NEWS
May 19, 2009
Endotis Pharma reports successful completion of phase I program with EP42675, a first in class synthetic parenteral anticoagulant
 
Two abstracts will be presented at the ISTH congress in July 2009

Biocitech Park, Paris (France), 19 May, 2009 - Endotis Pharma, the biopharmaceutical company
dedicated to the discovery and development of small-glyco drugs for applications in thrombosis and
oncology, announced that EP42675 has successfully completed its Phase I program.

EP42675 is the first representative of a new class of synthetic, parenteral, antithrombotic drugs with a
dual mechanism of action combining an indirect factor Xa inhibitor and a direct thrombin inhibitor in a
single molecule. Thus, EP42675 inhibits both thrombin formation and activity.

EP42675 was well tolerated in 100 healthy subjects enrolled in five phase I, including single-dose and
multiple ascending dose studies and a pharmacodynamic interaction study with a combination of oral
aspirin and clopidogrel. The only drug-related adverse effects were minor episodes of bleedings (mostly
at the injection or blood sampling site) explained by the anticoagulant activity of EP42675. Vital signs,
physical examination, ECG (including the QTc interval) and safety laboratory parameters did not show
any treatment-emergent clinically relevant abnormalities.

Treatment with EP42675 resulted in dose-dependent increases in standard and specific coagulation tests,
and decrease in thrombin generation. The pharmacodynamic and pharmacokinetic time-profiles of
EP42675 followed a parallel pattern, with a low intra and inter subjects variability. Further details will be
provided at the International Society of Thrombosis and Hemostasis (ISTH) congress to be held this July
in Boston, since two abstracts have been accepted.

Eric Neuhart, head of Endotis Pharma’s clinical Research and Development department commented:
“EP42675 is the first representative of a new class of parenteral synthetic anticoagulants combining
indirect Xa inhibition and direct free and clot-bound thrombin inhibition. EP42675 has a predictable
pharmacokinetic and pharmacodynamic profile and therefore is expected to be used either intravenously
or subcutaneously at a fixed dose regimen, without the need for routine anticoagulation monitoring.”

Eric Neuhart added: “Endotis is also developing EP217609, the neutralizable form of EP42675, and in
parallel its specific antidote avidin. Both drugs are expected to enter Phase I this summer. Avidin is able
to neutralize the anticoagulant activity of EP217609, and should represent a clinically relevant
advantage in the treatment of major bleeding and prevention of major bleeding risk over reference
anticoagulants. Endotis’ strategy is to pursue the clinical development of this new class of anticoagulant
with EP217609 in the treatment of patients with acute coronary syndromes undergoing a percutaneous
coronary intervention, the first target indication”.

Charles Woler, Endotis Pharma’s Chief Executive Officer added: “The successful completion of a fully
fledged Phase I program with EP42675 proves that Endotis’ clinical team is able to organize and execute
high-quality studies. The scientific value of the data generated has been acknowledged as the results of
these studies will be presented at the ISTH congress. Looking beyond this first success, the development
of other parenteral and oral anticoagulants is progressing well and should enable Endotis to benefit from
a broad and unique anticoagulant franchise, including neutralizable drugs such as EP217609”.


About Endotis Pharma (www.endotis.com)
Endotis Pharma is a biopharmaceutical company dedicated to the discovery and development of small-glyco drugs
(heparin / heparan sulphate mimetics) for applications in thrombosis, oncology and a range of other indications.
Its powerful discovery engine reduces risk by focusing on proven concepts, and by rationally designing drug
candidates with the properties required for commercial success. The value of this platform is demonstrated by the
breakthrough Endotis thrombosis franchise of oral and parenteral drugs in clinical and preclinical development, and
a promising oncology pipeline. Endotis has 35 employees based in Paris and Lille (France).

Disclaimer: the development of new drug technologies is difficult, erratic and unpredictable. Endotis Pharma’s forecasts and future economic performance depend on research that has yet to be performed and on a number of other factors. The company's future economic performance may differ significantly from that currently forecast.

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