Cuba's Centre for Genetic Engineering and Biotechnology has started Phase III trials of its diabetic foot ulcer drug Heberprot-P in China ahead of trials in hospitals across the European Union in 2013.
IHS Global Insight perspective | |
Significance | The Centre for Genetic Engineering and Biotechnology has begun Phase III trials of its diabetic foot ulcer (DFU) drug Heberprot-P in China and will be starting similar trials in hospitals across the European Union next year. |
Implications | For China, the approval and registration of the DFU treatment, which is expected late-2012–2013, will help strengthen the already existing bonds with Cuba in healthcare and pharma. For Europe, if Phase III trials of Heberprot-P are successful and if approval is granted, this would help create a strong pharmaceutical partnership and commercial bond with the Latin American country, fostering future partnerships and agreements in the field. |
Outlook | If the Cuban-produced DFU drug is approved in China and the EU as a result of successful Phase III trials, the partnerships will benefit Cuba from a revenue perspective, as well as China and the EU, which will be granted access to the treatment at contained prices. Heberprot-P provides a cheaper alternative for the current treatment of DFU, avoiding the need for costly surgeries. |
Cuba's Centre for Genetic Engineering and Biotechnology (Centro de Ingeniería Genética y Biotecnología, CIGB) has announced it has started Phase III trials of its diabetic foot ulcer (DFU) drug Heberprot-P in China, and that a possible approval and registration is expected by the end of 2012. In the European Union, Phase III trials of the drug are expected to start in hospitals in 2013, according to the Notimex news agency.
Epidermal growth factor (EGF) is Heberprot-P's active pharmaceutical ingredient which is applied by intralesional infiltration directly to the wound for the treatment of complex DFU. According to CIBG, 81 million patients in 20 different countries, mainly Latin America, are currently being treated with the drug. Dr Manuel Raices, who is part of the team developing Heberprot-P at CIGB, cited by Notimex, said the drug is unique in its therapeutic area and a result of the work by CIGB together with the Institute of Angiology and Vascular Surgery of Havana.
According to the source, China's Phase III clinical trials are currently taking place, with the aim of drug approval by year-end. In Europe, Phase III trials are set to start at the beginning of 2013, involving 11 EU countries, 100 hospitals and over 700 patients. Heberprot-P is patented in 40 countries across Latin America and Asia and CIGB expects annual revenues of USD100 million from sales across the globe by year-end.
Outlook and implications
The announcement of Phase III clinical trials of Heberprot-P in China and Europe are a demonstration of the leading role currently maintained by Cuban biotechnology and pharmaceutical products internationally. The EU trials mark the first time a Cuban drug at Phase III stage has undergone testing in Europe. Although Heberprot-P is at a more advanced stage of testing in the EU, another important Cuban drug, therapeutic lung vaccine CimaVax-EGF, is currently being tested in the United Kingdom (see Cuba: 1 December 2011: Cuban Lung Cancer Vaccine to Be Tested in UK). Since May, Heberprot-P has been tested in France, Spain, Russia, and China (see Cuba: 17 May 2012: Cuban Diabetic Foot Drug Heberprot-P in Trials in Europe, Russia, and China).
The approval and registration of Cuba's Heberprot-P is expected in China late-2012–2013 and will help the two countries strengthen their already existing bonds in healthcare and pharma. If the Phase III trials of Heberprot-P in Europe are successful and approval is granted in EU countries, this would help create a strong pharmaceutical partnership and commercial bond between the Latin American country and Europe. This partnership will benefit the EU too as the region would have access to innovative Cuban diabetes and cancer drugs at contained prices. Heberprot-P also provides a cheaper alternative to current treatments, reducing the need for costly surgeries.
Heberprot-P can be considered one of the most innovative Cuban biotechnology products. A new international congress on Heberprot-P for DFU patients is programmed to take place at the Convention Palace in Cuba's capital Havana from 12–14 December.