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10/07/2018

Paris, France, July 10th. 2018. Sofinnova Partners, a leading venture capital firm specialized in Life Sciences, today announced that Otsuka Holdings is acquiring its portfolio company ReCor Medical, a medical device company specialized in the treatment of hypertension. The terms of the acquisition are being withheld due to non-disclosure obligations.

ReCor Medical was created in 2009 by Sofinnova Partners, Mano Iyer – who was then entrepreneur-in-residence at Sofinnova Partners and now Chief Operating Officer of ReCor – and Professor Jacques Seguin, MD, who became a large private investor in ReCor. Prof. Seguin was previously founder and CEO of CoreValve, a past Sofinnova portfolio company and a leader in the transcatheter valve replacement space, which was sold to Medtronic. Sofinnova Partners was the sole venture capital investor in ReCor Medical and remained its largest shareholder until the sale to Otsuka.

ReCor Medical is an innovative medical device company that developed the Paradise System, a proprietary ultrasound ablation system for renal denervation (RDN). RDN is a new potential therapeutic approach for the treatment of hypertension, one of the most prevalent medical conditions. ReCor recently announced positive results of its landmark RADIANCE-HTN SOLO hypertension study at EuroPCR 2018.

Antoine Papiernik, Managing Partner at Sofinnova Partners and ReCor Board Member, said: “ReCor perfectly illustrates our investment strategy: we worked hand-in-hand with Mano Iyer to create the business vision and plan for ReCor. We then founded and funded the company, and opened our network of experts, key opinion leaders and board members to help grow it. We brought trusted entrepreneurs Jay Watkins as Chairman and Andy Weiss as CEO to help guide and operate the company through to a corporate transaction to our partner Otsuka.”

Jay Watkins, Chairman of ReCor Medical said: “Sofinnova Partners remains one of few VCs willing to fund early-stage med-tech ventures targeting large and important new markets. The firm played a critical role throughout ReCor’s life, and has proven to be a reliable, value-added partner for the company. The field of renal denervation has been a complex one over the last few years with periods of euphoria and periods of doubt. Sofinnova Partners’ support remained constant throughout, helping to build a strong partnership with Otsuka and then navigate through the challenges to a very successful trade sale.”

Mano Iyer, Founder and COO of ReCor Medical added: “ReCor is a success story because Sofinnova Partners, consistent with its philosophy, saw the value of an opportunity which did not yet exist. It had the vision to create and fund the company, not only in the very beginning, but also during the critical early years. Despite the dramatic swings in the field, Sofinnova Partners’ confidence in me and in the management team was essential to keep us motivated when others lost hope. This great exit is therefore particularly sweet.”

Andrew M. Weiss, CEO of ReCor Medical adds: “I came to ReCor thanks to Antoine Papiernik’s introduction to the company. With his help, our team developed the partnership with Otsuka and was able to remain focused on value creation. The recent announcement of our positive RADIANCE-HTN SOLO study results and now the merger with Otsuka demonstrate that our teamwork with Sofinnova Partners was successful. We now have an opportunity to transform the treatment of hypertension and benefit millions of potential patients while providing a solid return for our investors. I look forward to continuing to work to make this technology a possible standard of care in hypertension treatment”.

For more information, please contact:
SOFINNOVA PARTNERS
International: Anne Rein
Tel: +33 6 03 35 92 05
e-mail: anne.rein@strategiesimage.com
United States: Kate Barrette
Tel: +1 212 223 0561
e-mail: kbarrette@rooneyco.com

About Sofinnova Partners
Sofinnova Partners is a leading European venture capital firm specialized in Life Sciences. Based in Paris, France, the firm brings together a team of professionals from all over Europe, the US and China. The firm focuses on paradigm shifting technologies alongside visionary entrepreneurs. Sofinnova Partners seeks to invest as a lead or cornerstone investor in seed, start-ups, corporate spin-offs and late stage companies. It has backed nearly 500 companies over more than 45 years, creating market leaders around the globe. Today, Sofinnova Partners has over €1.9 billion under management. For more information: www.sofinnova.fr

About ReCor Medical, Inc.
ReCor Medical is a medical device company that designs and manufactures the Paradise System, a proprietary ultrasound ablation system for renal denervation (RDN). RDN is a new potential therapeutic approach for the treatment of hypertension, one of the most prevalent medical conditions. The Paradise System is approved for sale in the EU and bears a CE mark, but is not approved for sale in the United States. The System’s intravascular catheters denervate renal nerves by combining the protection of water-based cooling of the renal artery with high intensity ultrasound energy for circumferential renal nerve ablation. The Paradise System has been studied in clinical trials of approximately 300 patients to date. Following the positive outcomes of the RADIANCE-HTN SOLO trial, ReCor will continue its evaluations of Paradise in RADIANCE-HTN TRIO (a feasibility study of patients with resistant hypertension) and REQUIRE (a pivotal study of patients with resistant hypertension in Japan and Korea), and launch the RADIANCE II pivotal study (a study of patients with moderate hypertension) in the United States and Europe.
http://www.recormedical.com/

About Otsuka Holdings Co., Ltd. and Otsuka Medical Devices Co., Ltd.
Otsuka Holdings Co., Ltd. is the holding company of the Otsuka group, a global healthcare group headquartered in Tokyo, Japan. With operations in pharmaceuticals, nutraceuticals, medical devices and other health-related businesses, the group generated worldwide sales of JPY1,240 billion in the fiscal year ended December 2017.
http://www.otsuka.com/en/

Established in 2011, Otsuka Medical Devices Co., Ltd. is a fully-owned subsidiary of Otsuka Holdings and one of its core operating subsidiaries. Otsuka Medical Devices focuses on the development and commercialization of endovascular devices that provide new therapeutic options in areas where patient needs cannot be met through pharmaceutical or other conventional treatment.
Otsuka Medical Devices conducts the REQUIRE trial for renal denervation in hypertensive patients (n=140), who are uncontrolled on 3 or more medications including a diuretic, in Japan and Korea through its subsidiary JIMRO Co., Ltd.
http://www.omd.otsuka.com/en/

07/04/2014

Bagneux, France, le 7 Avril 2014 – DBV Technologies (Euronext : DBV – ISIN: FR0010417345), créateur de Viaskin®, nouvelle référence dans le traitement de l’allergie, a annoncé aujourd’hui la création d’une filiale américaine, DBV Technologies Inc. ainsi que la nomination de Mlle Susanna Mesa en tant que Vice-Présidente Finance US, Relations Investisseurs & Stratégie.

Les activités cliniques de DBV sont en partie tournées vers les Etats-Unis. C’est le cas en particulier du développement clinique du premier produit de la Société, Viaskin Peanut, premier traitement de l’allergie à l’arachide, dont les Etats unis sont le principal marché potentiel. La création de DBV Technologies Inc. est un élément important du plan stratégique de DBV.

« L’ouverture d’une filiale aux Etats-Unis représente une étape clef dans notre développement. Au moment où nous préparons l’entrée de Viaskin Peanut en phase III, notre but est de continuer d’augmenter la visibilité de DBV au sein de la communauté médicale et financière, et de renforcer notre engagement auprès de la communauté des allergologues américains » a déclaré Pierre-Henri Benhamou, président Directeur Général de DBV Technologies.

Mlle Susanna Mesa, en charge du développement et de la mise en oeuvre de la stratégie Relations Investisseurs aux Etats-Unis est la première employée de DBV Technologies Inc. Mlle Mesa est membre du Comité de Direction et reporte directement à David Schilansky, Directeur Administratif et Financier de DBV.

« Nous sommes très heureux d’accueillir Susanna, qui est extrêmement motivée par la mission de DBV et notre engagement fort auprès de nos actionnaires. Sa connaissance intime des marchés et sa capacité de communication auprès de la communauté financière seront des atouts cruciaux pour continuer d’augmenter notre visibilité aux Etats-Unis. » a déclaré David Schilansky, Directeur Administratif et Financier de DBV Technologies.

Susanna Mesa travaillait précédemment pour le Groupe Trout, une société de conseil en Relations Investisseurs et Stratégie spécialisée dans les sciences de la vie. Chez Trout, Susanna était en charge de l’augmentation de la base d’investisseurs, du pilotage d’opérations de marché et de certaines missions de business développement pour le compte de ses clients. Avant de rejoindre Trout en 2012, Susanna travaillait au développement stratégique de la Leukemia and Lymphoma Society et au sein de l’équipe de vente (equity sales) de Jefferies. Susanna est diplômée de Georgia University (Floride, Etats-Unis).

A propos de DBV Technologies
DBV Technologies ouvre une voie décisive dans le traitement de l’allergie, problème de santé public majeur en constante progression. Les allergies alimentaires représentent un véritable handicap quotidien pour des millions de personnes et un besoin médical hautement insatisfait. La Société, fondée en 2002, a développé une technologie propriétaire unique, brevetée mondialement, permettant d’administrer un allergène par la peau saine sans passage massif dans la circulation sanguine. Ce procédé, appelé Viaskin®, permet ainsi d’associer efficacité et sécurité au cours du traitement qui vise à améliorer la tolérance des patients à l’arachide et à minimiser considérablement les risques de réaction allergique généralisée en cas d’exposition accidentelle à l’allergène. Cette méthode révolutionnaire a fait l’objet d’un important développement ayant conduit à un produit aujourd’hui à un stade industriel. Sa sécurité d’utilisation, cliniquement prouvée, permet d’envisager enfin d’appliquer les techniques de désensibilisation à l’efficacité mondialement reconnue aux formes les plus sévères de l’allergie.

DBV Technologies se focalise sur les allergies alimentaires (lait, arachide) pour lesquelles il n’existe aucun traitement, et a conçu deux produits : Viaskin® Peanut et Viaskin® Milk. Le programme de développement clinique du Viaskin Peanut a obtenu le statut de ‘Fast Track Designation’ de la Food and Drug Administration (‘FDA’). La Société développera par la suite, Viaskin® pour les jeunes enfants allergiques aux acariens – véritable enjeu de santé public – cette pathologie étant l’un des principaux facteurs de risque de l’asthme chez l’enfant.
Les actions DBV Technologies sont négociées sur le compartiment C d’Euronext Paris (mnémonique : DBV, code ISIN : FR0010417345).
Pour plus d’informations sur DBV Technologies, visitez www.dbv-technologies.com

Contacts de DBV Technologies

David Schilansky
Directeur Administratif et Financier
DBV Technologies
Tél. : +33(0)1 55 42 78 75
david.schilansky@dbv-technologies.com

Nathalie Donne
Directeur Business Development & Communications Corporate
Tel. : +33(0)1 55 42 78 72
nathalie.donne@dbv-technologies.com
Contacts de DBV Technologies Relation Investisseur et Média

NewCap.
Communication financière et relations investisseurs
Emmanuel Huynh / Valentine Brouchot
Tél. : +33(0)1 44 71 94 94
dbv@newcap.fr ALIZE RP
Relations Presse
Caroline Carmagnol
Tél. : +33(0)6 64 18 99 59
caroline@alizerp.com

04/04/2014

Anti-CCL2 /MCP-1 Spiegelmer® emapticap pegol (NOX-E36) shows beneficial and lasting effects on albuminuria and glycemic control

Berlin, Germany – 4 April 2014 – NOXXON Pharma AG announced that Phase IIa proof-of-concept data from the emapticap pegol (NOX-E36) trial in diabetic nephropathy were presented at the ISN Nexus Symposium in Bergamo, Italy earlier today.
Emapticap pegol is a Spiegelmer® that binds and neutralizes CCL2/MCP-1 (C-C Chemokine Ligand / Monocyte Chemoattractant Protein-1), a pro-inflammatory chemokine that plays an important role in diabetic kidney disease, the most common single cause of chronic kidney failure and end-stage renal disease.
The objective of this randomized, double-blind placebo-controlled multi-center international study was to evaluate the efficacy, pharmacokinetics, safety and tolerability of treatment with emapticap pegol. Seventy-five type 2 diabetic patients with albuminuria on current standard of care to control hypertension, hyperglycemia and dyslipidemia were treated for 12 weeks with twice-weekly subcutaneous emapticap pegol or placebo. This treatment period was followed by a 12 week observational period to study the long-term effect of emapticap treatment on albuminuria. Importantly, the underlying standard of care mandatorily included stable renin-angiotensin system (RAS) blockade, which has been demonstrated to reduce albuminuria and to slow progression of diabetic nephropathy. Emapticap pegol was found to be safe and well tolerated with no treatment-related serious adverse events. For the primary efficacy analysis, patients with major protocol violations, on dual RAS blockade, or with concomitant hematuria and leukocyturia were excluded.
Results showed relevant, statistically significant reductions in urinary albumin excretion and improved glycemic control. Importantly, these effects were independent of hemodynamic changes and maintained after cessation of treatment, suggesting that emapticap pegol interferes with the underlying pathophysiology of diabetic nephropathy. Long-lasting effects on urinary albumin after cessation of treatment are not seen with agents currently approved to treat diabetic nephropathy (ACE inhibitors and ARBsi) or with other agents that act primarily via a hemodynamic mechanism of action such as endothelin A receptor antagonists.
Professor Dr. Hermann Haller, Director of the Department of Nephrology and Hypertension at Hannover Medical School and lead investigator of the study commented: “This Phase IIa study clearly shows that emapticap pegol is exceptionally safe and well tolerated in the target population and produces significant and clinically relevant beneficial effects on albuminuria and glycemic control after only three months of treatment. The observation that these effects are maintained even after cessation of treatment suggests that emapticap pegol interferes with the underlying pathophysiology and may be the first disease-modifying drug for this indication.”
Dr. George Bakris, Professor of Medicine and Director of the ASH Comprehensive Hypertension Center at the University of Chicago Medicine remarked: “From the data I’ve seen, I’m particularly impressed by the dissociation of emapticap pegol’s albuminuria lowering effect from hemodynamics. The fact that this beneficial effect is accompanied by an additional benefit on glycemic control is a unique feature that differentiates this drug from other compounds in development.”

Notes for editors:

About NOXXON Pharma AG
NOXXON Pharma is a biopharmaceutical company pioneering the development of a new class of proprietary therapeutics called Spiegelmers. Spiegelmers are chemically synthesized L-stereoisomer oligonucleotide aptamers, a non-immunogenic alternative to antibodies. NOXXON has a diversified portfolio of clinical-stage Spiegelmer® therapeutics:
• Emapticap pegol (NOX-E36), an anti-CCL2/MCP-1 (C-C chemokine ligand 2 / Monocyte Chemoattractant Protein-1) Spiegelmer®, has completed a Phase IIa study in patients with type 2 diabetes with albuminuria. CCL2 is a proinflammatory chemokine involved in the recruitment of immune cells to inflamed tissues.
• Olaptesed pegol (NOX-A12), an anti-CXCL12/SDF-1 (CXC chemokine ligand 12 / Stromal Cell-Derived Factor-1) Spiegelmer®, is currently in Phase IIa studies in two hematological cancers, multiple myeloma (MM) and chronic lymphocytic leukemia (CLL). CXCL12 is a chemokine mediator of tumor invasion, metastasis, and resistance to therapy.
• Lexaptepid pegol (NOX-H94), an anti-hepcidin Spiegelmer®, has completed a Phase IIa pilot study in cancer patients with anemia and will soon begin a study in EPO-hyporesponsive dialysis patients. Hepcidin is the key regulator of iron metabolism and responsible for the iron restriction leading to anemia of chronic disease.

The Spiegelmer® platform provides the company with powerful and unique discovery capabilities, which have generated a number of additional leads under preclinical investigation. Located in Berlin, Germany, NOXXON is a well-financed mature biotech company with a strong syndicate of international investors, and approximately 60 employees.
For more information, please visit: www.noxxon.com
 

Contact:

NOXXON Pharma AG
Instinctif Partners
Emmanuelle Delabre
T: +49-30-726247-0
edelabre@noxxon.com
Robert Mayer / Cora Kaiser
T: +49-89-30905189-13
noxxon@instinctif.com
i ACE – Angiotensin Converting Enzyme, ARB – Angiotensin Receptor Blocker

04/04/2014

Le syndicat d’investisseurs inclue aussi Pfizer Venture Investments et Venrock

Burlingame, CA (Etats Unis). 4 avril 2014 – RefleXion Medical, société d’équipement médical spécialisée dans le traitement du cancer qui développe le premier système de radiothérapie bio-guidée, annonce aujourd’hui avoir levé 8,5 M€ (11.6 M$) lors d’un tour de financement de série A. Le financement a été mené par Sofinnova Partners, rejoint par Pfizer Venture Investments (PVI), et Venrock. A cette occasion, Antoine Papiernik, de Sofinnova Partners, Bill Burkoth de PVI et Colin Cahill de Venrock, rejoignent le Conseil d’administration de la société qui compte déjà Jay Watkins, Président de RefleXion, Dr. Samuel Mazin et Akshay Nanduri, co-fondateurs.

Antoine Papiernik, Partenaire Associé chez Sofinnova Partners, déclare : “Chez Sofinnova Partners nous cherchons à investir auprès d’entrepreneurs visionnaires qui développent des technologies de rupture. RefleXion réunit ces caractéristiques et nous sommes ravis de les accompagner afin de concrétiser leur projet et améliorer radicalement le traitement du cancer”.

La technologie de RefleXion’s combine la tomographie à émission de position (TEP) à la radiothérapie, permettant au signal émis par la tumeur même de guider la délivrance des radiations thérapeutiques. S’appuyant sur un signal biologique comme système de guidage, la technologie de RefleXion devrait permettre en une seule session de diffuser de fortes doses de rayons focalisés sur des lésions cancéreuses multiples tout en épargnant les tissus sains environnants ; un degré de précision actuellement impossible à obtenir avec les traitements aujourd’hui disponibles. Les fonds levés vont permettre de développer les programmes de recherche avec pour objectif de démontrer au plus tôt le potentiel de la technologie de RefleXion sur des patients.

“Avec radiothérapie bio-guidée par la TEP en temps réel, nous avons enfin un moyen de personnaliser le traitement par radiothérapie”, declare Dr. Samuel Mazin, Président de RefleXion et inventeur de la technologie.

Dr. Ralph Weichselbaum, D.K Ludwig Professeur Président du département Radiation et Oncologie à l’Université de Chicago et membre du Conseil Scientifique de RefleXion, poursuit : “Je suis enthousiasmé par le potentiel de la radiothérapie bio-guidée. Parmi les nombreuses applications cliniques, je suis convaincu que le système de RefleXion sera particulièrement adapté pour traiter les cancers oligometastatiques”.

Akshay Nanduri, Vice Président du Business Développement de RefleXion, ajoute “Etre accompagné par un syndicat d’investisseurs spécialisés dans les sciences de la vie de cette qualité va nous permettre de déployer efficacement notre stratégie de croissance et apporter aux patients et aux cliniciens notre système de thérapie innovant ”.

A propos de Sofinnova Partners
Sofinnova Partners est une société de capital-risque indépendante basée à Paris, France. Depuis 40 ans, Sofinnova Partners a financé et accompagné près de 500 sociétés à différents stades de leur développement [création, spin-off et opérations de retournement], et accompagne des entrepreneurs européens clef dans l’industrie des Sciences de la Vie. Sofinnova gère actuellement 1.3 Md€ et se positionne comme investisseur leader en Europe dans l’accompagnement de sociétés jusqu’à la sortie. Pour plus d’informations merci de visiter: sofinnova.social-unit.fr

A propos de RefleXion Medical
RefleXion Medical est une société d’équipement médical spécialisée dans le traitement du cancer. La société développe le premier système de radiothérapie bio-guidée qui a le potentiel de transformer les pratiques de radiothérapie dans le domaine de l’oncologie. La technologie de RefleXion’s combine la tomographie à émission de position (TEP) à la radiothérapie permettant au signal émis par la tumeur même de guider la délivrance des radiations thérapeutiques. Pour plus d’information merci de visiter : www.reflexionmedical.com

Pour plus d’information, merci de contacter :
Akshay NANDURI
akshay[at]reflexionmedical.com

Anne REIN
STRATEGIES & IMAGE
anne.rein@strategiesimage.com
+33 6 03 35 92 05

01/04/2014

Basel, Switzerland, March 31, 2014 – Auris Medical announced today that results from its phase IIb clinical trial with AM-101 in the treatment of acute inner ear tinnitus have been published in the specialist journal Otology & Neurotology1. The trial demonstrated that AM-101 was well tolerated and safe and es-tablished proof of concept in the treatment of tinnitus arising from traumatic acoustic injury to the cochlea and otitis media. In particular the trial showed persistent, clinically relevant and statistically significant improvement in several patient-reported tinnitus measures.
“We are very pleased to see the design and the detailed outcomes of our phase IIb trial with AM-101 pub-lished in a leading peer reviewed publication”, commented Thomas Meyer, Auris Medical’s founder and CEO. He added: “The trial provided us with a wealth of data and insights into the sensitivity and robustness of various clinical endpoints and the natural history of tinnitus in the acute stage. We incorporated these find-ings in the design of our recently started phase III trials, which will be another great step forward towards the development of the first specific therapeutic for tinnitus.”
The double-blind, randomized, placebo-controlled, parallel-dose phase IIb trial with AM-101 was conducted at 28 study sites in Germany, Belgium, Poland and the Netherlands. A total of 248 patients suffering from persistent acute inner ear tinnitus were randomized to receive three i.t. injections of either AM-101 at 0.27 or 0.81 mg/mL or placebo over three consecutive days. Their tinnitus was triggered by acute acoustic trau-ma, sudden deafness (idiopathic sudden sensorineural hearing loss, ISSNHL) or otitis media and no older than three months. Trial participants were monitored over 90 days.
The trial demonstrated a dose-dependent and persistent improvement in several patient reported outcomes (PROs). Patients suffering from unilateral tinnitus following acute acoustic trauma or otitis media who re-ceived AM-101 0.81 mg/mL showed a gradual and statistically significant improvement 90 days post-treatment in tinnitus loudness, annoyance, tinnitus-related sleep difficulties and in overall tinnitus impact (THI-12 questionnaire) compared with placebo. In the analysis of covariance (ANCOVA), p-values were <0.02 for these outcomes. At Day 90, the mean improvement in tinnitus loudness was 48% in the high-dose group, compared to 28% in the low-dose group and 9% in the placebo group. Overall, 64% of patients in the high-dose group rated their tinnitus severity at Day 90 compared with baseline as ‘‘much improved’’ or ‘‘very much improved,’’ compared with 44% and 35% of patients in the low-dose and placebo groups, re-spectively.
Treatment effects of AM-101 were somewhat less pronounced in patients with bilateral rather than unilat-eral tinnitus since only one ear was treated as a precautionary safety measure. Efficacy outcomes with patients suffering from tinnitus related to ISSNHL were not conclusive for that subgroup overall, owing to an
unexpectedly large rate of spontaneous recovery and the heterogeneity in tinnitus origin. Psychoacoustic measures such as the minimum masking level turned out to be insufficiently reliable and did not show results that were consistent with PROs.

Furthermore, AM-101 showed good safety in the phase IIb trial, and the repeated intratympanic injections were well tolerated. Mean hearing thresholds improved slightly in all treatment groups; the frequency of clinically relevant hearing deterioration overall was low and not significantly different between groups. Adverse events were reported by similar proportions of patients across the treatment groups with no apparent clinically relevant differences in frequency, intensity, or relationship to the treatment. Local events accounted for greater than 50% of reported adverse events and related mostly to anticipated transient changes in tinnitus perception and hearing following the injection procedure. In 93% of cases, the eardrum was already fully closed again five days after the last injection.

About acute peripheral tinnitus
Tinnitus, the perception of sound without external acoustic stimulation, is a symptom common to various ear or other diseases. Peripheral (inner ear) tinnitus may be provoked by various injuries to the cochlea, the organ of hearing, such as overexposure to noise or inflammation. It may be short and just transitory; however, it may also become permanent. Tinnitus of less than three months of duration is considered acute, while older tinnitus is considered chronic. Peripheral tinnitus may be only a slight nuisance, but often it has a serious impact on the ability to sleep, relax, or concentrate, or it may lead to tiredness, irritation, nervousness, despair, frustration, or even depression. As of today, there exists neither a universal standard of care for acute inner ear tinnitus, nor a truly proven, effective treatment method.

About AM-101
AM-101 is a small molecule N-methyl-D-aspartate (NMDA) receptor antagonist formulated in a biocompatible gel for intratympanic injection. Emerging evidence suggests that NMDA receptors in the cochlea play a major role in the occurrence of tinnitus following inner ear excitotoxicity, which is characterized by excessive synaptic release of glutamate, the principal neurotransmitter in the auditory system. Cochlear excitotoxicity may be triggered by, for example, trauma (e.g. exposure to excessive noise), neuroinflammation, disturbances in inner ear blood supply (anoxia/ischemia), or the administration of certain ototoxic drugs. It has been proposed that the upregulation of NMDA receptors induced by cochlear excitotoxicity is responsible for aberrant excitation of auditory nerve fibers, which is perceived as tinnitus.
The development of AM-101 is based on research conducted at the INSERM Institute for Neurosciences of Montpellier, France. The clinical development of AM-101 was initiated by Auris Medical in 2007 and comprises three clinical trials to date. In 2013, Auris Medical reached agreement with the US Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for its pivotal TACTT2 study. Patents have been granted in more than 30 countries worldwide so far.

About Auris Medical
Auris Medical is a Swiss biopharmaceutical company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology. The Company is currently focusing on the development of treatments for acute peripheral tinnitus (AM-101) and for acute inner ear hearing loss (AM-111) by way of intratympanic injection with biocompatible gel formulations. In addition, Auris Medical is pursuing early-stage research and development projects. The Company was founded in 2003 and is headquartered in Basel, Switzerland.

Contact:
Dr. Thomas Meyer, CEO, ear@aurismedical.com
Gretchen Schweitzer, MacDougall Biomedical Communications, +49 172 861 8540
gschweitzer@macbiocom.com

27/03/2014

27 Mars 2014

« Mal de dos enfin une solution »…Le Parisien Aujourd’hui en France 27 March 2014 – Mainstay

24/03/2014

Ce communiqué ne doit pas être diffusé, directement ou indirectement, aux Etats-Unis, au Canada, en Australie ou au Japon

– Demande globale de 208 M€, offre sursouscrite 8,6 fois
– Prix de souscription : 8,25 € par action (haut de fourchette)
– Exercice intégral de la clause d’extension et de l’option de surallocation
– Début des négociations le 25 mars 2014

Avec le vif succès de son introduction en Bourse, McPhy Energy se donne les moyens d’accélérer sa stratégie de développement pour capturer les opportunités offertes pour ses solutions hydrogène dans un contexte de transition énergétique mondiale.

La Motte-Fanjas, le 19 mars 2014 – McPhy Energy, le spécialiste des solutions hydrogène dédiées au stockage d’énergie et aux applications industrielles, annonce aujourd’hui les modalités définitives de son Offre, comprenant une Offre à Prix Ouvert et un Placement Global, à l’occasion de l’admission de ses actions à la cotation sur Euronext Paris (compartiment C, code ISIN : FR0011742329, code mnémonique : MCPHY).

Grâce à cette opération, McPhy Energy lève 32 M€ qui lui permettront de mettre en oeuvre son plan de développement stratégique :

– en accélérant son déploiement commercial sur les territoires-clés d’Amérique du Nord, de l’Asie, de l’Europe de l’Est et de la Russie, ainsi que du Moyen-Orient et de l’Afrique

– en renforçant ses infrastructures de fabrication industrielle d’équipements de production et de stockage d’hydrogène,

– en intensifiant le déploiement industriel de sa technologie exclusive de stockage de l’hydrogène sous forme solide, et le développement de sa gamme d’électrolyseurs à destination des marchés de l’énergie, de la mobilité automobile décarbonée et de l’industrie.

L’Offre a rencontré un grand succès tant auprès des investisseurs français et internationaux qu’auprès des particuliers. La demande globale a porté sur 207,3 M€, dont 179,8 M€ pour le Placement Global et 27,5 M€ pour l’Offre à Prix Ouvert.

Le Directoire a fixé le prix de l’Offre à 8,25 € par action, soit le haut de la fourchette indicative, et a décidé la mise en oeuvre intégrale de la clause d’extension et de l’option de surallocation. Le nombre total de titres émis s’élève à 3 880 215, permettant la réalisation d’une augmentation de capital de 32 M€, prime d’émission incluse.

 » Nous sommes très heureux du succès de cette introduction en Bourse. Nous remercions de leur confiance les actionnaires individuels ainsi que les anciens et nouveaux actionnaires institutionnels qui nous donnent les moyens d’accélérer notre plan de développement stratégique. Forte de sa technologie unique de stockage de l’hydrogène sous forme solide et de son savoir-faire dans la fabrication d’équipements de production d’hydrogène, McPhy Energy dispose d’atouts décisifs pour devenir un acteur incontournable de la transition énergétique mondiale « , conclut Pascal Mauberger, Président du Directoire de McPhy Energy.

Principales caractéristiques de l’Offre

Prix de l’offre
› Le prix de l’Offre à Prix Ouvert et du Placement Global est fixé à 8,25 € par action.

Répartition de l’Offre
› Placement Global : 3 280 215 actions ont été allouées aux investisseurs institutionnels, soit environ 27 M€ et 85 % des titres offerts.
› Offre à Prix Ouvert : 600 000 actions ont été allouées au public, soit environ 5 M€ et 15 % des titres offerts.
› Dans le cadre de l’Offre à Prix Ouvert : la fraction d’ordres A1 sera servie à hauteur de 66,779 %, la fraction d’ordres A2 à 0 %.

Taille de l’Offre et produit de l’opération

› La société a décidé d’exercer en totalité la clause d’extension pour émettre 440 100 actions nouvelles et a constaté l’exercice immédiat et intégral de l’option de surallocation pour 506 115 actions supplémentaires.
› En conséquence, le produit brut de l’Offre à Prix Ouvert et du Placement Global représente un produit brut d’environ 32 M€, correspondant à l’émission de 3 880 215 actions nouvelles, représentant 42,8 % des actions en circulation (38,4 % sur une base entièrement diluée).

Calendrier de l’Offre
› 24 mars 2014 : Emission des actions – Règlement livraison
› 25 mars 2014 : Début des négociations sur Euronext

À propos de McPhy Energy
McPhy Energy, le spécialiste des solutions hydrogène dédiées au stockage d’énergie et aux applications industrielles, a été créé en 2008 à La Motte Fanjas dans la Drôme. Fort de sa technologie exclusive de stockage d’hydrogène sous forme solide et de sa longue expertise dans la production d’hydrogène par électrolyse de l’eau, McPhy Energy conçoit et fabrique des équipements flexibles de stockage et de production.

Ces solutions respectueuses de l’environnement offrent des avantages uniques de sécurité, d’indépendance et de simplicité d’utilisation. Elles s’adressent aux secteurs des énergies renouvelables, de la mobilité et de l’industrie où McPhy Energy compte plus de 1 000 clients.

Le groupe dispose de 3 sites de production en France, Allemagne et Italie ainsi que d’un laboratoire de R&D en France. En phase de fort développement, McPhy Energy bénéficie de l’appui d’actionnaires de premier plan : Sofinnova Partners, Bpifrance, Gimv, Amundi, Emertec, Areva.

Établissements introducteurs

Bryan, Garnier & Co
Coordinateur Global, Chef de File et Teneur de Livre

Portzamparc, Société de Bourse
Co-Chef de File, Membre du syndicat de placement

 

Contacts McPhy Energy

Calyptus
Relations presse
Marie-Anne Garigue
+ 33 1 53 65 68 63
marie-anne.garigue@calyptus.net

Relations investisseurs / actionnaires
Marie Calleux / Mathieu Calleux
+ 33 1 53 65 68 66 / 37 91
mcphy@calyptus.net

Des exemplaires du prospectus, visé sous le n° 14-063 en date du 28 février 2014 par l’Autorité des Marchés Financiers sont disponibles sans frais auprès de McPhy Energy et sur les sites www.mcphy.com et www.amf-france.org. Le public est invité à prendre connaissance des risques décrits au chapitre IV « Facteurs de risques » et Deuxième Partie / chapitre 2 « Facteurs de risques liés à l’offre » du Prospectus.

Ce communiqué ne constitue pas une offre de souscription de valeurs mobilières ou la sollicitation d’une offre de souscription de valeurs mobilières aux Etats-Unis ou dans quelque pays que ce soit. Les actions de McPhy n’ont pas été et ne seront pas enregistrées au titre du U.S. Securities Act de 1933, tel que modifié, et McPhy n’a pas l’intention de procéder à une quelconque offre au public de ses actions aux Etats-Unis.

Ce communiqué n’a pas été diffusé et ne doit pas être diffusé, directement ou indirectement, aux Etats-Unis, au Canada, en Australie ou au Japon

Cette annonce ne contient pas et ne saurait constituer une invitation, une incitation ou une sollicitation à investir. Ce communiqué de presse n’est destiné qu’à des personnes (1) se trouvant hors du territoire du Royaume-Uni, (2) qui sont des « investment professionals » au sens de l’article 19(5) du Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (tel que modifié) (l’ “Ordonnance”), ou (3) qui sont des « high net worth companies » et aux autres personnes auxquelles le communiqué peut légalement être adressé au sens de l’article 49(2)(a) à (d) de l’Ordonnance (toutes les personnes visées au (1), (2) et (3) étant ensemble désignées les « Personnes Habilitées »). Cette annonce est exclusivement destinée aux Personnes Habilitées et ne doit pas être utilisée ou invoquée par des personnes autres que les Personnes Habilitées. Tout investissement ou toute activité d’investissement en relation avec ce document est réservé aux Personnes Habilitées et ne peut être réalisé que par les Personnes Habilités. »

14/03/2014

Paris et Nancy, France, 13 mars 2014 – Inotrem SA, une société biopharmaceutique française spécialisée dans le contrôle de la réponse immunitaire au cours de maladies inflammatoires aigües, annonce aujourd’hui avoir bouclé un premier tour de financement de 18 millions d’euros, le plus important en Europe cette année pour une Série A.

Le financement a été co-piloté par deux fonds de capital risque leaders à l’échelle internationale, Edmond de Rothschild Investment Partners et Sofinnova Partners. BioMed Invest, un fonds Suisse, et Inserm Transfert Initiative, firme française spécialisée dans l’amorçage, ont également participé à cette opération. Gilles Nobécourt, d’Edmond de Rothschild Investment Partners, et Graziano Seghezzi de Sofinnova Partners, ont rejoint le Conseil d’Administration d’Inotrem.

Basée sur le travail innovant de Sébastien Gibot, médecin réanimateur et professeur à l’Université de Lorraine, et du Dr Marc Derive, co-fondateur et désormais Directeur Scientifique, Inotrem a construit une expertise autour du contrôle de la voie du TREM-1, une voie d’amplification de la réponse inflammatoire particulièrement impliquée dans le développement du choc septique. Le sepsis est une pathologie infectieuse et inflammatoire aigue et sévère qui peut aboutir à des dysfonctions d’organes. Le sepsis affecte jusqu’à 1% de la population et a une incidence croissante de 8% chaque année, ce qui en fait la 10ème cause de mortalité mondiale, et la première en service de réanimation médicale. C’est un véritable problème de santé public pour lequel il n’y a aucun traitement spécifique disponible aujourd’hui pour cette indication. Seuls les antibiotiques et des traitements symptomatiques sont disponibles. Inotrem développe une nouvelle approche prometteuse, un inhibiteur de TREM-1 ayant démontré son potentiel thérapeutique dans de nombreux modèles précliniques de sepsis.

Inotrem travaille également sur une approche de médecine personnalisée grâce au développement de biomarqueurs spécifiques qui permettront de stratifier et d’identifier les patients qui bénéficieront du traitement.

Cette levée supportera le développement pré-clinique et clinique précoce de l’inhibiteur de TREM-1 dans le sepsis ainsi que son potentiel thérapeutique dans d’autres maladies inflammatoires.

Le Dr Jean-Jacques Garaud, Directeur Général d’Inotrem, et ancien Directeur de la Recherche et du Développement Précoce chez Roche, commente : « Notre objectif principal est de fournir à la communauté médicale de nouveaux traitements efficaces pour combattre cette pathologie dévastatrice qu’est le sepsis. Inotrem développe une des approches les plus prometteuses dans le domaine, et nous sommes très fiers d’avoir pu réunir un syndicat d’investisseurs aussi prestigieux ».

 

Press contact for Sofinnova Partners

ANNE REIN | STRATEGIES & IMAGE
anne.rein@strategiesimage.com +33 6 03 35 92 05

11/03/2014

Dublin based medical device company hits key milestone.

Dublin – Ireland, 10th March 2014 – Mainstay Medical today announced that it has secured approval from Ethics Committees in Australia to start a clinical trial of ReActiv8, its innovative implantable neurostimulation device for the treatment of people with Chronic Low Back Pain (CLBP). Recruitment of subjects for the trial has commenced at three clinical sites in Australia.
The purpose of the clinical trial is to investigate ReActiv8 as a treatment for adults with debilitating Chronic Low Back Pain for whom surgery is not indicated.
One of the root causes of CLBP is impaired control by the nervous system of the muscles that stabilize the spine in the lower back, and an unstable spine can lead to back pain. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles and thereby help to restore muscle control and improve spine stability, allowing the body to recover from chronic low back pain.
“Our novel approach of electrical stimulation to help restore the muscle control system is based on published scientific research, and the performance of the therapy was demonstrated in the recently completed European Feasibility Study.” said Peter Crosby, the CEO of Mainstay Medical. “The energy and experience of the Mainstay Medical team has enabled us to complete the development of our innovative, therapy-specific device and obtain approval to start the ReActiv8 clinical trial within a year after the Feasibility Study results.”
People with debilitating CLBP usually have a greatly reduced quality of life and score significantly higher on scales for disability, depression, anxiety and sleep disorders. Their pain and disability can persist despite the best available medical treatments, and most of these people have no indications for spine surgery. Their ability to work or be productive is seriously affected by the condition and the resulting days lost from work, disability benefits and health resource utilisation put a significant burden on economies.
“Back pain specialists from all over the world have told us that they need a new approach to help the large group of people with CLBP who are stranded without a viable alternative. We believe, based on published research, that there are millions of such people in Europe and the USA today. The results of the European Feasibility Study encouraged us to believe that ReActiv8 can play an important role in helping these people,” Crosby mentioned.
Results from Mainstay Medical’s European Feasibility Study were presented at the meeting of the International Neuromodulation Society in Berlin in June 2013. Results showed a statistically significant and clinically important improvement in key outcome measures, including reduction in pain and disability from CLBP and an improved quality of life.

About Mainstay Medical Ltd
Mainstay Medical Limited is a medical device company which is developing an innovative implantable neurostimulation medical device, ReActiv8, for people with debilitating Chronic Low Back Pain (CLBP). Low Back Pain is the leading cause of activity limitation and work absence throughout much of the developed world, imposing a high economic burden on individuals, families, communities, industry, and governments. The Company is headquartered in Dublin, Ireland and has subsidiaries operating in the United States and Australia. Mainstay Medical is backed by investors including Sofinnova Partners (France), Fountain Healthcare Partners (Ireland), Medtronic (US), Capricorn Venture Partners (Belgium), Seventure Partners (France) and Twin Cities Angels (Minneapolis, USA).

Further information can be found at www.mainstay-medical.com

Media queries to:
Eilish Joyce, FTI Consulting
Tel: +353 1 663 3609 / +353 87 7914641
Email: eilish.joyce@fticonsulting.com
Paul McSharry, FTI Consulting
Tel: +353 1 663 3609 / +353 87 240 6642
Email: paul.mcsharry@fticonsutling.com
Jeanne Bariller, FTI Consulting
Tel: +33 1 47 03 6863 / +33 67 412 4452
Email: jeanne.bariller@fticonsulting.com

10/03/2014

Basel, Switzerland, March 10, 2014 – Auris Medical today announced enrollment of the first patient into the TACTT21 clinical trial. This phase 3 trial will evaluate the efficacy, safety and tolerability of intratympanic injections of AM-101 in the treatment of acute peripheral tinnitus following traumatic coch-lear injury or otitis media. TACTT2 will enroll 330 patients at more than 60 sites primarily in the United States and Canada. The initiation of the TACTT2 trial follows shortly after the start of TACTT3, its European counterpart. Both have been designed as pivotal double-blind, placebo-controlled trials and are part of Auris Medical’s phase 3 development program with AM-101. All participants completing one of the TACTT studies and continuing to meet certain criteria will be eligible to enter an open label safety study (AMPACT1, respectively AMPACT2)2 and receive up to three treatment cycles with AM-101 over up to nine months.

Thomas Meyer, Auris Medical’s founder and CEO, commented: “It is an exciting moment for the company to have both phase 3 trials underway. TACTT2 and TACTT3 are based on more than 10 years of research and development and represent the largest clinical trials ever conducted with an intratympanic treatment.” He added: “The phase 3 program will be an essential step in our quest for developing the first specific thera-peutic for acute peripheral tinnitus, a condition without any effective and safe treatment options. We ex-pect results from both TACTT2 and TACTT3 trials in late 2015.”

About acute peripheral tinnitus
Tinnitus, the perception of sound without external acoustic stimulation, is a symptom common to various ear or other diseases. Peripheral (inner ear) tinnitus may be provoked by various injuries to the cochlea, the organ of hearing, such as overexposure to noise or inflammation. It may be short and just transitory; how-ever, it may also become permanent. Tinnitus of less than three months of duration is considered acute, while older tinnitus is considered chronic. Peripheral tinnitus may be only a slight nuisance, but often it has a serious impact on the ability to sleep, relax, or concentrate, or it may lead to tiredness, irritation, nervousness, despair, frustration, or even depres-sion. As of today, there exists neither a universal standard of care for acute inner ear tinnitus, nor a truly proven, effective treatment method.

About AM-101
AM-101 is a small molecule N-methyl-D-aspartate (NMDA) receptor antagonist formulated in a biocompat-ible gel for intratympanic injection. Emerging evidence suggests that NMDA receptors in the cochlea play a major role in the occurrence of tinnitus following inner ear excitotoxicity, which is characterized by exces-sive synaptic release of glutamate, the principal neurotransmitter in the auditory system. Cochlear excitotoxicity may be triggered by, for example, trauma (e.g. exposure to excessive noise),
neuroinflammation, disturbances in inner ear blood supply (anoxia/ischemia), or the administration of certain ototoxic drugs. It has been proposed that the upregulation of NMDA receptors induced by cochlear excitotoxicity is responsible for aberrant excitation of auditory nerve fibers, which is perceived as tinnitus.
The development of AM-101 is based on research conducted at the INSERM Institute for Neurosciences of Montpellier, France. The clinical development of AM-101 was initiated by Auris Medical in 2007 and comprises three clinical trials to date. In 2013, Auris Medical reached agreement with the US Food and Drug
Administration (FDA) under a Special Protocol Assessment (SPA) for its pivotal TACTT2 study. Patents have been granted in more than 30 countries worldwide so far.

About Auris Medical
Auris Medical is a Swiss biopharmaceutical company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology. The Company is currently focusing on the development of treatments for acute peripheral tinnitus (AM-101) and for acute inner ear hearing loss (AM-111) by way of intratympanic injection with biocompatible gel formulations. In addition, Auris Medical is pursuing earlystage research and development projects. The Company was founded in 2003 and is headquartered in Basel, Switzerland.

Contact:
Dr. Thomas Meyer, CEO, ear@aurismedical.com
Gretchen Schweitzer, MacDougall Biomedical Communications, +49 172 861 8540
gschweitzer@macbiocom.com

21/02/2014

Basel, Switzerland, February 21, 2014 – Auris Medical today announced enrollment of the first patient into in the TACTT31 clinical trial – a phase 3 study designed to evaluate the efficacy, safety and tolerability of intratympanic injections of AM-101 in the treatment of acute peripheral tinnitus following traumatic cochlear injury or otitis media. The TACTT3 study will enroll 600 patients at more than 60 European sites: 300 during the acute tinnitus stage (up to 3 months from onset) and 300 during the post-acute tinnitus stage (4 to 12 months from onset).
It is one of two pivotal double-blind, placebo-controlled trials in Auris Medical’s phase 3 development pro-gram with AM-101. The second study, TACTT2, is expected to start enrollment in the United States and Can-ada shortly. All participants completing one of the TACTT studies and continuing to meet certain criteria will be eligible to enter an open label safety study (AMPACT1, respectively AMPACT2)2 and receive up to 3 treatment cycles with AM-101 over up to 9 months.
Thomas Meyer, Auris Medical’s founder and CEO, commented: “Acute peripheral tinnitus seriously affects the wellbeing and quality of life of many people around the world and represents a significant unmet medi-cal need. TACTT3 will be a major milestone on our way towards the development of the first specific thera-peutic for this condition,” he added. Results from TACTT3 are expected in late 2015.

About acute peripheral tinnitus
Tinnitus, the perception of sound without external acoustic stimulation, is a symptom common to various ear or other diseases. Peripheral (inner ear) tinnitus may be provoked by various injuries to the cochlea, the organ of hearing, such as overexposure to noise or inflammation. It may be short and just transitory; how-ever, it may also become permanent. Tinnitus of less than three months of duration is considered acute, while older tinnitus is considered chronic.
Peripheral tinnitus may be only a slight nuisance, but often it has a serious impact on the ability to sleep, relax, or concentrate, or it may lead to tiredness, irritation, nervousness, despair, frustration, or even depres-sion. As of today, there exists neither a universal standard of care for acute inner ear tinnitus, nor a truly proven, effective treatment method.

About AM-101
AM-101 is a small molecule N-methyl-D-aspartate (NMDA) receptor antagonist formulated in a biocompat-ible gel for intratympanic injection. Emerging evidence suggests that NMDA receptors in the cochlea play a major role in the occurrence of tinnitus following inner ear excitotoxicity, which is characterized by exces-sive synaptic release of glutamate, the principal neurotransmitter in the auditory system. Cochlear excitotoxicity may be triggered by, for example, trauma (e.g. exposure to excessive noise), neuroinflammation, disturbances in inner ear blood supply (anoxia/ischemia), or the administration of cer-tain ototoxic drugs. It has been proposed that the upregulation of NMDA receptors induced by cochlear excitotoxicity is responsible for aberrant excitation of auditory nerve fibers, which is perceived as tinnitus.

The development of AM-101 is based on research conducted at the INSERM Institute for Neurosciences of Montpellier, France. The clinical development of AM-101 was initiated by Auris Medical in 2007 and com-prises 3 clinical trials to date. In 2013, Auris Medical reached agreement with the US Food and Drug Admin-istration (FDA) under a Special Protocol Assessment (SPA) for its pivotal TACTT2 study. Patents have been granted in more than 30 countries worldwide so far.

About Auris Medical
Auris Medical is a Swiss biopharmaceutical company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology. The Company is currently focusing on the development of treatments for acute peripheral tinnitus (AM-101) and for acute inner ear hearing loss (AM-111) by way of intratympanic injection with biocompatible gel formulations. In addition, Auris Medical is pursuing early-stage research and development projects. The Company was founded in 2003 and is headquartered in Basel, Switzerland.

Contact:
Dr. Thomas Meyer, CEO, ear@aurismedical.com
Gretchen Schweitzer, MacDougall Biomedical Communications, +49 172 861 8540
gschweitzer@macbiocom.com