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Thrombotargets Corp announced today that it has submitted its Orphan Drug
Application of TT-103MH to the FDA for bleeding treatment in von Willebrand
patients
July 19th 2007: Thrombotargets Corporation announced today that it has
submitted its Orphan Drug Application of its Human Recombinant protein known as
TT-103MH to the United States Food and Drug Administration (FDA) for bleeding
treatment in von Willebrand patients “ We are extremely proud and remain very
optimistic that the FDA will look favorably on this designation, said Dr.
Pedreño Thrombotargets President and CEO, “We remain very optimistic given the
early Laboratory results, that demonstrate that TT-103MH is a viable and a very
efficacious alternative to current replacement therapy in hereditary coagulation
disorders as von Willebrand diseases and considering previous TT-103MH Orphan
Drug Designation for the treatment of Hemophiliacs ” said Dr. Pedreño president
and CEO.
The FDA grants orphan drug status for drug candidates that are intended to treat
rare life-threatening diseases that, at the time of application, affect no more
than 200,000 patients in the United States. The drug must have the ability to
provide significant patient benefit over currently available treatment or fill
an unmet medical need. Orphan drug designation entitles Thrombotargets corp. to
seven years of market exclusivity in the United States upon FDA approval,
provided that Thrombotargets Corp. continues to
ABOUT THROMBOTARGETS GROUP
Thrombotargets group is comprised by three companies; Thrombotargets
Corporation (Durham, NC, USA) is responsible for Drug Development and Business
Development; Thrombotargets Europe (Barcelona, Spain) for Target Identification,
Lead validation and Lead optimization and Biotech Libraries (Spain) for
engineered targeted libraries and High Throughput Screening.
Thrombotargets has developed and adapted to High Throughput Screening, a new
family of biological assays, Hemosta-BIOPLATFORMSCREEN™, capable to quantify
simultaneously clot formation and clot lysis , Oxidant- BIOPLATFORMSCREEN™ to
quantify total antioxidant capacity and Athero- BIOPLATFORMSCREEN™, to quantify
low-density lipoprotein modification. With these proven proprietary new HTS
Platforms (BIOPLATFORMSCREEN™), Thrombotargets group is creating a continuously
novel and promising pipeline of drug candidates. TT-103MH, Thrombotargets’ most
advanced drug candidate, has recently been granted with an Orphan Drug
Designation.
Contact:
Luis Caveda Ph.D.
Thrombotargets Corp.
COO
luiscaveda@thrombotargets.com
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