The News

Endotis Pharma has initiated a Phase I program with the neutralizable anticoagulant EP217609 and its specific antidote avidin, and signed a manufacturing and co-development agreement with Sigma-Tau for avidin

19/10/2009

Parc Biocitech, Paris (France), October 19th, 2009 - Endotis Pharma, a specialty biopharmaceutical company specialized in the discovery and development of synthetic oligosaccharides (« small-glyco drugs ») in thrombosis and cancer, announced the initiation of a Phase I program with both EP217609, a first in class synthetic neutralizable anticoagulant, and its specific antidote avidin. Endotis also announced the signature of a manufacturing and co-development agreement for avidin with Tecnogen, part of the Sigma-Tau group (Italy).

EP217609 is a synthetic parenteral neutralizable anticoagulant that is administered intravenously or subcutaneously at fixed dose without need for monitoring. EP217609 has a dual mode of action combining the properties of an indirect factor Xa inhibitor and a direct thrombin inhibitor. In addition,

EP217609 can be neutralized within a few minutes after administration of avidin.

EP217609 is the biotinylated form of EP42675. As announced in May 2009, EP42675 has successfully completed a phase I program in 100 healthy subjects. EP42675 was well tolerated and showed predictable pharmacokinetic (PK) and pharmacodynamic (PD) profiles with low intra- and intersubject variabilities. In animals, the PK/PD profiles of EP217609 and EP42675 are similar.

Based on EP42675 data, an optimized Phase I program has been defined for EP217609 which will allow a quicker entry in Phase II in two target indications: extracorporeal circulation (ECC) in cardiac surgery, and percutaneous coronary intervention (PCI) in acute coronary syndromes (ACS).
The global clinical development strategy of EP217609 and its antidote avidin has been endorsed by key national European Health Authorities and the US FDA.

Eric Neuhart, MD, Head of Endotis Pharma Clinical Research and Development said: "Endotis is pleased to start first-in-man phase I studies with EP217609 and its specific antidote avidin, which are the initial steps of an innovative clinical development plan. Endotis is committed to developing in parallel a true innovative anticoagulant drug and its antidote that will fulfill unmet medical needs in high-risk patients in several cardiovascular indications.

Eric Neuhart added:”EP217609 and avidin are promising candidates for ECC in cardiac surgery, in particular in high risk patients such as those with heparin-induced thrombocytopenia or at high risk of bleeding. Indeed, unfractionated heparin and its antidote protamine, used since the first cardiac operations 60 years ago, do not have real therapeutic alternatives.

EP217609 should also represent a clinically relevant advantage for ACS patients undergoing PCI.
The availability of avidin in the treatment of major bleedings and prevention of major bleeding risks such as urgent cardiac or non cardiac surgery represents a unique opportunity for improving the benefit risk ratio of anticoagulants in this patient population.”

Endotis also announced the signature of a manufacturing and co-development agreement for avidin with Tecnogen SpA, part of the Sigma-Tau group (Italy). Tecnogen will supply clinical -grade avidin to Endotis, and the two companies will collaborate during their respective clinical developments.
Charles Woler, Endotis Pharma's Chairman and CEO, commented: "The initiation of the clinical development of both EP217609 and avidin, backed by Health Authorities is an important step forward for Endotis Pharma. The partnership with Tecnogen and Sigma-Tau strengthens our portfolio as it secures access to avidin for clinical and commercial purposes”.

Charles Woler concluded: “As a biopharmaceutical company, we will offer to future partners a potential break through neutralizable anticoagulant that can be developed in a niche indication ECC, or a large indication ACS, or both”.

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. The value of this platform is demonstrated by the breakthrough Endotis thrombosis franchise of 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.

For more information:
Press contact: Alize RP
Caroline Carmagnol
+33 (0)6 64 18 99 59
caroline@alizerp.com

Juliette Vandenbroucque
+ 33 (0)1 41 22 07 32
juliette@alizerp.com

Investor contact: Endotis Pharma
Charles Woler, Chairman and CEO
charleswoler@endotis.com
Stéphane Degove, CFO
stephanedegove@endotis.com
+33 (0)1 48 46 84 87