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GenOdyssee Receives Broad Product Applications Protection in EU for Founding Natural Evolution Technology
Date:10/24/2008

GenOdyssee Has Received Notice of Allowance of European Patent Application

Covering Its Core Natural Evolution Technology Invented in 2002, and Received Broad Product Applications Protection Rights to All Cytokine

Families

PARIS, October 24 /PRNewswire/ -- GenOdyssee (GO), a biotechnology company dedicated to the discovery and development of improved 'next generation' human protein therapeutics, announced today that it has received notice of allowance from the European Patent Office of its Patent Application no.3 785 733.1 (PCT/EP03/13965) covering its core founding drug discovery technology process entitled "Method For Providing Natural Therapeutic Agents With High Therapeutic Index" for applications to all therapeutic cytokine families.

The company pioneered the vision that natural evolution has created in the general population superior genetic variants of key human protein therapeutic drugs as compared to the first wave of reference protein therapeutic variants isolated and developed during the first biotech boom in the 80s, which currently constitute standard of care.

"We have always believed that our technology has wide potential in the industry for discovery of second generation products. Our IFN and EPO products have been granted IP in all major countries in which we filed a product patent application, including the EU and the USA. Our IP portfolio now extends to 53 patents and patent applications in more than 19 countries. Importantly, the European patent office has now granted our technology broad product protection rights across all cytokine families. The granting of such broad IP product rights is relatively unusual and has been achieved in this case because GenOdyssee successfully demonstrated successful application of its technology across multiple products in various cytokine families," said Dr. David Brown, senior executive advisor for science & bus dev to GenOdyssee.

"This confirms the uniqueness of our proprietary technology as well as the global leadership of our company's platform in the protein therapeutics optimization arena. There is potential to apply our technology to additional important classes of therapeutic cytokines such as Interleukins and CSFs," added Dr. Escary, chief executive officer.

The company's first lead product is a novel, natural human IFN alpha variant protein called GEA007.1, a protein which is found in all major human populations It is a naturally occurring variant of human IFN alpha 17, which incorporates an innovative amino acid substitution G45R that provides a novel positive charge together with a change in 3-D structure of the protein receptor binding site. The biochemical and structural modifications induced in the protein binding site provide for superior anti-HCV efficacy using the industry gold standard replicon assay without significantly increased toxicity as demonstrated in Rhesus Monkeys compared to standards of care IFN alpha 2 molecules. GEA007.1 product patent applications have been granted in the EU and in the USA and are pending in an additional 17 countries including Japan and emerging countries like China where HCV is also a major health problem.

Examination procedures by the international patent offices have not revealed any relevant prior art to such product or to the natural evolution technology invented by the company.

About GenOdyssee S.A.

GenOdyssee applies its proprietary population-genetics-based drug discovery approach using a proprietary DNA databank representative of more than 90% of the different ethnicities that constitute the current human population, which is screened for natural genetic variants of therapeutic proteins with superior pharmacological properties. The company pioneered the vision that natural evolution has led to the generation in the current population of unpredictable mutations that confer superior or novel therapeutic status to known important human therapeutic proteins. GenOdyssee's technology is protected by the international patent application PCT/EP03/13965 and is the sole property of the company.

This technology has allowed GenOdyssee to identify in the population a variety of innovative variations on existing key protein drugs such as IFN alphas and EPO and to convert such variations into novel drug candidates. The company's lead virology and immunotherapy drug candidates are GEA007.1 and GEA009.2, respectively targeted at treatments of HCV infection and cancer.

For more information about the company, please visit the company's website at http://www.genodyssee.com

About GEA007.1

GEA007.1 is a novel and first in man natural human IFN alpha protein variant identified using the company's proprietary natural evolution technology. It is found in all major human populations (Pacific, Iberian, Italian, Mexican, African, Caucasian, Chinese, Indo-Pakistan, Middle-Eastern, Japanese). GEA007.1 is a naturally occurring variant of human IFN alpha 17, which incorporates an innovative amino acid substitution G45R that provides a novel positive charge together with a change in 3-D structure of the protein receptor binding site. The biochemical and structural modifications induced in the protein binding site provide for superior anti-HCV efficacy without increased toxicity of GEA007.1 as compared to IFN alpha 2 which is the core agent of current standard of care. Long lasting second generation pegylated IFN alpha 2's have given major improvements in HCV therapy in combination with ribavirin.

GEA007.1 is particularly positioned for use in HCV genotype 1 which has become the predominant genotype worldwide and which is the most difficult to treat, as well as in patients infected with HCV genotype 3 because of the following properties:

- Stronger anti-HCV activity in fresh human hepatocytes

infected with HCV type 3 (genotype 3a) virus, in which GEA007.1 reduced

HCV RNA to levels 3-4 fold lower than IFN alpha 2 drugs.

- Stronger anti-HCV activity in vitro in the HCV genotype 1b

subgenomic replicon assay (BM4-5 cells) as compared to IFN alpha 2.

GEA007.1 exhibits a 7 fold superior inhibitory activity on HCV genotype

1b RNA synthesis compared to IFN alpha 2.

- Viral clearance of HCV genotype 1b replicon subgenome was

obtained in BM4-5 cells after long-term administration (20 days) of

GEA007.1, as evidenced by elimination of HCV genotype 1b RNA (both

strands) replicon genome. In contrast, HCV genotype 1b RNA (both strands)

was still apparent in cells treated with IFN alpha 2 in same conditions.

- No rebound of HCV genotype 1 replication after cessation of

GEA007.1 treatment. HCV subgenomic RNA remained undetectable after 5

passages post-treatment in GEA007.1 treated cells, whereas a low amount

of positive strand HCV subgenomic RNA was maintained in IFN alpha 2

treated cells.

- Similar safety pharmacology in rhesus monkeys (Macaca

mulatta) to IFN alpha 2.

- Importantly, GEA007.1 is a natural human protein, which

means it is already functional and tolerated in man.

CONTACT: Dr. Jean-Louis Escary, CEO

Tel: +33(0)616-416-857

Email: escary@genodyssee.com


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SOURCE GenOdyssee SA
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