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Transgene

Regulatory Filings Oct 22, 2008

1715_rns_2008-10-22_3271d769-68a4-46b2-b6af-4326ed28d787.pdf

Regulatory Filings

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OSEO-supported ADNA program receives approval from the European Commission

Lyon, October 22, 2008 – The ADNA (Advanced Diagnostics for New Therapeutic Approaches) program which is being coordinated by Mérieux Alliance, has just been given the European Commission's approval for an allocation of state research and innovation aid from OSEO in the amount of €89.5 million.

With the support of Mérieux Alliance, the ADNA program brings together four players: bioMérieux and GenoSafe in the field of diagnostics, and Généthon and Transgene in the field of therapeutics. It also calls upon the expertise of other partners, such as: the French Atomic Energy Commission (CEA), the French National Scientific Research Center (CNRS), the Lyon University Hospitals (HCL), STMicroelectronics (ST), and Claude Bernard University in Lyon (UCBL).

The ADNA program intends to contribute to the development of more personalized medicine in the field of infectious diseases, cancer, and rare genetic diseases, by providing healthcare players with innovative products and services in the field of theranostics.

Since response to treatments varies from one patient to the next according to specific genetic and biological factors, the objective of this program is to develop diagnostic or treatment resources with the aim of determining or predicting the response to a given treatment, thus working toward a better handling of the patient through personalized healthcare.

The primary innovation of the ADNA program is based on the identification and development of biological markers — biomarkers — that will make it possible to guide the prescription of new therapies toward patients genuinely likely to benefit from them. Indeed, biomarkers are indicators that seek to establish an early diagnosis and improve the understanding of the progress of a disease and to track the patient's response to his or her treatment. Biomarkers also pave the way to new diagnostic tests associated with treatment solutions.

The following will be developed within the context of this program :

• by bioMérieux in conjunction with its partners CEA, CNRS, HCL, ST, and UCBL :

  • new molecular biology platforms for diagnosing infectious diseases and conducting analyses having a high medical value for cancer,
  • biomarkers in the field of diagnostics and prognoses for certain types of cancer and infectious diseases,

• by GenoSafe :

  • a technological platform for patient immunomonitoring, aimed at evaluating the safety and efficacy of new biotherapeutic products, from preclinical research to their marketing,

• by Généthon :

  • three gene therapy products for rare genetic neuromuscular diseases such as Duchenne's muscular dystrophy and limb girdle dystrophies (gamma-sarcoglycanopathy, calpainopathy),
  • treatment and diagnostic biomarkers for assistance with neuromuscular diseases, especially Duchenne's muscular dystrophy.

• by Transgene :

  • a new treatment vaccine against persistent human papilloma virus (HPV) infection, currently in the preclinical stage,
  • new areas of clinical development for the anti-cancer treatment vaccine TG4010,
  • biomarkers associated with these vaccines.

The ADNA program represents a total investment in research and development of nearly €400 million over the period of 2008-2017.

OSEO's support, which had been decided on in November 2006 by the Industrial Innovation Agency (the AII, now a part of OSEO), is broken down into €50.8 million in subsidies and €38.7 million in loans reimbursable in the event of success, distributed as follows: €47.3 million for bioMérieux and its partners (CEA, CNRS, HCL, ST, and UCBL); €20.3 million for Généthon; €18.4 million for Transgene; and €3.5 million for GenoSafe.

"Brussels' approval is going to allow us to implement the ADNA program. OSEO's significant aid confirms the pertinence of the scientific and technological choices presented within the context of this program. It gives us new resources for meeting the challenges of personalized healthcare by adapting the best possible treatment to each patient. ADNA will have to rise to lofty challenges in terms of public health and medical innovation," said Alain Mérieux, President of Mérieux Alliance.

About OSEO

OSEO supports innovation and growth in companies through its three major areas of activity: aid to innovation, guaranteeing bank financing and actions with its own funds, and financing of investments and the operational cycle. As such, it provides companies with products allowing them to cover all of their needs. For more information, go to: www.oseo.fr

Contacts :

Sabina Cristova +33 (0)1 41 79 98 85 [email protected]

About Mérieux Alliance

With many years' experience and recognized expertise in bioindustry, Mérieux Alliance, the family holding company of Alain Mérieux, is dedicated to constantly improving patient care throughout the world by developing new biotechnology-based solutions.

Mérieux Alliance comprises five healthcare companies dedicated to public health, which span the full range of healthcare: prevention, diagnosis, prognosis, treatment and clinical follow-up:

  • bioMérieux, based in Marcy l'Etoile (France), which is 59%-controlled. A worldwide group specialized in the field of in vitro diagnostics and industrial microbiological testing,
  • Silliker, based in Chicago (US), which is 89%-controlled. A network of food testing and consulting laboratories,
  • Shantha Biotechnics Ltd, based in Hyderabad (India), which is 79%-controlled. Specialized in developing and producing vaccines and therapeutic proteins,
  • Transgene, based in Strasbourg (France), which is 53%-controlled. Dedicated to the development of therapeutic vaccines and immunotherapeutic products in oncology and infectious diseases.
  • ABL Inc (Advanced BioSciences Laboratories), based in Washington D.C. (US), which is 100% owned. Specialized in virological research.

With over 9,300 employees worldwide, Mérieux Alliance reported 2007 consolidated revenue of €1.3 billion under the leadership of Alain Mérieux.

Contacts : Mérieux Alliance Image 7 Anne de Chiffreville : +33(0)6 24 48 36 70 [email protected]

Laurence Heilbronn +33 (0)1 53 70 74 70 [email protected]

Tiphaine Hecketsweiler : +33 (0)1 53 70 74 70 [email protected]

About bioMérieux

Advancing diagnostics to improve public health

A world leader in the field of in vitro diagnostics for 45 years, bioMérieux is present in more than 150 countries through 38 subsidiaries and a large network of distributors. In 2007, revenues reached €1.063 billion with 84% of sales outside of France.

bioMérieux provides diagnostic solutions (reagents, instruments, software), which determine the source of disease and contamination to improve patient health and ensure consumer safety. Our products are used for diagnosing infectious diseases and providing high medical value results for cardiovascular emergencies and cancer screening and monitoring. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products. bioMérieux is listed on the NYSE Euronext Paris market (Code: BIM – Code ISIN: FR0010096479). Other information can be found at www.biomerieux.com and www.biomerieux-industry.com

Contacts :

Investor Relations

bioMérieux LT Value

Isabelle Tongio Nancy Levain + 33 (0)4 78 87 22 37 + 33 1 55 27 15 88 [email protected] [email protected]

Media Relations

bioMérieux Fleishman Hillard Image Sept Koren Wolman-Tardy Andrea Moody Laurence Heilbronn + 33 (0)4 78 87 20 08 + 1 919 457 0744 +33 (0)1 53 70 74 70 [email protected] [email protected] [email protected]

Thiphaine Hecketsweiler +33 (0)1 53 70 74 70 [email protected]

About GenoSafe

GenoSafe® SAS is a Contract Services Organization specialized in evaluating innovative biotherapeutic products. From the initial steps in lab research to clinical trials, GenoSafe, based on the Genopole Evry biopark, has unique expertise in the development, validation and implementation of analytical methods for evaluating the safety and efficacy of biotherapeutic products such as gene and cell therapy products, vaccines, recombinant proteins and monoclonal antibodies. GenoSafe provides advice and project support to its customers (biotech firms, pharmaceutical companies and academic labs) by offering them a broad range of services in complementary fields: molecular analysis, evaluation of immunological responses, quality control of viral vector batches and the creation of custom cell lines.

For more information : www.genosafe.com

Contact : Vincent Zuliani +33 (0)1 69 47 11 57 [email protected]

About Généthon

A new era in therapeutics

Généthon is a not-for-profit biotechnology organization which is founded for 85% by AFM (Association Française contre les Myopathies). It mission is to discover, develop and produce innovative therapies (gene and cell therapies) for rare and orphan diseases. After having successively focused on human genetics and vector technology, Généthon is now tackling the clinical drug era via several therapeutic concepts: gene therapy in vivo, ex vivo cell therapy, and gene surgery (RNA interference, exon-skipping, ...). For more information : www.genethon.fr

Contact : Marie-Odile Ott +33 1 69 47 11 64 [email protected]

About Transgene

Transgene is a France-based biopharmaceutical company dedicated to the development of therapeutic vaccines and immunotherapeutic products in oncology and infectious diseases. The company has three compounds in Phase II trials (TG4001/R3484, TG4010 and TG1042) and one compound in Phase I studies (TG4040). Transgene has concluded a strategic partnership agreement with Roche for the development of its TG4001/R3484 therapeutic vaccine to treat HPV-mediated diseases. Transgene has bio-manufacturing capacities for viralbased vectors and technologies available for out-licensing. Additional information about Transgene is available on the Internet at www.transgene.fr.

Contacts: Transgene Capital MS&L Philippe Poncet Mary Clark CFO Anna Mitchell +33 (0)3 88 27 91 21 +44 20 7307 5330

[email protected] [email protected]

Elisabetta Castelli Head of IR +33 (0)1 44 08 55 05 [email protected]

About CEA Leti

The CEA (French Atomic Energy Commission), a public organization for technological research, carries out its missions in the domains of energy, information and health technologies and defense, building on the foundations of fundamental research at the highest level. Strengthened by the competence of its 15 000 researchers and collaborators, it is recognized internationally and constitutes a strong source of original ideas for public authorities, institutions and industries in France and in Europe.

Located in Grenoble, CEA Leti (Electronics and Information Technology Laboratory of the French Atomic Energy Commission) is at the leading edge of European research in microelectronics, microtechnology and nanotechnology: it employs nearly 1000 people and deposits around 200 patents per year. With 28 start-ups created or in the course of creation, it is one of the most important partners of the industrial world. Instigator of the MINATEC® pole of innovation, CEA Leti is also one of its principal partners, beside the INP Grenoble (Grenoble Institute of Technology) and the local authorities.

Further information on www.cea.fr. MINATEC® is a registered trademark of the CEA.

Contact :

Clément Moulet Press Relations +33 (0)4 38 78 03 26 [email protected]

About CNRS

The Centre National de la Recherche Scientifique (National Center for Scientific Research) is a governmentfunded research organization, under the administrative authority of the French Ministry of Research.

With 32,000 employees including 11,600 researchers, CNRS is organized in 6 research departments, 2 national institutes, 19 regional offices, ensuring decentralized direct management of laboratories, and 1,256 research units (90 % are joint research laboratories with universities and/or industry).

As the largest fundamental research organization in Europe, CNRS carries out research in all fields of knowledge including Life sciences.

CNRS has the following missions :

  • To evaluate and carry out all research capable of advancing knowledge and bringing social, cultural, and economic benefits for society.
  • To contribute to the application and promotion of research results.
  • To develop scientific information.
  • To support research training.
  • To participate in the analysis of the national and international scientific climate and its potential for evolution in order to develop a national policy.

CNRS encourages collaboration between specialists from different disciplines in particular with universities thus opening up new fields of enquiry to meet social and economic needs. CNRS has developed interdisciplinary programs, specially in "Life and its social implications", which bring together various CNRS departments as well as other research institutions and industry.

Contact :

Jacques Fontes +33 (0)4 72 44 56 75 [email protected]

About HCL

France's second-largest university hospital center, HCL has three key activities:

  • Healthcare, with 17 hospitals totaling 5700 beds and places. The various facilities are organized to suit patient pathologies, with multidisciplinary hospitals, specialty hospitals and healthcare centers for the elderly.
  • Teaching. Over 3000 professionals are trained each year in the schools of medicine and pharmacy as well as HCL's colleges and institutes.
  • Research, overseeing numerous clinical research programs. HCL is associated with three federative research institutes, 22 INSERM units, 22 CNRS units, two clinical investigation centers and one INRA unit. The pharmaceutical and biomedical industries are daily partners in numerous research ventures.

www.chu-lyon.fr

Contact : Céline Chaux +33 (0)4 72 40 70 88 [email protected]

About STMicroelectronics

STMicroelectronics is a world leader in the development and creation of silicon-based solutions intended for a large number of applications. Its expertise with silicon and systems, its industrial power, its portfolio of intellectual property, and its strategic alliances put ST on the cutting edge of chip-based system technologies and its products contribute fully to a convergence between applications and markets. STMicroelectronics is quoted on the New York Stock Exchange, the Paris Stock Exchange (Euronext), and the Milan Stock Exchange. In 2007, ST achieved a net sales figure of US \$10 billion. Additional information can be found at: www.st.com

Contact : Nelly Dimey +33 (0)1 58 07 77 85 [email protected]

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