Appointment of Gérard Picot as Vice President, Global Regulatory Affairs

Paris (France), 22 May 2008 — Ipsen today announced the appointment, of Gérard Picot as Vice-President, Global Regulatory Affairs. He reports to Stéphane Thiroloix, Executive Vice President, Corporate Development. This appointment is within the context of the retirement of Mr William Jones.

His main mission will be to enhance the regulatory position of Ipsen, its products and those of its partners worldwide, thanks to the strong network of teams based in Paris (France), Slough (United Kingdom), and Boston (United States). Gérard Picot brings along a history of solid delivery in the regulatory arena, a rich track-record of staff development, a strong strategic thinking ability and a proven drive to partner through change.


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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Ipsen and Medicis announce acceptance of Reloxin® BLA in aesthetics by FDA

Paris (France) and Scottsdale, Arizona (United States), 19 May 2008 — Ipsen (Euronext: IPN) and Medicis (NYSE: MRX) today announced that the Food and Drug Administration ("FDA") has accepted the filing of Ipsen’s Biologics License Application ("BLA") for Reloxin®, its botulinum toxin type A in aesthetic use (glabellar lines) in the United States. This acceptance signifies the start of the review process of the dossier.

In accordance with the agreement between the two parties, Medicis will pay Ipsen approximately $25 million in connection with the announcement made today. Subject to approval of the BLA by the FDA, Medicis will pay to Ipsen a further $75 million and will commercialize Reloxin^® in the U.S.


About Ipsen’s Botulinum Toxin Type A

As of October 2007, Ipsen’s botulinum toxin type A is approved for aesthetic indications in 21 countries: Argentina, Australia, Belarus, Brazil, Columbia, Ecuador, Egypt, Germany, Honduras, Israel, Kazakhstan, Mexico, Moldova, New Zealand, Philippines, Slovak Republic, Ukraine, Uruguay, Venezuela, Vietnam, and Russia (in Russia, it is the first botulinum toxin type A approved in this field). Ipsen is also pursuing regulatory approval for medical indications for the product in certain additional key international markets.

Dysport^® is a neuromuscular blocking toxin which acts to block acetylcholine release, hence reducing muscular spasm and was initially developed for the treatment of motor disorders and various forms of muscular spasticity, including cervical dystonia (a chronic condition in which the neck is twisted or deviated), spasticity of the lower limbs (heal) in children with cerebral palsy, blepharospasm (involuntary eye closure) and hemifacial spasm. It was later developed for the treatment of a wide variety of neuromuscular disorders and aesthetic medicine. Dysport^® was originally launched in the United Kingdom in 1991 and has marketing authorisations in over 70 countries (at 31 December 2006). Ipsen has just recently filed a BLA for Dysport^® in cervical dystonia to the FDA.

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.

About Medicis

Medicis is the leading independent specialty pharmaceutical company in the United States focusing primarily on the treatment of dermatological and aesthetic conditions. The Company is dedicated to helping patients attain a healthy and youthful appearance and self-image. Medicis has leading branded prescription products in a number of therapeutic and aesthetic categories. The Company's products have earned wide acceptance by both physicians and patients due to their clinical effectiveness, high quality and cosmetic elegance. The Company's products include the prescription brands RESTYLANE^® (hyaluronic acid), PERLANE^® (hyaluronic acid), DYNACIN^® (minocycline HCl), LOPROX^® (ciclopirox), PLEXION^® (sodium sulfacetamide/sulfur), SOLODYN^® (minocycline HCl, USP) Extended Release Tablets, TRIAZ^® (benzoyl peroxide), LIDEX^® (fluocinonide) Cream, 0.05%, VANOS^® (fluocinonide) Cream, 0.1%, and ZIANA^® (clindamycin phosphate 1.2% and tretinoin 0.025%) Gel, BUPHENYL^® (sodium phenylbutyrate) and AMMONUL^® (sodium phenylacetate/sodium benzoate), prescription products indicated in the treatment of Urea Cycle Disorder, and the over-the-counter brand ESOTERICA^®. For more information about Medicis, please visit the Company's website at www.medicis.com.

Medicis Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act. All statements included in this press release that address activities, events or developments that Medicis expects, believes or anticipates will or may occur in the future are forward-looking statements, including FDA’s acceptance of the Reloxin® submission, the timing associated with FDA’s response to the submission and the potential commercialization of Reloxin^®. These statements are based on certain assumptions made by Medicis based on its experience and perception of historical trends, current conditions, expected future developments and other factors it believes are appropriate in the circumstances. No assurances can be given, however, that these activities, events or developments will occur or that such results will be achieved. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of Medicis. Several of these risks are outlined in the Company’s most recent annual report on Form 10-K for the year ended December 31, 2007, and other documents we file with the Securities and Exchange Commission. Forward-looking statements represent the judgment of Medicis' management as of the date of this release, and Medicis disclaims any intent or obligation to update any forward-looking statements contained herein, which speak as of the date hereof.

NOTE: Full prescribing information for any Medicis prescription product is available by contacting the Company. RESTYLANE^® and PERLANE^® are trademarks of HA North American Sales AB, a subsidiary of Medicis Pharmaceutical Corporation. All other trademarks are the property of their respective owners.


Source: Ipsen

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Adenuric® (febuxostat) receives marketing authorisation in the European Union

Adenuric® represents the first major treatment of gout for more than forty years Paris (France), 5 May 2008 &mdash Ipsen (Euronext: FR0010259150; IPN) today announced that the European Commission granted marketing authorisation for Adenuric® (febuxostat) for the treatment of chronic hyperuricaemia in gout. Adenuric® thus pioneers the first major treatment alternative for gout, a severe debilitating disease, for more than 40 years.

"Recent surveys confirm that management of gout is often suboptimal, with less than half of patients receiving appropriate lifestyle advice or urate lowering treatment" said Michael Doherty, Professor of Rheumatology at the University of Nottingham (UK) and Co-chair of the 2006 EULAR Task Force for the Recommendations on Diagnosis and Management of Gout. "Recent European (EULAR) Recommendations emphasise the aim of "cure" by lowering serum urate levels below the saturation point for crystal formation. For some patients, the existing urate lowering therapies have limitations in terms of suitability or side effects. The availability of a new effective therapy that allows the therapeutic target to be achieved will improve the physicians armamentarium and ultimately benefit the population of patients with gout."

Adenuric^® (febuxostat) 80 mg and 120 mg tablets are indicated for the treatment of chronic hyperuricaemia for conditions in which urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis).

Adenuric^® will be marketed by Ipsen in France. Outside France, the commercialisation of the product will be partnered.


About the marketing authorisation

The European Public Assessment Report (EPAR) summary will be accessible at http:///www.emea.europa.eu). This decision follows the filing by Ipsen, of an application for marketing authorisation for Adenuric^® in the European Union in 2006. A positive opinion, recommending to grant a marketing authorisation was adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) on 21 February 2008.

The EU submission,included two of the largest industry sponsored studies to date studying treatment of chronic gout patients. The goal of chronic gout treatment is per EULAR guidelines (European League Against Rheumatism) to reduce and maintain sUA levels below 6 mg/dL. Febuxostat demonstrated superior ability to lower and maintain in patients, serum uric acid at a level inferior to 6 mg/dl compared to conventionally used doses of allopurinol (febuxostat 80 and 120 mg: 51 & 63 % resp. vs. allopurinol: 22%). In addition, one phase III study showed that gout patients with mild to moderate renal impairment (serum creatinine <1.5 - <2.0 mg/dl) had response rate of 44 and 45 % respectively with febuxostat 80 and 120 mg.

About Adenuric^® (febuxostat)

Gout, a particularly painful type of arthritis, is the most frequent arthritis in men. It is caused by elevated levels of uric acid in the body: hyperuricaemia. Febuxostat, an oral, once-daily medication, is a novel non-purine, selective inhibitor of xanthine oxidase studied for its effects on lowering levels of serum uric acid (sUA) in patients with gout.

The recommended oral dose of Adenuric^® is 80 mg once daily without regard to food. If serum uric acid is < 6 mg/dl (357 µmol/l) after 2-4 weeks, Adenuric^® 120 mg once daily may be considered. Adenuric^® works sufficiently quickly to allow retesting of the serum uric acid after 2 weeks. The therapeutic target is to decrease and maintain serum uric acid below 6 mg/dl (357 µmol/l). Gout flare prophylaxis of at least 6 months is recommended at initiation of treatment with Adenuric^®. Febuxostat is licensed to Ipsen for Europe from Teijin Pharma Limited, Tokyo. In 2003, Ipsen entered into a Research and Development partnership with Teijin Pharma Limited, the core company of Teijin Group’s pharmaceutical and home healthcare business. The Teijin group is a Japanese industrial conglomerate specialising in the businesses of fibres, films, plastics and information technology (IT) as well as pharmaceuticals and home healthcare. This partnership covers the development and subsequent commercialisation of four of Ipsen’s products by Teijin Pharma in Japan and the development and marketing by Ipsen in Europe (i.e. European Union and Russia) of febuxostat, a product owned by Teijin Pharma and known as TMX-67.

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 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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Polyplus-transfection unveils a new technology that improves intracellular delivery of small interfering RNAs in vivo...

...and opens the way to new therapeutic possibilities

The "STICKY SIRNA"^TM technology is already being tested in vivo by academic laboratories and biotech companies

Strasbourg, April 24th, 2008 — Polyplus-transfection, a company specialized in research, development and commercialization of innovative reagents for delivery of biomolecules, today announces the development of a new technology that improves in vivo delivery of small interfering RNAs (siRNAs) when they are associated with a cationic polymer. This technology is based on a new class of small interfering RNAs the company has developed: "STICKY SIRNA"^TM (ssiRNAs^TM).

The technology involves extending the opposite ends of interfering RNAs with short complementary A(5-8)/T(5-8) 3' sequences that are able to form concatemers in the presence of a cationic polymer such as in vivo-jetPEI^TM (also developed by Polyplus-transfection) and thus form complexes as stable as with genes. With this new technology, small interfering RNAs stay connected to their delivery reagent during the whole journey to the target cells, and induce the RNA interference mechanism. This innovation is applicable to therapeutic siRNAs, and a wide variety of pathologies could benefit from it such as cancers, allergies and viral diseases.

Up to now, the market for the delivery of therapeutic siRNAs has been dominated by the use of cationic lipids. Thanks to this ssiRNA^TM technology, cationic polymers such as in vivo-jetPEI^TM have now entered the market with clear advantages in specific areas.

"We are proud of having developed this new technology, for which we have filed a broad patent application as well as a trademark application," said the C.E.O. of Polyplus-transfection," Joëlle Bloch. "Within a few months, we have succeeded in offering our customers two major therapeutic advances: a GMP-compliant delivery reagent, in vivo.jetPEI^TM, and a new means of delivering siRNAs associated with this reagent. Our customers have already shown a keen interest in these two developments, and ssiRNAs^TM are starting to be tested in vivo by several academic laboratories and biotechnology companies."

Polyplus-transfection's new technology was outlined in an article published in Proceedings of the National Academy of Sciences of the United States of America in October 2007 under the title "Sticky overhangs enhance siRNA-mediated gene silencing", volume 104, pages 16,050-16,055, Bolcato-Bellemin et al.


RNA interference (RNAi)

RNA interference is a natural mechanism that operates in cells and makes it possible to selectively silencing or regulating specific gene expression. The mechanism of RNA interference is a major discovery in biology, whose potential therapeutic impact was recognized by the award of the Nobel Prize for Medicine in 2006. As many diseases are the result of the inappropriate activity of some genes, the ability to control these genes selectively through RNA interference has speeded up the understanding of the roles of these genes and their interrelations.

Since then, it has been shown that RNA interference could be a means of treating a large number of diseases. In effect, RNA interference can be induced by small, double-stranded RNA molecules called small interfering RNAs (siRNAs). Delivering these chemically synthesized molecules into cells is one of the means of activating RNA interference for therapeutic purposes, by targeting the messenger RNA of a gene to be knocked down. This process has the effect of stopping the production of a protein encoded by the target gene.

About Polyplus-transfection

Polyplus-transfection is focused on developing innovative solutions for delivery of biomolecules. The company has been marketing its transfection reagents worldwide since 2001 and is reinvesting most of its revenues in research and development.

Transfection consists in introducing a gene or a small interfering RNA into cells. This technique makes it possible to cross the cellular barriers and deliver such biomolecules into the cells for research or therapeutic purposes.

Customers of Polyplus-transfection's products and services include biotechnology and pharmaceutical companies as well as life science academic laboratories. Polyplus-transfection offers high quality consultancy, personalized scientific support and expertise in regulatory affairs related to the use of its reagents in clinical trials. Phases I/II cancer gene therapy and AIDS trials are underway in Israel, USA, Sweden and Germany using GMP-compliant reagents from Polyplus-transfection.

The Strasbourg-based company is recognized as a leading innovator in the transfection market, with ISO 9001:2000 certification, exclusive licenses from the CNRS and numerous patent applications pending.

Polyplus-transfection R&D has well-established partnerships with biotech companies and is also involved in several European research collaboration networks, such as GIANT (Gene Therapy, an Integrated Approach to Neoplastic Treatment) and RIGHT (RNA Interference Technology as Human Therapeutic Tool).

Polyplus-transfection recently extended its field of expertise to the development of new cationic oligonucleotides for molecular biology and diagnostics and is leading the corresponding OligoPlus research program.

For more information, visit: http://www.polyplus-transfection.com


Source: Polyplus-transfection

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Appointment of Dominique Bridon, PhD as Vice President, Discovery

Paris (France), 1st April 2008 — Ipsen (Euronext: FR0010259150; IPN) announced the appointment, of Dominique Bridon as Vice-President, Discovery of the Ipsen Group, effective today. He will report to Jacques-Pierre Moreau, Ipsen’s Executive Vice President, Chief Scientific Officer. Based in the research center of Ipsen in Boston, he will have under his responsibility the drug discovery teams (medicinal chemistry, endocrinology and oncology research, pharmacogenomics and genetics) and also be responsible for overseeing external research partnerships and collaborations.

Dominique Bridon, 49, is a graduate, from the École Nationale Supérieure de Chimie and joined the laboratory of Nobel Laureate Sir Derek Barton at Institut de Chimie des Substances Naturelles at Gif-sur-Yvette (France) where he was awarded a Doctorate in Science. For his post doctoral studies in organic chemistry, he moved to the University of California Berkeley with Pr. William Dauben.

His professional career started in 1989 at Abbott Laboratories within the Diagnostics Division; he was also associated with Bioinformatic Venture and Peptide Engineering. In 1997, he joined the start-up company Conjuchem in Montreal as V-P Research and Chief Technology Officer. While at Conjuchem, Dominique originated the discovery and development of in situ conjugates as a mean to achieve controlled release of peptides and proteins. More recently, he served as a member on the Board of Directors and on the Scientific Board of Directors for several start-up companies; he has also been an advisor to several biotech companies and venture capital funds.


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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Appointment of Frédéric Babin as Executive Vice President, Human Resources

Paris (France), 18 March 2008 — Ipsen (Euronext: FR0010259150; IPN) today announced the appointment, of Frédéric Babin as Executive Vice-President, Human Resources and member of Ipsen’s Executive Committee.

Frédéric Babin, 47, has over 20 years experience in the field of Human Resources with more than 15 years spent in international environments and in a variety of different sectors.

He started his career at Pasteur Vaccins where he took part in creating a Joint Venture with the Mérieux Institute to form the Pasteur Mérieux Sérums & Vaccins company. He also was Executive Vice-President Human Resources for Europe at the Hill-Rom US company, specialising in hospital beds and EVP Human Resources for medical activities at Air Liquide. He was also Head of Human Resources for other industry sectors such as the car industry where he worked for the English car components manufacturer, Wagon before joining Ipsen. He holds a Master of Business Law (Paris II-Assas) and a post-graduate diploma (DEA, Diplôme d’Etudes Approfondies) of Labour Law.


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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Ipsen and Medicis announce submission of Reloxin® BLA in aesthetics to the FDA

Paris (France) and Scottsdale, Arizona (United States), 17 March 2008 &mdash Medicis (NYSE:MRX) and Ipsen (Euronext: IPN) today announced that Ipsen has submitted a Biologics License Application ("BLA") for the botulinum toxin type A, Reloxin®1, in aesthetic indications (glabellar lines) to the U.S. Food and Drug Administration’s ( FDA ) Division of Dermatology and Dental Products, within the Center for Drug Evaluation and Research. This BLA submission by Ipsen is intended to address the concerns cited by the FDA when it declined to file the Reloxin® BLA in January 2008, which Medicis had submitted in late 2007. Standard response timeframe from the FDA is expected approximately 10 months following receipt of the Reloxin® submission. Subject to approval of the BLA by the FDA, Medicis intends to commercialize Reloxin® in the U.S. in accordance with the long-standing arrangement between Medicis and Ipsen. Changes from the original BLA submission relate primarily to sponsorship and ownership of the filing. The substantive elements of the original submission remain unchanged.

Jean-Luc Bélingard, Chairman and Chief Executive Officer of Ipsen, said: "We are pleased to have responded to the administrative issues raised by the FDA in coordination with Medicis in a timely and efficient manner. Together with Medicis, we look forward to working diligently with the FDA to obtain a successful marketing approval. Given Ipsen’s botulinum toxin positive track record on a global basis, we look forward to entering the North American market following FDA approval of Reloxin^®."

"We are pleased to announce this submission of the BLA for Reloxin^® in aesthetics with FDA," said Jonah Shacknai, Chairman and Chief Executive Officer of Medicis. "Both the Ipsen and Medicis teams have worked diligently with FDA to determine the best solution for submitting Reloxin^® in aesthetics. We thank everyone involved, and extend our appreciation to FDA for its willingness to work with us on a resolution in a timely fashion. We continue to believe the Reloxin^® BLA is strong, and anticipate entering in the growing, multi-million dollar aesthetic botulinum toxin market in the U.S. upon FDA approval."

In March 2006, Ipsen granted Medicis the rights to develop, distribute and commercialize Ipsen's botulinum toxin product in the United States, Canada and Japan for aesthetic use by physicians. Upon FDA’s acceptance of the Reloxin^® submission, Medicis will pay Ipsen approximately $25 million in accordance with the agreement between the parties.

According to the American Society for Aesthetic Plastic Surgery, injections of botulinum toxin type A were the number one non-surgical procedure in 2006, with over 3 million total procedures. Current growth estimates in botulinum toxin type A in dollars are estimated to be in excess of 20 percent over the prior year. This translates into a retail U.S. aesthetic market of approximately $300 million-$400 million.²

¹ The proposed name for the product in the U.S. aesthetic market is Reloxin^®, and it is called Dysport^® for medical and aesthetic markets outside the U.S.
² American Society for Aesthetic Plastic Surgery, Cosmetic Surgery National Data Bank Statistics, 2006 and Allergan company reports

About Ipsen’s Botulinum Toxin Type A

As of October 2007, Ipsen’s botulinum toxin type A is approved for aesthetic indications in 21 countries: Argentina, Australia, Belarus, Brazil, Columbia, Ecuador, Egypt, Germany, Honduras, Israel, Kazakhstan, Mexico, Moldova, New Zealand, Philippines, Slovak Republic, Ukraine, Uruguay, Venezuela, Vietnam, and Russia (in Russia, it is the first botulinum toxin type A approved in this field). Ipsen is also pursuing regulatory approval for medical indications for the product in certain additional key international markets.

Dysport^® is a neuromuscular blocking toxin which acts to block acetylcholine release, hence reducing muscular spasm and was initially developed for the treatment of motor disorders and various forms of muscular spasticity, including cervical dystonia (a chronic condition in which the neck is twisted or deviated), spasticity of the lower limbs (heal) in children with cerebral palsy, blepharospasm (involuntary eye closure) and hemifacial spasm. It was later developed for the treatment of a wide variety of neuromuscular disorders and aesthetic medicine. Dysport^® was originally launched in the United Kingdom in 1991 and has marketing authorisations in over 70 countries (at 31 December 2006). Ipsen has just recently filed a BLA for Dysport^® in cervical dystonia to the FDA.

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.

About Medicis

Medicis is the leading independent specialty pharmaceutical company in the United States focusing primarily on the treatment of dermatological and aesthetic conditions. The Company is dedicated to helping patients attain a healthy and youthful appearance and self-image. Medicis has leading branded prescription products in a number of therapeutic and aesthetic categories. The Company's products have earned wide acceptance by both physicians and patients due to their clinical effectiveness, high quality and cosmetic elegance. The Company's products include the prescription brands RESTYLANE^® (hyaluronic acid), PERLANE^® (hyaluronic acid), DYNACIN^® (minocycline HCl), LOPROX^® (ciclopirox), PLEXION^® (sodium sulfacetamide/sulfur), SOLODYN^® (minocycline HCl, USP) Extended Release Tablets, TRIAZ^® (benzoyl peroxide), LIDEX^® (fluocinonide) Cream, 0.05%, VANOS^® (fluocinonide) Cream, 0.1%, and ZIANA^® (clindamycin phosphate 1.2% and tretinoin 0.025%) Gel, BUPHENYL^® (sodium phenylbutyrate) and AMMONUL^® (sodium phenylacetate/sodium benzoate), prescription products indicated in the treatment of Urea Cycle Disorder, and the over-the-counter brand ESOTERICA^®. For more information about Medicis, please visit the Company's website at www.medicis.com.

Medicis Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act. All statements included in this press release that address activities, events or developments that Medicis expects, believes or anticipates will or may occur in the future are forward-looking statements, including FDA’s acceptance of the Reloxin® submission, the timing associated with FDA’s response to the submission and the potential commercialization of Reloxin^®. These statements are based on certain assumptions made by Medicis based on its experience and perception of historical trends, current conditions, expected future developments and other factors it believes are appropriate in the circumstances. No assurances can be given, however, that these activities, events or developments will occur or that such results will be achieved. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of Medicis. Several of these risks are outlined in the Company’s most recent annual report on Form 10-K for the year ended December 31, 2007, and other documents we file with the Securities and Exchange Commission. Forward-looking statements represent the judgment of Medicis' management as of the date of this release, and Medicis disclaims any intent or obligation to update any forward-looking statements contained herein, which speak as of the date hereof.

NOTE: Full prescribing information for any Medicis prescription product is available by contacting the Company. RESTYLANE^® and PERLANE^® are trademarks of HA North American Sales AB, a subsidiary of Medicis Pharmaceutical Corporation. All other marks are the property of Medicis or its affiliates.


Source: Ipsen

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Toremifene citrate 80 mg meets primary and key secondary endpoints in phase III clinical trial

...in advanced prostate cancer patients on androgen deprivation therapy Ipsen intends to submit toremifene citrate 80 mg in Europe before year-end 2008

Paris (France), 25 February 2008 — Ipsen (Euronext: IPN) announced today that GTx Inc. (NASDAQ: GTXI), from which it licensed the European rights for Acapodene^® (toremifene citrate 80 mg) in September 2006, presented the results of the first phase III study evaluating the efficacy and safety of toremifene citrate 80mg daily, on multiple side effects of androgen deprivation therapy (ADT) in advanced prostate cancer patients. On the basis of these positive results, Ipsen intends to file toremifene citrate 80 mg for this indication in the European Union before year-end 2008. Androgen deprivation therapy using either luteinizing hormone releasing hormone or surgical castration is the most common treatment for advanced prostate cancer and have clearly demonstrated their efficacy. However, their impact on testosterone and oestrogen levels could result in a decrease of bone mineral density (BMD) potentially leading to osteoporotic fractures, and other adverse effects such as lipid changes, gynecomastia and hot flashes.

Stéphane Thiroloix, Executive Vice President, Corporate Development of Ipsen, said: "We are very pleased with the results of this clinical trial, which confirm the efficacy and the good safety profile of toremifene citrate 80 mg. Subject to regulatory approval, this drug has the potential to address a significant unmet medical need by providing a new therapeutic approach to treat the side symptoms of androgen deprivation therapy. This product is an excellent fit with Ipsen’s existing Decapeptyl^® franchise, reinforcing our positioning in the treatment of hormone-dependent diseases and broadens the range of our prostate cancer related product portfolio."


About the study

In this large phase III study, 1389 ADT patients were randomized to evaluate the efficacy and safety of toremifene citrate 80 mg compared to placebo over two years in approximately 150 clinical sites in the United States and Mexico. All men enrolled were over 50 years or older with histologically documented prostate cancer, serum prostate specific antigen (PSA) 4 ng/ml or less and a history of orchiectomy, or treatment with GnRH agonist for at least 6 months or intermittent treatment with a GnRH agonist for at least 12 months. The primary endpoint of this study was reached with a significant reduction (p<0.05) in the incidence of morphometric vertebral fractures of at least 50% in the toremifene group as compared to the placebo group with a fracture rate of 2.5% vs 4.9% respectively (preliminary analysis). Furthermore, Bone Mineral Density (BMD) data have confirmed the anti-osteoporotic efficacy of toremifene citrate 80mg/day in significantly preventing bone loss (p<0.0001) at the spine as well as at the hip and femur level. Toremifene citrate 80 mg treatment compared to placebo also resulted in a decrease in total cholesterol (p=0.011), LDL (p=0.018), and triglycerides (p<0.0001), and an increase in HDL (p=0.001). In regard to the effect of toremifene citrate 80 mg on hot flashes, the evaluation of these data is still ongoing and will be reviewed with the final data set.

Tolerance of the treatment was good. Among the most common adverse events that occurred in over 2% of study subjects were arthralgia (treated 7.3%, placebo 11.8%), dizziness (treated 6.3%, placebo 5.0%), back pain (treated 5.9%, placebo 5.2%), and extremity pain (treated 5.0%, placebo 4.4%). There were 17 (2.4 %) venous thromboembolic events (VTE) in the toremifene citrate 80 mg treated group and 7 (1.02 %) in the placebo group. However the majority of VTE’s occurred in men with an high risk for a thromboembolic event including: age ><80 years, history of VTE, recent surgical procedure and immobilization.

About toremifene citrate 80 mg

Toremifene citrate 80 mg is a selective estrogen receptor modulator, or SERM, which GTx is developing as a daily tablet to treat the multiple estrogen related side effects of androgen deprivation therapy for advanced prostate cancer. Toremifene citrate was designed to bind to and selectively modulate estrogen receptors depending on the tissue type. GTx has rights to and plans to commercialize toremifene citrate 80 mg in the United States. GTx has licensed European rights to Ipsen Group, the leading marketer of ADT drugs in Europe.

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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EMEA recommends marketing authorisation of Ipsen’s Adenuric® (febuxostat) for the treatment of chronic hyperuricaemia in gout

Adenuric® represents the first major treatment of gout for more than forty years Paris (France), 21 February 2008 &mdash Ipsen (Euronext: FR0010259150; IPN) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) provided a positive opinion for Adenuric® (febuxostat) 80 mg and 120 mg tablets for the treatment of chronic hyperuricaemia in gout and recommended it for marketing authorisation. The CHMP recommendation will now be forwarded to the European Commission for final marketing approval, which typically occurs within 60 to 90 days. Following marketing approval, Adenuric® will become, since 1964, the first significant treatment alternative for chronic hyperuricaemia available to gout patients.

Adenuric^® is to be indicated for the treatment of chronic hyperuricaemia for conditions in which urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). The detailed recommendations for the use of this product will be described in the Summary of Product Characteristics (SPC), to be made available after the medication receives marketing authorisation from the European Commission.

Once the product receives its marketing authorisation and its price is agreed, Febuxostat will be marketed by Ipsen in France under the brand name Adenuric^®. Outside France, the commercialisation of the product will be partnered.

Jean-Luc Bélingard, Chairman and Chief Executive Officer of Ipsen, said, "We are very proud to receive this positive opinion for Adenuric^® from the EMEA, and look forward to bringing this new molecule to market, pending European Commission approval. This innovative drug pioneers the first major treatment of gout for more than 40 years. It confirms Ipsen’s ability to continue to bring to the market important new treatment options for severely debilitating diseases."


About Adenuric^® (febuxostat)

Gout, a particularly painful type of arthritis, is the most frequent arthritis in men. It is caused by elevated levels of uric acid in the body: hyperuricaemia. Febuxostat, an oral, once-daily medication, is a novel nonpurine, selective inhibitor of xanthine oxidase studied for its effects on lowering levels of serum uric acid (sUA) in patients with gout. Febuxostat is licensed to Ipsen for Europe from Teijin Pharma Limited, Tokyo.

The EU submission includes two of the largest industry sponsored studies to date studying treatment of chronic gout patients. The goal of chronic gout treatment is per EULAR guidelines (European League Against Rheumatism) to reduce and maintain sUA levels below 6 mg/dL. Febuxostat demonstrated superior ability to lower and maintain in patients, serum uric acid at a level inferior to 6 mg/dl compared to conventionally used doses of allopurinol (febuxostat 80 and 120 mg: 51 &: 63 % resp. vs. allopurinol: 22%). In addition, one phase III study showed that gout patients with mild to moderate renal impairment (serum creatinine >1.5 - <2.0 mg/dl) had response rate of 44 and 45 % respectively with febuxostat 80 and 120 mg.

CHMP press release can be accessed at http:///www.emea.europa.eu.

In 2003, Ipsen entered into a Research and Development partnership with Teijin Pharma Limited, the core company of Teijin Group’s pharmaceutical and home healthcare business. The Teijin group is a Japanese industrial conglomerate specialising in the businesses of fibres, films, plastics and information technology (IT) as well as pharmaceuticals and home healthcare. This partnership covers the development and subsequent commercialisation of four of Ipsen’s products by Teijin Pharma in Japan and the development and marketing by Ipsen in Europe (i.e. European Union and Russia) of febuxostat, a product owned by Teijin Pharma and known as TMX-67.

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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Clinical update for Decapeptyl® 6-month formulation in advanced prostate cancer

Presentation of efficacy and safety Phase III results by Ipsen’s partner, Debiopharm, at the 9th International Symposium on GnRH in Berlin (Germany)

Paris (France), 12 February 2008 — Ipsen (Euronext: FR0010259150; IPN) announced that its partner Debiopharm presented today the results of a phase III study with its new 6-month formulation of Decapeptyl^®1, a luteinizing hormone releasing hormone agonist (LHRHa) for the treatment of advanced prostate cancer. The results presented show similar efficacy and safety to the already marketed 1- and 3-month formulations of triptorelin.

This multicenter, open, non-comparative, phase III study on the efficacy and safety of two consecutive injections at a six-month interval of triptorelin 6-month formulation in 120 patients with advanced prostate cancer, showed that 97.5% of patients achieved castrate levels of serum testosterone 28 days after the first injection and that 93% of the patients maintained serum testosterone levels below castrate level (defined as < 1.735 nmol/L or 50 ng/dL) from week 8 to 48. These efficacy and safety results are similar to those obtained previously with repeated administrations of the 1- and 3-month formulations of triptorelin in previous studies. Furthermore, local tolerance is good with only 6.7% of the patients treated reporting spontaneously site injection adverse events.

On 31 October 2007, Ipsen exclusively in-licensed from Debiopharm know-how and new patent applications for the commercialization rights of Decapeptyl^® (triptorelin pamoate) in the world excluding North America, and some other countries (Sweden, Israel, Iran and Japan).

¹Triptorelin formulations are mainly sold as Decapeptyl^®, Diphereline^® and Pamorelin^®

About Decapeptyl^®

Decapeptyl^® is a peptide formulation for injection that was initially developed by Debiopharm and continues to be used mainly in the treatment of advanced metastatic prostate cancer. Additional indications developed subsequently include the treatment of uterine fibroids (a benign tumour of muscle tissues in the uterus), endometriosis (proliferation of endometrial tissue, the mucous membrane that lines the uterine wall outside the reproductive tract) prior to surgery or when surgery is not deemed appropriate, as well as early onset puberty and female infertility (in vitro fertilisation). Decapeptyl^® is available in monthly or quarterly sustained-release formulations, as well as a daily formulation. The active substance in Decapeptyl^® is triptorelin, a decapeptide analogue of GnRH (Gonadotrophin Releasing Hormone), a hormone secreted by the hypothalamus, which initially stimulates the release of pituitary gonadotrophins (hormones produced by the pituitary gland), which in turn control hormonal secretions by the testes and ovaries. Decapeptyl^® was initially launched in France during 1986. At 31 December 2007, Decapeptyl^® had marketing authorizations in over 60 countries, including 25 in Europe. In 2007, 59.7% of Decapeptyl^® sales were generated in the five major European Countries, and reached a total of 235.1M€.

Debiopharm, which holds the patent to pamoate formulations of Decapeptyl^® has granted Ipsen an exclusive licence to Decapeptyl^® within the European Union (outside Sweden) and in certain other countries. Debiopharm has also granted Ipsen a co-exclusive licence to manufacture Decapeptyl^® within the European Union (outside Sweden) and in certain other countries (with Debiopharm nonetheless retaining the right to manufacture and supply Decapeptyl^® for its own purposes and those of its otherDecapeptyl^® licensees in territories not licensed to the Group).

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 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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Polyplus-transfection has produced the first GMP-quality clinical batch of its nucleic acid transfer reagent

Polyplus-transfection will deliver GMP-compliant in vivo-jetPEI for a Phase II clinical trial Strasbourg, February 1st 2008 — Polyplus-transfection, a company specialized in the research, development and marketing of innovative reagents for transfection and RNA interference (RNAi), announces today the production of the first batch of its transfection reagent in vivo-jetPEI manufactured in full compliance with Good Manufacturing Practice (GMP). This GMP-compliant in vivo-jetPEI is required for clinical trials involving nucleic acids delivery (DNA and siRNA).

Polyplus-transfection carried out preliminary work to transfer production to GMP-compliance in 2007 thanks to financial support from the AFM, France's Muscular Dystrophy Association. This has made it possible for a Phase II clinical trial to start in the field of cancer therapy this year using Polyplus' GMP-compliant in vivo-jetPEI. Details of the clinical trial have not yet been disclosed.

Polyplus-transfection offers its customers the possibility of using the same transfection reagent from the early stages of preclinical research to clinical trials in humans. The in vivo-jetPEI molecule is able to transfect effectively both in vitro and in vivo — which is not the case with most of the commercially available transfection reagents.

A Drug Master File (DMF) describing the manufacturing of in vivo-jetPEI has been filed with the United States Food and Drug Administration (FDA). The DMF provides confidential detailed information about the manufacturing process of the reagent, thus simplifying the FDA documentation required for clinical trial applications. "We are proud to have delivered this first GMP-compliant batch of in vivo-jetPEI and to have completed the production process transfer," said Joëlle Bloch, CEO of Polyplus-transfection. "The GMP-compliant availability of our leading product for human clinical use is a crucial advantage in the choice of a transfection agent for therapeutic projects. It will speed up the growth of all Polyplus' in vivo transfection agents." And she added: "We are eagerly awaiting the beginning of this Phase II clinical trial using in vivo-jetPEI that is scheduled for 2008 in the field of anti-cancer therapy."

The development of the in vivo-jetPEI GMP-compliant process has required the design of new quality control tests to meet the current requirements in the US and the EU.


About Polyplus-transfection

Polyplus-transfection is focused on developing innovative solutions for intracellular delivery of nucleic acids. The company has been marketing its transfection reagents worldwide since 2001 and is reinvesting most of its revenues into research and development. Transfection consists in introducing a gene or a small interfering RNA into cells. This technique makes it possible to cross the cellular barriers and deliver such biomolecules into the cell for research or therapeutic purposes.

Customers of Polyplus-transfection's products and services include biotechnology and pharmaceutical companies as well as life science academic laboratories. Polyplus-transfection offers high quality consultancy, personalized scientific support and expertise in regulatory affairs related to the use of its reagents in clinical trials. Phases I/II cancer gene therapy and AIDS trials are underway in Israel, USA, Sweden and Germany using GMP-compliant reagents from Polyplus-transfection.

Polyplus-transfection R&D has well-established partnerships with biotech companies and is also involved in several European research collaboration networks, such as GIANT (Gene Therapy, an Integrated Approach to Neoplastic Treatment) and RIGHT (RNA Interference Technology as Human Therapeutic Tool). The company also drives the OligoPlus research program for the "Therapeutic Innovations" Competitiveness Cluster, focusing on new tools for diagnostic.

The Strasbourg-based company is recognized as a leading innovator in the transfection market, with ISO 9001:2000 certification, three exclusive licenses from the CNRS and numerous patent filed.

For more information, visit: http://www.polyplus-transfection.com


Source: Polyplus-transfection

[Read more!]

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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