French Biotechs

Juvisé Pharmaceuticals Acquires Multiple Sclerosis Drug PONVORY® (ex-US/Canada)

2024-04-16T07:00:00.000-07:00

PARIS-- March 26, 2024--The French pharmaceutical company, Juvisé Pharmaceuticals, announces the acquisition of global commercial rights (excluding the United States and Canada) to Ponvory® (ponesimod) from Actelion Pharmaceuticals Ltd., a Johnson & Johnson Company (Johnson & Johnson). Ponvory® is indicated for the treatment of adults with active forms of relapsing multiple sclerosis (RMS); it is protected by several patents, the latest of which expires in 2035. To fund this acquisition, the French sovereign fund Bpifrance and Pemberton Asset Management (‘Pemberton’), a leading European private credit manager, have acquired a minority stake in Juvisé Pharmaceuticals. Financial details of these transactions remain undisclosed.

“We are very excited about Ponvory® and its potential to have a very positive impact on the lives of patients with multiple sclerosis” announces Frédéric Mascha, founder and President of Juvisé Pharmaceuticals. “This acquisition is a strategic step for Juvisé as it expands our portfolio with the first patent protected product with strong development potential over the coming years. It is in line with what we have been doing for the past 16 years, which is providing essential medications to patients and specialist doctors. Following our latest partnerships established with Novartis, AstraZeneca and AbbVie, we are proud to establish a new partnership with a major pharmaceutical company and to have two strong partners such as Bpifrance and Pemberton enter our capital to support our future growth.”

The acquisition of Ponvory®: a strategic move in Juvisé Pharmaceuticals' growth strategy

Multiple Sclerosis (MS) is a chronic autoimmune pathology affecting over 2.5 million patients worldwide and enjoys therapeutic innovation.

Ponvory® (ponesimod) is a first-line treatment option in active forms of relapsing multiple sclerosis (RMS), which is the most common form of the disease (approximately 80% of patients), affecting particularly women around the age of 30-years-old. Ponvory® is the first oral Disease Modifying Treatment (DMT) to demonstrate superior efficacy compared to teriflunomide in a large head-to-head Phase III study (OPTIMUM) in adult patients with active RMS. Ponvory® demonstrated a 30.5% reduction in Annualized Relapse Rate (primary endpoint), as well as reduction in MRI activity and fatigue (secondary endpoints). (1)

Juvisé Pharmaceuticals will leverage its expertise in medical affairs, marketing, and distribution to commercialize and develop Ponvory® outside of the United States and Canada, with a focus on Europe, skills that the company has already demonstrated with the successful European relaunch of Pylera® in 2023. Juvisé Pharmaceuticals will work closely with Johnson & Johnson to ensure a seamless transition and continuous availability of Ponvory® for patients. Ponvory® is currently available in 30 countries, with the objective of expanding this scope. Finally, Juvisé Pharmaceuticals will assume the worldwide manufacturing duties for Ponvory® from sites based in France and Switzerland... Juvisé Pharmaceuticals' Press Release [PDF] -

1. Kappos L, Fox RJ, Burcklen M, Freedman MS, Havrdová EK, Hennessy B, Hohlfeld R, Lublin F, Montalban X, Pozzilli C, Scherz T, D'Ambrosio D, Linscheid P, Vaclavkova A, Pirozek-Lawniczek M, Kracker H, Sprenger T. Ponesimod Compared With Teriflunomide in Patients With Relapsing Multiple Sclerosis in the Active-Comparator Phase 3 OPTIMUM Study: A Randomized Clinical Trial. JAMA Neurol. 2021 May 1;78(5):558-567. doi: 10.1001/jamaneurol.2021.0405. PMID: 33779698; PMCID: PMC8008435

Ipsen’s Onivyde® regimen, a potential new standard-of-care first-line therapy in metastatic pancreatic adenocarcinoma, approved by FDA

2024-02-14T02:23:00.000-08:00

Ipsen’s Onivyde® regimen, a potential new standard-of-care first-line therapy in metastatic pancreatic adenocarcinoma, approved by FDA

Approval based on Phase III NAPOLI 3 clinical trial in which Onivyde® regimen (NALIRIFOX) demonstrated statistically significant superiority and clinically meaningful improvements in overall survival and progression-free survival versus nab-paclitaxel and gemcitabine
NAPOLI 3 represents the first positive Phase III trial in first-line metastatic pancreatic adenocarcinoma (mPDAC) to demonstrate superior overall survival versus the currently approved regimen of nab-paclitaxel and gemcitabine
Onivyde is the only FDA-approved treatment regimen to demonstrate efficacy in two Phase III trials across lines of therapy in mPDAC

PARIS, FRANCE, 13 February 2024 – Ipsen (Euronext: IPN; ADR: IPSEY) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application for Onivyde® (irinotecan liposome injection) plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) as a first-line treatment in adults living with metastatic pancreatic adenocarcinoma (mPDAC). This is the second approval for an Onivyde regimen in mPDAC, following the FDA’s approval in 2015 of Onivyde plus fluorouracil and leucovorin following disease progression with gemcitabine-based therapy.

“The results from the Phase III NAPOLI 3 trial represent the first positive data for an investigational regimen in first-line metastatic pancreatic adenocarcinoma versus the currently approved nab-paclitaxel and gemcitabine regimen,” said Christelle Huguet, EVP and Head of Research and Development, Ipsen. “With today’s approval, this Onivyde (NALIRIFOX) regimen can now offer a potential new standard-of-care treatment option with proven survival benefits for people living with metastatic pancreatic adenocarcinoma in the U.S.”

Pancreatic adenocarcinoma (PDAC) is the most common type of cancer that forms in the pancreas, with more than 60,000 people diagnosed in the U.S. each year and nearly 500,000 people globally. Since there are no specific symptoms in the early stages, PDAC is often detected late and after the disease has spread to other parts of the body (metastatic or stage IV). Characterized as a complex cancer due to rapid tumor progression, limited genetic targets and multiple resistance mechanisms, mPDAC has a poor prognosis with fewer than 20% of people surviving longer than one year. Overall, pancreatic cancer has the lowest five-year survival rate of all cancer types globally and in the U.S... Ipsen's Press Release -

BariaTek Medical Announces the First-in-Human Implantation of Its BariTon™ Device, a Non-Surgical Gastro-Intestinal Medical Device Aiming to Replicate the Efficacy of Obesity Surgery Without the Invasiveness

2024-02-08T01:03:00.000-08:00

PARIS--February 06, 2024--BariaTek Medical, a privately held medical device company dedicated to the development of minimally invasive endoscopically delivered solutions to treat obesity and diabetes, founded by Truffle Capital, announced it has initiated enrollment of patients in its First-in-human clinical trial in both Australia and Uzbekistan, and has successfully performed its first-in-human implantation.

Obesity is a chronic and debilitating disease affecting more than one billion people worldwide. It bears a tremendous economic burden to healthcare systems surpassing that of cardiovascular diseases and cancer and its prevalence is increasing worldwide. It often leads to diabetes, high blood pressure, heart disease and reduced life expectancy.

Bariatric surgery currently remains the most effective approach to treat obesity and limits the resulting complications, but surgery is poorly perceived, alters anatomy permanently, is costly, and can result in severe adverse events. Obesity pharmaceutical therapies could provide an effective alternative solution for some patients, but they are very expensive and poorly tolerated in many, resulting in their cessation and corresponding regain of the lost weight. Furthermore, they could be associated with multiple under-reported side-effects and off-label prescriptions. As for available minimally invasive endoscopic solutions, they enjoy variable safety but lack efficacy.

BariaTek Medical’s product candidate, the BariTon™, is a soft, atraumatic, reversible implant that is delivered via a simple endoscopy through the mouth within a few minutes and in an outpatient setting. It consists of a gastric part and an intestinal part, thereby having a dual effect: reduced food intake and calorie absorption. The BariTon™ is expected to be the first implant of its kind to potentially mimic the efficacy of sleeve gastrectomy and bypass surgery1 and offer superior safety, ease of use, reversibility, and lower cost... BariaTek Medical’s Press Relase -

Aelis Farma Announces Completion of Patient Randomization for Phase 2b Study with AEF0117 for the Treatment of Cannabis Addiction

2024-01-25T06:30:00.000-08:00

• As planned, 333 patients have been randomized at end of December 2023 across 11 clinical centers in the United States

• This major milestone confirms the announced availability of the first results of the study for the end of the second quarter of 2024

Bordeaux, January 9, 2024 - Aelis Farma (ISIN: FR0014007ZB4 – Ticker: AELIS), a clinical-stage biopharmaceutical company specializing in the development of treatments for brain disorders, announces to have reached a key milestone by successfully completing the recruitment of 333 patients suffering from cannabis addiction in its Phase 2b clinical study with AEF0117.

AEF0117 is the first of a new class of proprietary drugs developed by Aelis Farma, the Signaling Specific inhibitors of the CB1 receptor of the endocannabinoid system (CB1-SSi). The ongoing multicenter Phase 2b study aims to demonstrate the effectiveness of this "first-in-class" compound in treating cannabis addiction, currently defined as CUD (Cannabis Use Disorder) in the DSM-5, the reference diagnostic manual of mental disorders

The recruitment and randomization of the 333 study patients were accomplished across 11 clinical centers in the United States, under the coordination of Pr. Frances Levin from Columbia University (New York). The double-blind, placebo-controlled trial involves the administration of either placebo or one of the three tested doses of AEF0117 (0.1 mg, 0.3 mg, and 1 mg) once daily for 3 months. The primary objective of the study is to assess whether AEF0117 reduces cannabis consumption by demonstrating an increase in the proportion of subjects consuming cannabis ≤1 day per week compared to the placebo. The proportion of patients achieving other levels of reduced consumption, along with the potential improvement in their quality of life, will also be examined as secondary endpoint. Initial results are expected in line with the timeline previously announced for the second quarter of 2024... Aelis Farma's Press Release -

echOpen, a start-up spun off from AP-HP, unveils its ultraportable ultrasound probe to make medical imaging accessible to all caregivers around the world

2024-01-16T08:17:00.000-08:00

The ultrasound probe echOpen O1, connected to the healthcare professional's smartphone, makes it possible to visualize the inside of the body, thus increasing the clinical examination in order to better guide patients, reduce diagnostic doubt and speed up treatment.

Access to medical imaging remains a major issue in the French healthcare system, with only 4% of general practitioners equipped (vs. 60% in Germany). The initial investment remains the main obstacle to the equipment. By making its device accessible with a price that will allow each doctor to equip himself with a personal probe, echOpen wants to massively disseminate this technology to improve the health of populations on a large scale.

echOpen has chosen a strong positioning by creating the first personal ultraportable ultrasound probe that concentrates the essential medical needs for the practice of clinical ultrasound.

From the outset, the AP-HP wanted to support this project, which would provide a large number of clinicians with a new tool to better care for patients. Thus the project echOpen It was incubated in 2015 in the heart of the oldest hospital in Paris, the Hôtel-Dieu AP-HP, close to caregivers and patients. In 2021, once echOpen Having become a start-up in its own right, AP-HP has acquired a stake in the company – a first in the institution's history.

The partnership established by the AP-HP and echOpen testifies to the fruitful relationship that can be established between a university hospital and a start-up: in addition to the permanent dialogue between clinicians and engineers in order to understand the needs and design the probe, this close relationship has also resulted in the realization of two clinical trials conducted within AP-HP hospitals, which have proven the robustness and potential of the probe.

This partnership will continue in 2024, with the deployment of ultrasound probes echOpen O1 in a first series of pilot services of the AP-HP as part of a pre-deployment phase to assess all the impacts.

The AP-HP and echOpen will also jointly carry out the Echo93 project, selected and funded by the Ile-de-France Regional Health Agency, in order to improve the city-hospital care pathway by allowing an initial imaging diagnosis to be made during general clinical examinations in a rapid diagnostic unit in the hospital or in a city practice. This project strongly involves the Jean-Verdier AP-HP hospital and is supported by the @Hôtel-Dieu team... echOpen's Press Release -

Valneva Vaccinates First Participant in Pediatric Trial of Single-Shot Chikungunya Vaccine

2024-01-10T07:15:00.000-08:00

Saint-Herblain (France), January 10, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) announced that the first participant has been vaccinated in the Phase 2 clinical trial evaluating the safety and Immunogenicity in children of two different dose levels of Valneva’s single-shot chikungunya vaccine. The Company reported positive pivotal Phase 3 data in adolescents two months ago confirming the immunogenicity and safety profile observed in adults.

There is currently no approved chikungunya vaccine for children and Valneva’s vaccine IXCHIQ® is currently the only licensed chikungunya vaccine to address this unmet medical need in adults aged 18 years and older who are at increased risk of exposure to the virus. Once available, the Phase 2 pediatric data are intended to support a Phase 3 pivotal study in children with the objective to extend the label in this age group following initial regulatory approvals in adults and possibly in adolescents.

The multicenter, prospective, randomized, observer-blinded, Phase 2 clinical trial is planned to enroll approximately 300 healthy children one to eleven years of age at three trial sites in the Dominican Republic and Honduras. Following a safety run-in phase, participants will be randomized to receive either a full dose formulation of the vaccine (120 participants), a half dose formulation (120 participants) or a control vaccine (60 participants).

Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, “This pediatric trial is extremely important. Given the significant threat that chikungunya poses to individuals living in or traveling to endemic areas, it is crucial to make the vaccine accessible to all age groups. By doing so, we can broaden the protection against and reduce the impact of this debilitating disease.”

Valneva was granted approval from the U.S. Food and Drug Administration (FDA) for its chikungunya vaccine IXCHIQ® in November 2023. Three marketing applications are currently under review by the European Medicines Agency, Health Canada and the Brazilian Health Regulatory Agency (Anvisa) with potential approvals in 2024... Valneva's Press Release - Phase 2 Trial VLA1553-221 (Identifier: NCT06106581) -

TheraVectys announces IND clearance from the US FDA enabling Phase 1 initiation for its therapeutic vaccine candidate Lenti-HPV-07 against oropharyngeal and cervical cancers

2024-01-03T01:43:00.000-08:00

- Targeting to initiate dosing of Phase 1 clinical trial in Q1 2024 to evaluate Lenti-HPV-07 in patients having oropharyngeal or cervical cancers induced by HPV16 or 18.

- The multicenter, open-label Phase 1 trial will evaluate the safety of ascending doses of Lenti-HPV-07 in 36 patients

- Lenti-HPV-07 preclinical profile and clinical development carried out by the PasteurTheraVectys joint laboratory were published in EMBO Molecular Medicine journal on September 7, 2023

On November 27, 2023, TheraVectys a lentiviral vector immunotherapy company focused on developing vaccine candidates to drive the widespread treatment and prevention of cancer and infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has completed its safety review of the Investigational New Drug (IND) application and concluded that TheraVectys’proposed clinical study may proceed to evaluate the oncotherapeutic vaccine Lenti-HPV-07 for the treatment of human papillomavirus (HPV)-induced cancers.

The lentiviral vector-based intramuscular vaccine candidate has already demonstrated 100% preclinical efficacy against HPV-induced cancers. The results of the pre-clinical development work carried out by the Pasteur-TheraVectys joint laboratory were published in EMBO Molecular Medicine journal on September 7, 2023, in an article entitled : "Full eradication of pre-clinical human papilloma virus-induced tumors by a lentiviral vaccine”.

The clinical trial, scheduled to begin in the first quarter of 2024, will be conducted in the U.S. at four cancer centers, including Florida's Moffitt Cancer Institute.

The multicenter, open-label Phase 1 trial will evaluate the safety of ascending doses of LentiHPV-07 and determine its immunogenicity profile. It will include 36 patients with oropharyngeal or cervical cancers induced by HPV16 or 18. Group A will consist of patients with recurrent/metastatic cancers who have received multiple lines of treatment, including immunotherapies, and Group B of patients with newly diagnosed, treatment-naïve, locally advanced cancers. Patients in Group B will receive a single intramuscular injection of Lenti-HPV-07, while those in Group A will receive two intramuscular injections one month apart. They will be monitored clinically and immunologically for one year. [...]

About TheraVectys

TheraVectys, with more than 20 years of research into lentiviral vectors, brings innovative technologies to the fields of immunotherapies and vaccinology... TheraVectys' Press Release [PDF] -

Servier - Oncology: Further success in our collaboration with METHYS Dx

2023-11-16T06:57:00.000-08:00

7 NOVEMBER 2023 - Can liquid biopsy be used to identify tumor markers? Servier has filed a new patent for this very purpose, and the exclusive rights have been entrusted to METHYS Dx, a French start-up with whom we have a long-standing partnership. This breakthrough is particularly targeted to patients with non-small cell lung cancer (NSCLC). Once again, this achievement demonstrates the importance of combining expertise to accelerate research.

A fruitful collaboration in liquid biopsy

METHYS Dx, a French start-up specializing in liquid biopsy, has obtained a patent license for the application of its technology to patients with non-small cell lung adenocarcinoma (NSCLC). This is the start-up’s 4th licensed patent, in addition to the first three for biomarkers targeting pancreatic, endometrial, and gastric cancer.

Did you know?

Non-small cell adenocarcinoma (or cancer) is one of the many forms of lung cancer. Originating in the cells on the outer surface of the lung, it is distinguished from small-cell lung cancer (SCLC) by the way the tumor cells appear under the microscope.

A long-term academic collaboration

In 2016, Servier teamed up with Université Paris Cité to develop a method for identifying biomarkers in lung cancer with liquid biopsy. Spearheaded by researcher Valérie Taly, and later giving rise to METHYS Dx, the work focuses primarily on the diagnosis, prognosis, and therapeutic follow-up of patients using an approach that is less invasive than tissue biopsies... Servier's Press Release -

Guerbet : FDA Approves Lipiodol® (Ethiodized Oil) Injection for Imaging of Tumors in Adults with Known Hepatocellular Carcinoma

2014-04-11T06:19:00.000-07:00

FDA Approves Lipiodol® (Ethiodized Oil) Injection for Imaging of Tumors in Adults with Known Hepatocellular Carcinoma (HCC)

Guerbet LLC, USA (April 10, 2014) Princeton (NJ), Guerbet, a pioneer in the field of contrast agents for medical imaging announced that Lipiodol® was approved by the US Food and Drug Administration pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act indicated for selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC). HCC is the most common primary liver tumor and represents the third-leading cause of cancer-related death in the world, with prevalence in US estimated to affect in the range of 35,000 U.S. patients in 2013.

As previously announced in October 2013, Lipiodol has received an orphan-drug designation for management of patients with known HCC.

"Guerbet is pleased to have been granted approval for use of Lipiodol in patients with known HCC. This product has been supplied during the past three years under a temporary importation program. Guerbet’s efforts to improve the availability of Lipiodol in the USA are in line with our company mission offering reliable and innovative solutions to improve the efficacy of Interventional Radiology procedures”, commented Massimo Carrara, Guerbet US General Manager... [PDF] Guerbet's press Release - PDF Communiqué de Presse Guerbet -

FIRST EUROPEAN PATENT FOR OSE PHARMA FOR ITS TARGETED IMMUNE THERAPY FOR LUNG CANCER

2013-03-11T09:57:00.006-07:00

Paris, France, January 31, 2013 - OSE Pharma SA, dedicated to severe orphan lung diseases announces the allowance of its first patent in Europe related to OSE2101, its targeted cancer immune therapy product in phase 3 for lung cancer - the product OSE2101 developed by OSE Pharma targets 5 tumor antigens with 10 epitopes -an epitope is a small peptide or a fragment of tumor antigen. The patent covers a composition comprising these epitopes. They produce a response of particular cells named T cytotoxic, able to destroy the tumor cells expressing these tumor antigens.

The 5 tumor associated antigens (HER2/neu; P53; CEA; MAGE2; MAGE3) were selected due to the poor prognosis established when overexpressed in particular in lung cancer named Non-Small Cell Lung Cancer (NSCLC) and for the increasing risk when these Tumor antigens are associated.

The lung cancer is the leading cause of cancer death in the world and the Non Small Cell Lung cancers(NSCLC 88% of lung cancer) amounted to 1,41 million new cases each year with a high level of mortality: 1.21 million deaths. The HLA A2 positive patients (HLA A2 is a requirement for the immune T cytotoxic response) are the target population of OSE2101 and are representing 45% of the NSCLC population. This HLA A2 biomarker is a poor prognosis factor associated with an increasing invasive risk. This population of HLA A2 positive patients is the basis of the demand of an orphan drug status filed by OSE Pharma. The need of innovative drug is critically needed due to this aggressive NSCLC disease often discovered at late stage. Despite aggressive treatments, the 5-year relative survival rates are about 24% for patients with regional disease and less than 4% for patients with metastatic disease... OSE Pharma's Press Release -

Provence Technologies and Neuroptis Biotech partner to develop a new compound for treating dry eye syndrome

2012-06-04T10:43:00.003-07:00

Marseille, France, and Paris, France, 21 May, 2012 - Provence Technologies to optimize and transfer the production process for ML7, Neuroptis Biotech’s dry eye drug candidate

Provence Technologies, a service provider of specialist fine chemistry, and Neuroptis Biotech, specializing in the discovery and development of innovative therapies in neurology and ophthalmology, announce today the further strengthening of their collaboration for transferring the chemical development of Neuroptis Biotech’s drug candidate, ML7, and producing the first GMP batches before the end of 2012.

ML7 is a drug candidate for the treatment of dry eye syndromes. It is the first of a new therapeutic class and has the potential to provide a targeted and effective therapeutic remedy for the millions of people suffering from dry eye syndrome, Gougerot-Sjögren syndrome, and inflammations, especially ones caused by allergies. Provence Technologies and Neuroptis Biotech have already collaborated successfully in developing a synthetic pathway for ML7, manufacturing the first non-GMP batches, and devising associated analytical methods. The two companies have embarked on the process optimization phase to facilitate the transfer of the compound and the start of production on an industrial scale, scheduled for September this year... [PDF] Provence Technologies' Press Release - Neuroptis Biotech's Press Release - [PDF] Communiqué de Presse de Provence Technologies -

Vexim Continues Its Development and Sets up in Germany to Directly Market the SpineJack® Range

2012-05-09T14:01:00.000-07:00

TOULOUSE, France - Vexim, a Med-Tech company that specializes in minimally invasive treatment of vertebral fractures (called “minimally invasive anatomical restoration”), announces the creation of its German subsidiary in Ulme (between Stuttgart and Munich). Vexim GmbH will be responsible for promoting and marketing the SpineJack® range in Germany, in addition to training German physicians.

Germany is one of our key markets and we have decided to directly market SpineJack from February 2012 so as to ensure that our rollout and training plan is a success but also to maximize profits on German soil,” declared Vexim’s CEO Vincent Gardès. “The team we are recruiting will allow us to establish and maintain close relations with physicians, a necessary condition to guarantee our lasting presence in Germany.”...[PDF] Vexim's Press Release -

The French company Keosys, signs 10 international contracts within Clinical Research

2012-04-17T10:42:00.000-07:00

March 2012 - The French company Keosys, signs 10 international contracts within Clinical Research - For the past 6 years, Keosys has provided expertise for oncology clinical research trials utilizing innovative solutions in medical imaging and telecommunications. Keosys’ collaboration with the academic institutions is based on the implementation of a standardized, central reading platform for the academic multicentric clinical studies at major french and european institutions. Among these: EORTC (European Organization for Research and Treatment of Cancer), GELARC (Adult Lymphoma Study Group – Clinical Research) which is member of the European Lymphoma institutes, SFMN (French Society of Nuclear Medicine), UNICANCER (French Comprehensive Cancer Centers group), and VUmc (VU University medical center).

Medical imaging harmonization and standardization within clinical studies.

The aim is to standardize medical imaging workflow from the patient image acquisition (based on scanner qualification process), to the expert reading/assessment (based on the development of oncology follow-up tools for therapy response evaluation). Keosys’ innovative technology succeeds in reducing phase III study costs related to exam centralization of approximately 40% compared to current institutional processes...

[...]

...About Keosys

Keosys is an innovative company composed of a team of experts in medical imaging, IT and telecommunications. In 2011, after 10 years of scientific and academic collaboration within clinical research in nuclear medicine and radiology, Keosys has become a key player establishing 10 keen international partnerships with renowned institutions such as the EORTC, SNM, SFMN, and GELARC… Those partnerships are based on the supply of IMAGYS [TM] technology, medical imaging cloud services for exam centralization of patients enrolled in clinical studies (phase I-II). Medical imaging workflow via IMAGYS [TM] enables imaging exam availabilities in a timely manner offering optimized cost management in full compliance with regulation in force and the European and American GCPs (Good Clinical Practices)... [PDF] Keosys' Press Release -

Domain Therapeutics : EUR 933,000 grant for schizophrenia project

2012-03-29T09:50:00.000-07:00

Strasbourg, France, March 13, 2012 - GPCR specialist will lead EUR 5.1 million ATHOS Project to develop new therapie -

Domain Therapeutics, a biopharmaceutical company focussed on the discovery and early development of small molecules targeting G-Protein Coupled Receptors (GPCRs), one of the most important classes of drug targets, announced that ATHOS project has been selected for French government funding. ATHOS aims to develop new drug candidates and identify therapeutic targets for schizophrenia.

Total funding will amount to EUR 5.1 million over three years. Some 45 per cent of the ATHOS budget will be provided by central and regional government organizations, including the grant of EUR 933,000 to Domain Therapeutics.

Schizophrenia is a disease of the central nervous system generally starting in adolescence and becoming a chronic condition. It typically exhibits a dissociation of the personality, giving rise to auditory hallucinations, paranoid delirium and attention disorders. These problems affect not only the patient’s mental health but also life expectancy, which is 12 years shorter than that of the general population. Schizophrenia and related conditions affect 2-3 per cent of the world population but existing treatments do not improve the cognitive disturbances resulting from the disease and some patients remain completely resistant to available treatments...

[...]

...About Domain Therapeutics S.A.

Domain Therapeutics is a biopharmaceutical company located in Strasbourg, France, dedicated to the discovery and early development of small molecules targeting G-Protein Coupled Receptors (GPCRs), one of the most important classes of drug targets. Domain Therapeutics identifies and develops drug candidates using its DTect-All (TM) innovative proprietary technology. The company’s portfolio is composed of new chemical entities ranging from hits to optimized leads for leading indications such as schizophrenia, Parkinson's disease, and diabetes... [PDF] Domain Therapeutics' Press Release -

Echosens introduces the new FibroScan® 502 Touch with CAP™ (Controlled Attenuation Parameter) in Asia [APASL 2012]

2012-03-15T03:28:00.000-07:00

16/02/2012 - At the 2012 Conference of the Asian Pacific Association for the Study of the Liver (APASL) taking place this year in Taipei from February 16th to February 19th, Echosens, a pioneer and major player in non-invasive hepatic diagnosis, will present for the first time in Asia its latest product, the new FibroScan® 502 Touch, widening the range of FibroScan® devices now available.

Equipped with a new and more ergonomic tactile interface, and based on patented Vibration-Controlled Transient Elastography (VCTE™), the latest FibroScan®provides a reliable, accurate and reproducible assessment of liver tissue stiffness. This technology, developed by Echosens, is unique in measuring liver stiffness at a pre-determined and controlled 50 Hz frequency...

[...]

...About Echosens and Fibroscan

FibroScan is designed to quantify hepatic stiffness and ultrasound attenuation (CAP™) in a non-invasive manner in chronic liver diseases assessment.

Founded in 2001, Echosens supplies its products in more than 70 countries through a global network of suppliers. It dedicates a major portion of its activity to research and development in order to invent new medical devices and open up new medical perspectives. The organization works in close cooperation with health professionals and patients’ associations to facilitate management and therapeutic monitoring of patients. To date, there are more than 500 peer-reviewed publications which attest to the efficacy of FibroScan® in clinical practice...[PDF] Echosens' Press Release -

Sartorius Stedim Biotech and G-Con Manufacturing : Global Collaboration

2012-02-15T11:09:00.000-08:00

January 18, 2012

SSB and G-Con combine core competences for visionary production processes
Collaboration will support faster and more flexible facility construction and shortened time to market

Sartorius Stedim Biotech (SSB) and G-Con have agreed to a global collaboration to offer highly advanced and flexible production platforms for the biopharmaceutical manufacturing industry. The new product line will leverage G-Con Manufacturing’s novel modular, mobile clean-room “pods” and Sartorius Stedim Biotech’s well-established broad single-use and reusable product portfolio to create a totally integrated production process platform. SSB has incorporated its products into unit operations for media/buffer preparation, seed fermentation, cell cultivation and harvesting, ultra-diafiltration, membrane chromatography and viral clearance for biopharmaceutical development and manufacturing. Combining SSB’s technology with G-Con’s modular, scalable and flexible pod platform will provide the biopharmaceutical manufacturing industry with an unparalleled set of cost-effective, “plug and play” tools for next-generation manufacturing facilities...

[...]

...A profile of Sartorius Stedim Biotech

Sartorius Stedim Biotech is a leading provider of cutting-edge equipment and services for the development, quality assurance and production processes of the biopharmaceutical industry. Its integrated solutions covering fermentation, filtration, purification, fluid management and lab technologies are supporting the biopharmaceutical industry around the world to develop and produce drugs safely, timely and economically. Sartorius Stedim Biotech focuses on single-use technologies and value-added services to meet the rapidly changing technology requirements of the industry it serves. Strongly rooted in the scientific community and closely allied with customers and technology partners, the company is dedicated to its philosophy of “turning science into solutions”.

Headquartered in Aubagne, France, Sartorius Stedim Biotech is listed on the Eurolist of Euronext Paris. With its own manufacturing and R&D sites in Europe, North America and Asia and a global network of sales companies, Sartorius Stedim Biotech enjoys a worldwide presence. Its key manufacturing and R&D site is in Germany. The company employs nearly 2,600 people, and in 2010 earned sales revenue of 432.9 million euros... Sartorius Stedim Biotech's Press Release -

Alizé Pharma licenses its ASPAREC® therapy for Treatment of Acute Lymphoblastic Leukemia (ALL) to EUSA Pharma

2012-02-09T14:12:00.000-08:00

Lyon, France, February 2, 2012 - Alizé Pharma II, a drug development company focused on oncology and metabolism and part of the Alizé Pharma group, announced the signing of a licensing agreement with EUSA Pharma for ASPAREC®, a new L-asparaginase product currently in Phase I clinical development for the treatment of acute lymphoblastic leukemia.

Pursuant to the agreement, EUSA Pharma will be responsible for the development and worldwide commercialization of ASPAREC. In return, Alizé Pharma has received an upfront payment, and will be entitled to additional regulatory milestone payments and royalties on sales. The companies have not disclosed further financial information.

ASPAREC is Alizé Pharma’s PEGylated recombinant L-asparaginase derived from Erwinia chrysanthemi. It is being developed as a treatment for acute lymphoblastic leukemia (ALL) in patients with hypersensitivity to E. coli-derived L-asparaginase. Preclinical data indicate that ASPAREC is both longer acting and less immunogenic than the currently available Erwinia chrysanthemi derived L-asparaginase product...

[...]

...About Alizé Pharma

Alizé Pharma is a group of companies specialized in the development of innovative biopharmaceutical drugs, proteins and peptides, for the treatment of metabolic diseases and cancer. Its management is made up of a team of drug development experts and a board of directors offering wide international experience. Since its inception in 2007, the group has raised 5 M€ with private and institutional investors. The first of the two entities of the Group, Alizé Pharma SAS, is dedicated to AZP-01, a peptide derived from unacylated ghrelin, currently at the preclinical stage of development for the treatment of Type II diabetes and other metabolic and cardiovascular indications. The second entity, Alizé Pharma II SAS, is focused on the development of ASPAREC® (AZP-02), a new PEGylated recombinant L-asparaginase for the treatment of acute lymphoblastic leukemia, and currently in Phase I clinical development... Alizé Pharma's Press Release -

Pherecydes Pharma : DGA funding for evaluating the use of bacteriophages against infected, antibiotic resistant burns

2012-02-01T15:34:00.000-08:00

January 18, 2012 Paris, France - French defence procurement agency invests EUR 900,000 towards a Pherecydes Pharma managed EUR 1.2-million project -

Pherecydes Pharma, a biotechnology company specialized in the research and development of lytic bacteriophages for both therapeutic and diagnostic purposes, announces that it has received funding of EUR 900,000 from France’s General Directorate for Armaments (Direction Générale de l’Armement - DGA) to part-finance the PACOBURNS project. This project is set up to explore the possibility of using bacteriophages to combat bacterial infections that are resistant to antibiotics, especially skin infections.

The funds invested by the DGA fall within the framework of its RAPID program. The scheme supports dual innovation by small and medium-sized companies through providing financial assistance for projects that have great technological and commercial potential, are innovative in terms of industrial research, and have both military and civilian applications. The Institute of Genetics and Microbiology of the University of Paris XI and the Armed Forces Institute of Biomedical Research (Institut de Recherche Biomédicale des Armées - IRBA) are also involved in this project...

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About Pherecydes Pharma

...Pherecydes Pharma SA specializes in the research and development of lytic bacteriophages (or phages) for both therapeutic and diagnostic applications. The company provides innovative and adaptable solutions to combat multi-resistant bacteria, through developing mixtures of natural phages and their accelerated in vitro evolution. Pherecydes Pharma is the only company currently that has been able to harness this evolution technology, allowing a head start on any given bacterium.

Due to the unique knowledge of the company in the characterization and rapid isolation of natural lytic phages, Pherecydes Pharma has developed a large bank of bacteriophage mixtures for combating infections that are resistant to antibiotics, which have steadily increased in number since the 1980s. In particular, it possesses the world’s largest collection of phages against escherichia coli and is also working on pseudomonas and staphylococci, three bacteria that alone represent over 50 per cent of known infections in industrialized countries...[PDF] Pherecydes Pharma's Press Release -

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...

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...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...

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...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...

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...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 -