HEBERPROT-P, developed by Cuban biotechnology and the only one of its kind in the world capable of enhancing the healing process of ulcers in diabetics and reducing the risk of amputation, was officially registered in Turkey, making it available on the European market, to which it was previously denied access due to resistance from various multinational companies.
The news was announced in Havana during a press conference attended by Ömer Giray, President of GIRAYLAR S.A. and HASBIOTECH trading partner, both Turkish companies; Dr. Luis Herrera, director-general of the Cuban Center for Genetic Engineering and Biotechnology (CIBG) and Jorge Berlanga, of the CIBG biomedical research department.
Heberprot-P, which to date has benefited some 31,000 Cuban patients and more than 150,000 from 20 other countries, was registered in Turkey by HASBIOTECH, founded for the sole and exclusive purpose of collaborating with Cuba in the field of biotechnology.
Speaking to Granma, Giray described the registration as “An important step” stating that “Although Turkey is not a full member of the European Community, important agreements between our country and the Union have been signed, such as those relating to the pharmaceutical industry and the registration of medicines. Therefore, registering a product in Turkey is the same as having it registered in Europe.”
Dr. Luis Herrera, commented on the importance of registering the medicine at a commercial and regulatory level as well as its significance to bilateral relations, emphasizing that the availability of Heberprot-P in Turkey “should enable the prevention of 40,000 to 50,000 amputations,” which “translates into positive results for the well-being for the population.”
“We are talking about a nation of 80 million inhabitants, an estimated 5 million of which are diabetic. 100,000 people a year suffer from foot ulcers, no less than 60,000 of which should be able to buy this medicine,” he stated.
Herrera also highlighted the desire to “expand relations,” commenting that “biotechnology is one of the most important spheres of trade between both countries.”
According to Jorge Berlanga, among the advantages of using Heberprot–P are that it enables “the prolonged recovery of the affected patient and significantly reduces the chances that the ulcer will reoccur: benefits which, to date, none of the other internationally approved medicines provide.”
Berlanga noted that they conduct “systematic vigilance in terms of the competitiveness of other products,” stating that Heberprot-P continues to be the only alternative to invasive surgery.
According to experts, Cuba’s Heberprot-P – developed jointly by specialists from the CIGB and the National Institute of Angelology and Vascular Surgery – has proved effective in treating large and deep ulcers (stages 3 and 4 of 5 on the Wagner scale) in diabetic patients, which affect tendons and bones and are resistant to all types of conventional treatments.
Since 2011, Heberprot-P has held the Gold Medal of the World Intellectual Property Organization and from 2009 to date, is the leading biotechnological product exported by Cuba.
Heberprot-P was registered in Cuba in July 2006; in April 2007 it was included on the list of basic medicines, consisting of 888 essential products; and in June of this year the plan to make it available nation wide – at a primary care level – began.
Heberon Alfa-R, another important CIGB product, with proven antiviral effects and effective in stunting the development of cancerous cells, is also available in Turkey and Azerbaijan.
Giray reported on other collaborative projects in the field of biotechnology, such as the construction of a production plant in Turkey, to manufacture and package Cuban products, which is scheduled to be completed by the end of 2015.
“We also have high expectations for the results of a vaccine against hepatitis C which is currently in the experimental phase at the CIGB. We want to be partners and work together on all phases. We will assume all costs and risks without letting this affect the Cuban side and are confident of releasing a product onto the world market soon,” stated Giray.
Heberprot-P was patented in the U.S. a few years ago, however the blockade imposed on Cuba for more than 50 years by Washington, has prevented its citizens from accessing and benefiting from the drug.
Only recently did the Treasury Department approve the license in order to respond to an unresolved medical need, so that its maximum regulatory authority, the FDA, could test the product, whose effectiveness has already been proven by numerous patients throughout the world.
By Lilliam Riera, Digital Granma Internacional
September 29, 2014