Reinforcing Ipsen's presence on the American market clinical programme is underway for Ipsen's botulinum toxin in aesthetic medicine with Inamed

Ipsen Limited, the UK-based pharmaceutical company and subsidiary of the Beaufour Ipsen Group has announced the beginning of Phase II clinical trials in the United States of America (USA) on its botulinum toxin type A for use in aesthetic medicine. "Patients have now been enrolled and are being treated in this important study of botulinum toxin" said Dr Gary Monheit, a Dermatologist in Birmingham, Alabama, and Co-Principal Investigator in the study.

This announcement follows the filing of an Investigational New Drug (IND) application in September 2002, and the signing in July 2002 of a definitive agreement with Inamed Corporation, a global medical device company based in California. The agreement gives Inamed exclusive rights to develop and distribute Ipsen’s botulinum toxin type A for cosmetic indications in the USA, Canada and Japan.

In the past few years, botulinum toxin type A in its purified form, has revolutionised the face of cosmetic dermatology. It is a simple, reliable, reproducible, non-invasive procedure that can be administered successfully to manage a variety of cosmetic issues.

Dr Alistair Stokes, Chief Executive Officer of Ipsen and Group Vice-President, Corporate Development, Beaufour Ipsen said "These trials are part of our worldwide strategy to develop botulinum toxin in aesthetic medicine. Inamed has an excellent reputation in this marketplace, and our relationship with the company will help us to achieve our goal of increasing the use of botulinum toxin as a cosmetic treatment".

"The market in the USA for botulinum toxins is projected to exceed $400 million in 2002 and approach $800 million by 2005. The partnership with Ipsen gives us the potential to expand our product portfolio for the customer in a significant way" said Nick Teti, Inamed’s Chairman, President and Chief Executive Officer.

The exact nature of the cosmetic indication that will be submitted by Inamed will depend on the outcome of the clinical trial programme.

Botulinum toxin will be manufactured by Ipsen Biopharm in Wrexham, North Wales and supplied to Inamed for distribution in North America and Japan. Ipsen Biopharm is the UK pharmaceutical manufacturing and distribution arm of the Beaufour Ipsen Group.


Notes to editor

Botulinum toxin

Beaufour Ipsen’s botulinum toxin type A (which is branded as Dysport®) is now licensed in 50 countries for a variety of neuromuscular indications including: cervical dystonia, blepharospasm, hemifacial spasm, and the treatment of dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy. In addition Dysport® is licensed in some countries for post-stroke spasticity and hyperhidrosis.

Beaufour Ipsen

Present in over 80 countries with a total staff of 3423, the Beaufour Ipsen Group had a turnover of €704 million in 2001, 57% of which was outside France.

The Group specialises in oncology, haematology, neurology and endocrinology and has a portfolio of 30 products which are either peptides, derived from biotechnology, or based on natural sources. In 2001, 16.4% of Beaufour Ipsen’s turnover was reinvested in Research and Development (R&D).

The Group’s website is www.beaufour-ipsen.com

Inamed Corporation

Inamed is a global medical device company engaged in the development, manufacturing and marketing of products for breast and facial aesthetics and obesity intervention. These products include breast implants for aesthetic augmentation and for reconstructive surgery following a mastectomy; a range of dermal products to correct facial wrinkles; and minimally invasive devices for obesity intervention, including the LAPBAND® System indicated for severe obesity.

The Company’s website is www.inamed.com


Source: Ipsen

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Beaufour Ipsen and Roche to develop jointly and market Beaufour Ipsen’s novel anticancer drugs

Roche’s pipeline strengthened, with a fifth oncology transaction including a product in phase II Roche and Beaufour Ipsen (Paris, France) announced today that they have signed a global agreement to co-develop and market Beaufour Ipsen’s new anticancer candidates. Roche will have worldwide rights, excluding Europe, to market two Beaufour Ipsen products in development (diflomotecan and BN80927). Beaufour Ipsen retains these rights for Europe. In addition, mutual rights have been granted to future follow-on products in the same chemical family, the homocamptothecines, a new class of anticancer molecules discovered by Beaufour Ipsen.

Diflomotecan, which is entering Phase II clinical development, and a second compound (BN80927), currently in pre-clinical development, are being assessed for their efficacy in solid tumours, including colorectal, lung and breast cancer. Combination studies of diflomotecan and Roche’s Xeloda are expected to begin during the first quarter of 2003.

Diflomotecan is the first of a new generation of topoisomerase-1 inhibitors, with a proven mechanism of action, improved safety and efficacy profile. The second compound, BN80927, has a novel mechanism of action, including dual inhibition of topoisomerases I and II, and will be developed for a broad spectrum of indications.

"We are very pleased that Beaufour Ipsen has selected Roche to commercialise these promising drug candidates, especially in the US oncology market. With the completion of our fifth oncology deal this year and the continuous progress of our in-house pipeline, the strength of our portfolio continues to increase." said William M. Burns, Roche’s Head of Pharmaceuticals.

"We are delighted to be working with such a world class company and one of the world’s leading oncology companies to develop and market novel topoisomerase inhibitors discovered by Beaufour Ipsen" said Jean-Luc Belingard, CEO of the Beaufour Ipsen Group.


Financial Terms
Under the terms of the agreement Roche will have all rights to market and sell diflomotecan and BN80927 in the USA, Japan, and rest of the world, whereas Beaufour Ipsen will have the sole right to market and sell the products in Europe. Roche and Beaufour Ipsen will jointly pay all future research and development costs for selected indications according to their market potential. Beaufour Ipsen will receive up to US$150 million, consisting of over $20 million in committed payments, and additional payments contingent upon achievement of clinical, regulatory and commercial milestones. Beaufour Ipsen will receive royalties on net sales in the USA, Japan and rest of the world, while Roche will receive royalties on net sales in Europe.

About the Agreement
Roche and Beaufour Ipsen will jointly conduct clinical development of the products. The principal focus of the collaboration will be the clinical development and marketing of diflomotecan and BN80927. Roche and Beaufour Ipsen will also have mutual rights to follow-on compounds and improvements over the next three years. Any such products would also be co-developed and co-commercialised by Roche and Beaufour Ipsen for the treatment of cancer or other therapeutic areas.

Roche in Oncology
Roche is the world leader in oncology. Its franchise includes three drugs with survival benefit: MabThera (Rituximab), Xeloda (capecitabine), and Herceptin (Trastuzumab). It also includes NeoRecormon (epoetin beta), Roferon-A (interferon alfa-2a), and Kytril (granisetron HCL). In addition, Roche has entered several agreements in the current year with Antisoma, Kosan, Gryphon, and GeneMab to develop and commercialise various promising compounds in the oncology field. The Roche Group’s oncology program is supported by four Research sites (two in the USA, Germany and Japan) and five Development sites (two in the USA, UK, Switzerland and Japan).
Roche also offers a broad portfolio of tumor markers for prostate, colorectal, liver, ovarian, breast, stomach, pancreas and lung cancer, as well as a range of molecular oncology tests running on the LightCycler. Within its Integrated Cancer Care Unit the company develops new tests which will have a significant impact on disease management of cancer patients in the future.

About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-orientated healthcare groups. The company's two core businesses in pharmaceuticals and diagnostics provide innovative products and services, that address prevention, diagnosis and treatment of 3 diseases, thus enhancing people’s health and quality of life. The two core businesses achieved a turnover of 19.3 billion Swiss Francs in the first three quarters of 2002 and employed about 57,000 employees worldwide.

Beaufour Ipsen in oncology
Endocrinology/oncology is a significant line of development for Beaufour Ipsen, representing 33.2% of its turnover in 2001. Sales are based on two major products, Decapeptyl, a sustainedrelease (28 days and 3 months) peptide analogue of the hypothalamus hormone (GnRH), mainly indicated in the treatment of prostate cancer, and Somatuline, a sustained-release (28 days) somatostatin peptide analogue and inhibitor of growth hormone used in the treatment of carcinoid tumors.

About Beaufour Ipsen
Present in over 80 countries with a total staff of 3423, the Beaufour Ipsen Group had a turnover of €704 million in 2001, 57% of which was outside France. The Group develops products for four targeted disease area franchises: oncology, endocrinology, neurology and haematology. It currently has a portfolio of 30 products on the market which are either peptides, derived from biotechnology, or products based on natural sources. In 2001, 16.4% of Beaufour Ipsen's turnover was reinvested in Research and Development, which is carried out in four research centres (Paris, Boston, Barcelona and London) by an international network of around 500 scientific staff. The Group's website is www.beaufour-ipsen.com.


Source: Ipsen

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Genome express increases focus on integrated collaborative high throughput services and solutions

Company moves to strengthen position as link in partners' R&D value chain

Grenoble, France, November 15, 2002 - GENOME express, the developer of high value-added solutions for functional genomics and target discovery and validation, announces today that it is increasing its focus on integrated high throughput services and solutions for pharmaceutical, biotech and agri-food industries.

The company has already implemented a number of measures to support this strategy. These include the transfer of its oligonucleotide activity to Qbiogene, a Canadian company that develops and markets molecular biology and genomics products, and the recent launch of its proprietary Discriminative Analysis of Clone Signatures (DACS^TM) technology, a solution focusing on the discovery process of tissue- or cell-expressed genes.

"Remaining competitive and profitable in oligonucleotide activities would have demanded significant investment," said Yves Laurent, CEO of GENOME express. "We decided it would also be a distraction from our higher added value activities where we are engaged in the development and collaborative deployment of our unique integrated platform (genomics, gene profiling and proteomics, bioinformatics) to address real needs."

The recent launch of its Discriminative Analysis of Clone Signatures (DACS) technology is a good illustration of GENOME express' commitment to providing solutions offering real advantages to its customers and partners.

"In the fast-moving field of exploratory genomics, GENOME express intends to stay in the forefront of high value-added services," added Laurent. "Our new GE-DACS solution eliminates bottlenecks in the discovery process of genes expressed in tissue or in a cell and reduces the expense and time needed to generate resources and information for the expression analysis of these genes."

Future investments and collaborations will reinforce its already powerful in-house technology platforms and the company will continue to build a business that brings tangible, significant benefits to its customers. "We expect to make further exciting announcements that will show how GENOME express brings unique competitive advantages to its customers," concluded Laurent.


About GENOME express
GENOME express, Grenoble, France, develops and markets high value-added solutions for functional genomics. The company offers a unique platform that integrates proprietary tools for genomics (discovery and identification of SNPs — Syn-Quence^TM), transcriptomics (gene expression analysis), and proteomics (identification of proteins using genome mapping of mass spectrometry data — Pep Map^TM). Building on its success and experience as a service provider, GENOME express is currently making its platform accessible to private sector researchers and academics in the biopharmaceutical sector. This will be done through partnerships and enable GENOME express customers to outsource their R&D projects either in part or totally. The company is also developing its own research to discover new targets for therapeutic or diagnostic applications in the fields of metabolic diseases such as diabetes or obesity, the central nervous system and bacterial genomics.

For further information: http://www.genomex.com

Source: Genome Express

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Genome express launches proprietary technology to speed up gene discovery

DACS (Discriminative Analysis of Clone Signatures) cuts cost of creating improved genomic resources and simplifies gene expression analysis

Grenoble, France, October 23, 2002 - GENOME express, the developer of high value-added solutions for functional genomics and target discovery and validation, announces today the availability of its new proprietary technology, DACS.

The first application of this innovative technology is GE-DACS^TM (Gene Expression DACS). GE-DACS^TM eliminates bottlenecks in the discovery process of genes expressed in tissue or in a cell. Unlike existing processes, which are both complicated and costly, DACS reduces the expense and time needed to generate resources and information for the expression analysis of these genes. These resources are mainly PCR products that are "ready-to-spot" for an analysis tool such as micro-arrays. Micro-arrays have become an essential tool in the study of complex diseases such as diabetes, cancer and obesity.

DACS thus provides a significant breakthrough compared with other processes such as SAGE¹. DACS not only speeds up the discovery process but also facilitates expression analysis without the need to access data relating to the organism in question (genomic sequence or EST² sequences).

Furthermore, as it is built on the generation of complementary DNA clones, DACS ensures these biological resources are kept intact, and a link to the information produced is established for each clone. If, during the discovery process, researchers suspect the implication of a particular gene in a disease, they can access the initial biological resource and begin an in-depth analysis.

The simplicity of the process means that for the first time, experiments can be reproduced with ease. This is crucial for differential expression analysis, for example gene expression in a normal cell compared to a cancerous cell.

While the first application of DACS is for the study of gene expression, this technology developed by GENOME express can be applied far more widely for use in genomics. Examples include genome sequencing finishing and structural differential genome analysis.

"GE-DACS^TM enriches our technology portfolio with the addition of high-throughput differential expression analysis," said Yves Laurent, CEO of GENOME express. "DACS is proof of GENOME express' ability to develop innovative proprietary tools linking molecular biology to bioinformatics."

¹ — SAGE - Serial Analysis of Gene Expression
² — EST - Expressed Sequence Tag


About DACS
DACS (Discriminative Analysis of Clone Signature) is the new proprietary technology provided by GENOME express. The technology, based on EST sequencing reduces cost while offering the same advantages. DACS marks only one nucleotide of the four composing DNA — A, C, G, T — and includes a capillary multiplex sequencing thus offering high-throughput (1536 samples per run). A patented signal analysis technology applied on sequencing results discriminates identical clones from the different ones, thus allowing the discovery of genes expressed.

For further information: http://www.genomex.com

About GENOME express
GENOME express, Grenoble, France, develops and markets high value-added solutions for functional genomics. The company offers a unique platform that integrates proprietary tools for genomics (discovery and identification of SNPs — Syn-Quence^TM), transcriptomics (gene expression analysis), and proteomics (identification of proteins using genome mapping of mass spectrometry data — Pep Map^TM). Building on its success and experience as a service provider, GENOME express is currently making its platform accessible to private sector researchers and academics in the biopharmaceutical sector. This will be done through partnerships and enable GENOME express customers to outsource their R&D projects either in part or totally. The company is also developing its own research to discover new targets for therapeutic or diagnostic applications in the fields of metabolic diseases such as diabetes or obesity, the central nervous system and bacterial genomics.

For further information: http://www.genomex.com

Source: Genome Express

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Genome express appoints François Pons as new business development manager

Functional genomics company will benefit from François Pons' pharma and biotech experience in creating and managing scientific and industry collaborations

Grenoble, France, September 23, 2002 - GENOME express, the developer of high value-added solutions for functional genomics, announces today the appointment of François Pons as Director of Business Development.

Before taking up this appointment with GENOME express, Pons acquired eight years' high-level experience in the industry. He was Director of business development and scientific communication at the Centre d'Immunologie Pierre Fabre, in Saint Julien en Genevois, on the French side of the border between France and Switzerland. At Pierre Fabre, Pons was closely involved in the negotiation of a number of partnerships and licensing agreements, as well as the setting up and management of research consortia in immunotherapy for cancer and infectious diseases. He was also active in managing investment projects. He originally joined Pierre Fabre as biotechnology licensing manager after a period in strategic marketing with Baxter Healthcare France. His academic qualifications include a master's degree in biochemistry and microbiology (Marseille-Luminy), a diploma in food biotechnology and industry (ENSAIA, Nancy, a French school of agronomy and food industry), and a master's in industrial engineering and management of technological innovation (École Centrale, Paris).

François Pons comes to GENOME express during a period of intensive development. He is responsible for relations with both industry and research establishments and will develop collaborative and partnership alliances with these bodies. His overall mission is to promote GENOME express's integrated genomics and proteomics platform.

"GENOME express is at the stage where it needs to market its know-how in a more targeted and personalized way," said Yves Laurent, CEO of GENOME express. "François Pons brings the skills and experience required for this new phase. He possesses a combination of salesmanship, experience in negotiating and setting up contracts, and understanding of the scientific and pharmaceutical industry environments. This, together with his sheer enthusiasm, will make him one of the key players in the success of GENOME express. We are truly pleased to have him on board."

"I am looking forward to working with the GENOME express team in a vital, fast-growing field," said François Pons. "The company has demonstrated considerable quality throughout its existence and the excellent team has made the right scientific and industry choices, positioning itself in the functional genomics space. These are all good reasons why I want to make my contribution to the company's future success."


About GENOME express
GENOME express, Grenoble, France, develops and markets high value-added solutions for functional genomics. Its expertise covers a variety of disciplines including microbiology (library manufacturing), molecular biology (high throughput sequencing) and bioinformatics (proprietary software). Under development are an integrated genomics and proteomics platform designed to enable GENOME express to engage in proprietary target discovery. Siparex Ventures was lead banker for the fund-raising with co-lead Sud Partners (Sudinnova's fund management arm). Other investors were 3i, the original institutional investor, the Compagnie Financière Edmond de Rothschild, Aquasourça, SPEF Venture and Biotek Partenaires. Since the 12.4&nbps;million euro financing round, the company has received a further million euro grant from France's innovation agency, Anvar. GENOME express is one of the four members of the Genostar consortium, a bioinformatics platform for exploratory genomics that offers a unified way of representing biological knowledge.

Source: Genome Express

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Prostate cancer: Signature of a partnership agreement between Beaufour Ipsen and UroGene

Paris and Evry-Genopole, FRANCE — July 17, 2002 – The pharmaceutical group Beaufour Ipsen and the biopharmaceutical company UroGene have just signed a partnership agreement for the functional and clinical evaluation of a class of molecules in the field of prostate cancer. UroGene will be contributing its molecular genomic know-how, its biological and clinical expertise, and its biological resources and data base, in order to implement this programme.

"This agreement is very pertinent to the Beaufour Ipsen Group strategy since oncology is one of our major lines of therapeutic research. This agreement with UroGene regarding an important medical application is very satisfactory" stated Christophe Thurieau, Director of Research of the Henri Beaufour Institute. "We are convinced that evaluating our molecules for prostate cancer will open the way to extremely promising new therapeutic possibilities. Cancer of the prostate concerns millions of men the world over. Combining our joint expertise and developing the tools required to provide specialist care will give new hope to patients and clinicians involved in the management of this disease."

"We are particularly pleased with the Beaufour Ipsen decision to join forces with us. They are very prominent in the treatment of prostatic cancer and this agreement concurs with our strategy — an integrated oncological and urological approach. It is also a further demonstration that the means and know-how available to us can advance the development of new therapeutics" declared Philippe Berthon, President and Chief Scientific Officer of UroGene. "Further to our own therapeutic development plans — from gene to treatment — in the field of urological tumours, such cooperative work on new molecules can provide timely solutions in the quest for innovative treatment at the clinical stage."


Present in over 80 countries with a total staff of 3423, the Beaufour Ipsen Group had a turnover of €704 million in 2001, 57% of which was outside France. The Company specialises in oncology, haematology, neurology and endocrinology and has a portfolio of 30 products which are either peptides, derived from biotechnology, or based on natural sources. In 2001, 16.4% of Beaufour Ipsen's turnover is reinvested in Research and Development. R&D is focused on four major areas (biologicals, peptides, therapeutic agents of low molecular weight and drug delivery technology) and is carried out from 4 research centres (Paris, Boston, Barcelona and London) by an international network of around 500 scientific staff. The Group is directing its research efforts towards disabling diseases where current treatments remain unsatisfactory. Beaufour Ipsen currently has a pipeline of 15 projects in development. The Group has also set up research partnerships with prestigious universities in the USA and Europe, mainly in France and in the United Kingdom.

UroGene is a biopharmaceutical company with extensive physio-pathological clinical expertise for the accelerated discovery and development of novel onco-urological drugs (prostate, kidney, bladder).

UroGene's three major assets in order to accelerate the process and reach these objectives are:

• UroBank, a tissue and data bank fuelling research projects and enabling early identification of new pertinent therapeutic targets
• A very efficient — and therefore time saving — therapeutic target validation process
• Complete integration of the research and development platform (genomics, functional biology, proteomics, and medicinal chemistry) so that new treatment projects can progress freely from early molecular gene identity studies to molecules in the clinical trial phase involving patients. Several specialised collaboration agreements have been signed to complement the UroGene platform.

At this point, UroGene is working on four of its own therapeutic development programmes (small molecules and peptides) and one programme in partnership.


Source: Ipsen

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New collaboration to develop treatments for inflammatory disease

The University of Cambridge, one of the world's leading centres for biomedical research, and Beaufour Ipsen Group, a European-based global pharmaceutical company, have joined forces to develop and commercialise chemokine inhibitory compounds. Dr David J Grainger, a Royal Society Fellow at the University of Cambridge, has identified a family of peptides and small molecules that exhibit the ability to inhibit migration of inflammatory cells. While the majority of reported chemokine inhibitors are specific for one or a selected group of chemokines, the compounds identified by Dr Grainger exhibit broad chemokine inhibitory activity. These compounds have demonstrated efficacy in a variety of animal models, including those for atherosclerosis, asthma, stroke, endotoxaemia and dermal inflammation.

Under the terms of the agreement negotiated by the University's Technology Transfer Office, Beaufour Ipsen will fund research in Dr Grainger's laboratory, located in the Department of Medicine, Clinical School of Medicine at the University of Cambridge, and make additional payments related to commercialisation of products resulting from Dr Grainger's research.

The University of Cambridge will provide Beaufour Ipsen with exclusive worldwide rights to develop and market the chemokine inhibitory compounds discovered by Dr Grainger. Beaufour Ipsen will manage all phases of product development, including clinical trials and regulatory submissions. Further details of the agreement were not disclosed by either party.

"We are delighted to be working with Dr Grainger to develop his chemokine inhibitory compounds, which will further expand Beaufour Ipsen's strong commitment to the development of peptide-based pharmaceuticals," said Dr Jacques-Pierre Moreau, Beaufour Ipsen Group Vice President Research and Development.

"Dr Grainger is a remarkable young investigator, and his chemokine inhibitory compounds show great promise in the treatment of chronic inflammatory diseases, as evidenced by Dr Grainger's numerous publications in peer-reviewed journals. We are particularly enthusiastic about the prospect of employing these compounds in the area of pulmonary fibrosis, and are involved in animal model studies of pulmonary fibrotic syndromes."

"This agreement illustrates the University's commitment to the formation of commercial partnerships which translate our laboratory discoveries into drugs capable of treating previously incurable conditions," said David Secher, Director of Research Services at the University of Cambridge.


Notes for editors

Chemokines are small proteins that regulate the immune system, particularly chemotaxis (cell migration due to a chemical gradient). To date, four families of chemokines have been identified, consisting of over 50 proteins that bind to one or more of the 13 known chemokine receptors. Recent studies have demonstrated a role for chemokines in the pathogenesis of several inflammation-associated diseases, including asthma and atherosclerosis.

The Department of Medicine, University of Cambridge, comprises some 12 divisions: from anaesthesia and endocrinology to rheumatology. All divisions are involved in research related to human disease, with the broad aim of understanding disease processes at the molecular and physiological level and applying this knowledge to clinical management.

The Technology Transfer Office (TTO) facilitates the commercial development of University intellectual property — and that arising from projects undertaken within the Cambridge-MIT Institute. Specialist technology transfer staff manage all aspects of patents, copyright and contractual arrangements. Income from patents and software exceeds £1 million a year and is growing. The TTO licenses patents and other intellectual property to existing companies, both large and small, as well as to spinouts formed to exploit University and CMI technology. Working together with venture capital funds, the TTO forms around five new companies each year. The University holds equity in over thirty such companies (see www.rsd.cam.ac.uk/tto).

Present in over 80 countries with a total staff of 3440, the Beaufour Ipsen Group had a turnover of more than €700 million in 2001, 58% of which was outside France. The Company specialises in endocrinology, oncology, neurology, haematology, cardiology and gastroenterology and has a portfolio of 30 products which are either peptides, derived from biotechnology, or based on natural sources. Approximately 16.5% of Beaufour Ipsen’s turnover is reinvested in research and development (see www.beaufour-ipsen.com).

Research is focused on four major areas (biologics, peptides, small molecule therapeutics and drug delivery systems) and is carried out from three research centres (Boston, Barcelona, Paris) by an international network of around 500 scientific staff. They are involved in discovering innovative therapeutic responses for the most refractory diseases and to in creating original molecules. Beaufour Ipsen currently has a pipeline of 16 projects in development. The Group has also set up research partnerships with prestigious universities in the USA and Europe, mainly in France and in the United Kingdom.

Except for the historical information presented, certain matters discussed in this press release relating to the development of our products and the results of our collaboration with Beaufour Ipsen are forward-looking statements. Forward-looking statements are based on the opinions and estimates of management at the time the statements are made. They are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release.


Source: Ipsen

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Beaufour Ipsen markets a new injection formulation of somatuline in the UK, France and Portugal

The Beaufour Ipsen Group has obtained authorisation to market a new sustained-release injection formulation of lanreotide, Somatuline Autogel, in the UK, France and Portugal.

Somatuline Autogel is used to control growth hormone (GH) levels in people with acromegaly and also to provide symptomatic relief for patients with neuroendocrine tumours. Clinical studies have shown that Somatuline Autogel provides sustained drug release for at least 28 days.

 

Source: Ipsen

[Read more!]

Corixa and Beaufour Ipsen collaborate to develop and commercialize corixa’s anergix.mg™ technology for the treatment of myasthenia gravis

Seattle and Paris, Jan. 15, 2002 — Corixa Corporation (Nasdaq: CRXA), a developer of immunotherapeutics, and Beaufour Ipsen Group a European based global pharmaceutical company , today announced a license, development and commercialization agreement for Corixa’s AnergiX.MGTM technology for the treatment of myasthenia gravis, a chronic autoimmune neuromuscular disease that causes varying degrees of weakness of the skeletal muscles of the body.

Under the terms of the agreement, Corixa will provide Beaufour Ipsen with exclusive worldwide rights to develop and market its AnergiX.MG technology for the treatment of myasthenia gravis. Beaufour Ipsen will manage product development, including clinical trials and regulatory submissions. Beaufour Ipsen will pay Corixa an up-front license fee, guaranteed research support, success-based milestone payments and royalties in the event of Beaufour Ipsen product sales. The collaboration will be overseen by a joint steering committee made up of representatives from both companies. Further details of the agreement were not disclosed by either party.

"Our agreement with Beaufour Ipsen demonstrates the continued value of the AnergiX technology originally obtained in the Anergen acquisition and further extends the therapy potential of Corixa technology," stated Steven Gillis, Ph.D., chairman and chief executive officer of Corixa. "We hope that our collaboration with Beaufour Ipsen will provide a much needed treatment for those suffering from this debilitating neuromuscular disorder."

"We are excited to be working with Corixa to develop the AnergiX.MG technology, which will further expand our dedication to the treatment of neuromuscular diseases" said Jacques-Pierre Moreau, Beaufour Ipsen group Vice President Research & Development. "We share in Corixa’s commitment to discovering and developing innovative technologies and look forward to the possibility of developing a novel treatment for myasthenia gravis patients."


About Myasthenia Gravis

Myasthenia gravis is a chronic autoimmune neuromuscular disease characterized by varying degrees of weakness of the skeletal (voluntary) muscles of the body. Myasthenia gravis is caused by a defect in the transmission of nerve impulses to muscles. It occurs when normal communication between the nerve and muscle is interrupted at the neuromuscular junction — the place where nerve cells connect with the muscles they control. Normally when impulses travel down the nerve, the nerve endings release a neurotransmitter substance called acetylcholine. Acetylcholine travels through the neuromuscular junction and binds to acetylcholine receptors that are activated and generate a muscle contraction. In myasthenia gravis, antibodies block, alter, or destroy the receptors for acetylcholine at the neuromuscular junction that prevents the muscle contraction from occurring.

About Corixa

Corixa is a developer of immunotherapeutics with a commitment to treating and preventing autoimmune diseases, cancer and infectious diseases by understanding and directing the immune system. Corixa is focused on immunotherapeutic products and has a broad technology platform enabling both fully integrated vaccine design and the use of its separate, proprietary product components on a stand-alone basis. Corixa currently has 16 programs in clinical development and 22 programs in preclinical development, including its most advanced product candidate, Bexxar®, a monoclonal antibody conjugated to a radioisotope.

The company partners with numerous developers and marketers of pharmaceuticals, targeting products that are Powered by Corixa^TM technology with the goal of making its potential products available to patients around the world. Corixa was founded in 1994 and is headquartered in Seattle, Washington, with additional operations in Hamilton, Montana and South San Francisco, California. For more information, please visit Corixa's Website at www.corixa.com or call the company's investor relations information line at 1.877.4CORIXA or 877/426-7492.

About Beaufour Ipsen

Beaufour Ipsen is an independent European ethical pharmaceutical company which, aside from a traditional line of natural products (Gingko Biloba extracts & clays), has successfully developed and commercialized a range of specialist and biotech derived pharmaceuticals. Beaufour Ipsen is a leader in the development and production of controlled release formulation for therapeutic peptides used in the treatment of hormone responsive illnesses. Beaufour Ipsen market Dysport a brand of Botulinum toxin prescribed for the treatment of motor disorders & muscle spasticity. The company has sales in 80 countries.

Forward Looking Statements

Except for the historical information presented, certain matters discussed in this press release relating to the development of our products and the results of our collaboration with Beaufour Ipsen are forward-looking statements. Forward-looking statements are based on the opinions and estimates of management at the time the statements are made. They are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Factors that could affect Corixa's actual results include, but are not limited to the failure of the AnergiX.MG program to result in a safe or efficacious product for treating myasthenia gravis, the failure of Beaufour Ipsen to devote sufficient resources to the development and commercialization of AnegiX.MG and the other "Factors Affecting Our Operating Results, Our Business and Our Stock Price," described in Corixa’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2001, copies of which are available from Corixa’s investor relations department. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release.


Source: Ipsen

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Jean-Luc Belingard is appointed Chief Executive Officer of Beaufour Ipsen

Paris/London, December 3, 2001 — Jean Luc Belingard has been appointed Chief Executive Officer of Beaufour Ipsen, the fifth largest French pharmaceutical company, by the Board of Directors, effective January 2, 2002, hence succeeding Stéphane François. In this capacity, he will drive Beaufour Ipsen towards new challenges. In particular, Jean-Luc Belingard will implement a strategy based on alliances and co-operations with other pharmaceutical and biotechnology companies, leading to an initial public offering towards 2003.

Given Jean-Luc Belingard's wide ranging experience and expertise, the Board of Directors of Beaufour Ipsen expresses full confidence that he can deliver on his ambitious growth plans for the company, whilst maintaining its identity and core values. Jean-Luc Belingard's track record will confer Beaufour Ipsen an ever stronger dynamism in the years to come.

Jean-Luc Belingard, 53, a graduate from HEC, the premier French business school, who holds an MBA from Cornell University. He has spent the past 27 years in the pharmaceutical industry, successively with Merck & Co (1974-81), Roche (1981-99) and more recently with bioMérieux-Pierre Fabre, the third largest French pharmaceutical company.

At Roche, Jean-Luc Belingard was the youngest management board chairman within the group, at the helm of the French affiliate (1983-90), and the youngest group executive committee member (1990-99) heading the diagnostics division which was made into the world's leading diagnostics company during his tenure, notably through the acquisition of the PCR technology from Cetus Corp in 1991 and the acquisition and successful integration of Boehringer Mannheim in 1997. In addition, from his time at Roche, Jean-Luc Belingard has been elected to, and still sits on the Boards of Directors of Celera Genomics (US) and Laboratory Corporation of America (US), as well as that of French biotechnology company Exonhit Therapeutics. Jean-Luc Belingard joined Pierre Fabre in 1999 as Vice-Chairman and CEO, and following the merger with bioMérieux in 2000, he became Chief Executive Officer of the newly-created bioMérieux-Pierre Fabre.


Beaufour Ipsen: Facts & Figures 2000

Sales (Euros): 653 million Euros including 352 million Euros outside of France

Number of employees: 3,440 including 1,770 outside of France

Worldwide direct presence in over 30 countries

4 Research and Development Centers: Paris, Boston, Barcelona, London

12 manufacturing sites: France, Europe, China

5 therapeutic categories:
— Endocrinology/Oncology
— Neurosciences
— Haematology
— Cardiovascular
— Gastro-intestintal tract

Worldwide leadership in extraction technologies:
— clay-based products
— Ginkgo biloba

World-class drug delivery expetise in peptides

R&D focus on 5 major areas:
— Endocrinology
— Oncology
— Metabolic diseases
— Neurosciences
— Haematology


Source: Ipsen

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Transgene presents encouraging Phase II cancer vaccine data at 22nd Annual San Antonio Breast Cancer Symposium

San Antonio, Texas, December 10, 1999 — At the 22nd Annual Breast Cancer Symposium, TRANSGENE (NASDAQ:TRGNY; Nouveau Marché: TRANSGENE) today presented the results from a Phase II clinical trial using the Company's cancer vaccine, VV-MUC1-IL2, in women with metastatic breast cancer. These data, combined with pre-clinical data and results from another clinical trial in men with prostate cancer, demonstrate a favorable safety profile and anti-tumor activity in selected patients with advanced cancer treated with VV-MUC1-IL2. VV-MUC1-IL2 is a cancer vaccine in which the genes for the tumor antigen MUC1 and the immune stimulant IL2 have been inserted into a vaccinia virus. Treatment with the vaccine is intended to induce a reaction by the body's immune system against the MUC1 tumor antigen. MUC1 has been detected in tumor tissues of a majority of patients with breast cancer, prostate cancer, as well as several other types of tumors.

The Phase II study presented by Dr. David Miles of the Imperial Cancer Research Fund at Guy's Hospital, London, was conducted in 31 patients at sites in the United Kingdom, France, Belgium, and Israel. Treatment with the vaccine resulted in objective tumor regression and a partial remission in two patients, both of whom had advanced metastatic disease that did not respond to either chemotherapy or hormonal therapy.

"These results are notable in that we saw systemic anti-tumor activity," said Dr, Miles. "The ability to induce a partial remission in patients with visceral metastases who have progressive disease after intensive chemotherapy is important evidence of the potential role of therapeutic vaccines in the treatment of cancer."

"The use of vaccines for advanced cancer could represent an important new avenue in cancer treatment," said Michael Ross, Vice President of Medical and Regulatory Affairs of TRANSGENE. "The MUC1 tumor antigen provides an avenue to attack breast cancer, prostate cancer as well as other types of cancers. TRANSGENE's proprietary vaccinia virus platform has enabled us to move this product forward very rapidly."

The MUC1 product is part of TRANSGENE's broader effort to develop technologies that will enhance the human immune system's ability to reject cancer cells. Utilizing the same vaccinia virus vector, TRANSGENE has a second cancer vaccine in clinical trials based on the MVA strain carrying the genes for antigens from the human papilloma virus (HPV) type 16, which is responsible for more than 50% of cases of cervical cancer. TRANSGENE's second major focus in oncology is the general enhancement of the body's immune response to cancer, with currently three products in clinical trials: Adenovirus-IL2, Vero-IL2, and Adenovirus-IFN-γ.

"We are extremely encouraged by TRANSGENE's clinical progress in each of our anti-cancer initiatives," said Bernard Gilly, President and Chief Executive Officer of TRANSGENE. "This continued success and our commitment to an extensive and diverse vector platform confirms our dedication to the field of gene therapy."


TRANSGENE, based in Strasbourg, France, with US offices near Boston, Massachusetts, is a leading integrated gene therapy company dedicated to the discovery and development of gene delivery technologies and gene therapy products for the treatment of acquired or inherited diseases for which there is no cure or adequate therapy at present. The Company's proprietary technology platform consist of multiple vector families with a special emphasis on vaccinia virus, adenovirus and synthetic vectors. TRANSGENE has entered in two significant partnerships with Schering-Plough and Human Genome Sciences.

Source: Transgène

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Transgene initiates a Phase I trial with its MVA-HPV-IL2 product in cervical cancer

-Received Notice of Allowance of Additional US Patent for Cancer Vaccines-

Strasbourg, France, September 14, 1999 — TRANSGENE (NASDAQ:TRGNY; Nouveau Marché: TRANSGENE) announced today the initiation of its first clinical trial with MVA-HPV-IL2, the Company's sixth product in the clinic. The Phase I clinical trial is being conducted at the Baylor College of Medicine in Houston, Texas, in patients with grade 3 cervical intraepithelial neoplasia (CIN3), a pre-cancerous stage disease, under a TRANSGENE sponsored Investigational New Drug (IND). This is the company's third IND approved by the Food and Drug Administration. Two additional Phase I clinical trials with the same product are being implemented in the United States and in Switzerland.

The MVA-HPV-IL2 product is part of TRANSGENE's effort to develop cancer vaccines to enhance the human immune system's ability to reject cancer cells. The MVA-HPV-IL2 vaccine consist of TRANSGENE's proprietary vaccinia virus vector based on the MVA strain carrying the genes for antigens from the human papilloma virus (HPV) type 16, which is responsible for more than 50% of the cases of cervical cancer. Approximately 100,000 cases of cervical cancer are newly diagnosed in Europe and the United States per year. The clinical trials with this product are designed to explore its potential utility in the treatment and prevention of cervical cancer caused by HPV16.

In addition, TRANSGENE announced that it received Notice of Allowance from the United States Patents and Trademarks Office of a key patent covering its cancer vaccines technology. The patents, entitled "Expression of a tumor-specific antigen by a recombinant virus vector and use thereof", covers methods of treating virally-induced tumors and viral vectors encoding at least the essential region of a non-structural protein from papillomavirus, especially selected E1, E2, E4, E5, E6 and E7 of HPV-16. The US patent adds to TRANSGENE's portfolio of patents previously granted in Europe, the United States and Japan protecting intellectual property on the cancer vaccines technology which TRANSGENE is developing through the clinical trial above-mentioned.

"With this sixth product entering clinical development, TRANSGENE confirms its dedication to lead the development of gene therapy products, in particular in the field of oncology" said Bernard Gilly, President and Chief Executive Officer of TRANSGENE. "We are pleased to see this commitment supported by a strong patent position, allowing TRANSGENE to foresee the development of this additional product on a worldwide basis."

TRANSGENE's other approaches in oncology include another cancer vaccine using the vaccinia virus in which the virus expresses MUC1, a tumor antigen expressed in a wide range of adenocarcinomas, which is in Phase  clinical trials in the United States and Europe, in patients with breast and prostate cancers. The major direction of TRANSGENE's anti-cancer program is the general enhancement of the body's immune response to cancer, with currently three products in clinical trials: Adenovirus-IL2, Vero-IL2, and Adenovirus-IFN-γ.


TRANSGENE, based in Strasbourg, France, with US offices near Boston, Massachusetts, is a leading integrated gene therapy company dedicated to the discovery and development of gene delivery technologies and gene therapy products for the treatment of acquired or inherited diseases for which there is no cure or adequate therapy at present. The Company's proprietary technology platform consist of five vector families, including three of viral origin (adenovirus, retrovirus, vaccinia virus) and two of non viral origin (cellular and synthetic vectors). TRANSGENE currently has four Phase II studies ongoing in four different types of cancers. TRANSGENE has entered in two significant partnerships with Schering-Plough and Human Genome Sciences.

Source: Transgène

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Transgene initiates a phase I trial with its adenovirus-IFNγamma product in malignant melanoma

-Brings total number of products in the clinic to five-

Strasbourg, France, June 22, 1999 — TRANSGENE (NASDAQ:TRGNY) announced today the initiation of a new clinical trial using adenovirus-IFN-γ for the first time. This Phase I clinical trial is being conducted at the University of Rochester in Rochester, New York, in patients with advanced malignant melanoma, under a TRANSGENE sponsored Investigational New Drug (IND). This is the company's second IND approved by the Food and Drug Administration. Additional Phase I clinical trials are being implemented in Europe.

The adenovirus-IFN-γ project is part of TRANSGENE's effort to enhance the human immune system's ability to reject cancer cells and thus provide an improved, less toxic alternative to chemotherapy and radiation in the treatment of advanced cancer. The product is based on TRANSGENE's adenovirus technology and is designed to produce interferon-γ, a natural cytokine that helps to stimulate the body's immune system. Studies in laboratory animals have indicated the potential value of this compound in stimulating the immune system and enhancing the response against cancer, both alone and in combination with other forms of immunotherapy.

TRANSGENE has two other product in clinical trials which incorporate interleukin-2, another member of the cytokine family, which is known for it important role in stimulating the immune system. The other major approach in TRANSGENE's oncology program is based on the development of anti-cancer vaccines, where tumor specific antigens are produced by vaccinia viruses in an effort to boost the body's immune response against these antigens.

"With the launch of this new trial, TRANSGENE is advancing its strategy to fight cancer," said Bernard Gilly, President and Chief Executive Officer of TRANSGENE. "The very encouraging preliminary results from our breast cancer Phase II trial released a few weeks ago at the ASCO conference, ours various other ongoing trials and an extensive and diverse vector platform make TRANSGENE a leader in this field."


TRANSGENE, based in Strasbourg, France, with US offices near Boston, Massachusetts, is a leading integrated gene therapy company dedicated to the discovery and development of gene delivery technologies and gene therapy products for the treatment of acquired or inherited diseases for which there is no cure or adequate therapy at present. The Company's proprietary technology platform consist of five vector families, including three of viral origin (adenovirus, retrovirus, vaccinia virus) and two of non viral origin (cellular and synthetic vectors). TRANSGENE currently has four Phase II studies ongoing in four different types of cancers. TRANSGENE has entered in two significant partnerships with Schering-Plough and Human Genome Sciences.

Source: Transgène

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Transgene initiates a second Phase II trial with its Vero-IL2 product in mesothelioma

Strasbourg, France, March 10, 1999 — TRANSGENE (NASDAQ:TRGNY) announced today the initiation of a second Phase II clinical trial of its Vero-IL2 product in Freiburg, Germany, in the laboratory of Professor Mertelsmann, with the enrollment of the first two patients. The study will include 20 patients with malignant mesothelioma, a form of lung cancer arising in the pleura (lining) of the lung.

TRANSGENE's Vero-IL2 product is an immortal cell line genetically modified to produce interleukine-2, a natural cytokine that helps to stimulate the body's immune system. Earlier studies in cats and dogs shower Vero-IL2 to be beneficial in the treatment of spontaneously occurring tumors. More recently, two Phase I clinical trials completed in France and Switzerland have suggested some anti-tumor activity and demonstrated preliminary evidence of safety and tolerance to this therapy. In addition, the first Phase II trial with this product began in Spring 1998 in patients with malignant melanoma, the most aggressive form of skin cancer.

"The initiation of a second clinical trial for our Vero-IL2 product is a solid indication of the continued progress TRANSGENE is making in the clinic," said Bernard Gilly, President and Chief Executive Officer of TRANSGENE. "We are anxious to move this product along for the treatment of malignant mesothelioma, as there is a large unmet medical need for patients suffering with this disease. With the beginning of this trial, TRANSGENE will have four ongoing Phase II gene therapy clinical trials for the treatment of several cancers."

TRANSGENE's objective is to use its Vero-IL2 or a second vector, Adenovirus-IL2, to encourage the human immune response to reject cancer cells, thus providing the potential for a less toxic alternative to current chemotherapy and radiation treatments of advanced cancers. Another direction in TRANSGENE's anti-cancer program is continuing efforts for the development of anti-cancer vaccines, where tumor specific antigens are produced by vaccinia viruses in an effort to boost the body's immune response.


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 four 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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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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