Heberprot-P®: an idea turned into a product
Abstract
Diabetes mellitus has become a significant health problem throughout the world, where it constitutes the underlying cause for 84% of lower limb amputations due to recalcitrant ulcers. The Center for Genetic Engineering and Biotechnology (CIGB) at Havana, Cuba has designed an integrated strategy for preclinical testing, pharmaceutical development, production, clinical trials and business negotiations of an injectable drug for treating diabetic foot ulcers, denominated Heberprot-P®. This product, which uses epidermal growth factor as active ingredient and avoids these amputations, is the only registered drug of its type and has already had considerable medical, social and economic impact in Cuba and other nations, placing national science and the Cuban health system at the forefront of the fight against this disorder. Phase III trials are planned for 2013, pending approval of the Advisory Scientific Council of the European Medicines Agency (EMA), for examining its efficacy and safety in this continent. Research teams at CIGB continue to develop new Heberprot-P® versions, based on advanced controlled release systems employing micro and nanospheres, in order to continuously improve the product and extend its existing intellectual property coverage beyond the year 2030.
