Heberprot-P: medical breakthrough and commercial promise

A product of Cuban science has benefited more than one hundred thousand patients. Since  itsimplementation began, the Heberprot-P has become hope and comfort to thousands of diabetics, not only in Cuba. It was born in the laboratories of the Center for Genetic Engineering and Biotechnology (IGBC), thanks also to the human capital that devoted countless hours to study and research.

The drug has been created to care for Diabetic Foot Ulcers (UPD) advanced aspect that positions it as only one of its kind worldwide. Until 2007, the year in which is recorded in Cuba, no product for this condition had slowed slightly this hardly asked-for medical option: amputation.

According to the World Health Organization (WHO), approximately 366 million people suffer from Diabetes Mellitus. It is suggested that between 10 and 15% of patients develop a UPD at some point in their lives, and of those 10 to 15% ends in amputation. The therapeutic indication and the medical problem that the new drug is facing, mostly focuses on chronic terminal injuries, which involve a risk of mutilation over 90% of the times.

The finding goes back almost half a century of research on the Epidermal Growth Factor discovered by American scientist Stanley Cohen. From the contributions of his, many tried to come up with what today Cuban science holds, a medicine that is based on recombinant human growth factor (FCHrec.) applied by intralesional infiltration directly into the wound.

In 2008 Heber Biotec, marketer of IGBC, launched the product to the international market with patent in countries like the U.S., Japan, Australia, China, Singapore, Argentina, Mexico, Canada, European Union, etc.. It is currently on track to negotiate with Brazil, Thailand and Chile. In just five years it has achieved health records in 17 countries, a result also of its proven benefits and safety.

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The Center for Genetic Engineering and Biotechnology, since its inception in 1986, has been engaged in designing innovative products. This has become the largest biotechnology company in commercial impact in Latin America, with the hope also to penetrate other regions of high financial dynamism in this area. Heberprot-P addition to saving lives is one of the routes of commercial development of the Cuban nation.

Ernesto Lopez, director of Business and Project Development at IGBC, states that the product Heberprot-P is leading at institutional and country levels,  with revenues of around $ 100 million annually.

The drug has raised expectations worldwide, especially in Europe. But an example closer has been to Venezuela, where it is treated around 87,000 patients. Fifty-four months into the Comprehensive Care Program Patient with Diabetic Foot in that nation, 20 000 people with advanced lesions escaped amputation.

Cuba included the treatment in its Basic Table of Drugs in 2007. Subsequently it initiated a national outreach program that included secondary and tertiary care (hospitals and schools), and since 2008 was implemented in primary health care. Until April this year Heberprot-P has benefited 18 695 patients, reducing the average amputations (23%) 4.4 times.

In terms of improvements to the Cuban health system the drug also traces its path. Annual savings achieved $ 3,697,341 by entering therapy while avoiding major amputation in 2505 patients. Considering that 50% of patients who undergo surgery die within a period of five years, the effectiveness of Heberprot-P has saved 1253 lives in the same time range.

Some statistics, in the United States, for example, prove that about 65 percent of the more complex end ulcers end up in amputation nowadays. Each of these cases has accumulated a cost of up to $ 70 000.

The intention is to continue expanding the product around the world. It is also available for patients who want to be treated on Cuban soil in the Cira Garcia Central Clinic, institution specializing in health tourism.

However, one of the immediate aspirations of the researchers who gave life to Heberprot-P and IGBC in general is to get it inserted in the international pharmaceutical market.

Therefore there is the development of joint projects, supply agreements and technology transfers, as well as joint ventures in production and trade. These alternatives have encouraged collaboration and partnership with developing countries, as are strategies to survive in an industry dominated by powerful pharmaceutical multinationals.

In the way of a rare model of North-South technology transfer, IGBC has structured a production system in Vitoria, Basque Country, which guarantees high standards of good manufacturing practices the demand in Cuba and the world.

introducing a completely new product, safely applied in thousands of people, has not been easy for the chief promoters. Science Dr. Manuel Estate, Director of Novel Product Management Group IGBC highlights the importance of sharing spaces dedicated to Heberprot-P, which highlights the national and international workshops, international conferences, and sending staff to other countries for training on the application of therapy.

The advantages of Heberprot-P are not only recorded in the judgment of patients and doctors; worldwide recognition further confirms the excellence of the fruit of knowledge.

In 2010 it received FIHAV prize for being the most dynamic new commercial product. In 2011 it won the Gold Medal of the World Industrial Property for Best Invention Award and Best Young Inventor of the International Fair of Inventions in Geneva, especially given its creator Jorge Berlanga. From 2006 to date it has received the greatest of the awards: the acceptance and appreciation of people that one day saw their life in danger.

Author

Lisandra Díaz Padrón