European testing planned for Cuban diabetes medicine

A ground-breaking diabetes drug developed in Cuba will be tested in Europe next year and could be approved for use on the continent, according to a report in the Financial Times.
The paper states that Heberprot-P, an injectable biological medicine for diabetic foot ulcers, will be put through late-stage clinical trials involving 1,000 patients by Spanish pharmaceutical Praxis, following a deal between the company and the Cuban Center for Genetic Engineering and Biotechnology (CIGB).
Praxis chief executive, Javier Juliá, said the drugmaker had the rights to manufacture Heberprot-P, conduct clinical trials during 2013-14, and if approved, sell it across the EU as well as in Switzerland, Turkey, Brazil and Colombia.
According to the FT, such a move would represent a rare example of “western commercialisation of a drug produced in a Communist state”, although it could spark tensions with the USA which has a long-standing trade embargo with the Caribbean island.
Some leading international specialists remain unconvinced of the clinical benefits, safety and cost-effectiveness of Heberprot-P compared with other foot ulcer treatments for diabetics, and there is little data on the diabetes drug published in international peer-reviewed medical journals.
Dr Kristien Van Acker, of the International Working Group on the Diabetic Foot, convened by the International Diabetes Federatio, said: “Heberprot is set out as a wonderful product and people are working hard to commercialise it. But the studies don’t show proof it is better, and it is enormously costly.”

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