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Cuba's Advances in Biotech: A Developing Country with a Highly Developed Biotech Sector

18 September 2012 Chiara Cochetti

A recent opportunity to present a paper on the Cuban healthcare system has given me food for thought about the use of an advanced biotech sector to a developing country. On the 11th-13th September 2012, the University of Nottingham hosted the 15th Annual Cuba Research Forum. I attended on the 12 September and presented a paper on "The impact of Cuban Pharma and Biotechnology on a National and International Level". I also took part in the discussion panel on "Cuba's External Profile" together with Professor Imti Choonara, Professor in Child Health at the University of Nottingham and Diana Raby from the University of Liverpool.

On the 11 September, Ernesto Che Guevara's daughter Aleida Guevara, a Medical Doctor specializing on Paediatrics and Childhood Allergies currently touring the UK, presented a highly inspirational paper on Cuban healthcare and multiculturalism. The healthcare debate, which represented a consistent part of the conference, focused on pharmaceutical, healthcare and biotechnology advances in Cuba and how this may affect the country internally, and externally in terms of exports. In addition, the debate shifted to Cuban-Venezuelan relations and their role as founding members of ALBA (Bolivarian Alliance for the People of Our America) in December 2004 (an ambitious and innovative regional economic integration model comprising eight Latin American member states and providing an alternative to neoliberal capitalism.)

Since the beginning of my career in pharma, my main research interest, however, is Cuba. The inherent contradiction between a highly-developed biotech sector within a developing country has been a long-term research interest for me.

A Highly Developed Biotechnology System for a Developing Country
Biotechnology in Cuba emerged at the beginning of the 1980s to meet internal demand for chronic disease drugs, with the creation of the "West Havana Scientific Cluster", an ensemble of more than 40 organisations comprising about 12,000 employees, including 7,000 scientists and engineers.

A Different and Effective Model
Cuba has one of the most advanced, yet until recently, least known biotechnology industries in the world, and is one of the few developing countries counting on a developed biotechnology industry. The Cuban healthcare and biotechnology model differs from other emerging models as it characterizes itself for being less marketing driven and more focused on research aimed at bettering the quality of life of people affected by life deteriorating diseases such as cancer. The non capitalist socialist ideology intrinsic in all realms of Cuban life are the main ideology behind Cuba's success in biotech R&D.

R&D Boom
The Cuban pharmaceutical sector is enjoying a booming period nationally and internationally, especially in the areas of oncology and cardiovascular, and it's emerging as a major contender internationally in the areas of research and development. The Cuban government has injected over USD 1 billion in the past 16 years to boost its national biotechnology industry. At present, the Cuban biotechnology pipeline consists of 91 products being investigated in more than 60 clinical trials, with the participation of 65 hospitals across the world. Currently, 11 vaccines, more than 40 therapeutic biological compounds and (including mABS and recombinant proteins) and immunodiagnostic systems (including micro-Elisa machines) are manufactured in Cuba. Since its beginning in 1979, the Cuban industry now owns about 900 patents and markets pharmaceutical products and vaccines in 40 countries, generating yearly revenues of USD 300 million.

Impact of the 24th Cuban Biotechnology Conference: Wins in Oncology Research
As a result of the 24th Cuban Biotechnology Conference held in Havana at the beginning of March, Cuba has emerged into the spotlight for the latest biotechnology advances, especially in the oncology field.

Some of its oncology products have made it internationally, such as CIMAVAX-EGF, the most internationally recognised Cuban treatment to be exported: the product is currently under registration in the Americas and Europe and undergoing trials in the UK. Other treatments such as Labiofam's cancer natural treatment Vidatox and cardiovascular DFU (diabetic foot ulcer) drug Heberprot-P are currently undergoing review for approvals across most of Latin America and Europe. CIMAVAX-EGF is a therapeutic vaccine, which was developed entirely in Cuba and licensed in Cuba for use in adult patients with stage IIIB/IV NSCLC for the treatment of advanced stages of NSCLC. This vaccine is in the process of approval in Argentina, Brazil, Colombia, Ecuador, and Paraguay; is registered in Cuba and Peru; and is currently being tested in the United Kingdom, Canada, China and Malaysia. Plans are under way to undertake trials in Europe, Thailand and the United States.

CIMAVAX-EGF entered clinical testing in the UK at the beginning of December 2011. The UK trial is financed by Malaysian pharmaceutical group Bioven, which is also sponsoring trials in other EU countries, Australia, Thailand, and Malaysia. That the tests are to be carried out in the UK is promising in terms of exporting the product in the European market. It is interesting to note that it is the first time a Cuban product has been tested in the UK; if the trials are positive, it could enhance the chances of marketing agreements and strengthen bonds between the two countries. The vaccine is based on active immunotherapy by which an individual's immune response is manipulated to release its own antibodies against the EGF. The EGF is a well-known oncogene. Its over-activation can induce malignant transformation of a normal cell, signalling inhibition of apoptosis, cell proliferation, angiogenesis, metastasis and tumour-induced proinflammatory and immunosuppressive processes. Inducing EGF deprivation by active immunotherapy is an emerging concept developed by Cuban researchers that involves manipulating an individual's immune response to release its own effector antibodies against the EGF, reducing tumour size or preventing its progression.

A Viable Future-Implications for the International Market
Despite a skeptical Euro/U.S-centric vision on Cuba's indigenously produced drugs, drugs manufactured on the island have proved, throughout the years, to be highly successful across Latin America and Cuban products have proved to be viable contenders on the international market. Cuban biotechnology products have increasingly drawn interest as potential exportable products to other international markets, including the EU and Asia. Specifically, latest Cuban developments in the oncology realm have opened up opportunities for the future of research in developing and developed markets. The debate that triggered from the presentation highlighted an upcoming interest for the Cuban biotechnology sector coming from within the UK, which in my opinion carries great potential to grow further.

From an industry perspective, the UK and EU are awaiting upcoming results of Phase two clinical trials for NSCLC therapeutic vaccine CIMAVAX-EGF, and about two start Phase III clinical trials of such drug. Should tests on this drug carry successful results in the UK and EU this will, in my perspective, fully change the attitude towards Cuban biotechnology from a westernized developed perspective and may give way to perspective successful partnership between the EU and Cuba in the medium to long term, especially in the field of oncology.

Posted 18 September 2012



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