November 14, 2012 2:00 am

Foot ulcer drug: Cuba seeks breakthrough

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Communist Cuba has long made efforts to improve the health of its own citizens and those of its foreign partners through investment in healthcare systems and doctors, but now it is trying to break through into the western world with drugs, too.

The Center for Genetic Engineering and Biotechnology (CIGB) in Havana has signed deals with companies including Praxis in Spain to manufacture, test, seek regulatory approval and commercialise Heberprot-P, a biological drug to treat diabetic foot ulcers.

The product, injected around severe foot ulcers, has been shown in clinical trials to help the ulcers heal, avoiding the alternative of amputation.

The move – if successful – would mark a significant boost to Cuba, which has sought to create a pharmaceuticals research and development industry, reflecting a desire to boost its expertise in healthcare as well as to generate revenues.

Cuban doctors sent abroad have long been an instrument of both foreign policy and income, with low-cost placements in poor countries, while richer countries such as Venezuela and more recently Qatar have made large payments in return.

For biomedical products, past innovation has come from the Finlay Institute in Havana, which has developed a range of vaccines for infectious diseases in recent years. These are used nationally and donated or sold, notably in Latin America and Africa.

Cuba has also stepped up sales of bacterial-based larvicides into Africa, designed to prevent mosquitoes laying their eggs in stagnant water and spreading malaria. Yet the extent of internationally peer-reviewed data to support the use of such products remains limited.

The still higher and costlier western regulatory requirements on safety and efficacy of new medicines, as well as the need for expensive quality control on its factories, have so far left Cuba excluded from richer countries. For its large neighbour and an obvious potential market, it is also blocked by the terms of the longstanding US trade embargo.

Heberprot-P was first authorised for use in Cuba in 2006 and CIGB has already been granted patents on the product in more than 15 countries including the US. But the intellectual property protection does not guarantee it would be able to sell the drug.

Some international diabetes experts caution that Heberprot-P and similar medicines still need to prove their safety and efficacy with more trials, and that efforts of many countries would be better focused on earlier stage diagnosis and care of diabetics’ feet to avoid the emergence of severe ulcers requiring the treatment.

Meanwhile, although Cuba since the revolution has done much to tackle infectious diseases and strengthen primary care domestically, it has struggled just like its capitalist neighbours with obesity, diabetes and other chronic diseases. The underlying need for greater focus on the growing epidemic of diabetes is undisputed.

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