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Thursday, September 29, 2011

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

Novagali Pharma
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 -

Wednesday, September 21, 2011

HAC Pharma : New MA for Agrastat in France

HAC Pharma
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 -

Wednesday, September 14, 2011

CERMA : spin-off company cermaVEIN



CERMA8/30/2011 - 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.
CERMAVEIN

“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 -

Thursday, September 8, 2011

GENFIT GFT505 clinical results Diabetes Care

GENFITLille, 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’...

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...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 -

Wednesday, August 31, 2011

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

MedinCell
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 -

Tuesday, August 23, 2011

Bertin Pharma opens its Pharmaceutical Establishment

Bertin Pharma01-07-2011: 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.

Ellipse Pharmaceuticals
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 -

Wednesday, August 10, 2011

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

Eurofins Optimed Clinical ResearchAugust 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...

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...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 -