November 13, 2012 10:00 pm
Cuban diabetes drug set for Europe tests
By Andrew Jack
A revolutionary medicine for diabetes developed by Cuban scientists is
set to be tested in late-stage clinical trials in Europe next year, in
what could prove a pioneering example of western commercialisation of a
drug produced in a Communist state. However, such a move could trigger
tensions with the US.
The Cuban Center for Genetic Engineering and Biotechnology (CIGB) has
signed a deal with Praxis, a Spanish drug company, to test Heberprot-P,
a biological treatment for diabetic foot ulcers, in a thousand patients
ahead of submission for approval by European regulators.
The move signals a rare example of a modern drug developed by a
government institute in a state-dominated economy challenging the
current private sector-led approach to pharmaceuticals, while tackling
an important unmet medical need.
However, Heberprot-P would still need to win approval as safe,
efficacious and cost-effective, with some leading international
specialists sceptical of its clinical benefits and relative value
compared with other ways to deal with foot ulcers, a common consequence
of poorly managed diabetes.
Western approval would mark an important propaganda victory for Cuba and
could generate significant revenues, but would also risk triggering
tensions with the US because of the current trade embargo with the island.
Cuba does not report its revenues from drug exports and various
licensing agreements and joint ventures in countries such as Iran,
India, China and Brazil.
However, according to the government, revenues from the export of
pharmaceuticals and medical equipment exceeded $500m in 2011.
Javier Julián, chief executive of Praxis, said his company had the
rights to manufacture Heberprot-P in a factory in the Basque country,
conduct clinical trials during 2013-14 and – if approved – to sell it
across the EU as well as in Switzerland, Turkey, Brazil and Colombia.
CIGB says Heberprot-P, an injectable medicine known as a recombinant
human epidermal growth factor, has already been given to nearly 90,000
patients, treating those diabetics not only in Cuba but in more than 15
other countries, including Venezuela and China.
But there is little data published on the drug in international
peer-reviewed medical journals. Dr Kristien Van Acker of the
International Working Group on the Diabetic Foot, convened by the
International Diabetes Federation, 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."
She cautioned there was a risk that poorer countries purchasing it would
divert scarce healthcare funds from cheaper and earlier measures
designed to prevent ulcers developing, such as the provision of
specially adapted shoes.
Ricardo Silva Rodriguez, a business development executive with CIGB in
Havana, said: "Treating foot ulcers is a big need, especially where the
alternative is amputation. The US is an interesting market but we have
not filed there. It's a complex topic."
Additional reporting by Marc Frank in Havana.