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 wellbeing 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.