Transgene and AFM renew their gene therapy agreement

Strasbourg and Paris, November 25, 1998 — TRANSGENE and the "Association Française contre les Myopathies" (the "AFM") today announced the renewal of their agreement to accelerate the research and development of gene therapy treatments for neuromuscular diseases, particularly Duchenne's Muscular Dystrophy (DMD).

Under the agreement — which will expire on June 30, 2001, unless it is further extended — AFM is providing funding for a research program in an amount of 84 million French Francs (USD 14.7 million). Of this amount, 20 million French Francs (USD 3.5 million) will be loaned to TRANSGENE without interest and will be repayable upon the launch upon commercial lauch of a new therapy arising from the collaboration. TRANSGENE will contribute to the program its expertise and technology in the area of gene transfer, in particular its vector platform, and will continue its efforts in the development of a gene therapy for DMD.

TRANSGENE and AFM also expect to develop other gene therapies directed to the treatment of other neuromuscular and rare genetic diseases for which AFM has access to the rights on the genes of therapeutic interest. Under the agreement, TRANSGENE will be the exclusive development partner, with AFM reserving the right to develop gene therapies with third parties if TRANSGENE decides not to develop a gene therapy product for such diseases.

"The renewal of our collaboration with AFM testifies to the quality of our scientific team and technology" said Bernard Gilly, President and CEO of TRANSGENE. "It gives TRANSGENE additional resources to continue its efforts in the development of vectors, and especially to support the development of therapies for the treatment of muscular dystrophies. It also gives us an excellent opportunity to attack this very difficult scientific hurdle that the targeting of muscular cells represents."

"The successful development of gene therapy is dependent on an effective way to deliver therapeutic genes to specific target cells. TRANSGENE believes that its diversified vector platform could enable it to select a safe and efficient vector for the insertion of genes into muscles" Gilly added.


Since 1958, AFM has been organizing patients ailing from neuromuscular diseases and their families. In order to obtain sufficient means to stimulate genetic research in France, AFM launched the Telethon in 1987. Using the proceeds of the Telethon, AFM created Genethon in  1990, which produced, in 1992, the first maps of the human genome. This year, AFM launches "the Great Adventure" for the development of gene therapies, of which the agreement with TRANSGENE constitutes an essential part.

TRANSGENE, based in Strasbourg, France, is an integrated biotechnology company dedicated to the discovery and development of gene therapy technologies and products for the treatment of acquired or inherited diseases for which there is no cure or adequate therapy at present. Its proprietary technology platform includes adenoviral, vaccinia viral, retroviral, cellular and a range of synthetic vectors for gene delivery. Three of these vector families are currently in clinical development for several disease applications. TRANSGENE currently has three Phase II studies ongoing targeting a number of different cancers. TRANSGENE has two major partnering agreements with Schering-Plough and Human Genome Sciences.

Source: Transgène

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Human Genome Sciences and Transgene sign Gene Therapy Agreement

Rockville (MD) and Strasbourg, France — March 2, 1998 — Human Genome Sciences, Inc. (NASDAQ: HGSI) and TRANSGENE today announced that they have signed an agreement to accelerate the development of novel gene therapy drugs. This collaboration will combine HGSI's worldwide standing in genomics with TRANSGENE's broad technology platform of gene delivery systems.

The agreement covers a ten year program with HGSI and TRANSGENE working together to identify, from HGSI database, novel genes of potential interest for gene therapy. TRANSGENE will have the right to exclusively license, and sublicense, up to 10 genes and to develop, manufacture and commercialize any resulting gene therapy products worldwide. The two companies may also choose to co-develop and co-market the identified new gene therapy products, and, in such case, commercialization rights will be held by HGSI for North America and by TRANSGENE for Europe, and will be shared equally for the rest of the world's markets.

Under the terms and conditions of the agreement, HGSI will take a 10 percent interest in TRANSGENE's equity. TRANSGENE will pay an initial licensing fee and research funding in an amount equal to the proceeds to TRANSGENE from the HGSI purchase. Additional payments to HGSI are dependent upon the number of genes which TRANSGENE licenses and the accomplishment of certain milestones. Royalties on future product sales and partnering revenues will be paid by TRANSGENE to HGSI. On co-marketed products, HGSI and TRANSGENE will pay reciprocal royalties.

"We are very pleased to enter into a collaboration with TRANSGENE to develop novel gene delivery products said William A. Haseltine, Ph.D., Chairman and Chief Executive Officer of HGSI. We hope our combined efforts will open a second wave of gene therapy products for the treatment and possible cure of a wide variety of human diseases."

Since its founding, HGSI scientists have rapidly discovered human genes. At the current time, Company scientists believe that they have identified 95 percent of all human genes. In addition, the Company believes that it has full-length copies of approximately 70 to 80 percent of all expressed human genes. HGSI scientists are systematically reviewing several thousand novel genes to determine their medical utility. HGSI holds the rights to the genes it discovers.

"This collaboration will give TRANSGENE a tremendous opportunity to fill its future product pipeline and is another demonstration of the promise of its broad gene delivery platform said Bernard Gilly, President and Chief Executive Officer of TRANSGENE. We are delighted to team up with the premier genomics company, and strongly believe that based on the quality of both management teams and the mutual professional respect of the scientists, we can create a strong foundation to build upon the synergies between genomics and gene therapy."

Successful development of gene therapy products is dependent on two key elements: the identification of critical genes that provide a therapeutic function and an effective way to deliver and express these genes in specific target cells. TRANSGENE has developed a broad range of proprietary gene delivery systems designed to be used efficiently and safely in a number of specific applications.


Human Genome Sciences is a company whose mission is to develop products to predict, prevent, detect, treat and cure disease based on its leadership in the discovery and understanding of human and microbial genes. HGS and Human Genome Sciences are registered trademarks of Human Genome Sciences, Inc.

TRANSGENE, based in Strasbourg, France, is an integrated biotechnology company dedicated to the discovery and development of gene therapy technologies and products for the treatment of acquired or inherited diseases for which there is no cure or adequate therapy at present. Its proprietary technology platform includes adenoviral, vaccinia viral, retroviral, cellular and a range of synthetic vectors for gene delivery. Three of these vector families are currently in clinical development for several disease applications. TRANSGENE expects its programs against melanoma and breast cancer to begin Phase II clinical trials in the first quarter of 1998. Additional disease targets for TRANSGENE's gene therapy delivery systems include cystic fibrosis (Phase I completed), muscular dystrophy and cardiovascular diseases.

Source: Transgène

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Transgene appoints Prof. Paul Berg and Mr. Steven Burrill to its Board of Directors

STRASBOURG, France, February 17, 1998 — TRANSGENE S.A. today announced that Dr. Paul Berg and Mr. G. Steven Burrill have joined the company's board as directors.

"We are naturally pleased and proud that Dr. Paul Berg and Mr. G. Steven Burrill are joining our board said Bernard Gilly, President and Chief Executive Officer of TRANSGENE. Being able to benefit from their outstanding experience in science and industry is very important for us, as our research and development programs are gathering momentum and we are looking to continue expansion of our international business relationships."

Dr. Paul Berg is currently the Cahill Professor in Cancer Research in the Department of Biochemistry at Stanford University and Director of the Beckman Center for Molecular and Genetic Research at the Stanford University School of Medicine. In 1980, Dr. Berg received the Albert Lasker Medical Research Award and the Nobel Prize in Chemistry for his studies of the biochemistry of nucleic acids, with a specific emphasis on recombinant DNA. In addition to his position as Director, Dr. Berg will also participate in meetings of TRANSGENE's Scientific Board.

Mr. G. Steven Burrill is Chief Executive Officer of Burrill & Company, a private merchant bank specializing on life science companies. Pior to founding Burrill & Company, Mr. Burrill spent 28 years at Ernst & Young, where he was International Chairman of their biotechnology and high technology group. He works with industry leaders around the world helping life science companies sustain their growth. He serves on the Board of Directors of a number of biotechnology companies as well as several scientific and biotechnology companies in the US and in Europe. In addition to his position as Director, Mr Burrill will chair the Audit Committee of TRANSGENE's Board.

Commenting on the announcement, Dr. Paul Berg said: I look forward to contributing to TRANSGENE's development. The company is making good progress in improving its technology platform for early clinical testing.

"Gene therapy is a rapidly evolving field, with great potential as it aims to correct the underlying genetic defects causing disease. As such, gene therapy has the potential to be applied to many diseases where conventional medicine has failed" added Mr. Burrill.

The Board of Directors of TRANSGENE has been chaired by Alain Mérieux since 1991. Mr. Mérieux is also the founder and Chairman of bioMérieux, one of the top ten in vitro diagnostic companies.


TRANSGENE, based in Strasbourg, France, is an integrated biotechnology company dedicated to the discovery and development of gene therapy technologies and products for the treatment of acquired or inherited diseases for which there is no cure or adequate therapy at present. Its proprietary technology platform includes adenoviral, vaccinia viral, retroviral, cellular and a range of synthetic vectors for gene delivery. Three of these vector families are currently in clinical development for several disease applications. TRANSGENE expects its programs against melanoma and breast cancer to begin Phase II clinical trials in the first quarter of 1998. Additional disease targets for TRANSGENE's gene therapy delivery systems include cystic fibrosis (Phase I completed), muscular dystrophy and cardiovascular diseases.

Source: Transgène

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Schering-Plough and Transgene Collaborate on Gene Delivery Technology

MADISON, N.J., and STRASBOURG, France, February 4, 1998 — Schering-Plough Corporation (NYSE:SGP) and TRANSGENE today anounced a research collaboration and licensing agreement covering the use of TRANSGENE's adenoviral gene delivery systems in conjunction with Schering-Plough's p53 tumor suppressor gene and several other Schering-Plough proprietary genes to develop gene therapy products.

Under the terms of the agreement, Schering-Plough receives rights to existing and future adenoviral gene technology developed by TRANSGENE in conjunction with the p53 gene. In addition, Schering-Plough has the option the license TRANSGENE's adenoviral gene delivery systems for up to five additional Schering-Plough genes.

Under this agreement, Schering-Plough has agreed to pay to TRANSGENE $ 8 million in initial licensing fees. If Schering-Plough exercises it option to utilise TRANSGENE's adenoviral delivery systems for all six genes over the next five years, total revenue to TRANSGENE could exceed $ 88 million in additional licensing fees, research funding and milestone payments. The agreement also provides for royalties on future product sales.

"This collaboration with Schering-Plough confirms the quality of TRANSGENE's research and the potential of its technology platform in the field of gene therapy" said Bernard Gilly, President and Chief Executive Officer of TRANSGENE. "In addition, it also demonstrates TRANSGENE's ability to leverage its gene delivery technologies for developing products based upon the proprietary genes of pharmaceutical companies."

Successful development of gene therapy is dependent on two key elements: the identification of key cellular genes that provide a missing biological function associated with a specific disease, and an effective way to deliver these genes to specific target cells. TRANSGENE believes that its improved adenoviral vectors may be particularly efficient in delivering genes to tumors, and therefore may be a more effective gene delivery system for gene such as the p53 gene that need to be expressed within tumor cells.

Schering-Plough initiated a clinical development program for its recombinant adenovirus encoding human p53 (rAd/p53) gene therapy in a Phase I non-small-cell lung cancer trial in 1996. Early Phase trials are ongoing to investigate intratumoral administration of rAd/p53 in head and neck cancer, and intraperitoneal administration of rAd/p53 in patients with liver malignancies. In this trial, evidence of gene expression in tumors by this systemic route has been seen despite pre-existing antibodies to the adenovirus.

Schering-Plough's p53 gene therapy program began in 1994 as a research collaboration with Canji, Inc., a leading developer of gene-related therapeutic products. Canji was acquired by Schering-Plough in February 1996 and now is Scring-Plough's Research Institute's center for gene therapy discovery.


TRANSGENE, based in Strasbourg, France, is an integrated biotechnology company dedicated to the discovery and development of gene therapy technologies and products for the treatment of acquired or inherited diseases for which there is no cure or adequate therapy at present. Its proprietary technology platform includes adenoviral, vaccinia viral, retroviral, cellular and a range of synthetic vectors for gene delivery. Three of these vector families are currently in clinical development for several disease applications. TRANSGENE expects its programs against melanoma and breast cancer to begin Phase II clinical trials in the first quarter of 1998. Additional disease targets for TRANSGENE's gene therapy delivery systems include cystic fibrosis (Phase I completed), muscular dystrophy and cardiovascular diseases.

Schering-Plough Research Institute is the pharmaceutical research and development arm of Schering-Plough, a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical and health care products worldwide.

Source: Transgène

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