French Biotechs

BIOSYNEX Immunodiagnostic has acquired 100% stake of DIMA Gesellschaft fuer Diagnostika mbH

2012-01-25T16:03:00.000-08:00

January 5th, 2012 - The company BIOSYNEX Immunodiagnostic, based in France, has acquired 100% stake of DIMA Gesellschaft fuer Diagnostika mbH.

Biosynex is a French diagnostic company located in Strasbourg, one of the European capital cities at the crossroads of France and Germany. Our Research and Development laboratory and our state of the art manufacturing facility are continuously dedicated to meet news needs of the medical sector... DIMA's Press Release -

BioAlliance Pharma : New Achievements in the Collaboration with Its Strategic European Partner, Therabel

2012-01-18T15:58:00.000-08:00

January 04, 2012 - BioAlliance Pharma SA (Paris:BIO)(Euronext Paris - BIO), a company dedicated to specialty and orphan oncology products, today announces the achievement of the reserved capital increase and the payment of the €1 million milestone, as provided in the commercialization agreement signed with the Therabel Group for Loramyc® in Europe.

Therabel has actually subscribed for the maximum amount authorized by the General Assembly Meeting of June 29, 2011, i.e. 680.000 new shares, with a 15% premium over the last 20 business days preceding the operation (€3.65 per share).

Moreover, Therabel has finalized end of December 2011 the discussions with the Italian health authorities (Agenzia Italiana del Farmaco) regarding the price and the reimbursement for Loramyc®; publication in the Italian official journal should occur shortly. In this context, BioAlliance will receive from its partner an additional payment indexed on futures sales of Loramyc® in Italy up to a maximum amount of €500.000.

BioAlliance has received more than €11 million (royalties excluded) of which €3.5 million in 2011 since the signature of its partnership agreement with Therabel. An additional €1 million payment is planned end of 2012... BioAlliance Pharma's Press Release - Communiqués de Presse BioAlliance Pharma -

Hemarina : ANR selects HEMO2Perf® project

2012-01-11T15:07:00.000-08:00

Morlaix, Brittany, Novembre 7th, 2011 - The French National Research Agency is to fund the HEMO2Perf® project, demonstrating once again the scientific and therapeutic interest in the oxygen carriers that Hemarina develops. This funding will pave the way to the clinical use of the Hemo2Life® solution for preserving kidney grafts —

Hemarina, a French biotechnology firm specialized in the research and development of marine-derived oxygen carriers for therapeutic, industrial and research applications, announced that the French National Research Agency (ANR) selected the HEMO2Perf® project under the call for proposals for the ‘Biomedical Innovation through public-private Research Partnership (RPIB)’ program. The HEMO2Perf® project teams up Hemarina, the INSERM U927 research unit “Ischemia-reperfusion in kidney transplantation” at the Poitiers University Hospital, and the Health, Life, and Agricultural Sciences Infrastructures (IBiSA) facility ‘Surgery, Experimentation, Transplantation’ in Surgères.

“The HEMO2Perf® project involves the preclinical evaluation of HEMO2Life® for the storage of kidney transplants in preservation solutions and machine perfusion systems,” explained Professor Thierry Hauet from the INSERM U927 research unit and scientific officer of the IBiSA ‘Surgery, Experimentation, Transplantation’ facility in Surgères. “The first proof of concept has already been obtained for HEMO2Life® in cold static storage. These results were published in September 2011 in The American Journal of Transplantation and show that presevation solutions supplemented with HEMO2Life® lead to better preservation and faster recovery of kidney function after transplantation (« Supplementation with a new therapeutic oxygen carrier reduces chronic fibrosis and organ dysfunction in kidney static preservation ». R Thuillier et al. American Journal of Transplantation 2011; 11(9): 1845-1860). Machine perfusion can oxygenate the kidney during organ storage. Adding an oxygen carrier such as HEMO2Life® to a machine perfusion system may also enhance the preservation of ‘borderline’ kidney grafts in perfusion machines. This is what we seek to test during the HEMO2Perf® project.”... Hemarina's Press Release - Communiqué de presse Hemarina -

Company Overview

Hemarina SA is a privately held biotechnology company centered on the research and development of marine oxygen carriers for therapeutic and industrial applications.

Dr. Franck Zal founded Hemarina in March 2007. He is a world-renowned expert in the field of invertebrate hemoglobin and oxygen transport and has spent more than fourteen years in academic research centers (CNRS, University of California at Santa Barbara USA and University of Antwerp, Belgium) studying the relationships between the structure and function of invertebrate respiratory pigments (extracellular hemoglobin in annelids and hemocyanin in crustaceans). The discoveries arising from his research on extracellular hemoglobin in marine invertebrates and their oxygen-transport system have been patented and published in numerous scientific journals and form the crux of Hemarina’s technology

Hemarina offers products that constitute a decisive technological breakthrough in regard to current or past developments of hemoglobin-based oxygen carriers (HBOCs). Hemarina’s lead product, Hemarina M-101, is the only product under development that uses a natural, high-molecular-weight extracellular hemoglobin whose activity is totally independent of any cofactor. Furthermore, Hemarina M-101 functions in a wide range of temperatures (from 4°C to 37°C). Another major advantage of Hemarina M-101 is that it has no vasoconstrictor effect, which is frequently observed in first-generation HBOCs and responsible for significant side effects, particularly high blood pressure.

Hemarina positions itself as a R&D company focused on oxygen carrier molecules that have therapeutic and industrial applications. Our products have high-value market applications for which there are no true competitors — only potential partners. Therefore our business model revolves around finding win-win partnerships with life sciences or pharmaceutical companies who wish to incorporate Hemarina's technology in their medical devices or drug development process... Hemarina's Company Overview - L'entreprise Hemarina -

Eyebrain Tracker : to be used in clinical trial for Parkinson’s therapy

2012-01-04T16:58:00.000-08:00

December xx, 2011 - EyeBrain’s eye-tracking device will be used to evaluate the effects of levodopa on patients’ motricity -

EyeBrain, a company developing medical devices for the early diagnosis of neurological diseases, announces that its EyeBrain Tracker device is being used in a clinical trial exploring the dyskinesia induced by treating patients suffering from idiopathic Parkinson’s disease with levodopa.

The endpoint of the trial is to find biomarkers for the late-onset complications of a treatment regime using levodopa (BIODYS). This compound, which is naturally transformed into dopamine in the brain, is one of the only drugs available for slowing the effects of Parkinson’s disease. However, over time, it induces dyskinesia in these patients, which takes the form of abnormal movements primarily affecting the face (tongue, lips, jaw) and extending as far as the arms and legs.

Altogether, 30 people will be enrolled on the trial. Half of them will be Parkinson’s sufferers who have been treated with levodopa and have developed dyskinesia, while the other half will consist of healthy subjects who will be used as a control group...

[...]

...About EyeBrain

EyeBrain manufactures medical devices for the early diagnosis of neurological diseases. These devices are based on the movement of the eyes, and they make it possible to test specific regions of the brain by recording and analyzing eye movements using very sophisticated algorithms developed by the company. EyeBrain’s devices fill a gap in neurological diagnostics. For the first time, clinicians can rely on a simple set of eye movement parameters to differentiate between very similar syndromes, such as progressive supra-nuclear paralysis (PSP) and cortico-basal degeneration (CBD). The test is easy to carry out, non-invasive, and the results are available in less than 20 minutes for a small cost... [PDF] EyeBrain's Press Release - PDF du communiqué de presse de EyeBrain -

GTP Technology : Call for 40 Beta-Testers interested in blind testing a new CHO technology for recombinant MAb and more

2011-12-08T05:44:00.001-08:00

November 2011 - Call for 40 Beta-Testers interested in blind testing a new CHO technology for recombinant MAb and more.

From Nov 15, 2011 until Feb 15, 2012

Whether you are a scientist with a particular interest in innovative expression systems or looking for a competitive system to express your protein of interest, we hope you will be interested in our “experimental” approach.

As a beta-tester, you will have the chance to :

Evaluate with us, what we believe is a very innovative and promising technology for production in superior eukaryotic systems.
If you volunteer to beta test the technology with us, you will enjoy a one-shot production of your MAb at a very competitive price and, even better: have access to the compilation of all our beta test results (protein and participant names will of course remain confidential). Provided we have enough candidates, the results comparing expression yields, process duration should be statistically meaningful!... GTP Technology' Press Release -

About GTP Technology

Founded in 2000, GTP Technology has over 10 years experience addressing recombinant protein expression challenges.

Our comprehensive range of custom services, allow us to increase the research productivity of biopharmaceutical firms, diagnostic companies and academic laboratories involved in identifying and producing target proteins, therapeutic proteins, vaccines, disease biomarkers and reagent proteins.

We offer unparalleled capacity in producing batch sizes of recombinant protein suitable for research purposes, for pre-clinical and pre-industrial development, and for use in commercialised diagnostic kits... About GTP Technology - A propos de About GTP Technology -

FIRALIS : co-Authors SAFE-T review paper

2011-11-23T11:19:00.001-08:00

July 2011 - FIRALIS co-authors a foundation review paper :
Qualification of Drug Induced Organ Injury Biomarkers -

Firalis SAS, with several of its members, co-authored a paper outlining a generic qualification strategy for drug induced organ injury biomarkers. The paper was published in the peer reviewed journal Drug Discovery Today (Vol. 16 No 13&14/24) “A generic operational strategy to qualify translational safety biomarkers”. These safety biomarkers are intended to accelerate drug development by providing to the pharmaceutical industry tools to assess the effect of drug candidates on the liver, the kidneys and the vasculature. This strategy, established by the team of experts collaborating within the SAFET consortium, outlines a method to generate sufficient preclinical and clinical evidence for the qualification of translational safety biomarkers.

The SAFE-T consortium is a large public/private consortium funded by the European Commission Innovative Medicines Initiative (IMI). Firalis, the initiator of the public consortium, is playing a central role in this project by participating in the design of the scientific strategy, the execution of clinical studies, the development of biomarker assays and the analysis of biomarker data.

“Firalis’ position among this team of international experts testifies its expertise in biomarker qualification and highlights its place as a leading actor in this highly competitive and dynamic field.” commented Dr. Béatrice Molac, director of regulatory affairs at Firalis.

With this publication, the SAFE-T consortium targets a larger scientific community and expects to trigger a valuable exchange with key opinion leaders and other stakeholders on the proposed strategy...

[...]

...About FIRALIS SAS

Firalis is a privately owned life sciences biotechnology company, creating novel values via biomarker discovery, development and regulatory qualification; to establish an internal portfolio of biomarker-based diagnostic methods and provide customer-tailored biomarker solutions. Firalis is active in the field of cardiovascular, inflammatory and autoimmune diseases... FIRALIS' Press Release -

BioAlliance Pharma : Grant of « orphan designation » for clonidine Lauriad™ in Europe

2011-11-10T15:20:00.001-08:00

November 02, 2011 - BioAlliance Pharma SA (Euronext Paris - BIO) , a company dedicated to specialty and orphan oncology products, announced that clonidine Lauriad™ has been granted orphan designation by the European Commission in the prevention of radiotherapy-induced oral mucositis in patients with head and neck cancer.

Oral mucositis is a very frequent inflammation of the oral mucosa in head and neck cancer patients treated with radio- and chemotherapy (98,000 new patients estimated per year in Europe). Severe oral mucositis occurs in 60% of these patients and may induce intense oral pain and eating disability requiring artificial nutritional support. In 20 to 30% of cases, patients have to be hospitalized and the disease may result in a modification or a stop of the radiotherapy treatment in more than 10% of them. Radiotherapy-induced oral mucositis has currently no preventive cure.

In Europe, the orphan designation is granted for medicinal products in diseases affecting less than 5/10,000 patients. This status permits to benefit from incentives related to the clinical development, thus enabling a faster registration, and an extra protection with a 10- year commercial exclusivity after market authorization...

[...]

...About BioAlliance Pharma

Dedicated to cancer and supportive care treatment with a focus on resistance targeting and orphan products –– BioAlliance conceives and develops innovative products, for specialty markets especially in the hospital setting and for orphan or rare diseases.

Created in 1997 and introduced to the Euronext Paris market in 2005, BioAlliance Pharma’s ambition is to become a leading player in these fields by coupling innovation to patient needs. The company’s teams have the key competencies required to identify, develop and register drugs in Europe and the USA; the products’ commercialization rights are licensed to international commercial partners invested in the hospital setting. In areas where medical needs are insufficiently met, its targeted approaches help overcome drug resistance and improve patient health & quality of life... BioAlliance Pharma's Press Releases - Communiqués de Presse de BioAlliance Pharma -

Genticel has completed recruitment of patients for its Phase I trial with ProCervix

2011-11-03T15:02:00.000-07:00

Toulouse, France, October 19th 2011 - Genticel has completed recruitment of patients for its Phase I trial with ProCervix, its therapeutic vaccine against human papillomavirus (HPV) types 16 and 18 -

Genticel announces that it has completed the recruitment of all patients participating in its phase one clinical trial with a liquid formulation of ProCervix, its candidate therapeutic HPV vaccine designed for adult women already infected with human papillomavirus (HPV) genotype 16 or 18.

The trial takes place at the Centre for the Evaluation of Vaccinations in the Vaccine & Infectious Disease Institute of the University of Antwerp, under the direction of professor Pierre Van Damme. The key objectives are to evaluate the safety and immunogenicity of ProCervix.

In addition, Belgium’s Federal Agency for Medicines and Health Products (FAMHP) has recently also approved Genticel’s request to extend the phase I trial to confirm the safety of a lyophilized formulation of ProCervix.

“We are delighted with the advancement of this important phase I trial that should provide valuable information with regards to safety, local tolerance and immunogenicity,” said Dr Benedikt Timmerman, CEO of Genticel. “Now we have approval for the evaluation of our new lyophilized formulation, Genticel expects to have completed its full Phase I Program in the first half of 2012 and move on to Phase II before the end of the year.”

About ProCervix

This investigational vaccine, called ProCervix, uses the Adenylate Cyclase (CyaA), a protein vector delivering the E7 antigens from HPV16 and HPV18. The CyaA vector directly targets professional antigen presenting cells (APC). Through its unique delivery mode, CyaA allows the antigen to induce strong CD4+ and CD8+ T cell responses. ProCervix is the first HPV vaccine to leverage the CyaA’s mode of action... [PDF] Genticel's Press Release -

Areva Med acquires Macrocyclics

2011-10-20T23:45:00.000-07:00

October 20, 2011 - AREVA announced that its nuclear medicine subsidiary, AREVA Med, has acquired Macrocyclics, Inc.

AREVA Med has developed innovative methods for producing lead-212 (212Pb), a rare radioactive isotope at the heart of promising research projects in nuclear medicine to develop new treatments against cancer.

Macrocyclics, based in Dallas, Texas, is the world leader in the production of chelators, chemical agents that allow for the attachment of antibodies or proteins with radioactive isotopes for the development of powerful nuclear medical treat-ments targeted against aggressive types of cancer.

“This strategic acquisition allows us to be in a unique position in the global marketplace. As a result, we can now offer new technology for attaching our isotope to antibodies targeting cancerous cells,” said Patrick Bourdet, President and CEO of AREVA Med. “The experience and the outstanding know-how of the Macrocyclics team, together with that of AREVA Med, will allow us to target more diseases and accelerate the development of radioimmunotherapy treatments using AREVA’s lead-212,” added Bourdet.

“The acquisition of our company by AREVA Med comes at an ideal time when the therapeutic power of lead-212 has been proven. By bringing our expertise with chelators to the unique competencies of AREVA Med, we will develop new powerful and targeted treatments for patients. With AREVA Med’s support, we will be able to offer an even broader range of services to our clients,” added Garry Kiefer, CEO of Macrocyclics.

In January 2011, the U.S. Food & Drug Administration (FDA) gave AREVA Med authorization to begin clinical trials for a new medicine using lead-212 to combat particularly aggressive types of cancer.

The development of new treatments in nuclear medicine is limited by the avail-ability of isotopes. AREVA is building a new facility, the Maurice Tubiana Laboratory, to produce large-scale quantities of medical-grade lead-212 in the Limousin region of France... AREVA's Press Release - communiqué de presse AREVA -

Exonhit : Research Agreement With Pfizer to Identify Alzheimer’s Disease Biomarkers

2011-10-18T15:41:00.000-07:00

October 10, 2011 - Exonhit (Paris:ALEHT) announced that it has entered into a research agreement with Pfizer Inc. for the identification of new Alzheimer’s disease (AD) biomarkers using Exonhit’s Genome-Wide SpliceArray™ (GWSA) platform.

As part of the agreement, the two companies will jointly conduct a pilot study using Exonhit’s GWSA platform to gain insight on AD molecular markers associated with clinical parameters. More specifically, the purpose of the research work is to seek to identify progression and other biomarkers that could segregate healthy elderly controls, patients with mild cognitive impairment (MCI) and patients with AD. Test samples for the study will be provided by Pfizer from a number of subjects in each of these three groups over a period of time.

“Today’s announcement further demonstrates the interest in the potential of our GWSA discovery platform,” said Loïc Maurel M.D., President of Exonhit’s Management Board. “We are excited to collaborate with Pfizer and we hope that this study will identify new Alzheimer’s biomarkers and hence lead to the potential development of prognostic tests for patients”...

[...]

...About Exonhit Exonhit (Alternext: ALEHT) is a biotech company, focused on personalized medicine, which develops targeted innovative therapeutic and diagnostic products, in oncology and Alzheimer’s disease. Exonhit has a balanced development strategy with internal development programs and strategic collaborations, in particular with Allergan. Exonhit is headquartered in Paris, France and has a U.S. subsidiary in Gaithersburg, Maryland. The Company is listed on NYSE Alternext in Paris and is part of the NYSE Alternext OSEO innovation index... [PDF] Exonhit's Press Release - PDF du communiqué de presse Exonhit -

TFChem Merges with Canadian-based Sirona Biochem

2011-10-05T14:14:00.000-07:00

March 31, 2011 - TFChem and Canadian-based Sirona Biochem completed their merger on March 31, 2011. An official signing took place in Paris, France. – Sirona Biochem Corp. (TSX-V: SBM) (the “Company”), a biotechnology company specializing in therapeutics for diabetes and obesity, announced that it has completed its acquisition of TFChem S.A.S. An official signing took place in Paris, France.

“Carbohydrate-based molecules have tremendous potential as therapeutics and for other commercial applications, such as cosmetics, and this acquisition of TFChem gives Sirona Biochem the opportunity to earn revenue earlier by expanding into these exciting new commercial markets,” said Sirona Biochem’s President Mark Senner. “We feel the addition of TFChem’s expertise and portfolio leverages our therapeutics program and widely expands our partnering opportunities,” he added.

“TFChem has a strong proprietary chemistry method we feel improves the stability, bioavailability, selectivity and efficacy of carbohydrate-based drugs, which are typically very difficult to stabilize,” said Sirona Biochem’s Vice-President, Research & Development, Dr. Bertrand Plouvier. “TFChem’s award-winning chemistry is showing promise in overcoming these stabilization challenges.”

“We chose to partner with Sirona Biochem because we feel their development expertise and strong business model are a perfect match to successfully maximize the commercial value of our programs,” said Dr. Géraldine Deliencourt-Godefroy, Chief Scientic Officer and founder of TFChem...

[...] ...About TFChem

TFChem is a drug-discovery company using fluorine atom properties to develop new glycomimetic compounds. Based in Val de Reuil, France, TFChem aims at becoming a major developer of carbohydrate-based drugs... TFChem's Press Release - Communiqué de Presse TFChem - Sirona Biochem's Press Release -

Signing of an acquisition of a controlling interest in Novagali Pharma S.A. by Santen Pharmaceutical Co., Ltd.

2011-09-29T14:25:00.000-07:00

Osaka, Japan and Évry, France, September 28, 2011 – Santen Pharmaceutical Co., Ltd. (Osaka, Ticker Code 4536JP) (hereafter “Santen”), a leading Japanese pharmaceutical company, and Novagali Pharma S.A. (hereafter “Novagali”), a French biopharmaceutical company specializing in ophthalmology and focusing on new ocular therapeutics, announce today that Santen, Novagali and certain of its shareholders, including the funds managed by Edmond de Rothschild Investment Partners, Auriga Partners, IdInvest Partners and CDC Innovation, have entered into a share purchase agreement (hereafter “SPA”), whereby Santen shall acquire shares representing 50.55%1 of the share capital of Novagali for a cash consideration of €6.15 per share, representing a premium of 71.3% over the last traded price as of September 27, 2011, which may be increased to €6.25 as described below (the “Block Purchase”). The Block Purchase is not subject to any conditions and is expected to be completed in the next few days. The shares of Novagali Pharma are listed on NYSE Euronext Paris - Compartment C.

Santen intends to promptly purchase all remaining shares of Novagali at the same price per share and will consequently file a mandatory tender offer (offre publique obligatoire) with the French Autorité des marchés financiers (“AMF”) in accordance with article 234-2 et seq. of the general regulations of the AMF (the “Tender Offer”). Santen intends to implement a mandatory squeeze-out of remaining shares of Novagali in the event, Santen would hold, following the Tender Offer, at least 95%of the shares and voting rights of Novagali.

In the event that upon completion of the Tender Offer Santen holds at least 95% of the share capital and voting rights of Novagali, the price per Novagali share to be paid to all Novagali shareholders who sold their shares as part of the Block Purchase or tendered their shares into the Tender Offer shall be increased by an additional €0.10 per share, representing an aggregate price of €6.25 and a premium of 74.1% over the last traded price as of September 27, 2011... [PDF] Santen Pharmaceutical's Press Release - [PDF] Novagali Pharma社の買収（子会社化）について - [PDF] Novagali Pharma's Press Release - PDF du communiqué de presse de Novagali Pharma -

HAC Pharma : New MA for Agrastat in France

2011-09-21T15:17:00.000-07:00

01-03-2011 - New MA for Agrastat in France since January 2011 the 29th, including a High Dose Bolus for patient undergoing PCI (refer to SPC in Products section) ... HAC Pharma's Press Release - communiqué HAC Pharma - Company ..."The management team of H.A.C.Pharma are experienced executives from the bio-pharmaceutical industry and from University Hospitals across Europe. H.A.C.Pharma is focused on acute care or hospital based products and services. Our company specializes in partnering with hospital healthcare professionals. We provide innovative therapeutic treatment solutions through extensive business collaborations with, national and international, biotechnology and pharmaceutical companies looking to reach hospital based physician audiences in Europe."... HAC Pharma's strategy - La politique d'H.A.C. Pharma -

CERMA : spin-off company cermaVEIN

2011-09-14T15:23:00.000-07:00

8/30/2011 - ARCHAMPS, France -- French emerging medical technology company CERMA, specialized in the development of innovative and minimally invasive devices in phlebology and oncology, announced the creation of spin-off CERMAVEIN. CERMAVEIN was launched to expand commercialization of its proprietary Steam Vein Sclerosis (SVS™) technology for endovenous thermal ablation. SVS is the only product on the market to treat all types of varicose veins in a single session: patients need only visit the clinic once; physicians save time on procedurEstablished in 2001, CERMA Inc. is a medical company offering a pipeline of innovative products based on a technology for which CERMA masters the know-how and the intellectual property. This technology, the Targeted Multi Therapy, allows delivering diverse active agents locally in a mini invasive way with a therapeutic multi-approach.es, and capacity at the treatment centre is freed up more rapidly.

“The SVS technology has been proven to be simple to use in clinical practice, because our technology is flexible and our catheter can be easily introduced into all veins, making the procedure easy for physicians to carry out,” comments Dr. Sophie Humbert, CEO of CERMAVEIN. “We have a great opportunity to fill a genuine unmet medical need in many markets and thanks to our technology’s features, the size of our potential market is significantly increased. For example, in the United States 75 percent of patients need multiple treatments that now could be done in one single session using SVS.”... [PDF] CERMA's Press Release -

About CERMA

Founded in 2001, CERMA Inc. is a medical company, 13485 ISO-certified, which designs mini-invasive medical devices in phlebology and oncology, based on its TMT (Targeted Multi Therapy) innovative concept. This exclusive technology is the result of constant investments in R&D leading to a portfolio of international patents. Located in the heart of the science park of Archamps (1st Euro-Swiss Technopole), CERMA benefits from a strategic setting in an international pole including young and innovative companies. 15 minutes away from Geneva and 20 minutes from Annecy, this territorial peculiarity has a real leverage effect on the economical development of companies implanted on this site... about CERMA -

GENFIT GFT505 clinical results Diabetes Care

2011-09-08T14:34:00.000-07:00

Lille, France, and Cambridge, Mass., September 6th, 2011- After critical review by independent experts, the results of the GFT505-209-3 and GFT505-209-4 studies are published in « Diabetes Care », an official international scientific journal of the ADA (American Diabetes Association). – GENFIT (Alternext: ALGFT; ISIN: FR0004163111), a biopharmaceutical company at the forefront of drug discovery and development, focused on the early diagnosis and preventive treatment of cardiometabolic and associated disorders, announced the publication in « Diabetes Care » of a scientific article presenting the results of the GFT505-210-3 and GFT505-210-4 clinical trials.

The article reports the beneficial effects of GFT505 on glucose and lipid metabolism, inflammation, and liver function in patients with abdominal obesity, mixed dyslipidemia, and/or pre-diabetes. After critical review and approval by independent experts, the manuscript is published under the title ‘Effects of the new dual PPARα/δ agonist GFT505 on lipid and glucose homeostasis in abdominally obese patients with combined dyslipidemia or impaired glucose metabolism » (B. Cariou, Y. Zair, B. Staels, and E. Bruckert, Diabetes Care, 34: 2008-2014) in the category « Emerging Treatments and Technologies’...

[...]

...About GENFIT:

GENFIT is a biopharmaceutical company focused on the Discovery and Development of drug candidates in therapeutic fields linked to cardiometabolic disorders (prediabetes/diabetes, atherosclerosis, dyslipidemia, inflammatory diseases…). GENFIT uses a multi-pronged approach based on early diagnosis, preventive solutions, and therapeutic treatments and advances therapeutic research programs, either independently or in partnership with leading pharmaceutical companies (SANOFI, SERVIER, …), to address these major public health concerns and their unmet medical needs. GENFIT’s research programs have resulted in the creation of a rich and diversified pipeline of drug candidates at different stages of development, including GENFIT’s lead proprietary compound, GFT505, that is currently in Phase II... [PDF] GENFIT's Press Release - PDF du communiqué de presse GENFIT -

MedinCell Invites Data Review for Long-Acting, Controlled-Release Schizophrenia Treatments

2011-08-31T15:42:00.000-07:00

MONTPELLIER, FRANCE and SAN DIEGO, CA - Aug 9, 2011 – MedinCell, developer of the MedinGel™ biodegradable drug release platform, is pleased to invite potential pharmaceutical development partners to review data from their RisperMed pilot program. “Schizophrenia is a tragic and severe condition with challenging dose and compliance issues. We’ve designed the RisperMed program to address clinical needs that are unmet by today’s oral and injectable Risperidone products,” said Dr. Stephane Lucchini, MedinCell’s Business Development Manager. “RisperMed, if approved, will be the first once-quarterly, subcutaneous antipsychotic product available for the long-acting injectable antipsychotic market. Additionally, by using subcutaneous delivery to minimize administration discomfort, we believe RisperMed will improve treatment adherence — which has been estimated to cost the US over $1.4 billion per year,” Lucchini concluded. Potential partners may request access to the RisperMed Data Room through MedinCell’s web portal, and will have until September 23, 2011 (4:00 pm EDT) to gauge the effectiveness of the MedinGel formulations and propose licensing terms. The repository includes an analysis of the schizophrenia treatment market space, in vitro and in vivo pharmacokinetic data from candidate Risperidone formulations, and histopathology comments regarding injection safety in animal models. MedinCell will also show release profile and cost of goods comparisons with the only existing long-acting injectable risperidone product, Risperdal® Consta®*, which achieved global sales of $1.5 billion in 2010... [...] ...About MedinCell Using proprietary polymer technology, MedinCell designs controlled-release formulations that form a biodegradable, biocompatible matrix after administration. This patent-pending MedinGel™ technology limits the initial release of drug molecules to reduce off-target effects and extend release duration. This also allows Medincell’s formulations to use substantially reduced API amounts in sustained release formulations... MedinCell's Press Release -

Bertin Pharma opens its Pharmaceutical Establishment

2011-08-23T14:50:00.000-07:00

01-07-2011: Bertin Pharma opens its Pharmaceutical Establishment -

...This new platform of 2 000 m2, renovated and labelled Good Manufacturing Process, offers you a large range of expertise and equipments giving you access to all the formulations including highly potent drugs.

Bertin Pharma is a one of the major European actors as Contract Research Organisation for pharmaceutical industry... Bertin Pharma's news -

About Bertin Pharma

Bertin Pharma is a global R&D solution provider offering R&D outsourcing services along with bioreagent tools, in the fields of pharmacy, biotechnologies, cosmetics and nutrition for both industries and academic research.

Bertin Pharma, subsidiary of Bertin Technologies , results from the merging of 4 complementary French companies (SPI-Bio, Biotec Centre, Ellipse Pharmaceuticals & IDPS) to bring... About Bertin Pharma -

SPAULDING CLINICAL AND EUROFINS OPTIMED CLINICAL RESEARCH : NEW JOINT PARTNERSHIP FOR GLOBAL CLINICAL STUDIES

2011-08-10T15:00:00.000-07:00

August 8, 2011 – Eurofins Optimed Clinical Research, an experienced European clinical research service provider and Spaulding Clinical Research, LLC., US-based, leading-edge Clinical Pharmacology, Cardiac Core Lab, and Medical Device Manufacturer, announce a joint partnership agreement. This partnership leverages the strengths of both companies and facilitates collaboration on integrated clinical services to engage pharmaceutical clients who demand a global footprint.

Both companies disclosed that a primary driver of this relationship was finding a high-quality partner that would meet their standards for study conduct and participant safety, with metrics to back up their claims. “The culture of excellence and research facilities designed to execute high-quality studies was very impressive to our team. We felt immediately comfortable with the Optimed clinical team and witnessed their efficient execution of studies”, states Daniel Selness, General Manager and Senior Vice President of Operations. “We were very impressed that Spaulding achieved ISO certification, which is not common among US clinical research facilities. Their innovative systems approach with Electronic Data Capture is something that we have been looking to implement, so the partnership will allow us to consider how to collaborate more closely as these systems are put in place”, states Yves Donazzolo, MD, CEO and President of Optimed...

[...]

...Eurofins Optimed (www.optimed.fr), founded in 1990, is located in France and provides services in clinical research, from phase I to phase II-IV clinical trials and surveys. Eurofins Optimed operates 100 beds in two clinical pharmacology units, in Grenoble and Lyon. Studies in healthy volunteers or ambulatory patients are conducted in the units while patient trials are set up and performed in various European centers. As a member of the Eurofins Group, the company offers a complete and customized range of services in drug development, in an international environment... Spaulding Clinical Research's Press Release -

MEDICREA'S GRANVIA®-C: Launch of a Pre-Ide Pilot Trial With a View to Initiating the Approval Process in the United States

2011-08-03T14:17:00.000-07:00

June 30, 2011 - LYON, France -

Worldwide (outside of USA): Marketing schedule reaffirmed and launch in 6 new countries over the second half of the year

The MEDICREA Group (FR0004178572-ALMED) (Paris:ALMED), listed on Alternext by NYSE Euronext Paris, a medical device company specialized in the development of innovative surgical technologies for the treatment of spinal pathologies, reaffirmed its ambitious marketing schedule for GRANVIA®-C, its next-generation cervical disc prosthesis, and also announced the launch of a pre-IDE pilot trial with a view to initiating the approval process in the United States.

GRANVIA®-C: a patented technological feat.

A flagship product of MEDICREA’s Research & Development laboratories, GRANVIA®-C is the first cervical disc prosthesis that allows “natural” physiological movement and extreme longevity, thus providing patients with very similar functionalities to those of healthy cervical discs.
In terms of biomechanics, cervical mobility is offered by 6 degrees of freedom, through differentiated centers of rotation and a patented mobile core with an integrated shock absorber system. In terms of material, the prosthesis’ high-tech ceramic design allows both a reduction in friction and optimal wear and fatigue resistance, giving the prosthesis a very long lifespan. Furthermore, using ceramic also ensures that it is perfectly MRI1 compatible, unlike the cervical prostheses currently on the market, whose metallic components result in MRI artifacts incompatible with visualizing the spinal cord, discs and soft tissue around the zone concerned.

Matching MEDICREA’s development philosophy of “innovating for next-generation vertebral implantology”, the GRANVIA®-C prosthesis is supplied with a disposable sterilized inserter. This has a number of advantages: it is easy to insert so saves significant time, and therefore enhances patient wellbeing and lowers hospital costs. Furthermore, this also minimizes the risk of infection and optimizes traceability, resulting in an unparalleled improvement in safety conditions...

[...]

...About MEDICREA :

MEDICREA specializes in the design, development, manufacture and distribution of orthopedic implants dedicated to spinal surgery.
In a $9 billion market, MEDICREA is a very dynamic small to medium-sized business of 100 employees with unique innovation capabilities. The Company enjoys an excellent and ever-improving reputation and develops unique relationships with the most visionary and creative spine surgeons in France, the UK, and the USA. Products developed and patented by MEDICREA provide neurosurgeons and orthopedic surgeons specialized in the spine with new and less-invasive surgical solutions that are faster and easier to implement than traditional techniques. The Group’s headquarters are based in Lyon, France, and it also has a manufacturing facility located in La Rochelle as well as three distribution subsidiaries in the USA, the UK and France... MEDICREA's Press Releases - Communiqués de presse de MEDICREA -

Innovative Health Diagnostics : Results of Its IHD-Amy Blood Tests for Alzheimer’s Disease

2011-07-26T14:37:00.000-07:00

July 18, 2011 - PARIS & STRASBOURG, France - Best results obtained to date for a blood test for Alzheimer’s disease with 83% sensitivity and 82% specificity;

Results presented to ICAD (International Conference on Alzheimer’s disease) in Paris on 17th and 18th July

Innovative Health Diagnostics (IHD), the innovative company specialising in the development of diagnostic blood tests for Alzheimer’s disease and neurodegenerative illnesses presents its first clinical results for its IHD-Amy blood test for Alzheimer’s disease.

With the IHD-Amy test, IHD is making it possible to have a diagnostic test based on a peripheral biochemical marker, which is therefore straightforward and economic to carry out, making it one of the most promising ways forward in the research into the diagnosis of Alzheimer’s disease. In addition to this, the fact that this kind of test is carried out at an early stage means that treatment can be followed through far more efficiently, and also means that patient hospitalisation can be delayed. On a longer term basis, this kind of test could be a useful diagnostic tool and a crucial element of the establishment of a proactive public health policy initiative.

The development of these tests is made possible by recent advances in medical knowledge and the discovery of fluorescent probes that can detect proteins that are specific to the disease. Just one drop of blood – 100 to 200 micro litres – is enough to carry out an analysis. These blood tests have the advantage of being quick, minimally invasive, and economic to carry out: just like the IHD-Amy test... Innovative Health Diagnostics' Press Release - communiqué de presse d'Innovative Health Diagnostics -

Theralpha : Collaboration and Business Agreement with Flamel Technologies to develop controlled-release formulation of analgesic peptide

2011-07-18T14:08:00.000-07:00

May 9, 2011 - Theralpha Announces Collaboration and Business Agreement with Flamel Technologies to develop controlled-release formulation of analgesic peptide - Theralpha SAS announced that it has entered into a joint development program with Flamel Technologies (NASD: FLML) for a Medusa®-enabled, long-acting formulation of Theralpha’s THA-902. THA902 is a natural peptide that is a potent and highly specific Acid Sensing Ion Channel 3 (ASIC 3) inhibitor. It is effective in inflammatory pain animal models following subcutaneous injection and has a number of possible indications, including post-operative pain, osteoarthritis pain and fibromyalgia. The development agreement has been structured to leverage Theralpha’s pioneering intellectual property regarding Acid Sensing Ion Channels (ASICs) and Flamel’s expertise in creating fully bioactive long-acting formulations of peptides, proteins, and other biologics.
The compound to be developed, THA902 XL, is a Medusa-based controlled-release formulation of THA 902. Flamel Technologies will be responsible for formulation chemistry with the objective to potentially improve tolerability and dosing, by reducing administration frequency, and consequently, allowing better patient compliance. Theralpha will be responsible for pre-clinical testing of THA902 XL pharmacodynamics...

[...]

...About Theralpha

Theralpha SAS is a product development-oriented company, focusing on preclinical and clinical development of new pain therapeutics. Theralpha drug candidates originate from worldwide exclusive licenses from IPMC (Institut de Pharmacologie Moleculaire, CNRS, Sophia Antipolis, France) based on research made by Professor Michel Lazdunski and his team who have pioneered the discovery of peptides found in animal venoms that selectively inhibit Acid Sensing Ion Channels (ASICs) which are directly implicated in pain signal transmission. Theralpha is also developing an analgesic venom derived peptide generated at Protherapeutics, a National University of Singapore (NUS) spin-off, and licensed worldwide to Theralpha.

About Flamel Technologies

Flamel Technologies SA (NASDAQ: FLML) is a leading drug delivery company focused on the goal of developing safer, more efficacious formulations of drugs that adress unmet medical needs. Its product development pipeline includes biological and chemical drugs formulated with the Medusa® and Micropump® proprietary platforms. Several Medusabased products are at various clinical stages of development; Medusa’s lead internal product candidate IFN-α XL (long-acting interferon alpha-2b) is currently the subject of a Phase 2 trial in HCV patients. The Company's has developed FDA- and EMA-approved products and manufacture Micropump-based microparticles. Flamel Technologies has collaborations with a number of leading pharmaceutical and biotechnology companies, including Baxter, GlaxoSmithKline (Coreg CR®, carvedilol phosphate), Merck Serono and Pfizer... [PDF] Theralpha's Press Release -

CALIXAR presented its team, technologies and current developments

2011-07-12T13:56:00.000-07:00

07/06/2011 - CALIXAR in partnership with CREALYS and CNRS presented its team, technologies and current developments during first press conference at its headquarter (Lyon- IBCP)... PDF du communiqué de presse CALIXAR -

About CALIXAR

CALIXAR helps pharmaceutical and biotechnological companies as well as academic life sciences organizations to preserve and resolve the original structure of proteins.

CALIXAR provides a range of services based on innovative technologies for extraction, solubilization, stabilization and crystallization of functional membrane proteins.

We improve the performances of high throughput screening and structure-based drug design approaches, the production of vaccines, biodrugs and biomarkers.

Stryker Announces Definitive Agreement to Acquire Privately-Held Memometal Technologies S.A. for $162 Million

2011-07-05T14:06:00.000-07:00

June 6, 2011- Stryker Corporation (NYSE:SYK) announced a definitive agreement to acquire privately-held Memometal Technologies S.A. (Memometal) in an all cash transaction for $150 million and up to an additional $12 million of milestone payments. France based Memometal develops, manufactures and markets products for extremity indications based on its proprietary methods for preparing and manufacturing a shape memory metal alloy. Memometal is rapidly establishing its differentiated technology in the global extremity device market with a broad range of products for the foot and ankle as well as the hand and wrist market. With sales in 2010 of roughly $30 million, Memometal's differentiated, comprehensive and proprietary product portfolio will allow Stryker to gain broader access into the fast growing extremities market... Stryker's Press Release -

{...]

About Memometal Technologies

MEMOMETAL is a company based in France that designs, manufactures and markets implants consecrated to hand and foot orthopaedic surgery. As specialists in shape memory alloys, we are in total control of manufacturing procedures and thus ensure optimum monitoring of our products to achieve the best results for patient safety.

MEMOMETAL is renowned for its revolutionary products that have been adopted by some of the best world-known surgeons. The company is present in over 80% of the international market with subsidiaries in the USA, Germany and United Kingdom, together with a sales office in Switzerland and worldwide distributors. Our complete range of unique and innovative products , combined with our exceptional quality of service, provide complete satisfaction and contribute to your successful reputation... Memometal Technologies' Mission -

Adocia : positive phase I clinical results on HinsBet®, a fast-acting human insulin

2011-06-28T15:40:00.000-07:00

Lyon-France, March 15, 2011, Adocia, a privately-held biotechnology company specialized in
regenerative medicine and in the treatment of chronic diseases, announced positive
results from its phase I clinical study evaluating the safety and clinical utility of HinsBet®, its fast-acting human insulin product for the treatment of diabetes. This project benefits from FEDER support.
The trial compared the product candidate, HinsBet®, to NovoLog® (Novo Nordisk), a fast-acting insulin analog, and Actrapid® (Novo Nordisk), a regular human insulin. It was a double blind study involving 12 healthy volunteers. The pharmacokinetic and pharmacodynamic profiles were obtained using the glucose clamp technique.
On the primary endpoint of safety, HinsBet® showed identical results to the commercial products tested, giving excellent local tolerance and absence of pain at the site of injection...

[...]

...About Adocia SAS

Adocia (Lyon, France) is a privately held French biotechnology company in specialized regenerative medicine and in the treatment of chronic diseases. Adocia is developing innovative protein formulations based on its proprietary technology, BioChaperone®. These include new formulations of BMPs (bone morphogenic proteins) for bone repair and other indications. Adocia is also engaged in two collaborative programs on the formulation of monoclonal antibodies using its BioChaperone® platform with two biopharma companies, and it has three collaborations with medtech companies... [PDF] Adocia's Press Release -

PathoQuest SAS, raises 2M€ with Kurma BioFund in its first round of financing

2011-06-23T13:32:00.000-07:00

Paris, 2011 the 29th of march - French pathogens discovery biotechnology start–up, PathoQuest SAS, raises 2M€ with Kurma BioFund in its first round of financing -
Founded in September 2010 by Professor Marc Eloit and Luc Boblet (PhD), PathoQuest SAS completed, on March 11th 2011, its first round of financing securing 2 M€ with the Kurma BioFund. A spin-off from the Pasteur Institute and the Ecole Nationale Vétérinaire d’Alfort (ENVA), PathoQuest has developed a proprietary expertise in metagenomics and pathogens identification by “Binning” or “De novo assembling” of high-throughput generated sequences.

By discovering the etiology of major pathologies, in the field of infectious diseases and oncology, PathoQuest is committed to providing valuable new targets for diagnosis and vaccines to majors companies...

[...]

...About PathoQuest

A spin-off from the Pasteur Institute and l’Ecole Nationale Vétérinaire d’Alfort (ENVA), PathoQuest is a biotechnology start-up company dedicated to identifying pathogens by means of High Throughput Sequencing (HTS). PathoQuests’ extensive range of R&D programs in the fields of infectious diseases and oncology - both in-house and in collaboration with academic/industrial partners, permits PathoQuest to discover the etiology of major pathologies. PathoQuest is committed to providing diagnosis and vaccine pharmaceutical companies with valuable new targets. PathoQuest ultimately aims to be a pioneer in HTS-based medical diagnosis.

About Kurma Life Sciences Partners

Kurma Biofund is a venture capital fund managed by Paris based Kurma Life Sciences Partners (KLS Partners). Founded in July 2009, Kurma manages in excess of 135M€. KLS Partners is supported by two long-term investors (Natixis, part of Group BPCE the second largest French bank, and stateowned Caisse des Dépots et Consignations – CDC). Kurma actively invests in all stages of the biotech value chain, from technology transfer through to more established companies... [PDF] PathoQuest's Press Release - PDF du communiqué de presse de Kurma bioFund -