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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Polyplus-transfection obtains an AFM grant for the development of its gene/drug delivery tool for clinical applications

Strasbourg, France, May 14, 2007 — Polyplus-transfection, a company specialized in research, development and marketing of innovative reagents for drug delivery, gene therapy and transfection, announces today that it has obtained a EUR 80,000 grant from AFM (Association Française contre les Myopathies), France’s Muscular Dystrophy Association. The grant will finance the cGMP (current good manufacturing practices) compliant production process of its in vivo-jetPEITM reagent, thus enabling its use in gene therapy.

Polyplus-transfection believes this upgrade to the cGMP production process will accelerate the use of in vivo-jetPEI^TM in gene therapy clinical trials in humans. The funding also covers the development of new quality control procedures as well as stability studies.

In vivo-jetPEI^TM is a synthetic molecule, polyethylenimine (PEI). PEI is a cationic linear polymer recognized as being the most effective reagent on the market for in vivo delivery of nucleic acids. With in vivo-jetPEI^TM, Polyplus-transfection offers clinicians an alternative technology for gene therapy to the commonly used viral approach using deactivated viruses. In vivo-jetPEI^TM is easy to use and does not trigger an immune response, a huge advantage compared to viruses which are very immunogenic and do not allow repeated use.

"Today Polyplus-transfection offers the only solution on the market to deliver genetic material using a synthetic molecule instead of a virus," said Joëlle Bloch, CEO of Polyplus-transfection. "With the help of the AFM funding for the development of a cGMP production process, in vivo-jetPEI^TM will be available to customers for use in clinical trials. This new gene/drug delivery tool represents a new hope for patients."

"At Polyplus-transfection we believe that this new process will accelerate our growth as well as demonstrate our expertise in the field of gene delivery, offering a serious alterative to viral approaches and emphasize the strength of our reagents for in vivo assays."


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 the delivery of gene candidates in clinical trials.

The Strasbourg-based company has a 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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LibraGen launches its first family of active products obtained by enzymatic transformation of natural substances

Biocatalysis technology provides new way to produce active cosmetic, nutritional and therapeutic molecules

Toulouse, France, April 12, 2007 — LibraGen, specialist in the discovery and production of molecules for the healthcare, fine chemicals and cosmetics industry, announces today the availability of its first family of unique active products obtained through a patented enzymatic process.

The launch of this new range marks a significant step forward for LibraGen as an industry player in its own right for the design and production by biocatalysis of innovative high value-added molecules.

Using its proprietary technology platform, LibraGen has designed an exclusive enzymatic production process to allow the use of naturally derived active molecules which have hitherto proved difficult to exploit because of their physical and chemical properties. This first family of original products is aimed at the cosmetic manufacturers, pharmaceutical industry, and those in the nutrition sector.

This LibraGen's process transforms the raw materials into water-soluble active molecules. These are chemically more stable and have an improved biological availability thus opening up new opportunities to use the compounds for therapeutic, dermo-cosmetic and nutritional applications. This first series of compounds covers a wide and diverse range of biological structures and activities belonging to the polyphenols family.

"The market availability of this first collection of pioneering products is the result of LibraGen’s know-how in the development of new enzymatic reactions and the implementation of biocatalytic production processes," said Renaud Nalin, CEO at LibraGen. "This new range gives a glimpse of the potential we have with our technology and production capabilities as they are all applicable to other active ingredients. Some of our biosynthesized products have already been marketed on a large scale by our customers, and other dedicated product ranges are being produced for marketing in the future by major players in the field of natural products.


About LibraGen

LibraGen, Toulouse, France, specializes in the development of bioprocesses for the production of healthcare molecules and the discovery of new chemical scaffolds with cross-industry applications. By focusing on untapped biodiversity, the company has developed a platform of proven proprietary technologies to identify, validate and produce high added-value enzymes and molecules for industrial, pharmaceutical, chemical, cosmetic and environmental applications. The overall combination of LibraGen’s scientific and production know-how, technology platform and research results has already achieved a number of successful partnerships in research and production in the fields of cosmetics, pharmaceuticals and fine chemistry. In parallel with these partnerships with leading pharma companies, LibraGen’s internal research is building up a pipeline of new active molecules with anti-infectious and anti-cancer applications. For more information, visit www.libragen.com


Source: LibraGen

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Newcomer Minakem is banking on opportunities in the market for contract APIs

The first tentative claims of a possible rebound in the business of contract-manufacturing active pharmaceutical ingredients (APIs) were only starting to be heard last year when Minakem made its move. The company, established expressly to enter the business by its chief executive officer, Frédéric Gauchet, and other investors, acquired the SEAC contract manufacturing assets of NuPharm in Beuvry-la-Forêt, France, for $29 million.

This summer, Minakem made a second investment, buying Chemtec Leuna at the former East German Leuna Works. The business was purchased for an undisclosed sum from Schenectady International, yet another diversified chemical company opting to slough off a small, noncore contract manufacturing operation.

Small is a good thing, Gauchet says, but service orientation is even more important. Gauchet says the trick to succeeding in this business is to concentrate on supporting clients' efforts in developing and commercializing new drugs without attempting to garner intellectual property. And Gauchet believes Minakem can succeed.

"I know it's not the general opinion, but for a small business I think there are growth opportunities," Gauchet says. With annual sales of $69 million, Minakem is preparing to take on what Gauchet sees as the kind of cradle-to-grave manufacturing package that both large and small drug companies most want to outsource.

According to Gauchet, drug companies are focusing on optimizing internal resources at a time when pipelines are filling up. Most firms have several projects at various stages, and the chemistry is becoming increasingly sophisticated, he says. "Our business model is to take care of the overflow of needs that our customers have when they get involved in several molecules," Gauchet says. "They need us. But what we have to do is perform a service that is at least at the same level as the ones they have internally."

This means taking a life-cycle project management approach. Minakem is not, like some firms in the sector these days, shifting its focus to early-stage synthesis, Gauchet says. "We are not a lab company—we don't do grams for money," he says. "When we work on a project, we do it with the idea that there will be an industrial process at the end of the job."

Yet, Michael Staff, president of Minakem LLC, the company's North American marketing subsidiary in Saddle Brook, N.J., says this approach requires the company to have expertise ranging from gram production to commercial scale-up. "It is our objective to fill reactors," he says, "and to do this, we need the nursery of projects at the early stage."

Staff emphasizes the importance of relationship building at the early stage of drug intermediate or API synthesis. "The sample does not leave our site until we have a process that's ready to be implanted into our pilot plant," he says. "Once the customer gets a sample, it's a commitment from us to move it forward."

This approach may take longer than producing lab-scale samples without regard for the larger scale chemistry needed for clinical trial production and beyond, but it's worth the extra time for Minakem, Staff says. The idea is for existing customers to see a fit for Minakem's life-cycle development approach when they embark on new projects.

Gauchet says drug companies are quite amenable to the idea of contract manufacturing firms taking this long view. "The customer is spending $1 million a day when it gets to clinical trials," he says. Putting off process development could lead to changes in purity profiles when clinical trials start, which delays Food & Drug Administration filing.

Gauchet estimates that 80% of Minakem's business is with major pharmaceutical companies, down from nearly 100% at SEAC when Minakem bought the plant. "Because we are very active in the American market, emerging pharma and biotech are taking a larger percentage," he says.

This shift has intensified the need to cater chemistry precisely to customer needs. Large drug companies only contract a small part of their business to firms such as Minakem, but emerging companies and biopharmaceutical start-ups with one or two projects in development are making a much larger commitment. "When you help them," Gauchet says, "you have to make sure you really can do the chemistry."

Gauchet says Minakem is constantly recruiting Ph.D. chemists. "We have become very diversified and have remained up-to-date in our chemical capacities," he says. "And we have a catalog business, which is exactly what we need in order to show our technical capacity to our customers. Especially the new customers." Minakem lists phosgene, epichlorohydrin, and strained small-ring chemistry such as cyclopropyl and cyclobutyl among its chemical specialties.

Minakem saw a need to beef up its large-scale production capabilities early this year, Gauchet says. With the former SEAC plant geared more toward prelaunch custom synthesis, the company needed to add capacity to manufacture building blocks and facilitate replicable commercial-scale production. Gauchet says Chemtec Leuna seemed like an ideal opportunity, given its seven large-scale production lines (three with FDA current Good Manufacturing Practice certification); its fixed-bed hydrogenation reactors; and its capacity for handling difficult chemistry such as phosgene, ammonia, chlorine, and phosphorus pentachloride.

Gauchet also liked Chemtech Leuna's location and its chemistry. "They do a lot of protective agents, especially for amino acids," he says. "It's one of the tools you need to master custom synthesis."

But even with the Chemtec Leuna acquisition, Minakem needs to further scale-up its operations, Gauchet says. The company is currently investing about 10% of sales in expanding its pilot plants in France and Germany. It is also expanding its R&D capabilities at Beuvry-la-Forêt and its commercial-scale production at Leuna.

Gauchet is gauging the need for yet more capacity from the growth in business it has experienced over the past year. "I can't say it's the market coming back, because we are a small player," he says. "But we had significant developments in 2005 and 2006."

Peter Pollak, an independent industry analyst, agrees. "I would not conclude from Minakem's experience that Europe is on a buying spree in regard to fine chemicals," Pollak says. He adds, however, that the Chemtec Leuna purchase can be viewed as a reasonable bet on Minakem's part. "Chemtec Leuna is a large Eastern European producer, probably with a lot of intelligent people," he says. "Minakem has carved out for itself a part of the fine chemicals market that is in pretty good shape."

Gauchet acknowledges the risk of doing business in contract fine chemicals, especially in Europe, given the crowded field of competitors zeroing in on the pharma pipeline. But he says his focus is not on the competition. "We don't pay attention to what our competitors are doing in order to see what we should do," Gauchet says. "We listen to our customers to see that we have everything in place to meet their expectations."

Rick Mullin

Chemical & Engineering News
ISSN 0009-2347
Copyright © 2006 American Chemical Society


Source: Minakem

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LibraGen and Sanofi-Aventis sign research partnership to identify new candidate molecules for treatment of infectious diseases and cancer

Pharmaceutical group will use LibraGen’s innovative technology in field of non-cultivable microorganisms Toulouse, France, October 25, 2006 — LibraGen, a bacterial diversity-based process and discovery specialist, announces today it has signed a partnership agreement with sanofi-aventis covering the use of LibraGen’s know-how in microbial biodiversity. The goal of this collaboration is the discovery of new chemical structures derived from non-cultivable microorganisms.

The global partnership is split into two phases, the first of which is a pilot. If successful, this may give rise to a long term collaboration between LibraGen and sanofi-aventis. The two companies did not disclose the financial terms of the agreement which are based on milestones fees and royalties.

Initially, LibraGen will transfer to sanofi-aventis laboratory-extracted samples of existing non-cultivable microorganisms. Sanofi-aventis will add these to its chemical library and thus access new unique compounds, produced under a reproducible process using LibraGen technology. Depending on their biological activity, these compounds may be selected either for optimization of their chemical structure via synthesis so as to enhance their properties, or for direct pharmaceutical development.

"We finalized this partnership after a lengthy due-diligence procedure by sanofi-aventis to check out LibraGen’s know-how and the quality of our technology," said Renaud Nalin, CEO of LibraGen. "This contract strengthens LibraGen’s position on the market and provides recognition of our know-how in identifying new active molecules and in producing high value-added molecules."

"LibraGen’s technology allows us to build up our supply strategy for natural substances by giving us access to sources of new molecules that have been hitherto inaccessible," said Jean-Pierre Maffrand, director of discovery research at sanofi-aventis. "These molecules could well be essential for our research programs for new medicines."

A successful pilot phase will trigger a long term collaboration in which LibraGen will supply a large number of active extracts that have been qualified on antiinfectious or antiproliferative targets.

Sanofi-aventis will have the right to acquire and/or develop any of these molecules in return for the payment of milestones and royalties to LibraGen. The pharmaceutical group also holds exclusivity on part of the collection of original active extracts from LibraGen.


About LibraGen

LibraGen, Toulouse, France, specializes in the development of bioprocesses for the production of healthcare molecules and the discovery of new chemical scaffolds with cross-industry applications. By focusing on untapped biodiversity, the company has developed a platform of proven proprietary technologies to identify, validate and produce high added-value enzymes and molecules for industrial, pharmaceutical, chemical, cosmetic and environmental applications. The overall combination of LibraGen’s scientific and production know-how, technology platform and research results has already achieved a number of successful partnerships in research and production in the fields of cosmetics, pharmaceuticals and fine chemistry. In parallel with these partnerships with leading pharma companies, LibraGen’s internal research is building up a pipeline of new active molecules with anti-infectious and anti-cancer applications. For more information, visit www.libragen.com.

About sanofi-aventis

Sanofi-aventis is the world’s third largest pharmaceutical company, ranking number one in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine, and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
For more information, visit www.sanofi-aventis.com.


Source: LibraGen

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LibraGen extends partnership with Yves ROCHER in the biocatalityc production of dermocosmetic compounds

LibraGen moves into skin care, uses know-how in compound synthesis via biocatalysis to boost production of an active plant ingredient at Yves Rocher Toulouse, France, 6 July 2006 — LibraGen, a bacterial diversity-based process and discovery specialist, announces today it has extended its partnership with Yves Rocher into a new area. The new area involves the optimization of production bioprocesses using enzymes in the presence of natural solvents and the delivery of the first batches of this active ingredient.

The agreement follows the successful conclusion of the first project carried out for Yves Rocher which involved the optimization of the biocatalytic synthesis of the same active plant ingredient. LibraGen’s first collaboration with Yves Rocher resulted in a significant improvement in the space of a few months in the enzymatic synthesis reaction of an active plant ingredient, giving a 50-fold increase in concentration. The plant-based product using this biological procedure for which Yves Rocher holds the patent is expected to be highly effective and able to be directly incorporated in Yves Rocher’s skin care products. The new process that LibraGen has now delivered moves the collaboration forward to allow mass production of the bioactivated natural plant molecule.

"Our successful partnership shows once again LibraGen’s ability to set up innovative synthesis processes very fast, as well as our know-how in applied biocatalysis in research, development and industrial use," said Renaud Nalin, CEO of LibraGen. "The fact that Yves Rocher is extending its collaboration and doing new research with us shows the industrial potential of this new bioconversion process for the plant compound."

"This partnership is in line with Yves Rocher’s strategy of continuous innovation in the development of new natural products on the plant cosmetics market so as better to respond to its clients’ expectations in our future cosmetic ranges," said Claude Fromageot, Scientific Director at Yves Rocher. "LibraGen will now use its know-how to use biological conversion to produce the active plant ingredient in an ecological manner which respects the environment."


About LibraGen

LibraGen, Toulouse, France, specializes in the development of bioprocesses for the production of healthcare molecules and the discovery of new chemical scaffolds with cross-industry applications. By focusing on untapped biodiversity, the company has developed a platform of proven proprietary technologies to identify, validate and produce high added-value enzymes and molecules for industrial, pharmaceutical, chemical, cosmetic and environmental applications. The overall combination of LibraGen’s scientific and production know-how, technology platform and research results has already achieved a number of successful partnerships in research and production in the fields of cosmetics, pharmaceuticals and fine chemistry. In parallel with these partnerships with leading pharma companies, LibraGen’s internal research is building up a pipeline of new active molecules with anti-infectious and anti-cancer applications.
For more information, visit www.libragen.com.

About Yves-Rocher Laboratories

Yves Rocher’s 150 scientists work daily to explore how plant-based substances can contribute to skin care. These scientists bring a multitude of disciplines to bear on the challenge. The team includes botanists, biologists, phytochemists, histologists, pharmacists and dermatologists, all of whom work together in an environment where creativity and scientific curiosity are encouraged. They work with other scientists at international level, present and publish their work regularly, and form partnerships with many research labs and innovative companies.

Forty years’ know-how, innovation and results mean that Yves Rocher is number one brand worldwide for plant-based cosmetics. With more than 50 families of patent filed and 30 million customers in 90 countries, Yves Rocher is also the leading brand of beauty salons in France. The Plant Biology Laboratories of Yves Rocher are committed to bring together plant resources, scientific advances and respect for nature.

Yves Rocher in figures: 298 million products sold worldwide, 30 million customers, 1,500 beauty centers, EUR 1.2 billion sales in 2005.

For more information: www.yves-rocher.com.


Source: LibraGen

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