FDA accepts for filing a Biologics License Application (BLA) for Dysport® in cervical dystonia

Paris (France), 31 January 2008 — Ipsen (Euronext: FR0010259150; IPN) today announced that the Food and Drug Administration (FDA) has accepted the filing of its BLA for Dysport^® in the United States to treat patients with cervical dystonia. This acceptance signifies the start of the review process of the dossier.

About Dysport^®

The active substance in Dysport^® is a botulinum neurotoxin type A complex, which acts at the level of the neuromuscular junction in the targeted muscle. Dysport®, Ipsen’s botulinum toxin type A, is a neuromuscular blocking toxin which acts to block acetylcholine release at motor nerve ends and reduces muscular spasm. It was initially developed for the treatment of movement disorders such as cervical dystonia (a chronic condition in which the neck is twisted or deviated), blepharospasm (involuntary eye closure), hemifacial spasm and various forms of muscle spasticity, including post-stroke arm spasticity, spasticity of the lower limbs (calf) in adults and children with cerebral palsy. Dysport® was originally launched in the United Kingdom in 1991 and has marketing authorisations in over 70 countries.
The product is currently referred to as Reloxin^® in the United States aesthetic market and Dysport^® for medical and aesthetic markets outside the U.S.

About Ipsen

Ipsen is an innovation driven international specialty pharmaceutical group with over 20 products on the market and a total worldwide staff of nearly 4,000. The company’s development strategy is based on a combination of products in targeted therapeutic areas (oncology, endocrinology and neuromuscular disorders) which are growth drivers, and primary care products which contribute significantly to its research financing. This strategy is also supported by an active policy of partnerships. The location of its four Research and Development centres (Paris, Boston, Barcelona, London) gives the Group a competitive edge in gaining access to leading university research teams and highly qualified personnel. In 2006, R&D expenditure was €178.3 million, i.e. 20.7% of consolidated sales, which amounted to €861.7 million while total revenues amounted to €945.3 million (in IFRS). 700 people in R&D are dedicated to the discovery and development of innovative drugs for patient care. Ipsen’s shares are traded on Segment A of Eurolist by Euronext^TM (stock code: IPN, ISIN code: FR0010259150). Ipsen’s shares are eligible to the "Service de Regrave;glement Différé" ("SRD") and the Group is part of the SBF 120 index. For more information on Ipsen, visit our website at www.ipsen.com.

Forward-looking statements

The forward-looking statements and targets contained herein are based on Ipsen's management's current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. Moreover, the Research and Development process involves several stages at each of which there is a substantial risk that the Group will fail to achieve its objectives and be forced to abandon its efforts in respect of a product in which it has invested significant sums. Thus, in order to develop a product which is viable from a commercial point of view, the Group must demonstrate, by means of pre-clinical and human clinical trials, that the molecules are effective and not dangerous to human beings. Therefore, the Group cannot be certain that favourable results obtained during pre-clinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the product concerned, or that the regulatory authorities will be satisfied with the data and information provided by the Company. Ipsen expressly disclaims any obligation or undertaking to update or revise any forward looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. Ipsen's business is subject to the risk factors outlined in its information documents filed with the French Autorité des Marchés Financiers.


Source: Ipsen

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Endotis Pharma Raises €25 million in a Second Financing Round led by the Wellcome Trust

Biocitech Park, Romainville (France), January 23rd, 2008 — Endotis Pharma, the specialty pharma company dedicated to the discovery and development of small-glyco drugs (SGDs) for applications in thrombosis and oncology, today announced the completion of a €25-million Series B funding round. With the Wellcome Trust (UK) as lead investor, the international funding round also attracted Endeavour Vision (Switzerland) and NIF SMBC Ventures (Japan), in addition to Sofinnova Partners (France), Endotis' longstanding investor.

The funds raised will be used to finance the development of:

1. Endotis Pharma's portfolio of preclinical and clinical-stage compounds in-licensed from Organon/Schering Plough: EP42675 (an anticoagulant in phase I), EP217609 (the neutralizable form of EP42675) and EP224283 (a neutralizable antithrombotic currently in preclinical development). These oligosaccharides-based compounds will be developed for the prevention of arterial thrombosis.
2. The company's in-house discovery programmes — notably EP37 (dedicated to the oral prevention and treatment of venous and arterial thromboses) and EP8000 programme (focused on compounds with activity against a number of biological factors involved in angiogenesis, tumour growth and metastasis).

"I wish to thank our new international investors for the confidence they have placed in us and, equally, Sofinnova Partners for its continued overall assistance & financial support" commented Charles Woler, Endotis Pharma's Chairman and CEO. "This round will enable us firstly to accelerate development of the three advanced antithrombotics to which we acquired the exclusive development and commercialisation rights from Organon, secondly to actively progress our in-house programmes originated from Endotis’ unique oligosaccharides know-how and thirdly to also consider other development strategies".

"Endotis is developing a unique portfolio of low-risk compounds for the prevention and treatment of arterial and venous thrombosis in validated indications, along with a novel cancer drug discovery engine. We believe in the company’s technology, commercial prospects and management team", emphasized Rafaèle Tordjman, Partner at Sofinnova Partners.

"We are delighted to have invested in Endotis Pharma — the company has a unique and very promising portfolio in the field of coagulation and thrombosis, and so we are very keen to be associated with a team known for its excellence and ability to deliver", commented Daniel Schulman, Healthcare Investment Manager at the Wellcome Trust.


About Endotis Pharma (www.endotis.com)
Incorporated in 2003, Endotis Pharma is a specialty pharma company dedicated to the discovery and development of small-glyco drugs (SGDs) for applications in thrombosis and oncology. These SGDs are analogues of glycosaminoglycans, the core field of expertise of Endotis' scientists. Proof of concept has already been obtained with oligosaccharides in thrombosis (venous and arterial cardiovascular diseases) and oncology, another promising therapeutic field. Endotis Pharma has built a well-balanced portfolio of pre-clinical and clinical stage compounds (either in-licensed or generated by the company's own R&D programmes) and currently has 28 employees (including 14 PhDs/MDs) based in Paris and Lille (France). To date, Endotis Pharma has raised a total of €34 million.

About Sofinnova Partners: Paris-based Sofinnova Partners is one of Europe's leading independent venture capital firms. It invests in ambitious start-ups and early-stage IT or life science companies in France, other European countries and the United States. Sofinnova Partners' investment ticket is at least half a million euros and can go as high as €20 million after several rounds of funding. The company essentially targets companies capable of attracting pan-European consortia where it can act as lead or co-lead investor, play an active role as a Board member and deliver added value to the management team. Sofinnova Partners generally invests in first or second rounds as lead or co-lead investor, in collaboration with the leading European, American and Asian funds (primarily in Great Britain, Switzerland, Germany, Scandinavia and the Benelux).

About The Wellcome Trust: The Wellcome Trust is the largest charity in the UK and the second largest medical research charity in the world. It funds innovative biomedical research, in the UK and internationally, spending around £500 million each year to support the brightest scientists with the best ideas. The Wellcome Trust supports public debate about biomedical research and its impact on health and wellbeing.
Website: www.wellcome.ac.uk

About Endeavour Vision: Endeavour Vision combines a team of experienced venture capital professionals who have collectively invested in 65 companies in 12 countries in both the life sciences and information/communication technologies since 1989. The firm invests across Europe in early-stage companies which have the potential to become global leaders. Past life sciences investments by Endeavour Vision's professionals include Actelion (SWX: ATLN), Novimmune, Axovan (acquired by Actelion), Kuros Biosurgery, Endoart (acquired by Allergan, NYSE: AGN) and Molecular Partners AG.

About NIF SMBC Ventures Co., Ltd: NIF Ventures (a member of Daiwa Securities Group) and SMBC Capital (a member of Sumitomo Mitsui Financial Group) merged on October 1, 2005 to form NIF SMBC Ventures. Both were well-established brands within the venture capital industry, being involved in listing various companies. After the merger, having grown out of a securities firm and a bank, NIF SMBC Ventures is a venture capital firm that maximizes use of its broad business network, longstanding experience and know-how while implementing investment operations.

Disclaimer: the development of new drug technologies is difficult, erratic and unpredictable. Endotis Pharma’s forecasts and future economic performance depend on research that has yet to be performed and on a number of other factors. The company's future economic performance may differ significantly from that currently forecast.


Source: Endotis Pharma

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BT PHARMA enforces its alliance with the Institut Pasteur on the development of therapeutic cancer vaccines

Toulouse, 11 January 2008 — The Institut Pasteur has agreed to add a new patent under the exclusive license granted to BT PHARMA with regards to the Adenylate Cyclase vector technology. This patent has been filed in all major markets of the OECD as well as in China and India.

The patent claims a novel combination cancer treatment, which associates a chemotherapeutic agent with an immunotherapeutic agent, resulting in a dramatically improved specific immune response against the malignant tissues. In fact, the treatment induces simultaneously an adaptive cellular immune response (tumour cell specific), an amplified innate immune response and decreases the immune tolerance that tumours typically acquire. This patented combination has, for the first time in appropriate animal models, allowed to totally eliminate very large vascularized solid tumours.

The new patent reinforces BT PHARMA’s intellectual property portfolio, which consists of proprietary patents and patents exclusively in licensed from the Institut Pasteur. The results protected under this most recent patent filed by the Institut Pasteur were obtained by the team of Professor Claude Leclerc, Director of the Department for Immune Regulation and Vaccinology, INSERM U883, Institut Pasteur. Professor Claude Leclerc is also member of the Science Board of the "Cancéropôle Ile-de-France" and is a member of the Scientific Advisory Board of BT PHARMA.

« This is the second patent of the Institut Pasteur this year that BT PHARMA has integrated in its exclusive license arrangement with regards to the Adenylate Cyclase vector technology » said Benedikt Timmerman, Chief Executive Officer of BT PHARMA; « Already in May 2007, we have acquired the commercial rights to a patent filed by the Institut Pasteur, which claims the use of the Adenylate Cyclase carrying tumour-derived antigenic peptides. Together with the patent covering combination therapy of CyaA with chemotherapy, these two patents substantially reinforce BT PHARMA’s position in the domain of cancer immunotherapy ».


With regards to BT PHARMA S.A.

BT PHARMA is a bio-pharmaceutical company, spun out from Institut Pasteur incubator in 2002 (Pasteur-Biotop) and currently headquartered in Toulouse, France. The company strives to improve the well-being of people through the development of therapeutic vaccines for infection, dysplasia and cancer provoked by the Human Papillomavirus (HPV). BT PHARMA’s key technology is a recombinant protein-based antigen delivery system: the Adenylate Cyclase vector (CyaA). CyaA allows "re-educating" the immune system such that protective cellular immunity is activated against certain serious diseases, including cancer. The CyaA technology stands out because of its universal applicability, its target specificity, its potency and relative simplicity. BT PHARMA focuses on the HPV domain but invites industrial partnerships for development of vaccines against other cancers as well as preventive vaccines against infectious diseases.

ProCervix^®, the most advanced product candidate of the company, will enter phase I/II clinical trials in 2008. This bivalent therapeutic vaccine targets high grade neoplasia and cervical cancer provoked by Human Papillomavirus HPV16 and HPV18, which affect more than 70% of women with these indications. If effective, ProCervix^® could replace Loop Electrosurgical Excision Procedure (LEEP) or cervical conisation in millions of women infected by HPV16 or HPV18 and at risk of developing cervical cancer. Please note that preventive HPV vaccines are not proscribed for people that are already infected by the virus. On average 12% of the population is carrier of HPV, of which a fraction will develop high-grade intra-epithelial lesions that can progress to invasive cancer. It is for these people that BT PHARMA intends to provide a less invasive solution.


Source: BT Pharma

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Ipsen and The Salk Institute Enter into Strategic Research Agreement

Collaboration creates the "Ipsen Life Sciences Program" at the Salk Institute

Paris (France) and La Jolla (California, USA), 11 January 2008 — Ipsen (Euronext: FR0010259150; IPN) and The Salk Institute for Biological Studies announced today that they will be signing a memorandum of understanding setting the framework for the creation of the Ipsen Life Sciences Program at The Salk Institute. The mission of the partnership is to advance knowledge in the field of proliferative and degenerative diseases through fundamental and applied biology research.

The Ipsen Life Sciences Program will, for a period of up to five years, sponsor three< categories of research programs through targeted, core and innovation grants. Ipsen will provide funding for targeted research programs carried out at The Salk Institute by researchers in the field of proliferative diseases with a particular emphasis on novel therapeutic concepts for the treatment of pituitary adenomas. Core grants will support basic research on the contribution of chronic inflammation to malignant diseases such as cancer, loss of cognitive functions, movement disorders and metabolic syndromes. Innovation grants will fund the exploration of advanced scientific concepts.

Jean-Luc Bélingard, Chairman and Chief Executive Officer of Ipsen, stated: "We are very pleased to have reached this major agreement with one of the leading research institutions in the world, with which Ipsen has had a longstanding relationship. This agreement confirms Ipsen’s commitment to innovation and research, and reaffirms the company’s capacity to work with leading worldwide academic centers of excellence, both in Europe and in the U.S., to transform knowledge into therapies."

"We are delighted about the establishment of Ipsen Life sciences Program at The Salk Institute, which will allow us to advance our ongoing research in the areas of cancer biology, mechanisms of degenerative diseases and the growing epidemic of maladies associated with metabolic syndrome", said Nobel Laureate Dr. Roger Guillemin, interim President of the Salk Institute.

Ipsen’s presence in the US dates back to 1976. Its research center located near Boston, MA specializes in the engineering of protein and peptide hormones for therapeutic uses. The center’s primary objective is to seek in-depth knowledge of hormone dependent pathophysiological mechanisms as a basis for the conception of novel medicines. In March 2005, at the same site as the research center, Ipsen inaugurated a new bioprocess science unit dedicated to the engineering of proteins for therapeutic purposes.


About The Salk Institute

The Salk Institute for Biological Studies in La Jolla, California, is an independent nonprofit organization dedicated to fundamental discoveries in the life sciences, the improvement of human health and the training of future generations of researchers. Jonas Salk, M.D., whose polio vaccine all but eradicated the crippling disease poliomyelitis in 1955, opened the Institute in 1965 with a gift of land from the City of San Diego and the financial support of the March of Dimes.

About Ipsen

Ipsen is an innovation driven international specialty pharmaceutical group with over 20 products on the market and a total worldwide staff of nearly 4,000. The company’s development strategy is based on a combination of products in targeted therapeutic areas (oncology, endocrinology and neuromuscular disorders) which are growth drivers, and primary care products which contribute significantly to its research financing. This strategy is also supported by an active policy of partnerships. The location of its four Research and Development centres (Paris, Boston, Barcelona, London) gives the Group a competitive edge in gaining access to leading university research teams and highly qualified personnel. In 2006, R&D expenditure was €178.3 million, i.e. 20.7% of consolidated sales, which amounted to €861.7 million while total revenues amounted to €945.3 million (in IFRS). 700 people in R&D are dedicated to the discovery and development of innovative drugs for patient care. Ipsen’s shares are traded on Segment A of Eurolist by Euronext^TM (stock code: IPN, ISIN code: FR0010259150). Ipsen’s shares are eligible to the "Service de Regrave;glement Différé" ("SRD") and the Group is part of the SBF 120 index. For more information on Ipsen, visit our website at www.ipsen.com.

Ipsen Forward-Looking Statements

The forward-looking statements and targets contained herein are based on Ipsen's management's current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. Moreover, the Research and Development process involves several stages at each of which there is a substantial risk that the Group will fail to achieve its objectives and be forced to abandon its efforts in respect of a product in which it has invested significant sums. Thus, in order to develop a product which is viable from a commercial point of view, the Group must demonstrate, by means of pre-clinical and human clinical trials, that the molecules are effective and not dangerous to human beings. Therefore, the Group cannot be certain that favourable results obtained during pre-clinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the product concerned, or that the regulatory authorities will be satisfied with the data and the information provided by the Company. Ipsen expressly disclaims any obligation or undertaking to update or revise any forward looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. Ipsen's business is subject to the risk factors outlined in its information documents filed with the French Autorité des marchés financiers.


Source: Ipsen

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