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

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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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Japanese accreditation certificate for Haupt Pharma Livron

Haupt Pharma Livron received an accreditation certificate from Japan’s Ministry of Health, Labour and Welfare. With this the company has been given the go-ahead as foreign contract manufacturer for the Japanese pharmaceutical market.

 


Source: Haupt Pharma

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PolyPeptide Laboratories Group Acquires NeoMPS

Leading Manufacturer of Peptides Expands Capacity and Worldwide Operations Hoofddorp, Netherlands, — November 19, 2007 — PolyPeptide Laboratories Group, a leading global provider of custom and generic GMP-grade peptides for a range of pharmaceutical and biotechnology applications, today announced its acquisition of peptide manufacturing Group NeoMPS from Isochem, the fine chemicals subsidiary of the French Groupe SNPE. NeoMPS operates facilities in France (Strasbourg) and the United States (San Diego).

The acquisition bolsters PolyPeptide Laboratories’ manufacturing capacity and capabilities, from small-scale custom peptides for research to large-scale peptides for therapeutic applications. Such capabilities complement the Group’s long-established core strength in GMP manufacturing, and will help service a range of projects from conception through commercialization. NeoMPS also manufactures cosmetic peptides and brings an extensive catalog business to the PolyPeptide Laboratories Group.

"The addition of NeoMPS to the PolyPeptide Laboratories Group is a great fit, and offers customers of both companies an even more comprehensive range of services for every stage of development," said Jane Salik, CEO of PolyPeptide Laboratories Group. "With this acquisition, we are expanding our capacity to meet the needs of customers who demand the most robust, scalable and cost efficient peptide manufacturing available."

NeoMPS CEO Serge Plaué added, "By joining PolyPeptide Laboratories Group, we are able to offer customers our combined, highly complementary experience and capabilities. Together, we can provide an unparalleled range of services."

With the NeoMPS acquisition, PolyPeptide Laboratories Group operates GMP facilities in the United States (Torrance and San Diego, California), France (Strasbourg), Denmark (Hillerod) and Sweden (Malmo). Ongoing expansions in Malmo, Torrance, and Strasbourg are continuing as planned. The Group is also constructing a new, soon-to-be-launched GMP facility in Mumbai, India that will be focused on generic peptides.

The acquisition announced today will not affect ongoing activities at the NeoMPS facilities in Strasbourg and San Diego. Harmonization of procedures to ensure consistency, continuity and quality within the expanded PolyPeptide Laboratories Group will be implemented in the coming months.

NeoMPS was formed by the 2004 merger of France-based Neosystem and California-based Multiple Peptide Systems, both of which were launched as independent companies in 1986. Details regarding financial aspects of today’s announced acquisition by PolyPeptide Laboratories Group were not disclosed.

Peptides, like proteins, are naturally-occurring chains of amino acids involved in virtually every life process. They help regulate body functions such as the release of hormones and the regulation of blood sugar levels. Advances in genomics and proteomics have boosted the demand for peptides, particularly in the development of pharmaceuticals. Synthetic peptides serve as the active pharmaceutical ingredient (API) in peptide-based drugs that treat diabetes, HIV/AIDS, endocrine and nervous system disorders, and other health conditions.


About PolyPeptide Laboratories Group

PolyPeptide Laboratories Group is a leading provider of custom and generic GMP-grade peptides for a range of pharmaceutical and biotechnology applications. With corporate roots that began in the 1950s, the Group was formally launched in 1996. Today, it operates a growing international network of peptide manufacturing facilities. Its world-class chemists and support personnel offer an unparalleled range of services for clients of every size and at every stage of product development. More information about PolyPeptide Laboratories Group is available at www.PolyPeptide.com.

Source: NeoMPS

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Endotis Pharma signs an exclusive, worldwide license agreement on antithrombotic compounds with Organon

Biocitech Park, Romainville, France, October 30, 2007 — Endotis Pharma, a specialty pharma company dedicated to the discovery and development of small glycodrugs (SGDs) for applications in thrombosis and oncology, today announced that it has signed an exclusive, worldwide license agreement with Organon, the human healthcare business unit of Akzo Nobel, concerning the development and commercialization of three antithrombotic compounds with unprecedented, dual mechanisms of action.

Under the terms of the agreement, Endotis has acquired exclusive rights to develop and commercialize Org 42675, Org 217609 (a neutralizable follow-up of Org 42675) and Org 224283, three antithrombotic compounds with unprecedented dual mechanism of action.

Org 42675 / Org 217609 display a new and original dual mechanism of action, combining blood coagulation factor Xa inhibition and thrombin inhibition. Org 42675 has successfully completed two phase I clinical trials. Org 224283 also displays an innovative dual mechanism of action, combining factor Xa inhibition and an antiplatelet effect, both effects being neutralizable by a specific antidote. Org 224283 is at a preclinical-stage of development.

Charles Woler, Chairman and CEO of Endotis Pharma, declared: "We are delighted to sign this licensing agreement, as these compounds will strongly reinforce our position in thrombosis. Due to their oligosaccharide structure, they perfectly fit with our focus on small-glyco drugs. We are proud that Organon has chosen Endotis to develop these very promising compounds."

David Nicholson, executive vice president Research and Development of Organon added: "We are excited to bring this opportunity to Endotis and Organon will continue to bring in its expertise in manufacturing and development. This deal maximizes the chances of bringing these innovative compounds to patients in need of anti-thrombotic care."

Together with these three advanced in-licensed compounds from Organon, Endotis is using its productive and innovative drug engine to building a unique pipeline of compounds in thrombosis and oncology. Endotis' drug discovery platform has already generated a number of promising SGD compounds, including:

a. the EP37 program, dedicated to oral prevention and treatment of thrombosis and for which a development candidate will be available in early 2008.
b. the EP8000 program, focused on multi-target compounds with activity against a number of growth factors involved in cancer development, angiogenesis and metastasis.

About Endotis Pharma (www.endotis.com)

Founded 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. Endotis Pharma has built a well-balanced portfolio of pre-clinical and clinical stage compounds, either in-licensed (from Organon: EP42675, an anticoagulant that has completed two phase I, EP217609, the neutralizable form of EP4675 and EP224283, an antithrombotic which is in preclinicals) or generated by the company's own drug discovery platform (EP37 program, focused on the oral prevention and treatment of thrombosis, and EP8000 program in oncology). The SGDs developed by Endotis are based on fully synthetic oligosaccharides mimicking glycosaminoglycans, which is the core field of expertise of Endotis' scientists. Proof of concept has already been established with synthetic oligosaccharides in cardiovascular/thrombosis, with oncology being the next promising therapeutic area. Endotis currently has 26 employees (including 14 PhDs/MDs) based in Paris and Lille (France). Sofinnova Partners is a lead investor in Endotis Pharma.

About Organon (www.organon.com)

Organon creates, manufactures and markets innovative prescription medicines that improve the health and quality of human life. Through a combination of innovation and business partnerships, Organon seeks to leverage its position as a leading biopharmaceutical company in each of its core therapeutic fields: fertility, gynecology and selected areas of anesthesia. It has extensive expertise in neuroscience and a rich and focused R&D program. Research areas also include immunology and specific areas of oncology. Organon products are distributed in over 100 countries worldwide, of which more than 50 have an Organon subsidiary. Organon is the human healthcare business unit of Akzo Nobel.

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 forecasted.


Source: Endotis Pharma

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Polyplus-transfection to supply RNAi therapeutic delivery technology to Alnylam Pharmaceuticals

Collaboration targets improving delivery of RNAi-based therapies Strasbourg, France, September 21, 2007 — Polyplus-transfection, a company specialized in the research, development and marketing of innovative reagents for RNA interference (RNAi) and transfection, announced today that it has signed a collaboration agreement with Alnylam Pharmaceuticals, the leading RNAi therapeutics company, based in Cambridge, Massachusetts.

Under the terms of the agreement, Polyplus-transfection will provide Alnylam with its RNAi therapeutic delivery solutions and share its expertise in formulation for siRNAs, the molecules that mediate RNAi, in vivo. Alnylam will evaluate Polyplus' formulations for delivery of RNAi therapeutics. Other terms were not disclosed.

The companies believe the collaboration has the potential to bring about improvements in the delivery of siRNA therapies. Although there has been significant progress in this area to date, creating delivery solutions for RNAi therapeutics remains an important component in realizing the full potential of this promising technology.

"As Alnylam is the leading RNAi therapeutics company, we at Polyplus-transfection are delighted to be collaborating with a firm at the cutting edge," said Joëlle Bloch, CEO of Polyplus-transfection. "A big advantage of this relationship is that Polyplus-transfection will benefit from having its chemical carriers tested in several disease models while working with the most advanced target sequences and mixed chemical siRNA modifications from Alnylam."

Polyplus-transfection is developing several in vivo siRNA formulation solutions based on its lead compounds in vivo-jetPEI (now GMP available) and INTERFERin, as well as on an original RNA modification, sticky siRNA (ssiRNA).


RNA interference (RNAi)

RNA interference (or RNAi) is a naturally occurring mechanism within cells for selectively silencing and regulating specific genes. The discovery of RNAi has been widely acknowledged as a major breakthrough in biology, and the technology was recognized for its potential broad impact in medicine with the award of the 2006 Nobel Prize for Physiology or Medicine. Since many diseases are caused by the inappropriate activity of specific genes, the ability to silence genes selectively through RNAi has accelerated the understanding of these genes and their related pathways. Additionally, RNAi could provide a new way to treat a wide range of human diseases. RNAi is induced by small, double-stranded RNA molecules. One method to activate RNAi is with chemically synthesized small interfering RNAs, or siRNAs, which are double-stranded RNAs that are targeted to a specific disease-associated gene. The siRNA molecules are used by the natural RNAi machinery in cells to cause targeted gene silencing.

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

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BT PHARMA appoints Martin Koch as Vice President Finance and Administration

Professional in Biotech Finance brings top management and international experience to BT PHARMA &mdash forerunner in Therapeutic Vaccines

Toulouse, France — Monday September 17, 2007. BT PHARMA S.A., forerunner in the development of therapeutic vaccines for treatment of neoplasia and cancer caused by the Human Papillomavirus (HPV), announced today that Martin Koch, engineer and INSEAD MBA, has been elected to the position of Vice-President Finance and Administration.

Before joining BT PHARMA, Martin Koch had an international career in financial and operational management positions at Eli Lilly Company, Cap Gemini / Ernst & Young, Elan Pharmaceuticals, Zeneus Pharma and Cephalon Pharmaceuticals. In particular, Mr Koch was instrumental in the transaction whereby a large part of Elan’s continental European activities were spun off to Zeneus Pharma.

"We are very pleased to welcome Martin Koch who brings over 15 years of pharmaceutical industry experience to our management team", explained Benedikt Timmerman, Chief Executive Officer of BT PHARMA. "We are entering in an accelerated growth phase and the recruitment of Martin fits well in our objective to reinforce our management with executives of top management level. Martin’s experience will be of great value for BT PHARMA as we start identifying strategic partners to finance our clinical trials Phase I and II."


About BT PHARMA S.A.

BT PHARMA is a privately held biopharmaceutical company spun out of the Institut Pasteur in 2002 and registered in Toulouse, France (home of Airbus Industries). The company develops immuno-therapeutics for cervical neoplasia and cancer. BT PHARMA’s key technology is a protein-based delivery system (the Adenylate Cyclase vector) that allows inducing tailor-made and targeted T cell immune responses in the patient. BT PHARMA exploits this technology to develop innovative therapeutic vaccines in-house and in partnership with biotech and pharmaceutical companies.

The young company’s most advanced product, ProCervix^®, will enter phase I / II clinical trials in 2008. This bivalent therapeutic vaccine targets cervical neoplasia and cancer provoked by the human Papillomavirus (HPV). ProCervix^® aims to replace ablative surgery or conisation in millions of women already infected by HPV16 or HPV18 and at risk for invasive cervical cancer.

Further information: http://www.btpharma.com


Source: BT Pharma

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New facilities for an extended R&D synthesis laboratory in Beuvry

Minakem, a fine chemistry company serving the life-science industries has started building new facilities for an R&D synthesis laboratory in Beuvry-la-Forêt, close to Lille, North of France, where the group has its headquarters. The investment amounts to a total of USD 2.1 millions, and should be put into operation by the end of 2007. It will be dedicated to the development of new molecules, active principles for the pharmaceutical and cosmetic industries.

Minakem employs an overall of 32 researchers and 13 developers jointly in Beuvry and Leuna (Germany). Every year, Minakem develops around thirty new syntheses for the life-science industry.

The new laboratory will be twice the size of the existing facility, which will be converted to handle industrial process improvement programs and hazardousness studies. It will include the latest research technologies used in organic chemistry in order to face the increasing demand for new synthesis routes.


Source: Minakem

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Creation of PX'Monoclonals

Creation of PX'Monoclonals, a new subsidiary of Protein'eXpert dedicated to the development and production of monoclonal antibodies for research and therapeutic applications

Further to the call for projects issued by LyonBiopole-Mérial, the company PX’Monoclonals has been created in July 2007 and will propose custom research and production services in the monoclonal antibody field by October 2007.

Based in Lyon, PX’Monoclonals will offer services ranging from the generation of high affinity murine antibodies for research and diagnostics applications to the development of humanized and human antibodies for therapeutic purposes. In order to develop a competitive technology platform and to propose innovative approaches, PX’Monoclonals will also initiate internal R&D programmes in collaboration with Biotech companies and academic laboratories.

PX’Monoclonals is a subsidiary of the company Protein’eXpert and will therefore benefit from its experience in terms of enterprise development, technology platform, management and commercialization of research services.

Source: Protein’eXpert

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Polyplus-transfection launches "Polyplus in vivo Consortium" to speed development of gene therapy clinical trials

Innovative reagent specialist forms network of researchers and clinicians using Polyplus' synthetic gene transfer reagents Strasbourg, France, June 7, 2007 — Polyplus-transfection, a company specializing in research, development and marketing of innovative reagents for drug delivery, gene therapy and transfection announces today that it is setting up a group called the "Polyplus in vivo Consortium". This group will be developed on a user group model and bring together research scientists and clinicians in an international network of users of Polyplus-transfection's gene therapy reagents. Polyplus-transfection expects the new group to increase the number of clinical trials using its synthetic gene transfer reagents and accelerate their development.

The Polyplus in vivo Consortium aims at letting users of Polyplus-transfection's products and solutions share their experience to accelerate the implementation of clinical trials and give them access to Polyplus-transfection's latest technology. The company plans to organize regular meetings and workshops and will actively support the Polyplus in vivo Consortium members in their preclinical and clinical therapeutic projects. Members will benefit from personalized support, from Polyplus-transfection's expertise regarding in vivo delivery as well as preferential conditions for products used for therapeutic development. Among other services, Polyplus-transfection will supply appropriate certificates of analysis for preclinical and toxicology studies.

Polyplus-transfection's in vivo-jetPEI compound will play a key role in the Consortium. It is derived from the synthetic molecule polyethylenimine (PEI) for which Polyplus-transfection holds the exclusive worldwide license for the transfection of nucleic acids. In vivo-jetPEI is widely used for in vivo experiments. It allows intracellular delivery of nucleic acids and has become a benchmark in gene delivery.

"The Polyplus in vivo Consortium will make research and development of gene therapy applications easier," said Joëlle Bloch, CEO of Polyplus-transfection. "The project meets a real need that was revealed by the first clinical research teams using our products. It will allow Polyplus-transfection to build a true network where users of our transfection reagents can exchange know-how and experience. This network will help our customers get their clinical trials under way and also help Polyplus-transfection develop solutions that suit users' needs."


About Polyplus-transfection

Polyplus-transfection researches, develops and markets products for drug delivery, gene therapy and innovative transfection reagents. Transfection consists of introducing a gene or a small interfering RNA into a cell. This technique makes it possible to cross the cellular barriers and deliver such biomolecules into the cell for scientific or therapeutic purposes. Customers for Polyplus-transfection's products and services include biotechnology and pharmaceutical companies as well as life science research laboratories.

In addition to transfection reagents for research, Polyplus-transfection offers high quality consultancy and personalized scientific support. The company has acquired expertise in regulatory affairs related to the use of its reagents for gene delivery in clinical trials.

The Strasbourg-based company has 20 members of staff, an international distribution network and numerous academic and industrial partnerships. Polyplus-transfection is one of the technology leaders in the transfection market with ISO 9001:2000 certification, three exclusive licenses from the CNRS and six patents filed.

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


Source: Polyplus-transfection

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Clinical Data’s Cogenics Division Launches Services on Schedule

NEWTON, Mass. — June 6, 2007 — Clinical Data, Inc. (NASDAQ: CLDA) announced today that its Cogenics division has successfully launched the 454 Genome Sequencer FLX system (the "454 FLX system") at its facility in Meylan, France, some eight weeks after the signing of the co-marketing agreement with Roche Diagnostics Inc., to offer "next generation" sequencing services. The system enhances Cogenics’ portfolio of services by providing whole genome sequencing, Expressed Sequence Tag sequencing, identification of small RNAs, transcriptome analysis, and metagenomics on the new platform.

"Our team is enthusiastic about the level of customer interest in the 454 FLX system and pleased to be able to meet our customers’ growing needs by providing complete solutions for low-cost and high-efficiency sequencing programs," stated Robert Bondaryk, Ph.D., Senior Vice President and General Manager of Cogenics. "We have already attracted new customers for the first projects on the platform and we have a strong pipeline of current and new customer interest in 454 FLX sequencing as a companion to traditional automated Sanger sequencing."

"I am truly excited about the speed and professionalism with which our team installed the 454 technology. This represents another example of Cogenics’ strong technical abilities and commitment to leveraging proven advances in technology and quality for its clients," stated Drew Fromkin, Clinical Data’s President and CEO. "We feel that the platform’s ability to deliver value to our clients will translate into rapid, healthy returns for Cogenics."

For more information about Cogenics’ offering of the 454 FLX system, as well as its other genomic resources and services, please contact Laure Turner, Product Manager for Sequencing, at +1-314-303-9147, or Claire Vigneron, Cogenics’ European Marketing Manager, at +33 (0)4 56 38 11 03. For more information about Clinical Data, visit the company’s website at www.clda.com.


About Cogenics (www.cogenics.com)

Cogenics offers more than 18 years of experience as a trusted provider of the broadest range of pharmacogenomics and molecular biology services available globally. Cogenics provides integrated services for nucleic acid extraction, genotyping, sequencing, QPCR, and gene expression, as well as serving as a biorepository, for both research and regulated environments: GLP, cGMP and CLIA. Cogenics combines operations from the acquisitions of Genaissance Pharmaceuticals, Lark Technologies (US & UK), Icoria, and Genome Express (France). Its customers include some of the world’s most respected pharmaceutical and biotechnology companies, agencies of the US National Institutes of Health, leading government and academic researchers in the international life science community, and major agricultural companies and agencies.

About Clinical Data, Inc. (www.clda.com)

Clinical Data, Inc. is a global biotechnology company unlocking the potential of molecular discovery, from targeted science to better healthcare. Its Cogenics division provides molecular biology and pharmacogenomics services to pharmaceutical and biotech companies and academics institutions in both research and regulated environments. Its PGxHealth division focuses on genetic test and biomarker development to help predict drug safety and efficacy, thereby reducing health care costs and improving clinical outcomes. Its Vital Diagnostics division offers in vitro diagnostics solutions for the clinical laboratory. Through these divisions, Clinical Data is leveraging advances in molecular discovery to provide tangible benefits for patients, doctors, scientists, and health plans worldwide.

Source: Cogenics

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Jean-Michel Alarcon is appointed Chief Executive Officer of Minakem SAS as of June 1st, 2007

Jean-Michel Alarcon is appointed Chief Executive Officer of Minakem SAS as of June 1st, 2007. He will be as well in charge of the Corporate development of Group Minakem, and will be a member of the Group’s General Management Committee.

Chartered chemical engineer, graduated from IMD (Lausanne-CH) in economics and management, Jean-Michel Alarcon joined Hoechst in 1986. He was first assigned to the process development unit in Lamotte factory, before being promoted R&D Director in 1996. In 2002, he was nominated "Global Business Director Glyoxal Derivatives" for Clariant, and Life Sciences Division Director of the French subsidiary. He had been in charge of "Specialty Intermediates" since 2005, one of the 27 Clariant business units, with responsibility for 3 manufacturing plants, Lamotte (France), Gainesville (USA), and Roha (India). He had been as well President of Clariant Specialty Fine Chemicals (France) since 2006.

The members of the Group’s General Management Committee are Frédéric Gauchet: President, Jean-Michel Alarcon: CEO of Minakem and Director of Corporate development, Jean Pierre Diehl: CEO of Minasolve (Building Blocks) and Project Manager for China, Karsten Fischer: CEO of Chemtec, Philippe Guerret : CFO, Michael Staff : President of Minakem USA and Business Development North-America, and Pierre Dedenys : Project Manager and Committee’s Secretary.


About Minakem Group:

MINAKEM is a "one-stop-shop" group serving the life-science industries, namely, the pharmaceutical and cosmetic industries. The companies focus on the synthesis of the tailor-made molecules, their formulation, their dose-forming and the production of the registration dossiers for approval of the manufacturing processes.

For more information visit www.minakem.com or www.chemtec-leuna.de

Source: Minakem

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BT PHARMA successfully closes €1.3 million bridging round

Bridging funds to move candidate therapeutic vaccine up to phase I / II clinical trials for treatment of patients suffering from high-grade lesions provoked by Human Papillomavirus.

Toulouse, France — Monday, May 28th 2007.BT PHARMA is pleased to announce that it has successfully closed on €1.3 million in new investment from current shareholders and a new private investor. This bridging round will enable the Company to move its candidate therapeutic vaccine through preclinical development and up to phase I/II clinical trials for the treatment of high-grade neoplasia provoked by the Human Papillomavirus (HPV).

Dr. Benedikt Timmerman, Chief Executive comments: "This investment allows BT PHARMA to take lead candidate ProCervix^® through the entire preclinical phase and up to the next key milestone: placebo-controlled clinical trials in women bearing CIN II / CIN III lesions. We have spared no effort to render GMP production and protein purification processes of our bivalent product robust and to pharmaceutical grade. Our placebo-controlled trial is planned for the 1st trimester of 2008. The awareness of the medical need to treat infection, neoplasia and cancer provoked by Human Papillomavirus by other means than surgery has come to age. It coincides well with our clinical timelines and may allow BT PHARMA to be one of few key players in this exciting new market."

ProCervix^® exploits the unique characteristics of the Adenylate Cyclase vector (CyaA) that targets tumour cell-specific antigens to antigen-presenting cells in patients in vivo and induces strong and specific cellular immune responses. This bivalent therapeutic vaccine targets cervical neoplasia and cancer provoked by HPV16 and HPV18. ProCervix^® aims to replace ablative surgery or conisation in millions of women already infected by HPV and at risk for invasive cervical cancer. The CyaA technology was exclusively licensed from the Institut Pasteur, with whom BT PHARMA has a strategic alliance. The CyaA technology, which has unique immune cell-targeting features, has since been industrialized and the patent estate broadened by newly filed proprietary patents, which cover pipeline products such as ProCervix^®.


About BT PHARMA S.A.

BT PHARMA is a privately held biopharmaceutical company incorporated in October 2001 and spun out of the Institut Pasteur in October 2002. The company headquarters and laboratories are currently based in Labège (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).


Source: BT Pharma

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