FDA’s first-cycle review of Dysport® to be completed by year-end: US launch of Dysport® on track

Paris (France), 30 September 2008 — Ipsen (Euronext; IPN) today announced that the U.S. Food and Drug Administration (FDA) provided notification that the Prescription Drug User Fee Act (PDUFA) action date for Dysport^® (botulinum toxin of type A) Biologics License Application (BLA) for the treatment of patients with cervical dystonia has been extended to no later than 28 December 2008. This regulatory decision will not impact the anticipated company launch plan timing.

The FDA has not requested additional safety or clinical studies for review.

In accordance with first-cycle review of new therapies, the FDA requested a Risk Communication Plan in order to ensure safe use of the product in treating patients. The Agency has therefore extended the PDUFA action date to no later than December 28, 2008, in order to finalize the review of those items.

"We are assembling the requested information from the dossier, in close coordination with the FDA," said Stéphane Thiroloix, Executive Vice-President, Corporate Development of the Ipsen Group. "We strongly believe that appropriate recommendations through vehicles like patient medication guide and appropriate direct communications to attending physicians are the way forward to enhance and further define information already available in the package inserts. In meeting the Agency’s information need, Ipsen also addresses a patient-care imperative.".

Dysport^® has been granted orphan product status by the FDA as a treatment for cervical dystonia, an orphan disease in the United States. The BLA submission relies on data from two pivotal Phase III studies performed in the United States and abroad totalling 252 patients followed-up for up to 12 treatment cycles, in addition to substantial patient exposure in other clinical studies in cervical dystonia.

The timeline for the US commercialisation of Dysport^® is unchanged from original plans, and the US neurology team is preparing diligently for the launch.

Used in patient care in the United Kingdom since 1991, Dysport^® has marketing authorizations in more than 70 countries. Patient exposure is estimated to be above two million single treatment cycles representing more than 600 000 patients/year of treatment. Dysport^® is approved outside the US for eight indications including cervical dystonia (involuntary distorsions of the neck).


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.

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. Its development strategy is based on a combination of specialty products, which are growth drivers, in targeted therapeutic areas (oncology, endocrinology and neuromuscular disorders), and primary care products which contribute significantly to its research financing. The location of its four Research & Development centres (Paris, Boston, Barcelona, London) and its peptide and protein engineering platform give the Group a competitive edge in gaining access to leading university research teams and highly qualified personnel. More than 700 people in R&D are dedicated to the discovery and development of innovative drugs for patient care. This strategy is also supported by an active policy of partnerships. In 2007, Research and Development expenditure was about €185 million, in excess of 20% of consolidated sales, which amounted to €920.5 million while total revenues amounted to €993.8 million. Ipsen’s shares are traded on Segment A of Euronext Paris (stock code: IPN, ISIN code: FR0010259150). Ipsen’s shares are eligible to the "Service de Règlement 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, objectives and targets contained herein are based on the Group’s management strategy, 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 targets described in this document were prepared without taking into account external growth assumptions, as announced on June 5, 2008 and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by the Group. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties. The Group does not commit nor gives any guarantee that it will meet the targets mentioned above. Furthermore, 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. 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. The Group 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. The Group’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers.


Source: Ipsen

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Minakem — Company Profile

Minakem SAS 145, chemin des Lilas 59310 Beuvry-la-Forêt France Tel.: +33 (0)3 20 64 68 30 Fax: +33 (0)3 20 64 68 31 Email: contact@minakem.com Website: http://www.minakem.com/

Minakem is a manufacturer of fine chemicals, advanced cosmetology, pharmaceutical intermediates and active pharmaceutical ingredients (APIs).

We offer an independent partnership providing fine services for the life science industries.

Today, the largest pharmaceutical and biopharmaceutical companies are routinely utilizing Minakem as their approved partner, developer and manufacturer for high-profile, proprietary compounds.

MINAKEM core business activities are :

— Synthesis of Starting Materials for the fine chemical industry in dedicated facilities with cost-effective processes, within or out of cGMP guidelines when not required.

— Custom Manufacturing of Key Intermediates for the pharmaceutical industry with finishing stages in qualified cGMP plants

— APIs manufacturing under cGMP guidelines

History

1952: Company’s foundation by Mr. Claude Dufour in the western suburb of Paris (Boulogne under the name of "Laboratoires du Bois de Boulogne" and renamed later on as SEAC.

1962: SEAC moves its industrial operations to its current location north of France in Beuvry la Foret near Lille.

1988: SEAC becomes a 100% subsidiary of the French company CFPI.

1998: CFPI is acquired by Nufarm Limited, the Australian chemical group, further positioning itself in the agrochemical market. SEAC remains managed as a stand-alone company within the group, focusing on fine chemicals.

2005: Minakem Holding SAS acquired all the assets related to the custom synthesis, including the R&D laboratories, pilot plant and manufacturing resources from SEAC.

Operating under the name of Minakem SAS, headquarters were relocated to Beuvry la Forêt. The company is privately owned.

Minakem establishes Minakem, L.L.C in the United States (New Jersey). This new affiliate manages the groups North-American business and support its development within the domestic market.


Source: Minakem

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Endotis Pharma — Company Profile

Endotis Pharma Parc Eurasanté 70, rue du Docteur Yersin 59120 Loos France Website: http://www.endotis.com/

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. Endotis Pharma has built a well-balanced portfolio of pre-clinical and clinical stage compounds.


Corporate Profile

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 (veinous 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 euros with Sofinnova Partners (France), The Wellcome Trust (UK), Endeavour Vision (Switzerland) and NIF SMBC (Japan).

Business Strategy

Endotis business strategy consists in:
— Developing a de-risked portfolio of antithrombotic compounds from pre-clinical to clinical stages
— Leveraging its unique small-glyco drug engine in oncology

Partnering strategy:
Endotis will seek to partner antithrombotic drugs when proof of concept in man is reached, and to partner its oncology platform after proof of concept in animals is reached.
Endotis will also study other partnering opportunities.

In order to guide Endotis development, the company has built a strong management team under the leadership of Charles Woler, and assembled a Scientific Advisory Board and a Clinical Advisory Board with worldwide renowned in Glycoscience and Thrombosis.


Source: Endotis Pharma

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Ipsen announces the filing of Decapeptyl® 6-month formulation for the treatment of locally advanced or metastatic prostate cancer in Europe

The filing of the new Decapeptyl®1 6-month formulation is in accordance with Ipsen’s regulatory timeline

Paris (France), 25 September 2008 — Ipsen (Euronext: FR0010259150; IPN) today announced the start of the filing process in Europe of the 6-month sustained release formulation of Decapeptyl^®, a luteinizing hormone releasing hormone agonist (LHRHa) developed by Debiopharm for the treatment of locally advanced or metastatic hormone-dependent prostate cancer.

On 31 October 2007, Ipsen exclusively in-licensed from Debiopharm know-how and new patent applications for the commercialization rights of the new 6-month formulation of Decapeptyl^® (triptorelin pamoate) in the world excluding North America, and some other countries (Sweden, Israel, Iran and Japan).

¹1depending on the countries, Ipsen commercialises Decapeptyl^® under different brand names (Diphereline^®, Pamorelin^®, Arvekap^®)

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^® is mainly indicated in the treatment of locally advanced or metastatic prostate cancer. In this indication, Decapeptyl^® temporarily increases the concentration of testosterone and dihydro testosterone, but continuous administration paradoxically leads to a reduction in plasmatic testosterone concentration. After two to three weeks of treatment, testosterone is reduced to levels below the castration threshold, thereby depriving prostate tumours of one of the main hormones promoting tumour development. 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, 60.9% of Decapeptyl^® sales were generated in the 5 major European Countries. Debiopharm, which holds the patent to pamoate formulations of Decapeptyl^® has granted the Group an exclusive license to commercialise Decapeptyl^® within the European Union (outside Sweden) and in certain other countries. Debiopharm has also granted the Group a non-exclusive license 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 other 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. Its development strategy is based on a combination of specialty products, which are growth drivers, in targeted therapeutic areas (oncology, endocrinology and neuromuscular disorders), and primary care products which contribute significantly to its research financing. The location of its four Research & Development centres (Paris, Boston, Barcelona, London) and its peptide and protein engineering platform give the Group a competitive edge in gaining access to leading university research teams and highly qualified personnel. More than 700 people in R&D are dedicated to the discovery and development of innovative drugs for patient care. This strategy is also supported by an active policy of partnerships. In 2007, Research and Development expenditure was about €185 million, in excess of 20% of consolidated sales, which amounted to €920.5 million while total revenues amounted to €993.8 million. Ipsen’s shares are traded on Segment A of Euronext Paris (stock code: IPN, ISIN code: FR0010259150). Ipsen’s shares are eligible to the "Service de Règlement 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, objectives and targets contained herein are based on the Group’s management strategy, 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 targets described in this document were prepared without taking into account external growth assumptions, as announced on June 5, 2008 and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by the Group. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties. The Group does not commit nor gives any guarantee that it will meet the targets mentioned above. Furthermore, 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. 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. The Group 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. The Group’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers.


Source: Ipsen

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Pierre Fabre Castres - Peraudel — Company Profile

Institut de Recherche Pierre Fabre 17, Avenue Jean Moulin 81106 Castres Cedex France Tel.: +33 (0)5 63 71 42 00 Fax: +33 (0)5 63 35 66 29 Website: http://www.pierre-fabre.com/

Medical chemistry (central nervous system, cardio-vascular diseases).

Sector of activity
Research & Development

Branch of activity
Pharmacy

Personnel
232 Persons


Source: Pierre Fabre

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Pierre Fabre Ramonville - Ariane — Company Profile

Institut de Recherche Pierre Fabre Parc Technologique du Canal 3, rue Ariane 31527 Ramonville Cedex France Tel.: +33 (0)5 61 73 73 00 Fax: +33 (0)5 61 73 73 73 Website: http://www.pierre-fabre.com/

Innovation Development Center Pierre Fabre.

Sector of activity
Research & Development

Branch of activity
Pharmacy

Personnel
142 Persons


Source: Pierre Fabre

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MidiMed — Company Profile

MidiMed ZI du Bousquet 31360 Boussens France Tel.: +33 (0)5 61 97 69 69 Fax: +33 (0)5 61 87 17 59 Website: http://www.midimed.com/

MidiMed manufactures reagents for cell culture. We are committed to provide quality products and services to research laboratories and industrialists according to their needs.

• Standard and innovative culture media,
• Additives and antibiotics,
• Sera, albumins, plasma of most species and origins,
• Immunoglobulins,
• An innovative serum free range of products, "SafeCell".

MidiMed was created in July 2004; our 2000 m² factory located in Boussens, south of Toulouse offers you:

• Standard and customized Culture media.
• Serum Free media, based on containing vegetable extracts.
• Serums and plasma of most species and origins.
• Capacity to produce lots above 1000 litres.
• Additives and antibiotics for cell culture.
• Albumins and immunoglobulins.

The MidiMed company invested in several research projects in order to replace animal proteins by plant proteins.


Source: MidiMed

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Genibio — Company Profile

Genibio Voie Haussmann ZI du Couserans 09190 Lorp-Sentaraille France Tel.: +33 (0)5 61 04 80 18 Fax: +33 (0)5 61 04 80 38 Website: http://www.genibio.eu/

Founded in the late 1990s, GENIBIO develops innovative and natural ingredients such as probiotics, protein hydrolysates and vegetal extracts for the food supplement, pharmaceutical and cosmetic markets.

• From science to industry: GENIBIO is present all along the innovation chain and proposes an integrated approach from research and validation of active compounds and extracts to the production of the final ingredient.
• With high quality standards: Since 2004, a quality policy with an approach based on GMP (Good Manufacturing Practices) and HACCP (Hazard Analysis Critical Control Point) has been established.
• A partnership strategy: GENIBIO develops strong partnerships, with industrial groups and academic research units. Located in the South-West of France, GENIBIO benefits from the proximity of Toulouse, one of the key French scientific centers in the field of health and biotechnology.

With a high dedicated skills panel and a powerful technological platform, GENIBIO is now the right partner for innovation from research to production of natural ingredients, used in health, health foods and cosmetics markets.


History

With the initial aim of developing research-based innovation for the market of food and cosmetic ingredients, GENIBIO was focused on R & D strong partnerships in the field of services.

1998: Creation of GENIBIO in Toulouse by François Paul, after a rich and diversified professional course in industrial and academic worlds.
With the initial aim of developing research-based innovation for the market of food and cosmetic ingredients, GENIBIO was focused on R & D strong partnerships in the field of services.

1999: Creation of GENIBIO INDUSTRIE.
Located in Lorp-Sentaraille and created to manufacture the ingredients issued from GENIBIO research, GENIBIO INDUSTRIE started up with the production of plant protein hydrolysates by enzyme technology.

Since 2002: GENIBIO research team settled in the same place as GENIBIO INDUSTRIE.
Now, GENIBIO is fully operational in its industrial site and offers a complete service from research to production of vegetal ingredients and probiotics.


Organisation

Currently, the site of GENIBIO employs about 30 persons, with one third of the people involved in R&D activities and distinguishes by its diverse and young team with expertise in biocatalysis, microbiology, extraction techniques, production processes, analytical methods and quality assurance.

GENIBIO R & D provides services for the development of innovative ingredients: natural plant extracts and probiotics.

Staff 10 persons
Facilities:

• Laboratory of Microbiology: selection and objectivation of lactic acid bacteria and bifidobacteria, development of probiotics and synbiotics formulae
• Laboratory of Biochemistry: development of extraction techniques and analytical methods

GENIBIO INDUSTRIE offers infrastructures for plant extraction and enzymatic hydrolysis processes.

Staff 20 persons
Industrial facilities: 2,000 m²
GENIBIO premises include a main production area for the manufacturing of fine powders (protein hydrolysates and other plant extracts), an alcoholic plant extraction platform, a control quality laboratory and two separated warehouses for raw materials and finished products.


Key Facts

Skills and Know-how:

• Research & Development and Production of natural ingredients
• Dedicated skills in Microbiology, Biocatalysis, Extraction technology, separation and filtration techniques

Core business areas:

• Probiotics, prebiotics and synbiotics: PRIMAFLOR^®
• Herbal and seaweed extracts
• Soy germ extracts and fermented soy germ: PRIMASOY^®
• Enzymatic protein hydrolysates and peptides: HYPRO^®

Markets:

• Food supplements
• Natural cosmetic ingredients
• Health, notably PAP (Pharmaceutical Active Principles) for phytotherapy

Source: Genibio

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BT Pharma — Company Profile

BT Pharma Headquarters and Laboratories Prologue-Biotech Rue Pierre et Marie Curie BP 28262 31682 Labège-Innopole Cedex France Tel.: +33 (0)5 61 28 70 60 Fax: +33 (0)5 61 28 70 69 Email: business@btpharma.com Website: http://www.btpharma.com/

BT PHARMA is an emerging biopharmaceutical company focused on developing innovative therapeutic vaccines caused by human papillomavirus (HPV) for the treatment of cervical cancer and associated neoplasia. The company's lead candidate therapeutic vaccine, ProCervix^® is scheduled to receive approval for its first clinical trials in 2009. BT PHARMA plans to develop ProCervix^® to proof of concept stage.

The company was created in October 2001 and is based in Labège (Toulouse), France.

Corporate Profile

BT PHARMA is an emerging biopharmaceutical company focused on developing innovative therapeutic vaccines for the treatment of cervical cancer and associated neoplasia.

Cervical cancer and associated neoplasia are a major healthcare problem. They are the result of infection by the Human Papillomavirus (HPV) and are one of the most common sexually transmitted diseases affecting women.

BT PHARMA’s lead candidate therapeutic vaccine, ProCervix^® is scheduled to receive approval for its first clinical trials in 2009. ProCervix^® is based on BT PHARMA’s unique CyaA vector system which is able to deliver the appropriate HPV antigens needed to induce strong and specific T cell responses. BT PHARMA plans to develop ProCervix^® to proof of concept stage. The company then intends to work with an appropriate partner to further develop and commercialize this exciting new therapeutic vaccine product.

In addition, BT PHARMA has a number of other therapeutic vaccine development programs based on its CyaA vector system. These are TAAVAC, for Tumour Associated Antigen Vaccine for a range of human cancers, and DOGTAA, which targets many cancers in companion animals.

Finally, the company also has a second vaccine vector called PepTel^® which uniquely has intrinsic adjuvant ability. This promising technology platform is available for licensing.

BT PHARMA is managed by a team of experienced biotech professionals and has developed a strong network of collaborators. The company continues to work with scientists, at Institut Pasteur, who are the world leading experts in the CyaA vector technology. The company also works with leading clinicians with significant experience in conducting clinical trials with cervical cancer vaccines.

BT PHARMA started operations in October 2001 following its spin off from the Institut Pasteur. The company is headquartered in state-of-the-art facilities in Labège (Toulouse), France and employs 18 people.

Source: BT Pharma

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Orfagen — Company Profile

Orfagen Parc Technologique du Canal 4, rue Marie Curie BP 22132 31521 Ramonville Saint Agne Cedex France Tel.: +33 (0)5 62 24 76 83 Fax: +33 (0)5 61 24 76 86 Website: http://www.orfagen.com/

A pharmaceutical company dedicaded to dermatological rare disorders.
Subsidiary company of the Pierre Fabre Laboratories, ORFAGEN develops new drugs for patients affected by rare diseases with dermatological impact.


Orfagen is a new pharmaceutical laboratory, working with the best dermatologists in the field towards an objective of creating new drugs and medicines from research to market place.

Profile

Orfagen develops pharmaceutical and biotechnology products to treat patients suffering from skin disorders, and is particularly interested in the innovation of treatments for rare and serious skin conditions where treatment has not, as yet, been provided. Orfagen will also make available more conventional treatments that are insufficiently dispensed and reimbursed to patients.

with the Pierre Fabre Laboratories, whose interests and expertise in dermatology is world renowned, as the main shareholder. Orfagen’s current research portfolio has thus been carried out without the need for supplementary outside funding.

Key Points

• The Pierre-Fabre Group as major shareholder, highly dedicated to dermatology
• Assured long-term funding
• Advanced research portfolio
• Worldwide expertise in dermatology

Strategy

Resulting from the use of an original technique for the identification of new molecules and drug discovery (Capture-Recapture Search and Validation technique, CARES-V), Orfagen’s current portfolio includes seven research projects. Product sources are products developed in-house, in-licensed products and products developed in cooperation with outside partners. Orfagen’s partners are either large international pharmaceutical companies, which cannot devote resources or focus on orphan products, or biotechnology companies seeking a co-development and/or commercial partner in Europe. Universities and public research institutes also participate with Orfagen in the development of certain projects.

For its commercial activities, Orfagen will implement its own marketing resources and sales forces throughout the European Union. Promotion of Orfagen’s products will be mainly directed towards university hospitals and specialised centres. Orfagen can also take advantage of the worldwide commercial structure of Pierre-Fabre, which is represented in more than 100 countries.

Human Resources

Orfagen currently employs staff covering activities in clinical drug development, regulatory affairs and administration. The marketing and commercial structures will be implemented in the near future.

Achievements

Four projects in Orfagen's portfolio have already reached their clinical development phase. The company owns five orphan drug designations granted by the European Agency for Medicinal Products (EMEA), and two designations by the US Food and Drug Administration (FDA). Acquisition of value is also built on exclusive licensing rights in some projects.

Fields of Interest

• Dermatology
• Rare disorders
• Dermatological diseases with unresolved medical needs
• Innovative therapies and projects
• Biotechnologies

Source: Orfagen

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Pierre Fabre Labège I — Company Profile

Centre de Développement Pierre Fabre (CDPF) Rue Jean Rostand BP 687 31319 Labège-Innopole Cedex France Tel.: +33 (0)5 62 24 27 00 Fax: +33 (0)5 61 39 96 50 Website: http://www.pierre-fabre.com/

Invent a new galenic, ensure the development of new actives, validate pre-clinical and clinical drug dossiers.

Brands
Pierre Fabre Medicament

Sector of activity
Research & Development

Branch of activity
Pharmacy


Source: Pierre Fabre

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Pierre Fabre Gaillac — Company Profile

Plantes & Industrie ZA des Clergous 16, rue Jean Rostand 81603 Gaillac Cedex France Tel.: +33 (0)5 63 81 24 00 Fax: +33 (0)5 63 57 32 07 Website: http://www.pierre-fabre.com/ Website: http://www.plantes-industrie.com/

Plant extracts, pure actives, neutraceutics. Actives produced through hemisynthesis or total synthesis. FDA approval.

Brands
Pierre Fabre Medicament

Sector of activity
Research & Development

Branch of activity
Pharmacy

Personnel
329 persons


Source: Pierre Fabre

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LibraGen — Company Profile

LibraGen Bâtiment Canal Biotech 1 3, rue des Satellites 31400 Toulouse France Tel.: +33 (0)5 62 19 32 90 Fax: +33 (0)5 61 73 27 56 E-mail: contact@libragen.com Website: http://www.libragen.com/

Building on bacterial diversity, we discover, develop and improve innovative bioprocesses for the industrial production of healthcare molecules.

Corporate Overview

Summary
LibraGen uses innovative and proprietary functional genomic technologies in combination with industrial expertises to develop new bioprocesses for the discovery of novel bioactives and the improvement of production processes of added value molecules.
Libragen's competitive edge is embodied by its ability to turn the huge genetic and chemical diversity of the 99% of bacteria that can not be cultured under conventional conditions into an accessible reservoir of biomolecules. These biomolecules are an unlimited bioresource for the development of active pharmaceuticals, agrochemicals and food ingredients as well as intermediates and bulk chemicals. Mastering the whole process from the discovery to the industrialisation, LibraGen reinforces its client's competitiveness and market share.

Mission
LibraGen aims at becoming a leader in the discovery and development of bacterial diversity-deriver processes for the industrial production of molecules that concerns the red (healthcare) as well as the white (industry) sectors of modern biotechnology. LibraGen masters the whole process, from lab-based discovery to industrialization. To maximise the industrial application of the research and development activity, LibraGen includes the industrial constraints of the used of bioprocesses for large scale production at early stage in the definition of the research strategy. The company intends to rapidly meet the needs of businesses due to increasing pressure on production costs and therefore the needs for innovation. LibraGen considers that this is a major business opportunity one which is likely to generate significant added value.

LibraGen main features
LibraGen's resources cover all aspects of biocatalysis, namely new biocatalyst discovery by taking advantage of its metagenomic technology as well as selection of accessible enzymes and cultivable microbes, molecular evolution, substrate choice and supply or substrate synthesis using classical chemistry, target or bioassay oriented screening of biomolecules, biotransformation medium engineering, product recovery, purification, characterisation and identification.
LibraGen starts with functionnal genomics (genes and biosynthetic pathways) by taking advantage of its metagenomic platform to end at the establishment of the optimised production protocols with the production of sample amounts. LibraGen combines in-house projects and fully integrated projects within the framework of contract research and development agreements (full services and out-sourcing), R&D partnership and alliances. In house projects, in collaboration with wellknown european academic partners, allow all the company to build up continuously its resources and to keep abreast of the latest technological advances in molecular biology, chemistry as well as in the biocatalysis and fermentation fields. With a strong know-how in molecular biology, fermentation, biotransformation reactions, extraction and purification of biomolecules, its commitment to custom-made, cost-effective and confidential collaborations, LibraGen carries out tailor-made multitechnology R&D projects in a reliable manner as far as the technical and management aspects are concerned.

• Incorporated in February 2001 and located in Toulouse (France).
• Highly skilled scientific and managerial employers.
• 500 sq. m of equiped lab with the state-of-the art techniques in Microbiology, Molecular Biology and Chemistry.
• Strategic combination of expertises optimized with an important European academic network.
• Bioprocessing pilot plant available in an integrated capabilities, From discovery to Kilolab technology platform.
• Exclusive technologies.

Facilities
New Active Molecules and Biocatalysts discovery from untapped bacterial diversity.

• Molecular High Through-put Screening.
• Primary screening for the discovery of anti-infectious and anti-tumoral compounds.
• Molecular Evolution.

Chemistry unit for natural product purification and characterisation and organic synthesis

• Up/Down stream processes improvement (optimization in fermentation and biocatalysis)
• Scale-up transfer to the industrial partner.

Source: LibraGen

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IDD-Tech — Company Profile

IDD-Tech International Drug Development Technopole 27, chemin des Peupliers BP 66 69572 Dardilly Cedex France Tel.: +33 (0)4 72 17 27 11 Fax: +33 (0)4 78 35 76 48 E-mail: lyonoffice@idd-tech.com Website: http://www.idd-sa.com/tech/en/

IDD-Tech is a research and development technical centre for healthcare products and the cosmetics industry.

At the heart of the healthcare industry

The IDD-Tech site in Dardilly, 10km outside Lyon, is strategically located within easy reach of the region’s international airports and dense rail and road networks, and is surrounded by other outstanding scientific centres working in the healthcare industry. This exceptional business setting led to the area being granted the government’s prestigious "competitive cluster" status in July 2005.

International expertise

Until 2005, the Dardilly plant was one of Schering Plough’s leading research and development sites. Supported by its highly professional workforce and state-of-the-art equipment, IDD-Tech is a player on an international scale working to the highest regulatory standards (FDA – EMEA – Japan).

A global approach to development

IDD-Tech can offer its clients step-by-step management of the whole development process, from preformulation through to the manufacture and release of pilot batches of all pharmaceutical forms (solid, liquid, sterile) and biotechnology products (lyophilisates), all on one site.

IDD-Tech is a pharmaceutical plant and is qualified to manufacture and release clinical trial batches.

The IDD-Tech site in Dardilly

Analytical Development

Formulation Development

Quality Control

Cold Generator System

Purified Water System

Steam Generator

Source: IDD-Tech

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LemnaGene — Company Profile

LemnaGene Espace Florentin 71, chemin du Moulin Carron 69570 Dardilly France Website: http://www.lemnagene.com/

LemnaGene SA, offers a new era in Biomanufacturing.

Created in October 2003, LemnaGene^TM is since July 2005 a fully owned subsidiary of Biolex Therapeutics.

LemnaGene^TM has obtained an ANVAR Grant from the French Research Ministry in 2003.

LemnaGene^TM is based in Lyon, France, the 8th largest economic region in Europe with a high density in Life Science activities.

LemnaGene^TM has signed a Research & Development Agreement with Bayer CropScience, BioScience, to investigate the expression of aprotinin in lemna.

In addition, LemnaGene^TM has secured several agreements with other Industrial Partners in the pharma and human/animal vaccine areas.

Lemna

Lemna is a unique PMP (Plant Made Protein) Platform meeting industrial requirements as well as safety concern. Lemna is a recent option that offers its own advantages compared to other plant species. Belonging to Lemnaceae, Duckweed is a group of small, free-floating, fresh water plants, used as feed and food, mostly in Asian countries. It is also used in North America for waste-water management.

Main Advantages of Lemna for the production of recombinant proteins:

Due to its easy clonal propagation on water containing salts using light and CO₂, Lemna is a choice organism for the production of recombinant proteins. The Weizmann Institute, team of Meir Edelman and Avi Perl have designed unique conditions for the insertion of genes and the growth of Lemna to obtain high protein production.
Lemnaceae thus offer numerous advantages compared to other technologies used for biomanufacturing such as:

• Security and safety, for both the environment (all steps including the production, are done under confined conditions) and for human and animal since there is no risk of viral contamination;
• High productivity due to its rapid growth (doubling time is about two days) and a high protein content (45% of dry weight);
• Flexibility since production can be done during all year around and also production capacity can easily be adapted to the needs;
• Speed from access to the gene to the commercialisation;
• Low costs due to low capital investment and running costs.

Products

LemnaGene^TM is using its technology to produce several types of active ingredients dedicated to different market areas:

• Recombinant proteins for the pharmaceutical and veterinary industry;
• Recombinant vaccines for humans and animals;
• Feed additives such as enzymes or probiotics;
• Enzymes and monoclonal antibodies for diagnostics and laboratory reagents.

The active ingredient produced can be delivered in different formats:

Pure: The active ingredient can be purified and used as drugs or vaccines;

Dry: Lemna can be dried and sold as a powder in the form of capsules or tablets; It can also be sprayed on feed for animals during the formulation process of the feed;

Fresh: Non-transgenic Lemna has been already sold as salads for human consumption and is widely used as animal feed in developing countries.


Source: LemnaGene

Editor's note: LemnaGene does not exist anymore.

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DSM and LibraGen sign agreement to co-develop transaminases for production of chiral amines

Parsippany, USA; Vienna, AUS; Toulouse, FR 16 September 2008 — DSM and LibraGen, a bacterial diversity-based process and discovery specialist, announced today that they have signed an agreement to co-develop new omega-transaminases for production of chiral amines. Under the terms of the partnership, LibraGen will use its proprietary enzyme discovery and development to identify new enzymes for efficient conversion of a large spectrum of ketons into optically pure R- and S-amines, a compound class highly relevant for fine chemicals and pharmaceuticals industries.

DSM will produce the enzymes at industrial scale using DSM’s fermentation capabilities and proprietary expression platform, PluGbug^TM. LibraGen will sell the enzymes in kit form and both parties will use them for screening activities and the development of biocatalytic processes for third parties.

"This collaboration with LibraGen grows the number of available large-scale biocatalysts and will contribute to increasing competitiveness of the transaminase technology for production of chiral amines" said Oliver May, Competence Manager Biocatalysis at DSM Pharmaceutical Products. "In addition, by combining LibraGen’s enzyme discovery and DSM’s manufacturing capabilities the development timelines from enzyme discovery and screening to final product delivery to our customers will be significantly reduced" said Ronald Gebhard, R&D Director at DSM Pharmaceutical Products.

"We are delighted that we have signed this partnership with DSM," said Renaud Nalin, CEO of LibraGen. "It marks another step forward in the development of LibraGen’s industrial biocatalysis capabilities. Customers of DSM and LibraGen will be able to use these new enzymes on a laboratory or industrial production scale to produce intermediates and APIs, thus making our response to market demands even more effective."

LibraGen expects this alliance to bring the company additional openings to provide its services to the fine chemicals, pharmaceutical and cosmetics customers, and to develop and optimize enzymatic synthesis processes for complex molecules.

Financial details of the collaboration were not disclosed.


About LibraGen

LibraGen, Toulouse, France, specializes in the development of innovative bioprocesses for molecule synthesis using biocatalysis for fine chemicals, cosmetics and pharmaceutical industries. One of LibraGen’s key assets is its ability to look for high performance enzymes in bacteria populations that have not previously been explored and convert them into production tools. By combining the skills needed to go from R&D to pilot production, LibraGen is fulfilling a market need by giving its customers high performance and competitive synthesis solutions. Since the company was set up in 2001, LibraGen’s reactivity and innovation has resulted in its becoming the exclusive producer of active enzymes for a number of third parties. More information: www.libragen.com.

About DSM Pharmaceutical Products

DSM Pharmaceutical Products is a global provider of high quality custom contract manufacturing and development services to the pharmaceutical and biopharmaceutical industries. DSM contract manufacturing services include: chemical development, registered intermediates, registered starting materials, active pharmaceutical ingredients (API's), fermentation, mammalian cell production of monoclonal antibodies and proteins, formulation development, clinical trial manufacturing and finished dose form manufacturing of solids, semi-solids, and scheduled drugs, aseptic liquid and lyophilized products. More information: www.dsmpharmaceuticals.com.

DSM — the Life Sciences and Materials Sciences Company

Royal DSM N.V. creates innovative products and services in Life Sciences and Materials Sciences that contribute to the quality of life. DSM’s products and services are used globally in a wide range of markets and applications, supporting a healthier, more sustainable and more enjoyable way of life. End markets include human and animal nutrition and health, personal care, pharmaceuticals, automotive, coatings and paint, electrics and electronics, life protection and housing. DSM has annual sales of almost EUR 8.8 billion and employs some 23,000 people worldwide. The company is headquartered in the Netherlands, with locations on five continents. DSM is listed on Euronext Amsterdam. More information: www.dsm.com.

Forward-looking statements
Any forward-looking statements contained in this press release that involve inherent risks and uncertainties are based on current expectations, estimates and projections of the management of DSM and information currently available. The statements involve certain risks and uncertainties that are difficult to predict and therefore DSM does not guarantee that its expectations will be realized. Furthermore, DSM has no obligation to update any statements contained in this press release.


Source: LibraGen

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Transgene's therapeutics vaccine TG4010: promising additional clinical data in non small cell lung cancer Phase IIb trial

Strasbourg, France, September 15th, 2008 — Transgene (Euronext Paris: FR0005175080) today announced further positive clinical results relating to its therapeutic vaccine TG4010 (MVA-MUC1-IL2) as an adjunct to first line chemotherapy for the treatment of patients with advanced non-small cell lung cancer (NSCLC). These results, which come from the controlled phase IIb study involving 148 patients randomized in two arms of treatment, were presented Saturday, September 13th at the 2008 annual meeting of ESMO (European Society of Medical Oncology) held in Stockholm.

The promising clinical data presented on June 2nd 2008, during the ASCO meeting are fully confirmed. After 17 months of median follow up, we can now report that long term survival is greater for those patients who received TG4010 in combination with first line (gemcitabine plus cisplatin) chemotherapy (experimental arm) than for those patients who received the chemotherapy alone (control arm). In the experimental arm, 39% of the patients are still alive today, compared to 23% of the patients in the control arm.

Furthermore, a quality of life analysis performed during the clinical study with the tool FACT-L (a survey based on patient filled questionnaires), showed no significant difference between the study arms. This provides further evidence that TG4010 can be combined to the standard first-line chemotherapy of advanced stage NSCLC patients without further altering their quality of life.

Recent data also confirms the very encouraging earlier results of Transgene’s biomarker program, associated with the study of TG4010. The study had already demonstrated in June 2008, at 13 months of median follow up, that patients who had a normal blood level of activated Natural Killer cells ("NK" cells, a group of cytotoxic lymphocytes) at baseline had a substantially longer median survival in the experimental arm than in the control arm. This sub-population represents 101 out of the 138 patients who could be evaluated for immunological analysis.

Indeed, for these patients, the most recent analysis shows an increase of 6.7 months of median survival for patients treated with TG4010 and chemotherapy (18 months) versus patients treated with chemotherapy alone (11.3 months). Moreover, all other classical metrics for efficacy demonstrate a significant benefit for patients in the experimental arm versus the control arm, as summarized in the following table:

Patient population with a normal blood level of activated NK cells at baseline	TG4010 + Chemotherapy (n=48)	Chemotherapy alone (n=53)	p-value and Hazard ratio
Six-month PFS	58%	38%	p=0.04
Median Time to Progression	6.4 months	4.4 months	p=0.005 HR: 0.57 [95CI:0.38-0.85]
Response Rate	56%	26%	p=0.007
Overall Survival	18 months	11.3 months	p=0.02 HR: 0.55 [95CI:0.33-0.92]

"We are delighted by the additional clinical data announced today, which once again validates our technological platform of immunotherapeutic products and our past investment in TG4010. In highlighting the biomarker findings, we wish to demonstrate the critical importance of associating translational research to the clinical development of innovative products," said Philippe Archinard, Chief Executive Officer of Transgene. "Overall, these results are extremely promising. We will still be gathering further results over the coming months whilst already preparing the next development steps toward registration of TG4010 for advanced NSCLC. In parallel Transgene is seeking a collaborative partnership that will ensure the product’s future clinical development for this indication, as well as for other indications and settings".


About the phase IIb Trial

The phase IIb trial is a randomized, open label and controlled study designed to assess the efficacy of TG4010 in combination with cisplatin and gemcitabine compared to the chemotherapy regimen alone. The trial completed the enrolment of 148 patients at the end of May 2007 and was conducted in 27 centres located in France, Poland, Germany, and Hungary. The patients had NSCLC of all histology types including squamous cell carcinoma expressing MUC1, either stage IIIB with effusion (8%) or stage IV (92%), and had not received prior systemic treatment for their advanced disease. Half of the patients were randomized to receive the combination regimen of TG4010 vaccine plus chemotherapy (experimental arm). The other half of the patients received chemotherapy alone (control arm). The statistical primary endpoint was to observe at least 40% of patients free of progression six months after randomization in the experimental arm. Secondary endpoints were response rate, time to progression, overall survival, safety, immunological responses, proteomics, transcriptomics and genomics.

The ASCO and ESMO posters, together with previous communication on TG4010, are available on Transgene’s website (www.transgene.fr).

About TG4010 cancer vaccine

TG4010 (MVA-MUC1-IL2) uses the Modified Vaccinia Ankara virus vector, a poxvirus that combines distinguishing advantages for an optimized systemic vaccination:

• MVA is a highly attenuated strain which has been tested extensively in humans as a smallpox vaccine and is known to strongly stimulate innate and adaptive immune responses to antigens.
• MUC1 is a major tumor-associated antigen that provides a viable target for vaccination.
• TG4010 expresses the entire MUC1 gene sequence and has the potential to generate an immune response to all antigenic epitopes of MUC1.
• The sequence coding for the cytokine Interleukin 2 (IL2) is included to help stimulate specific T-cell response.

About Transgene

Transgene is a France-based biopharmaceutical company dedicated to the development of therapeutic vaccines and immunotherapeutic products in oncology and infectious diseases. The company has three compounds in Phase II trials (TG4001/R3484, TG4010 and TG1042) and one compound in Phase I studies (TG4040). Transgene has concluded a strategic partnership agreement with Roche for the development of its TG4001/R3484 therapeutic vaccine to treat HPV-mediated diseases. Transgene has bio-manufacturing capacities for viral-based vectors and technologies available for out-licensing. Additional information about Transgene is available on the Internet at www.transgene.fr.

Cautionary note regarding forward-looking statements

This press release contains forward-looking statements referring to the planned development and clinical testing of one of Transgene’s therapeutic vaccine candidates. However, successful product development and clinical testing depend on a variety of factors, including the timing and success of future patient enrolment and the risk of unanticipated adverse patient reactions. Results from future studies with more data may show less favourable outcomes than prior studies, and there is no certainty that product candidates will ever demonstrate adequate therapeutic efficacy or achieve regulatory approval or commercial use For further information on the risks and uncertainties involved in the testing of Transgene’s product candidates, and in connection generally with the development of its products, see Transgene’s Document de référence on file with the French Autorité des marchés financiers on its website at http://www.amf-france.org and Transgene’s website at http://www.transgene.fr.


Source: Transgène

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NeoMPS S.A. — Company Profile

NeoMPS SA 7, rue de Boulogne 67100 Strasbourg France Tel.: +33 (0)3 88 79 08 79 Fax: +33 (0)3 88 79 18 56 Email: neo@neomps.com Website: http://www.neomps.com/

NeoMPS provides a full spectrum of products and services in the field of custom peptide synthesis for research and development, amino acids, peptide building blocks and custom organic synthesis, as well as GMP manufacturing.

Since its creation in 1986, NeoMPS SA has been in perpetual evolution, consistently adapting operations to meet the always expanding needs of its customers.

NeoMPS SA has supplied over 35.000 different products in milligram to gram quantities to the scientific community, acquiring a great deal of expertise in the manufacture of unusual amino acids, peptides and peptide derivatives.

In 1998, our GMP production facility became fully functional enabling us to supply hundreds of grams to kilogram quantities of Active Pharmaceutical Ingredients (APIs) to biopharmaceutical companies around the world.

From the beginning, our goal at NeoMPS SA is to provide a full spectrum of technologies of products and services. We offer custom peptide synthesis for research and development, amino acids, peptide building blocks, custom organic synthesis and GMP manufacturing.

Nearly one thousand regular customers worlwide trust our company and can attest to our reliability. This is the result of good technology placed in well-qualified hands enhanced by the dedication our people bring to their work.

Now with two facilities on two different continents: NeoMPS, Inc. in California, USA, and NeoMPS SA in France are united to serve you with separate geographical distributions and complementary capabilities.



Source: NeoMPS

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Polyplus-transfection S.A. — Company Profile

Polyplus-transfection SA BIOPARC Boulevard Sébastien Brant BP 90018 67400 Illkirch France Tel.: +33 (0)3 90 40 61 80 Fax : +33 (0)3 90 40 61 81 Website: http://www.polyplus-transfection.com/

Polyplus-transfection is a research-focused biotechnology company developing and marketing innovative solutions for transfection and therapies based on nucleic acid delivery.

Transfection allows the introduction of nucleic acids, such as a gene or small interfering RNA (siRNA), into cells using chemical compounds. The technique is widely used in experimental research and in protein production.

Introducing a gene into a cell nucleus triggers the expression of the corresponding protein. Conversely, transferring siRNA will block the production of a protein. Inappropriate gene expression is the root cause of numerous diseases. As a result, the ability to control those genes through gene therapy or RNA interference opens up new therapeutic approaches where efficient intra-cellular drug transfer is key to success.

Using its know-how in nucleic acid delivery, the R&D department at Polyplus-transfection is focused on the development of innovative synthetic compounds designed to take account of the latest advances in the transfer of biomolecules, especially the in vivo delivery of small interfering RNA. Polyplus-transfection is one of the technology leaders in the transfection market.

Polyplus-transfection has established a number of R&D partnerships with biotechnology companies involved in therapeutics. It also plays an active role in European research networks such as GIANT (Gene therapy, and 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, ZNA (Zip Nucleic Acid), for molecular biology and diagnostics.


Source: Polyplus-transfection

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