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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/

18/02/2014

BAGNEUX, FRANCE, le 18 février 2014 – DBV Technologies (Euronext : DBV – ISIN : FR0010417345), créateur de Viaskin®, nouvelle référence dans le traitement de l’allergie, a annoncé aujourd’hui la signature d’un accord de collaboration avec l’Icahn School of Medicine, de New-York, visant à étudier l’efficacité et le mécanisme de tolérance épicutanée induit par Viaskin® pour le traitement de la maladie de Crohn.

La maladie de Crohn est une affection chronique qui, en l’absence de traitement satisfaisant, fait l’objet de recherches intenses afin d’améliorer la qualité de vie des patients qui en sont atteints. DBV a déjà démontré, à travers plusieurs études précliniques, que l’immunothérapie par voie épicutanée (EPITTM) constituait une voie originale et robuste d’activation des cellules immunitaires régulatrices innées et acquises. Des travaux préliminaires ont démontré que ces cellules jouent un rôle dans la protection de l’intestin contre l’inflammation. DBV s’est associé à l’équipe de l’hôpital Mount Sinai, reconnue dans le monde entier pour sa connaissance des mécanismes cellulaires impliqués dans la maladie de Crohn. Ces chercheurs ont, en outre, déjà démontré que l’administration de cellules T-régulatrices à des patients atteints d’une forme sévère de la maladie de Crohn était bien tolérée et efficace. Ce projet permettra, en conjuguant la technologie de DBV et l’expertise de l’équipe de l’hôpital Mount Sinai, de développer une approche innovante d’induction de la tolérance et de réduction de l’inflammation intestinale.

Pr Jean-Frédéric Colombel, Directeur de la Fondation Leona M. et Harry B. Helmsley, Centre dédié aux maladies inflammatoires de l’intestin de l’hôpital Mount Sinai (New-York, NY, USA), commente, « Nous sommes très heureux de cette collaboration. Le besoin médical dans la maladie de Crohn est immense et largement non satisfait à ce jour. Cette nouvelle technologie permettrait d’offrir de nouvelles opportunités aux patients et de proposer une approche originale visant à amplifier l’effet de cellules immunitaires régulatrices au lieu de cibler la suppression immunitaire et ses effets secondaires potentiels associés. »

Dr David Dunkin, Professeur adjoint de Pédiatrie dans le Département de Gastro-entérologie pédiatrique de l’école de médecine Icahn du Mount Sinai (New-York, NY, USA), commente, « Cette collaboration est passionnante car elle ouvre de nouvelles voies dans le traitement de la maladie de Crohn en utilisant la réponse immunitaire normale d’un patient pour traiter la maladie. Grâce à la technologie de DBV et à l’expertise scientifique des deux institutions travaillant en collaboration, nous espérons un jour offrir à nos patients une nouvelle thérapie sûre pour le traitement de la maladie de Crohn. »

Dr Pierre-Henri Benhamou, Président Directeur Général de DBV Technologies, commente : « L’hôpital Mount Sinai est l’un des grands pôles de gastro-entérologie dans le monde et à l’avant-garde de la recherche sur la maladie de Crohn. Nous sommes fiers de contribuer, avec le Pr Colombel et le Dr Dunkin, au développement d’une nouvelle approche basée sur Viaskin® pour lutter contre cette maladie grave, pour laquelle aucune alternative thérapeutique n’est disponible aujourd’hui. Notre collaboration avec ce centre d’excellence dans ce nouveau domaine de recherche va sans nul doute renforcer le potentiel de la plate-forme Viaskin et démontrer sa capacité à induire une modulation profonde et durable du système immunitaire. »

Cette collaboration va étudier une nouvelle approche de traitement de la maladie de Crohn basée sur l’administration épicutanée par Viaskin® dont l’effet d’induction sur les cellules T-régulatrice a été largement documenté. Les études précliniques auront pour objectif de :
-évaluer la capacité de l’induction épicutanée de la tolérance avec Viaskin® à traiter la colite inflammatoire ;
-déterminer la capacité fonctionnelle des Treg spécifiques à l’antigène induites par l’exposition épicutanée avec Viaskin® à éliminer les réponses inflammatoires dans l’intestin ;
-acquérir une meilleure connaissance des mécanismes mis en jeu.
Ces activités et études devraient durer au moins 12 mois.

À propos de la maladie de Crohn
La maladie de Crohn est une inflammation chronique du tube digestif, qui se caractérise par des douleurs abdominales, de la diarrhée et différentes complications digestives et non digestives, avec alternance de poussées et de rémissions. L’incidence de la maladie de Crohn est en augmentation, en particulier chez les jeunes enfants et les nourrissons, ce qui constitue un problème de société croissant. Cette maladie est plus courante dans les pays du nord-ouest de l’Europe, où l’incidence est comprise entre 1 et 10/100 000 et la prévalence est d’environ 1-0,5/1 000. La maladie de Crohn affecte les hommes et les femmes et son diagnostic est généralement établi entre 20 et 30 ans.

À propos des investigateurs de l’école de médecine Icahn du Mount Sinai à New-York
Pr Colombel est particulièrement reconnu pour sa participation à l’identification des NOD2 comme gène impliqué dans la maladie de Crohn, à celle d’un nouveau sous-type d’Escherichia coli associée à la maladie de Crohn, ainsi qu’au développement d’un test anticorps anti-Saccharomyces cerevisiae (ASCA) qui reste le marqueur le plus sensible et spécifique pour le dépistage de la maladie de Crohn. Il est l’auteur ou le coauteur de plus de 500 articles et de livres sur les maladies inflammatoires de l’intestin.
Dr Dunkin est Professeur adjoint de Pédiatrie du Département de Gastro-entérologie pédiatrique. Dr Dunkin a obtenu son diplôme de premier cycle à l’Université Cornell et son doctorat de médecine à l’école de médecine de Sackler. Il a ensuite complété sa formation en pédiatrie à l’Hôpital pédiatrique de Yale puis en gastro-entérologie pédiatrique au Mont Sinaï. Dr Dunkin s’est ensuite orienté vers la recherche sous la direction du Dr Lloyd Mayer. Ses travaux visent à comprendre les mécanismes par lesquels le corps humain développe ou non une tolérance aux allergènes, y compris la nourriture et la flore intestinale qui mène à des maladies telles que les allergies et les maladies inflammatoires de l’intestin. Il a publié des travaux sur la sensibilisation par la peau et a publié plusieursarticles avec ses collaborateurs du Centre de médecine chinoise, étudiant l’utilisation de thérapies à base de plantes chinoises pour le traitement des maladies inflammatoires de l’intestin.

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 désensibili ation 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 ‘FastTrack 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

Avertissement
Les prévisions, objectifs et cibles contenus dans ce document sont établis selon la stratégie du management de la Société, ses opinions et hypothèses actuelles. De telles déclarations impliquent des risques connus et inconnus et des incertitudes qui pourraient faire différer les résultats, performances et événements actuels de ce qui est anticipé ci-dessus. En outre, le processus de R&D implique différentes étapes, lesquelles induisent un risque substantiel que la Société puisse ne pas tenir ses objectifs et soit amenée à abandonner ses efforts sur un produit, dans lequel auraient été investis des montants significatifs. De plus, la Société ne peut pas être certaine que des résultats obtenus durant les études pré-cliniques, bien que favorables, soient confirmés par la suite par les études cliniques, ou que les résultats des études cliniques soient suffisants pour démontrer l’innocuité et la nature du produit concerné.
L’activité de DBV Technologies est sujette aux facteurs de risques soulignés lors de l’enregistrement de ses documents signés par l’Autorité des Marchés Financiers.

Contacts de DBV
David Schilansky
Directeur Administratif et
Financier
DBV Technologies
Tél. : +33(0)1 55 42 78 75
david.schilansky@dbvtechnologies.

Contact du Mount Sinai
Sid Dinsay
sid.dinsay@mountsinai.org
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.comcaroline@alizerp.com

12/02/2014

C’est la troisième IPO réussie en moins d’un an d’une société du portefeuille après BioAmber et Omthera Pharmaceuticals

Paris, le 12 février 2014. Sofinnova Partners, société de capital-risque basée à Paris, annonce le succès de l’introduction en bourse de Flexion Therapeutics sur le NASDAQ Global Market à New York. L’opération qui a permis de lever 65 M$ (47,6 M€) a porté sur 5 millions de titres dont le prix a été fixé à 13$. La cotation des titres démarrera le 12 février 2014 sous le symbole “FLXN.” C’est la troisième introduction en bourse en un an d’une société du fonds Sofinnova Fund VI, après BioAmber qui a levé 80 M$ (62 M€) sur le NYSE New York en mai 2013 et Omthera Pharmaceuticals qui a levé 64 M$ (49 M€) sur le NASDAQ Global Market à New York en avril 2013.

Crée en 2007, et basé à Woburn (Massachussets, Etats Unis), Flexion est spécialisé dans le développement et la commercialisation de produits thérapeutiques innovants pour les troubles musculo-squelettiques tels que l’ostéoarthrite, une maladie dégénérative pour laquelle il n’existe à ce jour aucun remède efficace. La technologie propriétaire que développe Flexion vise à fournir un traitement analgésique local d’une efficacité supérieure sur la durée tout en réduisant les effets annexes systémiques. En l’absence de traitement, il est fondamental de contrôler la douleur et retarder le moment de l’intervention chirurgicale. Il y a 27 millions d’américains et plus de 100 millions de personnes à travers le monde qui souffrent de ce handicap; un nombre qui a vocation à progresser avec le vieillissement de la population, la tendance au surpoids et l’accroissement des blessures liées au sport. Grâce à ses thérapies innovantes, tournées vers le patient, Flexion a le potentiel de devenir un leader sur son marché. Les deux cofondateurs de Flexion, le Dr Clayman, DG, et le Dr. Bodick, directeur médical, bénéficient d’une expérience reconnue dans le domaine du développement des thérapies innovantes. Le Dr Clayman était précédemment Vice Président de Lilly Research Laboratories et Directeur Général de Chorus; le Dr Bodick a crée Chorus. Le principal produit de Flexion, le FX006, est un stéroïde à longue durée d’action intra-articulaire pour les patients souffrants de douleurs d’ostéoarthrites modérées et sévères. La société développe deux autres produits, le FX007 pour les douleurs post-opératoires, et le FX005 pour les patients aux stades les plus avancés d’ostéoarthrite. Les fonds levés font permettre d’accélérer le développement clinique et commercial de ces produits.

Rafaèle Tordjman, Partenaire Associée de Sofinnova Partners, déclare: « Nous sommes ravis d’avoir accompagné Flexion depuis la série A et tout au long du processus d’IPO. Flexion illustre parfaitement la stratégie d’investissement de Sofinnova Partners: des fondateurs et une équipe exceptionnels qui se concentrent sur des technologies de rupture sur des marchés porteurs ».

L’introduction en bourse de Flexion Therapeutics porte sur la totalité de ses actions. La société a également attribué aux souscripteurs une option pendant 30 jours pour acquérir jusqu’à 750 000 actions supplémentaires. La clôture de l’offre est prévue le 18 février 2014, dans les conditions habituelles de marché. Pour d’avantage d’information, veuillez-vous référer au communiqué publié par Flexion Therapeutics.


A propos de Sofinnova Partners
Sofinnova Partners est une société de capital-risque indépendante basée à Paris. Depuis 40 ans, la société a financé près de 500 sociétés – start-up, spin-off et opérations de retournement. Elle a accompagné les plus grands entrepreneurs européens dans le domaine des sciences de la vie. Avec 1,3 milliard d’euros sous gestion, l’équipe de Sofinnova Partners, reconnue pour sa capacité à aider et à soutenir les entreprises de son portefeuille de la création à la sortie, a permis l’émergence de leaders sur leurs marchés. 
sofinnova.social-unit.fr

A propos de Flexion Therapeutics 
Flexion est une société spécialisée dans le développement de produits thérapeutiques innovants pour les troubles musculo-squelettiques. La société vise à fournir des produits avec une efficacité et une sécurité supérieures. La société développe un portefeuille de candidats-médicaments best-in-classe qui ont le potentiel de traiter les formes légères, modérées et sévères de l’ostéoarthrite. Le principal produit de Flexion, le FX006, est un stéroïde intra-articulaire à longue durée d’action pour les patients souffrants de douleurs ostéoarthrites modérées et sévères. La société développe deux autres produits, le FX007 pour les douleurs post-opératoires, et le FX005 pour les patients aux stades les plus avancés d’ostéoarthrite. 
http://flexiontherapeutics.com

 

 

12/02/2014

Burlington, MASS., February 11, 2014 – Flexion Therapeutics, Inc. (Nasdaq: FLXN) announced today the pricing of its initial public offering of 5,000,000 shares of common stock at a price to the public of $13.00 per share. The shares are scheduled to begin trading on the NASDAQ Global Market under the ticker symbol “FLXN” on February 12, 2014. Flexion is offering all of the shares of common stock. Flexion has also granted the underwriters a 30-day option to purchase up to an additional 750,000 shares of common stock. The offering is expected to close on February 18, 2014, subject to customary closing conditions.
BMO Capital Markets and Wells Fargo Securities, LLC are acting as joint book-running managers. Needham & Company and Janney Montgomery Scott are acting as co-managers. 
The Securities and Exchange Commission declared effective a registration statement relating to these securities on February 11, 2014. The offering is being made only by means of a prospectus. A copy of the prospectus relating to the offering may be obtained from BMO Capital Markets Corp., 3 Times Square, New York, NY 10036, Attention: Equity Syndicate Department, Telephone: (800) 414-3627, Email: bmoprospectus@bmo.com; or from Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York, 10152, Telephone: (800) 326-5897, Email: cmclientsupport@wellsfargo.com.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Flexion Therapeutics
Flexion is a clinical-stage specialty pharmaceutical company focused on the development and commercialization of novel pain therapies. The company is currently advancing a portfolio of drug candidates that together have the potential to treat mild, moderate and severe forms of pain. The company’s lead program, FX006, is an intra-articular sustained release steroid in development for patients with moderate to severe osteoarthritis pain. The company is developing two additional product candidates, FX007, a locally administered TrkA receptor antagonist for post-operative pain, and FX005, an intra-articular, sustained-release p38 MAP kinase inhibitor for end-stage osteoarthritis patients.

Media Contact
Jamie Lacey-Moreira
PressComm PR, LLC
T: 410-299-3310
jamielacey@presscommpr.com

Corporate Contact
Lisa Davidson, MBA
Vice President, Finance and Administration
Flexion Therapeutics,
T: 781-305-7765
ldavidson@flexiontherapeutics.com

29/01/2014

New CE-marked Generator and 5Fr Radial Artery Catheter bring innovation to the field of Renal Denervation

PALO ALTO,Calif. and AMSTERDAM, Jan. 28,2014 – ReCor Medical today announced major advances in its Paradise System™ for renal denervation (RDN), confirming its commitment to lead in the treatment of patients with resistant hypertension (HTN). The Company announced that it has received CE-mark for the latest generation of its ultrasound-based renal denervation system. The first patients were treated with the new system in December, 2013 at the Universitats–Herzzentrum, Bad Krozingen, Germany, by Professor Thomas Zeller, MD and Dr. Elias Noory, MD. « The initial procedures with the new Paradise System highlighted the new generator’s ability to automatically customize energy delivery based on the patient’s artery size while maintaining a consistent level of cooling protection, » saidProf. Zeller and Dr. Noory. « Our first patient treated with the new Paradise System was a non-responder of two different radio frequency-based procedures. We are optimistic that the circumferentialenergydelivery of the Paradise ultrasound system will provide a more reliable treatment. » ReCor also announced the first use of its new catheter line, called Radiance, which is 5Fr and rapid-exchange compatible, and thus sized to be introduced via the radial artery – as opposed to the femoral artery. « Last Friday’s procedures using the new Radiance catheter with access via the radial artery marks a significant new approach to making the RDN procedure quicker, safer, and potentially more cost-effective for hospitals and patients, » remarked Drs. Nicolas Van Mieghem and Joost Daemen from Erasmus Medical Center in Rotterdam, the Netherlands, who performed the first radial procedure. « This system’s radial artery access and 10 second ablation time should allow us to treat a patient in a minimally invasive way within 30 minutes, and then let that patient go home the same day. » The Paradise System is the only CE-Marked RDN system that uses radial ultrasound as its energy source – as opposed to radio frequency (RF) electrical energy – together with water-based convective cooling, allowing for the potential of faster procedures, more thorough renal denervation, and improved vessel safety. « Following the recent publication of negative results from one of the RDN clinical trials, some competitors have announced that they are either delaying, reducing or abandoning efforts to commercialize their RF-based RDN products. Having reviewed our own clinical results and spoken to clinicians who have collectively treated hundreds of patients with resistant hypertension using different RDN systems, ReCor is convinced that our product is well-differentiated from these RF-based approaches, » said ReCor Medical President & CEO, Andrew M. Weiss. « We remain convinced that RDN has the potential to become a key component of HTN therapy, and believe that our Paradise System provides the safe, reliable and complete denervation needed to become the category leader in this field. »

About ReCor Medical, Inc. ReCor Medical is a private, venture-backed medical device company offering a novel therapeutic ultrasound ablation system for RDN. ReCor Medical is backed by European and U.S. investors includingSofinnova Partners, one of the largest life science investors in Europe, and offers its technology through dealers in Scandinavia, northern Europe and Italy. RDN is a new therapeutic option for treatment of hypertension, one of the most prevalent global medical conditions. The Company’s CE-Marked PARADISE® System is unique in its use of a radial ultrasound energy source with water based cooling to simultaneously provide circumferential energy delivery and convective cooling for denervation of the renal nerves and arterial protection.

For more information about ReCor Medical, please visit www.recormedical.com. TheParadise® System is approved for sale in Europe; it is not approved for sale or investigational use in the United States. For additional information, contact Andrew M. Weiss, President & CEO, ReCor Medical, Inc. +1-650-542-7700. SOURCE ReCor Medical, Inc.

28/01/2014

Les fonds vont permettre le développement du cathéter de Lithoplasty™destiné au traitement de patients souffrants de calcification vasculaire importante et de cardiopathies valvulaires.

Fremont, Californie (Etats Unis) et Paris (France), 10 janvier 2014. Shockwave Medical, Inc. (“Shockwave”), spécialisé dans l’instrumentation médicale intravasculaire pour les patients atteints de calcification cardiovasculaire a levé 9,2 M€ (12,5 M$) lors d’un financement de série A mené par Sofinnova Partners, qui devient le principal investisseur. A cette occasion, Antoine Papiernik de Sofinnova Partners rejoint le Conseil d’administration de la société.
Shockwave a été créé par Daniel Hawkins, John Adams et Dr. Todd Brinton. Précédemment, Daniel Hawkins a cofondé Calibra Medical, vendue à Johnson & Johnson en 2012. Figure de l’instrumentation médicale, Daniel Hawkins travaille dans le domaine depuis plus de 20 ans pour des entreprises telles Intuitive Surgical et Advanced Cardiovascular Systems (Abbott Vascular). Serial entrepreneur, actif dans le secteur depuis plus de 35 ans, John Adams a cofondé Calibra Medical, Endogastric Solutions et InControl (vendu à Guidant en 1998). Dr. Brinton est un éminent clinicien, cardiologue interventionnel à l’Université de Stanford. Il est également Co-directeur du programme de « Biodesign Innovation » à Stanford. Les fonds levés vont permettre de poursuivre le développement et les essais cliniques de la technologie développée par Shockwave pour traiter les maladies artérielles coronariennes et périphériques graves. Le système Lithoplasty™ combine la facilité des ballons cathéters d’angioplastie traditionnels avec la puissance de la lithotripsie qui permet de traiter les calcifications vasculaires ; il propose une alternative simple face aux limites des cathéters et traitements pharmaceutiques actuels. En développement depuis 2010, le système Lithoplasty™ a fait l’objet de premiers essais sur des patients atteints de maladies artérielles périphériques (MAP) graves en 2012 en Nouvelle Zélande. La société s’apprête à démarrer le processus clinique en Europe en vue d’un marquage CE.
Mr. Hawkins, PDG de Shockwave, déclare : “ ce financement important mené par Sofinnova Partners va permettre de finaliser les essais cliniques sur les MAP en vue d’une autorisation réglementaire. Shockwave prévoit de déployer sa technologie sur d’autres pathologies avec une approche innovante qui a le potentiel de devenir un standard pour traiter les calcifications vasculaires et valvulaires ”.
Dr. Andrew Holden, qui a dirigé les premiers essais cliniques humains du système de Lithoplasty™, poursuit : “ la technologie de Shockwave répond à l’un des principaux défis pour traiter les patients atteints de maladies artérielles vasculaires en proposant une solution simple et efficace sur le plan technique, et peu invasive pour le patient ».
Fred Moll, Président du Conseil d’administration de Shockwave, indique : “ Avec ce closing, l’équipe de Shockwave a désormais les moyens de développer leur approche technologique particulièrement innovante permettant d’améliorer le traitement de patients souffrants de pathologies cardiovasculaires graves ”.
Antoine Papiernik, Partner Associé chez Sofinnova Partners déclare : “alors que les médecins sont face à des patients présentant des calcifications vasculaires et valvulaires de plus en plus complexes, nous pensons que la technologie de Shockwave apporte une solution pertinente face à des besoins grandissants. Nous sommes ravis de nous associer à Shockwave et contribuer à réaliser leur vision ».

Contact for Shockwave Medical
Daniel Hawkins, CEO
510-279-4262

Contact pour Sofinnova Partners
STRATEGIES & IMAGE | Anne Rein
anne.rein@strategiesimage.com
+33 6 03 35 92 05

A propos de Shockwave Medical
Shockwave Medical développe Lithoplasty™, une gamme de ballons cathéters de dilatation qui incorporent de minuscules électrodes de lithotripsies conçues pour améliorer l’adhésion des rigidités vasculaires et lésions vasculaires en amont d’une dilatation à basse pression. Cette approche limite les atteintes aux tissus sains et évite de nombreux inconvénients associés aux techniques actuelles de revascularisation. S’appuyant sur un dispositif de ballon cathéter traditionnel, la technologie de Shockwave est simple et facile à utiliser à la fois par les cardiologues, les cardiologues interventionnistes et les chirurgiens vasculaires.
Pour en savoir plus, consultez www.shockwavemedical.com

A propos de Sofinnova Partners
Sofinnova Partners est une société de capital-risque indépendante basée à Paris. Depuis plus de 40 ans, la société a financé près de 500 sociétés – start-up, spin-off et opérations de retournement. Elle a accompagné les plus grands entrepreneurs européens dans le domaine des sciences de la vie. Avec 1,3 milliard d’euros sous gestion, l’équipe de Sofinnova Partners, reconnue pour sa capacité à aider et à soutenir les entreprises de son portefeuille de la création à la sortie, a permis l’émergence de leaders sur leurs marchés.
Pour en savoir plus, consultez sofinnova.social-unit.fr

28/01/2014

BAGNEUX, France, 28 janvier 2014  DBV Technologies (Euronext : DBV – ISIN : FR0010417345), créateur de Viaskin®, nouvelle référence dans le traitement de l’allergie, a annoncé aujourd’hui la présentation de cinq communications sur sa technologie propriétaire lors de la conférence annuelle de l’AAAAI (American Academy of Allergy, Asthma & Immunology) qui se tiendra à San Diego en Californie du 28 février au 4 mars 2014. Les résumés seront également publiés dans le supplément de février 2014 du Journal of Allergy and Clinical Immunology (JACI).

Pierre-Henri Benhamou, Président-directeur général de DBV Technologies, a déclaré : « DBV enrichit en permanence ses connaissances sur l’immunothérapie épicutanée (EPITTM). Nous sommes fiers de présenter à l’occasion de la conférence annuelle de l’AAAAI, en collaboration avec l’équipe du Mount Sinai Hospital, des résultats précliniques révolutionnaires démontrant l’efficacité du mécanisme d’action de Viaskin®. Nous avons réussi à caractériser les mécanismes cellulaires clés et les modulations épigénétiques induites par l’EPIT. Nous pensons que ces découvertes sont de nature à modifier en profondeur le futur de l’immunothérapie et du traitement de l’allergie.»

Quatre posters sur la technologie de DBV et son mode d’action seront présentés ; ils démontrent que l’EPITTM agit comme un agent immunomodulateur puissant et durable, opérant sur l’expression de l’ADN par des modifications épigénétiques.

• La communication « Epicutaneous Immunotherapy Induces Epigenetic Changes In Sensitized Mice » sera exposée oralement par le Dr Lucie Mondoulet lors d’une session orale de posters (Numéro : 1000, Session n° : 5606, Titre de la session : New Forms of Immunotherapy, le mardi 4 mars 2014 de 14h30 à 14h45).

• La communication « Epicutaneous Immunotherapy-Induced Regulatory T Cells Could Migrate To More Various Sites Of Allergen Exposure Compared To Sublingual Or Subcutaneous Immunotherapy In Mice Sensitized To Peanut » sera présentée par le Dr Vincent Dioszeghy lors d’une session de posters (Numéro : 172, Session n° : 2211, Titre de la session : Oral Immunotherapy, dans le hall d’exposition B2, rez-de-chaussée, San Diego Convention Center, le samedi 1er mars 2014 de 9h45 à 10h45)

• La communication « Long Term Protection Against New Sensitization After Milk-Epit In Mice Sensitized To Milk Is Mediated By Tregs » sera présentée par le Dr Lucie Mondoulet lors d’une session de posters (Numéro : 171, Session n° : 2211, Titre de la session : Oral Immunotherapy, dans le hall d’exposition B2, rez-de-chaussée, San Diego Convention Center, le samedi 1er mars 2014 de 9h45 à 10h45)

• La communication « De Novo Generation Of Gastrointestinal Regulatory T Cells In Response To OIT and ???I?» sera présentée par le Dr Cécilia Berin de l’Icahn School of Medicine at Mount Sinai, Jaffe Food Allergy Institute, New York, États-Unis, lors d’une session de posters (Numéro : 170, Session n° : 2211, Titre de la session : Oral Immunotherapy, dans le hall d’exposition B2, rez-de-chaussée, San Diego Convention Center, le samedi 1er mars 2014 de 9h45 à 10h45)

Le Pr Christophe Dupont, investigateur principal pour l’étude pilote de phase II Arachild de l’Assistance Publique – Hôpitaux de Paris (AP-HP) sur Viaskin Peanut présentera :

• « Peanut Epicutaneous Immunotherapy (EPITTM) In Peanut-Allergic Children: 18 Months Treatment In The Arachild Study » lors d’une session de posters (Numéro : 357, Session n° : 3207, Titre de la session : Food Allergy I, dans le hall d’exposition B2, rez-de-chaussée, San Diego Convention Center, le dimanche 2 mars 2014 de 9h45 à 10h45). Aucune donnée plus récente que celles communiquées à ce jour ne sera communiquée au cours de cette session.

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

Avertissement
Les prévisions, objectifs et cibles contenus dans ce document sont établis selon la stratégie du management de la Société, ses opinions et hypothèses actuelles. De telles déclarations impliquent des risques connus et inconnus et des incertitudes qui pourraient faire différer les résultats, performances et événements actuels de ce qui est anticipé ci-dessus. En outre, le processus de R&D implique différentes étapes, lesquelles induisent un risque substantiel que la Société puisse ne pas tenir ses objectifs et soit amenée à abandonner ses efforts sur un produit, dans lequel auraient été investis des montants significatifs. De plus, la Société ne peut pas être certaine que des résultats obtenus durant les études pré-cliniques, bien que favorables, soient confirmés par la suite par les études cliniques, ou que les résultats des études cliniques soient suffisants pour démontrer l’innocuité et la nature du produit concerné. L’activité de DBV Technologies est sujette aux facteurs de risques soulignés lors de l’enregistrement de ses documents signés par l’Autorité des Marchés Financiers.

Contacts

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

23/01/2014
  • Contract guarantees 100% of the output from 100,000 ton per year plant will be sold for 15 years
  • Vinmar partnership supports BDO technology’s progress and economic attractiveness
  • Agreement is commercial foundation for large-scale BDO plants in addition to Sarnia plant
  • Vinmar off-take obligation and equity participation will facilitate financing of planned BDO facility

MINNEAPOLIS, MN, Jan. 22, 2014  – BioAmber Inc. (NYSE and EURONEXT Paris: BIOA), an industrial biotechnology company producing sustainable chemicals, today announced it has signed a take-or-pay contract for bio-based 1,4-Butanediol (« BDO ») with Vinmar International. Under the terms of the 15-year master off-take agreement, Vinmar has committed to purchase 100% of the BDO produced in a 100,000 ton per year capacity plant that BioAmber plans to build in North America and commission in 2017. Vinmar also plans to invest in the BDO plant alongside BioAmber.

BDO is a building block chemical that is used in a wide range of products, including engineering plastics for the automotive industry, polyurethanes, biodegradable plastics and spandex. The current size of the global BDO market is approximately $4 billion. BioAmber produces BDO by combining its succinic acid technology with a catalyst technology licensed from DuPont and the company believes its bio-based BDO is cost competitive with petroleum derived BDO. To date, BioAmber has validated the high quality of its bio-based BDO with over 20 purchasers of petroleum BDO.

Following the financing, construction and commissioning of the 100,000 ton BDO plant, Vinmar will be obligated to purchase 100% of the BDO produced for 15 years, and BioAmber will be obligated to sell exclusively to Vinmar. Vinmar also plans to invest in the BDO plant, taking a minority equity stake of at least 10%. As part of the agreement, Vinmar has a right of first refusal to invest in and secure 100% of the off-take from a second BDO plant that BioAmber would build in the future.

In order to seed the market for its bio-based BDO, BioAmber plans to initially produce approximately 4,000 tons of BDO annually at a toll manufacturing facility that the company expects to commission in 2015. The tolling facility will convert bio-succinic acid produced at the Sarnia, Canada plant that is currently under construction. Under the terms of the agreement announced today, Vinmar has committed to also purchase 100% of the BDO produced at the planned tolling facility.

« This partnership with Vinmar positions BioAmber to become a producer of BDO, a second platform chemical beyond succinic acid. We believe this take-or-pay contract will help us to secure significant project financing for our first commercial BDO plant. We expect to leverage this project financing, along with co-investment by Vinmar and other equity partners such as Mitsui & Co., to limit the cash BioAmber needs to contribute in order to be the majority owner of the plant, » said Jean-Francois Huc, Chief Executive Officer of BioAmber.

« We believe our partnership with Vinmar will significantly de-risk the construction and operation of the commercial-scale BDO plant we plan to build in North America. Vinmar has a proven track record of selling large volumes of BDO, has global logistics expertise and vast experience executing large chemical projects, » added Fabrice Orecchioni, Chief Operations Officer of BioAmber.

« BioAmber has an attractive new route that we believe will offer customers competitively priced BDO with an improved carbon footprint. This agreement is consistent with Vinmar’s strategy to partner with best-in-class technologies and bring competitively priced chemicals to market, » added Dr. Serge Verma, President of Vinmar Projects.

Vinmar International Ltd is a privately held marketing, distribution and project development company headquartered in Houston, Texas. Over the past 35 years Vinmar has grown to over 450 employees in 30 countries, with sales in excess of 3 million metric tons consisting of petrochemicals, polymers and elastomers, and generating revenues of over US$4 Billion in 2012. The Houston Chronicle ranked Vinmar the third largest privately held company by revenue in its 2013 annual rankings for the Greater Houston region. Vinmar is part of the Goradia Group of Companies that also includes Goradia Capital, which acquires and operates chemical manufacturing plants and has participation in grass-roots petrochemical projects.

Vinmar’s business model is to sign long-term take-or-pay agreements. Vinmar purchases the output of a plant and sells the product into the market, optimizing global logistics and marketing across its broad portfolio of chemicals. Vinmar leverages its global marketing capabilities and its off-take agreements to facilitate project financing. Vinmar has considerable experience in marketing BDO, having been the principal off-taker of a Saudi Arabia based, 75,000 ton per year capacity BDO plant from its start up in 2005 until 2013.

About BioAmber
BioAmber (NYSE and EURONEXT Paris: BIOA) is an industrial biotechnology company producing sustainable chemicals. Its proprietary technology platform combines industrial biotechnology and chemical catalysis to convert renewable feedstock into sustainable chemicals for use in a wide variety of everyday products including plastics, resins, food additives and personal care products. For more information visit www.bio-amber.com

Forward-Looking Statements
This press release contains forward-looking statements, including statements related to the timing of the completion of our planned facility in Sarnia, Ontario, the production of bio-based BDO at a toll manufacturing facility, the planned construction of a BDO production facility, the funding sources for the construction and operation of these facilities, the equity ownership of that facility, the purchase by Vinmar of the Company’s bio-based BDO, and the addressable market for BDO. All statements other than statements of historical fact contained in this press release are forward-looking statements. These statements often include words such as « believe, » « expect, » « anticipate, » « intend, » « plan, » « estimate, » « seek, » « will, » « may » or similar expressions. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond BioAmber’s control. BioAmber’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in BioAmber’s most recent registration statement on Form S-1 filed with the Securities and Exchange Commission, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company’s limited operating history, the inability of the Company to execute on its manufacturing expansion strategy, including the construction of our planned facility in Sarnia, Ontario, the inability of the Company to comply with milestone covenants contained in certain of its agreements, the Company’s limited sales of bio-succinic acid to date, the Company’s inability to obtain additional financing, the Company’s inability to leverage its bio-succinic acid technology to develop and commercialize derivatives of bio-succinic acid and other bio-based building block chemicals, and a decrease in demand for bio-succinic acid, bio-based 1,4 BDO and other bio-succinic acid derivatives. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

17/12/2013

• Meaningful clinical development progress and key corporate partnerships established in 2013
• Significant scientific and clinical news flow expected in 2014

BAGNEUX, France, Dec. 17, 2013 — DBV Technologies (Euronext: DBV – ISIN: FR0010417345), creator of Viaskin®, a new paradigm for the treatment of allergies, announced today a summary of corporate activities in 2013 and provided news flow guidance for 2014. 
Dr. Pierre-Henri Benhamou, Chairman & CEO of DBV Technologies, said: “It has been an extremely successful year for the evolution of DBV. We have strengthened our team with several new talented individuals, and we completed a €29.9m private placement that provides us with the necessary cash to file for Viaskin Peanut’s marketing approval with the FDA. We have also rebalanced our shareholder base with top-tier US healthcare investors, which allows for further valuation potential.” Dr. Benhamou concluded: “We look forward to 2014 with great confidence, as this will be a pivotal year and should reveal the potential value that lies in the Viaskin platform.”

Summary of 2013: strong progress in clinical development and corporate partnerships
In 2013, Viaskin® solidified its position as the world’s first and only EPIT-based therapy developed for peanut allergy, a tremendous unmet medical need. 
• Viaskin® Peanut’s safety was confirmed in DBV’s 12-month phase IIb clinical study (VIPES), which is currently ongoing in North America and Europe; 
• Viaskin® Peanut’s initial efficacy results showed a strong response in children aged 5-11 in a phase II academic study (ARACHILD); 
• OLFUS-VIPES is evaluating the long-term efficacy and safety of Viaskin® Peanut; 
• NIH-sponsored Consortium of Food Allergy Research (CoFAR) started enrolling a Phase II clinical study with Viaskin® Peanut for the treatment of peanut allergy in leading US centers for food allergy.
Throughout 2013, DBV has continued to diversify its Viaskin® platform beyond the field of food allergies by establishing partnerships with leading industrial partners or leading academic centers worldwide. 
• DBV partnered with Stallergenes for the development of respiratory allergy treatments using the Viaskin® platform. The first collaborative product, now at pre-clinical stage, is in Birch pollen allergy;
• DBV announced collaborations with the University of Geneva and BioNet-Asia for whooping cough boost vaccine; 
• DBV and INRA (Institut National de la Recherche Agronomique) are exploring a Viaskin®-based product in respiratory syncytial virus (RSV).

During 2013, DBV also expanded it capabilities for phase III and commercialization through the following activities: 
• In-house industrial scale up to manufacture 30 million Viaskin® patches per year; 
• Strategic manufacturing agreement with Sanofi for Active Pharmaceutical Ingredients (API) based on whole natural allergens;
• Creation of a market access function with the appointment of Véronique Foutel as Chief Strategic Marketing Officer.

Scientific and clinical news flow guidance for 2014
• Medical meeting presentations
a. In February 2014, DBV will present 3 abstracts and 1 oral presentation at AAAAI (American Academy of Allergy Asthma and Immunology) (http://annualmeeting.aaaai.org/);
b. In April and June 2014, respectively, DBV will present at EAACI (European Academy of Allergology and Clinical Immunology) (http://www.eaaci2014.com) and at CFA (Congrès Francophone d’Allergie) (http://www.congres-allergologie.com/) during a dedicated session on Specific Immunotherapy. 
• In terms of clinical development during 2014, DBV anticipates the following news flow for 5 clinical studies using Viaskin® :
a. Release Viaskin® Peanut’s phase IIb (VIPES) topline safety and efficacy results in early Q4 2014;
b. Launch a phase II clinical trial in mid-2014 with Viaskin® Milk for the treatment of severe cow’s milk allergy in children;
c. Fund a pilot study for the treatment of eosinophilic eosophagitis (‘EoE’), which will be conducted at the Children Hospital of Philadelphia (USA) in mid-2014;
d. In H2 2014, launch a clinical proof–of-concept study using Viaskin® PT, which is Viaskin® with a recombinant non-toxic Pertussis Toxin (rPT). This will be conducted in partnership with the University of Geneva and BioNet-Asia;
e. Liaise with its academic partner, Assistance Publique – Hôpitaux de Paris (AP-HP), a network of French Hospitals, to publish Viaskin® Peanut’s Arachild 36-month data in H2 2014.

Financial news flow in 2014
DBV Technologies will announce the company’s financial and operating results as follows:
• Full Year 2013 topline financial results and cash position on January 30, 2014 
• Full Year 2013 audited financial results on March 17, 2014
• First Half 2014 financial results on July 28, 2014 
• First nine months topline financial results and cash position on October 14, 2014.
• DBV Technologies’ Annual General Meeting will be held on June 3, 2014 in Paris, France.

About DBV Technologies
DBV Technologies is opening up a decisive new approach to the treatment of allergy – a major public health issue that is constantly increasing in prevalence. Food allergies represent a true handicap in everyday life for millions of people and thus constitute a major unmet medical need. DBV Technologies has developed a unique, proprietary, worldwide-patented technology for administering an allergen to intact skin and avoiding massive transfer to the blood. The Viaskin® technology combines efficacy and safety as part of a treatment that seeks to improve the patient’s tolerability of peanut and thus considerably lower the risk of a systemic, allergic reaction in the event of accidental exposure to the allergen. The company’s significant development program has taken this revolutionary method through to the industrial stage in Europe, initially. The product’s clinically proven safety of use enables the application of effective desensitization techniques (the efficacy of which is acknowledged worldwide) in the most severe forms of the allergy. DBV Technologies is focusing on food allergies (milk and peanut) for which there are currently no effective treatments. It has developed two products: Viaskin® Peanut and Viaskin® Milk. The clinical development program for Viaskin® Peanut has received Fast Track designation from the US Food and Drug Administration. The company will subsequently develop a Viaskin® patch for young children with house dust mite allergy – a true public health issue because this pathology is one of the main risk factors for childhood asthma. DBV Technologies shares are traded on segment C of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345). 
For more information on DBV Technologies, please visit our website: www.dbv-technologies.com
CAUTION: Viaskin® is not approved for sale in the USA.

Forward Looking Statement
The forward-looking statements, objectives and targets contained herein are based on the Company’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. Furthermore, the Research and Development process involves several stages each of which involve the substantial risk that the Company may fail to achieve its objectives and be forced to abandon its efforts with regards to a product in which it has invested significant sums. Therefore, the Company cannot be certain that favorable results obtained during pre-clinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the product concerned. DBV technologies’ business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers.

DBV Technologies Contacts 
DBV Technologies
David Schilansky
Chief Financial Officer
Tél. : +33(0)1 55 42 78 75
david.schilansky@dbv-technologies.com

US & UK investors
The Trout Group
Investor Relations
Alan S. Roemer
Tél. : +1 646 378-2945
aroemer@troutgroup.com

French investors 
NewCap.
Financial Communication and investor relations
Emmanuel Huynh / Valentine Brouchot
Tél. : +33(0)1 44 71 94 94
dbv@newcap.fr

US press & media
Ronald Trahan, APR
Press relations
Ronald Trahan
Tél. : +1 508 359 4005
rctrahan@ronaldtrahan.com

17/12/2013

New funds to drive development of best-in-class fully human VH antibody fragment therapeutics

 Cambridge, UK. 17th December 2013 – Crescendo Biologics Limited (Crescendo) today announces it has raised £17.5m ($28m) in a Series A financing led by Imperial Innovations and including new investor Astellas Venture Management (AVM). Founding seed investor Sofinnova Partners also contributed significantly to the round. The funds raised will be used to advance Crescendo’s in-house development programmes in inflammation and oncology utilising its best-in-class Vfragment discovery platform centred on the Crescendo Mouse.

VH domains are the smallest, most robust antibody fragments and as such have advantages for tissue and tumour penetration, engineering of multivalent products, topical delivery and simple manufacture. They are also the most extensively validated fragment in the clinic. The unique Crescendo Mouse harnesses the benefits of in vivo maturation, which naturally optimises affinity and biophysical properties, to generate human VH with superior properties for drug development. Critical to this is the use of the Company’s proprietary triple knockout mouse background which eliminates all mouse antibody light chain contamination. 

Crescendo is establishing an internal pipeline including a transformational topical biologic for psoriasis and multivalent products for oncology indications. These programmes draw on the power of Crescendo’s Vplatform to produce novel, high-value product candidates to address areas of significant medical need.

Mike Romanos, CEO of Crescendo, said, “Transgenic mice have had a truly major impact in monoclonal antibodies, where they have delivered the majority of recent product approvals. The Crescendo Mouse now achieves the same benefits for VH antibody fragments, that is fully human sequence with excellent potency and druggability. These properties enable us to properly address key industry needs, such as plug and play engineering of fully-human multivalent products, and robust topical biologics. This new investment will allow us to accelerate our inflammation and oncology programmes to the clinic and to provide a powerful platform for strategic partnerships with pharmaceutical and biotechnology companies.”

Rob Woodman of Imperial Innovations, who joins the Crescendo Board, said, “We are delighted to lead this round of investment in Crescendo Biologics. Having successfully developed its unique transgenic VH technology, a major bioengineering achievement, Crescendo is ideally positioned to deliver highly differentiated therapeutics. Imperial Innovations is excited to be working alongside Crescendo management and other investors to further build the company’s capabilities and pipeline.”

Graziano Seghezzi, Partner at Sofinnova Partners, said, “Crescendo was founded around seminal IP generated at the Babraham Institute – the same institute where technologies behind Medarex and Abgenix were developed. Having recognised the potential from the beginning, it is very satisfying to see that Mike and the team have developed the best-in-class technology, identified unique product opportunities and attracted excellent new investors to move the first Crescendo VH into the clinic.”

Sakae Asanuma, President and CEO of Astellas Venture Management, said, “AVM is very excited to participate in this Series A financing of Crescendo Biologics, which is applying its fully human VH fragments produced by the Crescendo Mouse, a breakthrough in antibody technology, to areas in which we have a strong strategic interest as a corporate venture capital arm for Astellas Pharma Inc.”

 

Contacts

Mike Romanos
Crescendo Biologics

Tel: +44 (0) 1223 497140

Email: mromanos@crescendobiologics.com

 

Chris Gardner

Citigate Dewe Rogerson

Tel: +44 (0)207 638 9571

Email: chris.gardner@citigatedr.co.uk

 

About Crescendo Biologics Ltd

Crescendo Biologics, based in Cambridge, UK, is focused on the discovery and development of best-in-class human VH antibody fragment therapeutics using its novel transgenic platform. Crescendo is enabling the major VH product formats (multivalent, half-life-extended and topical) for its own pipeline, focused in inflammation and oncology, and to make it the partner of choice for human VH fragment therapeutics.

www.crescendobiologics.com

 

About Imperial Innovations

Innovations creates, builds and invests in pioneering technologies addressing global problems in healthcare, energy, engineering and the environment. It combines deep understanding of science and technology with commercial acumen and strong investment expertise. In December 2010 Innovations raised £140m to accelerate the making of, and increase the size of, investments in companies established under its existing intellectual property pipeline agreement with Imperial College London. The Group also intends to invest in companies founded by or based on technology from the University of Oxford, the University of Cambridge and University College London.

www.imperialinnovations.co.uk

 

About Astellas Venture Management

Astellas Venture Management LLC. is the corporate venture capital arm of Astellas Pharma Inc., a global pharmaceutical company headquartered in Tokyo, Japan, which was formed through the merger of Fujisawa Pharmaceutical Co. Ltd. and Yamanouchi Pharmaceutical Co. Ltd. in April 2005. AVM’s investment objective is to find a venture company with a proprietary technology and facilitate its growth by utilising Astellas’ experience and network within the biotechnology field. AVM’s ability to offer not only investment funds, but also the Astellas Group’s powerful combination of scientific and technical expertise, depth of drug development and marketing knowledge and long-term business perspective, can give entrepreneurs and investors the very best chance for their rapid growth and success.

www.astellasventures.com

 

About Sofinnova Partners

Sofinnova Partners is an independent venture capital firm based in Paris, France. For more than 40 years, the firm has backed nearly 500 companies at different stages of their development – pure creations, spin-offs, as well as turnaround situations – and worked alongside Europe’s key entrepreneurs in the Life Sciences industry. With €1.3 billion of funds under management, Sofinnova Partners has created market leaders with its experienced team and hands-on approach in building portfolio companies through to exit.

09/12/2013

BOULDER, Colo. – Dec. 3, 2013– Clovis Oncology, Inc. (Nasdaq: CLVS) announced today the pricing
of an underwritten public offering of 2,000,000 shares of its common stock at a price to the public of $57.50 per share. All of the
shares are being sold by certain existing stockholders who acquired the shares of the Company’s common stock as consideration
in connection with the Company’s acquisition of EOS (Ethical Oncology Science) S.p.A.
J.P. Morgan Securities LLC is acting as the sole manager for the offering. The selling stockholders have granted J.P. Morgan
Securities a 30-day option to purchase up to an additional 300,000 shares of common stock from the selling stockholders to
cover over-allotments, if any. All net proceeds from the sale of the common stock will be received by the selling stockholders.
The Company will not receive any of the proceeds, and the total number of shares of its outstanding common stock will not
change as a result of the offering.
The shares of common stock are being sold by the selling stockholders pursuant to an effective shelf registration statement. This
offering is being made only by means of a prospectus and related prospectus supplement, copies of which may be obtained from
J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by calling
toll-free (866) 803-9204. The offering is expected to close on December 9, 2013, subject to customary closing conditions.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these
securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or
qualification under the securities laws of any such state or other jurisdiction.

About Clovis Oncology
Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anticancer
agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific
subsets of cancer populations, and simultaneously develops diagnostic tools that direct a compound in development to the
population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, and has additional
offices in San Francisco, California and Cambridge, UK.
Source: Clovis Oncology, Inc.

Clovis Oncology, Inc.
Anna Sussman, 303-625-5022
asussman@clovisoncology.com
or
Breanna Burkart, 303-625-5023
bburkart@clovisoncology.com