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Thrombotargets Corporation Receives Orphan Drug Designation from the U.S.
Food and Drug Administration for its Procoagulant Agent, TT-103MH, in the
Treatment of Bleeding Episodes in Hemophiliacs
Thrombotargets Corporation, a company focused on the research and development
of new therapies in the fields of thrombosis, hemostasis, atherosclerosis, and
oxidation, today announced that the Company proprietary TT-103MH received an
Orphan Drug Designation from the U.S. Food and Drug Administration for use in
the treatment of non-life threatening mild-to-severe bleeding episodes due to
cutaneous injuries or dental procedures in hemophiliac patients. Hemophilia is a
hereditary genetic disease in which an essential clotting factor is either
partly or completely missing. This causes a person with hemophilia to bleed for
longer than normal.
Orphan Drug Designation is a special status granted by the FDA to drugs which
treat diseases or conditions affecting fewer than 200,000 patients in the United
States based upon review of an Orphan Drug Designation Request submitted by the
sponsor. As an orphan drug, TT-103MH will qualify for seven years of marketing
exclusivity in the U.S.; the sponsor may also benefit from certain tax credits
and grants as well as a waiver of the company's obligation to pay a New Drug
Application user fee for the product under the designated orphan indication.
“We are pleased to receive an Orphan Drug Designation from the FDA for TT-103MH
for the treatment of mild-to-severe cutaneous bleeding episodes in hemophiliac
patients,” said Dr. Pedreno, CEO and President of Thrombotargets.
About TT-103MH
TT-103MH is a new recombinant protein produced by Thrombotargets through a
proprietary process and developed for use in the treatment of non-life
threatening mild-to-severe bleeding episodes due to cutaneous injuries or dental
procedures in hemophiliac patients. It has been observed to prevent death in a
lethal model of hemophilia in mice; TT-103MH also reduced blood coagulation time
up to 90% in ex vivo studies using hemophiliac blood.
About Thrombotargets Group
Thrombotargets is an emerging biotech group pioneering the development of a new
generation of High Throughput Screening (HTS) platforms (BioPlatformScreenTM)
useful to discover innovative drugs for the treatment of prevalent and relevant
diseases such as hemorrhagic and thrombotic disorders (acute myocardial
infarction, angina and stroke). Thrombotargets group is creating a continuously
growing and innovative pipeline.
Contact:Luis Caveda Ph.D.
Thrombotargets Corp
luiscaveda@thrombotargets.com
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