Anaya Cruz and Mariana Martin Fernandez.

A study by the two authors underlines that vaccine development has led to the eradication of diseases like polio, diphtheria, measles, German measles and mumps in Cuba, and drastic reductions in the incidence of meningococcal meningitis type B and hepatitis B, thanks to the mass vaccination program for children.

“This scientific development is due to political will, and is an expression of a conception of human rights in which resources and investment are devoted to the welfare of the country’s people as well as that of other countries,” Concepción Campa, the head of the Finlay Institute, told IPS.

VAMENGOC-BC, the only vaccine in the world effective against meningitis caused by type B meningococci, was developed in the Finlay Institute’s laboratories. A production plant opened in partnership with Brazil in 2007 is making 50 million doses of the vaccine this year to fight meningitis in over a score of African countries, Campa said.

The joint Cuban-Brazilian production of the vaccine supplies the needs of the World Health Organization (WHO), which says 400 million people in 21 African countries are at risk from meningitis. “The incidence is more than 1,000 cases per 100,000 population during outbreaks,” Campa said.

The plant has been enlarged for future production of other vaccines, such as the anti-pneumococcal vaccine which will undergo clinical trials in 2010.

Pneumococcus is a disease organism that affects humans nearly exclusively, causing infections such as pneumonia, sinusitis and peritonitis as well as severe invasive processes like pneumococcal meningitis and septicaemia.

Among CIM’s most recent products is a vaccine for therapeutic treatment of advanced lung cancer. Registered in 2008, it has proved effective in prolonging patient survival and improving quality of life.

In mid-2009, the Canada-based drug development company YM Biosciences obtained a license for clinical trials in the United States of the monoclonal antibody Nimotuzumab (CIMAher), for the treatment of advanced tumors of the head, neck and brain, another achievement of Cuban biotechnology.

YM Biosciences owns 80 percent of CIMYM, the company holding the rights to Nimotuzumab in North America, Europe, Japan and other regions. The remaining 20 percent is owned by CIM, as developers of the vaccine. Trials are expected to last three or four years.

If the drug trials are successful, changes will be needed to the U.S. embargo, which bans all trade with Cuba, before it can be sold in the United States. Previously, pharmaceutical companies SmithKline Beecham and CancerVax obtained licenses for experimental trials of the vaccines against meningitis and for treating lung cancer, although they decided not to continue with clinical trials.

Political stumbling blocks aside, Cuba’s biotech industry has proved to be a resounding success in every way: by generating new products, and due to their impact on public health, the number of patents registered, the volume of exports and the returns on investments, according to Cruz and Martin Fernandez.

The industry is presently enjoying steady growth, and even higher economic returns are to be expected in future, the study says.