What's new?

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:
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.

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.

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.


This Proof of concept study aims to capitalize on DBV’s safe and non-invasive technology and Inserm’s unique expertise to address refractory Hemophilia A, a severe orphan disease with no cost-effective and convenient treatment today available to patients

BAGNEUX, FRANCE, October 22nd, 2013 – DBV Technologies (Euronext: DBV – ISIN: FR0010417345), creator of Viaskin®, a
new standard in the treatment of allergies, announced today that it has entered into a research collaboration with Institut
national de la Santé et de la recherche médicale, Inserm and Inserm Transfert, to investigate the effect of epicutaneous
delivery of recombinant Factor VIII (FVIII) protein via Viaskin in an animal model of hemophilia A. DBV and Inserm are
teaming up to combine the Viaskin® technology and a world-class expertise in hemophilia A to develop a potential standard
of care for refractory hemophilia A patients, by providing a cost-effective, and non-invasive treatment.

Dr. Sébastien Lacroix-Desmazes, CNRS (Inserm Team UMRS 872, Immunopathology and Therapeutic Immuno-
Intervention), said, “Preventing the immune response to therapeutic proteins upon induction of tolerance is the approach of
choice for patients with hemophilia A. To date, the only strategy to induce tolerance to FVIII in patients who have developed
anti-FVIII antibodies consists in flooding the immune system with enormous amounts of FVIII every day, for periods that can
extend up to several months or years. This obviously faces issues with patients’ compliance and treatment costs. Being able
to induce FVIII-specific tolerance in hemophilia A patients using low doses of antigen, such as is the case with the Viaskin
delivery system, would drastically improve the life of alloimmunized hemophilia A patients and solve a crucial societal

Dr. Pierre-Henri Benhamou, Chairman and CEO of DBV Technologies, said, “The establishment of a partnership with Dr.
Sebastien Lacroix-Desmazes and Inserm, with their extensive expertise in Hemophilia A, can potentially open a new path for
Viaskin to become the future of hemophilia A treatment as a non-invasive, prophylactic alternative against an alloimmune
response to therapeutic Factor VIII.” Dr. Pierre-Henri Benhamou concluded: “This research should reinforce the relevance of
the Viaskin® platform, as a technology enabling deep and durable modulation of inappropriate immune responses.”

The protective effect conferred by the immunological response induced by epicutaneous immunotherapy using Viaskin®
will be tested at the humoral level, and is expected to induce tolerance to FVIII in mice with severe hemophilia A. The DBVInserm
research collaboration will last 12 months. Different mice cohorts will be treated with Viaskin containing the FVIII
protein versus placebo for 45 days. After 45 days, all mice will be subject to a protocol of replacement therapy for 4 weeks.
The levels of anti-FVIII IgG and of FVIII inhibitors will then be assessed by immunological and functional assays. Various
approaches have investigated treatments aimed at inducing tolerance to exogenous FVIII in hemophilic mice. Through the
Viaskin platform, DBV Technologies has developed a first-in-class approach to deliver antigens of choice to immunosensitized
organisms as a method to induce antigen-specific tolerance, and in this case, tolerance to therapeutic FVIII in
hemophilia A.

About Hemophilia A
Hemophilia A is a rare X chromosome-linked recessive hemorrhagic disorder that affects one individual out of 5,000—
10,000. Genetic abnormalities in the gene encoding FVIII result in the absence of production of FVIII or in the production of
defective FVIII molecules. In up to 30% of the patients, replacement therapy is complicated by the occurrence of anti-drug
antibodies, referred to as inhibitory anti-FVIII antibodies (or FVIII inhibitors), that preclude the use of FVIII as treatment.
Inhibitory anti-FVIII antibodies are of the IgG isotypes, and mostly part of the IgG1 and IgG4 subclasses. Mortality is high
and ranging between 12.5% and 22%, usually because of fatal hemorrhage.

About Inserm
Understand and improve human health
Founded in 1964, the French National Institute of Health and Medical Research (Inserm) is a public scientific and technological institute
which operates under the joint authority of the French Ministry of Health and French Ministry of Research.
As the only French public research institute to focus entirely on human health, in 2008 Inserm took on the responsibility for the
strategic, scientific and operational coordination of biomedical research. This key role as coordinator comes naturally to Inserm thanks to
the scientific quality of its teams and its ability to conduct translational research, from the laboratory to the patient’s bed.
In April 2009, national coordination was strengthened by Aviesan, the Alliance nationale pour les sciences de la vie et de la santé (French
National Alliance for Life and Health Sciences), which Inserm co-founded with other research institutes and the Conférence des
présidents d’université (Association of University Presidents).

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 Contacts
DBV Technologies
David Schilansky
Chief Financial Officer
Tél. : +33(0)1 55 42 78 75

US & UK investors
The Trout Group
Investor Relations
Alan S. Roemer
Tél. : +1 (646) 378-2945

French investors
Financial Communication and investor relations
Emmanuel Huynh / Valentine Brouchot
Tél. : +33(0)1 44 71 94 94
US press & media
Ronald Trahan Associates Inc.
Press relations
Ronald Trahan, APR
Tél. : +1 508 359 4005
Inserm Contacts
Tel. : +33(0)1 44 23 60 97

  • Stallergenes pourra exercer une option de développement et de commercialisation sur un nouveau produit dans l’allergie au pollen de bouleau 
  • DBV est éligible à des paiements d’étape ainsi que des redevances sur les ventes de Stallergenes  
  • Stallergenes acquiert une participation dans DBV 


ANTONY et BAGNEUX, France, le 18 octobre 2013 – Stallergenes S.A. (Euronext Paris : GENP), leader mondial de l’immunothérapie allergénique, et DBV Technologies (Euronext Paris : DBV), créateur du Viaskin®, une nouvelle référence dans le traitement de l’allergie, ont annoncé avoir signé un accord de recherche et de développement pour la mise au point d’un nouveau traitement de l’allergie au pollen de bouleau. Cette collaboration est le premier accord s’inscrivant dans le cadre du partenariat entre les deux sociétés dédié au développement de traitements innovants dans le domaine des allergies respiratoires. L’accord signé aujourd’hui permettra d’associer l’expertise mondialement reconnue de Stallergenes dans le domaine des allergies respiratoires à la nouvelle technologie de délivrance épicutanée de DBV, Viaskin®, permettant de moduler la réponse immunitaire.


Pour télécharger la version française du communiqué de presse, cliquez sur le lien:
Stallergenes et DBV Technologies signent une collaboration de recherche


List Recognizes the Top Private Companies in Clean Technology
Amsterdam, the Netherlands – October 10, 2013 Today Cleantech Group, a global market intelligence and consulting firm announced that Avantium, is named in the prestigious 2013 Global Cleantech 100. This is the fourth year in a row that Avantium is named in this unique list, in which the promise of private clean technology companies from all around the world is highlighted. The Cleantech Group focuses on those companies which the players in the market feel are currently the most likely to make the most significant market impact over the next 5-10 years.
―This is our fourth consecutive year to be named in the Global Cleantech Top 100. We are very pleased that the jury confirms our potential to change the world with our YXY technology to produce PEF. It is our goal to make PEF the next generation plastic. Avantium was listed in the Global Cleantech 100 in 2010 for the first time, and our progress has accelerated since that period. We established partnerships with The Coca-Cola Company, Danone, and ALPLA. These industry leaders joined Avantium in developing and commercializing PEF bottles for major consumer markets. We have successfully scaled our YXY technology from lab to pilot plant scale. Our 100% biobased PEF bottles perform superiorly compared to today’s bottles at competitive costs. Being listed in the Global Cleantech 100 is a great recognition of our progress at an important time in the development of our company‖ said Tom van Aken, CEO of Avantium.
The list is derived from Cleantech Group’s own data and research, combined with the weighted qualitative judgments of hundreds of nominations, and the viewpoints of a global 90-person expert panel. This panel was drawn principally from leading financial investors and representatives of multi-national corporations, located in Asia, Europe, and North America. This diversity results in a list of companies that command a broad base of respect and support from many important players within the global cleantech innovation ecosystem. To qualify for the list, companies must be independent, for-profit, cleantech companies that are not listed on any major stock exchange.
―The Global Cleantech 100 is a natural extension of our vision to help corporations and investors connect with innovation around the world,‖ said Sheeraz Haji, CEO of Cleantech Group. ―This list celebrates inspiring entrepreneurs, and serves as the industry standard on gauging where innovation is headed across key sectors.‖
This year 5,864 companies from 60 countries were nominated. These companies were weighted and scored to create a short list of 300 companies. Vital information on these short-listed companies—including key data from Cleantech Group’s i3 platform—was presented to the expert panel for final input. The end result was 100 companies from 18 countries.

About Cleantech Group
Cleantech Group helps clients accelerate sustainable innovation. The company’s i3 platform allows subscribers to discover companies and explore cleantech trends strategically with proprietary real-time data. Cleantech Forums bring together thought leaders and innovators in the cleantech and sustainability ecosystem. The company’s advisory services leverage expertise in designing and
executing corporate strategies for sustainable growth and innovation sourcing. Details at www.cleantech.com
For more information about Cleantech Group, please contact Millen Paschich: tel: +1 (415) 233 9712, email: media-services@cleantech.com.

About Avantium
Avantium is a leading technology company specialized in the area of advanced high-throughput R&D. The company develops and commercializes YXY – the brand name for its technology platform to catalytically convert plant based carbohydrates into chemical building blocks like Furanics and Levulinics. These chemical building blocks can be applied for making green materials with superior product properties at competitive pricing. Currently the focus of the YXY technology platform is on a building block called FDCA, (2,5- furandicarboxylic acid). FDCA can be polymerized together with ethylene glycol (EG) to form PEF (Polyethelyne Furanoate), which is Avantium’s lead application. Combined with the significant reduction in carbon footprint, PEF fulfills key criteria to become the next generation biobased plastics for bottles, film and fibers. PEF for example has gas barrier to oxygen, carbon dioxide and water is superior to PET, leading to longer product shelf life and offering the potential for light weighting of packages. Avantium has demonstrated the value and commercial potential of its unique technology by collaborating with leading companies in the energy and chemical industries. Avantium offices and headquarters are based in Amsterdam, the Netherlands, and Avantium is running an YXY pilot plant in Geleen, the Netherlands.
For more information about Avantium, please contact Mariette Hoogendoorn: tel: +31 (0)20 5868010, email: info@avantium.com.


Minneapolis, Oct. 1, 2013 – BioAmber Inc. (NYSE: BIOA) announced today a payment to Cargill for achieving the final milestone in their development agreement, under which BioAmber has exclusively licensed the Cargill yeast technology for succinic acid production. Completion of this milestone signals that the succinic acid producing yeast has met performance expectations. BioAmber began work in August 2013 on a 30,000 MT plant in Sarnia, Ontario, and has engineered the facility to operate with this proprietary yeast.
« This milestone achievement is the culmination of three years of joint development with Cargill. We licensed this yeast in 2010 because we strongly believed it is the best technology platform in the industry for making organic acids, and because Cargill has experience in the development and commercialization of organic acids that strengthened our succinic acid program, » said Jim Millis, BioAmber’s Chief Technology Officer.
« BioAmber and Cargill’s collaboration has been successful and our yeast technology has proven effective for making succinic acid. We look forward to BioAmber commercializing the yeast when it brings on line its bio-succinic acid facility in Sarnia, » said Gary Folkert, Cargill’s Biotechnology Director of Licensing.
« Our proprietary technology platform has been significantly strengthened with the Cargill yeast. This is an important milestone and we plan to continue to work with Cargill to develop alternative feedstock options for our succinic acid platform and to bring to market our adipic acid yeast platform, which we have also licensed exclusively from Cargill, » said Jean-Francois Huc, BioAmber’s Chief Executive Officer.

About BioAmber
BioAmber (NYSE and EURONEXT Paris: BIOA) is a sustainable chemicals company. Its proprietary technology platform combines industrial biotechnology and chemical catalysis to convert renewable feedstock into 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.

About Cargill
Cargill is an international producer and marketer of food, agricultural, financial and industrial products and services. Founded in 1865, the privately held company employs 140,000 people in 65 countries. Cargill helps customers succeed through collaboration and innovation, and is committed to applying its global knowledge and experience to help meet economic, environmental and social challenges wherever it does business. For more information, visit www.cargill.com.


La Motte-Fanjas, France, Sept. 27, 2013 / – Inauguration of large-scale, onsite system for both generating hydrogen by electrolysis of water and storing it in a safe, solid form
McPhy Energy, a leading developer and manufacturer of solid state hydrogen storage, presented today the world’s first system coupling an industrial-scale hydrogen generator with a 100 kg solid hydrogen storage unit. The demonstration, which showed the results of the first phase of the French PUSHY program, was given at the company’s headquarters in La Motte-Fanjas, in the department of the Drome,France. While such systems enable the supply of onsite hydrogen for industry, they also mark a world premiere in the transition to renewable energies, enabling approaches such as « power-to-gas » and hydrogen mobility to become both technical and commercial realities.

The McPhy Energy technology for storing hydrogen in the form of hydrides is a safe, low-pressure, high-density solution.
The generator, which produces hydrogen through the electrolysis of water, is manufactured by McPhy Italy and powered by 60 KW of electricity from the local electrical grid. The demonstrator shown today can produce 12m[3]of hydrogen per hour. The gas is then stored in McPhy’s HDS 100 system, which is based on magnesium hydride technology developed and manufactured by McPhy Energy in La Motte-Fanjas, France.
The system inaugurates the first commercial product line for onsite industrial hydrogen users worldwide. This first model, which has a storage capacity of 100 kg (for an energy content of 3.3 MWh), is the first in a commercial range reaching up to 500 kg of stored hydrogen (16.5 MWh).
It enables traditional hydrogen logistics (high-pressure delivery) to be replaced with production that is located at the point of use and aligned with demand. This ambitious project, funded by BPI France (formerly OSEO/ISI) was developed in an industrial consortium lead by McPhy Energy, with the CEA (the French Atomic & Alternative Energy Agency) and the company WH2.
« The pilot presented today at our manufacturing site in La Motte-Fanjas is the first deliverable of the PUSHY project. In 2014, it will be followed by a demonstration of hydrogen production by hydroelectric energy, for the storage and exploitation of renewable energies inFrance as in Europe and across the globe, » said Pascal Mauberger, CEO of McPhy Energy. « With the deployment of renewable energies, storage requirements are substantial, and solutions are needed to respond to those needs. That is the objective of this demonstrator model, which marks the beginning of a complete line of groundbreaking products. »

About McPhy Energy
McPhy Energy S.A., which is headquartered near Grenoble, France, develops and manufactures innovative and safe hydrogen technologies. Besides solid-state storage of hydrogen based on metal hydrides, McPhy is consistently expanding activities in on-site generation of hydrogen by means of water electrolysis. With the acquisition of PIEL (Italy) in early 2013, McPhy now has a global installed base of over 3000 systems. For three consecutive years, McPhy has been listed in the « Global CleanTech 100 » group of companies and is one of the « Top 5 CleanTech France » enterprises. The Group has manufacturing sites in France and Italy.


London, September 24th 2013. Synthace, the applied synthetic biology company developing high value chemical and biological products, announces that it has closed a funding round raising £1.3 Million. Sofinnova Partners’ Green Seed Fund led the financing, joined by a syndicate of angel investors.
Synthace is applying its world leading platform of technologies to rapidly engineer and optimise novel biological systems for the production of specialty chemicals and biological products. Synthace bioengineering is enabled by a tight integration of computational modelling and big data analysis with wet lab experimental design and novel molecular biology tools. The company’s platform is broadly applicable across multiple industry sectors, including chemicals, healthcare, energy and agriculture, and has the potential to create as yet uncharted markets and opportunities.
Tim Fell, CEO of Synthace, commented: « We are delighted to have attracted Sofinnova Partners’ Green Seed Fund and see this funding as a very strong validation of our company, technology and commercial focus. It will allow us to demonstrate production of our first chemical products at scale, prior to forming partnerships within the chemicals industry to take them to market.”
Joško Bobanović, Partner at Sofinnova Partners responsible for the fund, added: « Synthace offers a unique combination of a revolutionary technical platform, entrepreneurial and visionary team, developing advanced products for extremely large markets. Green Seed Fund focuses on European investments in renewable chemistry and has recognised Synthace as one of the leaders in this sector offering, in a way, version 2.0 of synthetic biology application.”

For further details, please contact:
Tim Fell, CEO Synthace Tel: + 44 (0) 20 3642 1350

Notes to Editors:
Synthace is the UK’s first dedicated synthetic biology company with a world leading platform of technologies for the rapid engineering and optimisation of novel biological production systems. A spin out of University College London, Synthace harnesses the ability of micro-organisms to produce complex, high-value chemical and biological products from sustainable and renewable feedstocks. In addition to equity funding, the company has received a £500,000 Technology Strategy Board award entitled ‘Rapid Engineering of Cellular Factories’, in collaboration with University College London and University of Manchester. While Synthace bioengineering is broadly applicable across multiple industry sectors, the company is initially focused towards applications in the production of specialty chemicals.
More information is available at www.www.synthace.com
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. sofinnova.social-unit.fr


Paris, France, 29 août 2013. Sofinnova Partners, société de capital-risque basée à Paris, a mené le financement de Série A qui a permis à ObsEva SA, une société biopharmaceutique basée en Suisse et spécialisée en médecine de la reproduction féminine, de lever 32M CHF (25,6M EUR). Pour ce premier tour de financement, Sofinnova Partners a été rejoint par deux co-investisseurs, Sofinnova Ventures et Novo A/S.

ObsEva est spécialisée dans le traitement de la menace d’accouchement prématuré. La société a été cofondée en novembre 2012 par Ernest Loumaye, MD, PhD, un serial entrepreneur que Sofinnova Partners a déjà accompagné avec succès dans PregLem, une société spécialisée en médecine de la reproductionet plus particulièrement le traitement du fibrome utérin. PregLem a été acquise en 2010 par Gedeon Richter pour 445M CHF (361M EUR). L’équipe dirigeante d’ObsEva est pilotée par ses deux co-fondateurs, Ernest Loumaye, Directeur Général, et André Chollet, PhD, Directeur Scientifique.

Simultanément à l’opération de financement, ObsEva a signé un accord de licence mondial avec Merck Serono pour développer et commercialiser certains de leurs produits dans le domaine de l’obstétrique. Dans le cadre de cet accord, Merck Serono a acquis une participation minoritaire au capitald’ObsEva. Le financement va permettre d’accélérer le développement de ces produits qui ont le potentiel d’être des « best-in-class ». En combinant un rationnel biologique solide à un profil pharmaceutique différenciant, ObsEva est ainsi parfaitement positionné pour développer une nouvelle classe de médicaments capables d’apporter aux patientes des solutions de rupture dans la menace d’accouchement prématuré, un domaine médical où il existe un important besoin clinique à combler.

Rafaèle Tordjman, MD, PhD, Partenaire Associée chez Sofinnova Partners, déclare : « Au fil des ans, nous avons développé des liens solides avec Ernest Loumaye. Dans la continuité du succès de PregLem, Sofinnova Partners a financé l’amorçage d’ObsEva. Nous sommes ravis de continuer à soutenir une équipe d’une telle qualité et favoriser le développement d’une nouvelle génération de thérapies pour traiter la menace d’accouchement prématuré ». Ernest Loumaye, PDG, poursuit : « ObsEva répond à des besoins essentiels aujourd’hui encore insatisfaits car les thérapies existantes pour traiter la menace d’accouchement prématuré demeurent limitées en termes d’efficacité ou de sécurité. Aujourd’hui, nous estimons que le coût lié à la menace d’accouchement prématuré est autour de 27 milliards de dollars par an aux Etats Unis. Les produits que nous développons devraient permettre d’améliorer radicalement les options thérapeutiques proposées à des millions de femmes ».

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. sofinnova.social-unit.fr

A propos d’ObsEva SA
ObsEva est une société biopharmaceutique basée en Suisse spécialisée dans le développement des traitements innovants dans le domaine de la reproduction féminine. ObsEva s’intéresse particulièrement au traitement de la menace d’accouchement prématuré. ObsEva a été créée en 2012 par Ernest Loumaye MD, PhD et André Chollet PhD. Ernest Loumaye est un spécialiste de la médecine reproductrice féminine avec une expérience de plus de 20 ans dans l’industrie biopharmaceutique. Il a précédemment co-fondé et dirigé PregLem. André Chollet est un spécialiste de la chimie médicale et pharmaceutique, fort d’une expérience de plus de 30 ans dans le secteur, notamment chez Biogen, GSK et Merck Serono. www.obseva.com


Zürich-Schlieren, Switzerland, July 29, 2013 – Following recently signed collaborations with GlaxoSmithKline Biologicals (GSK) and Janssen Pharmaceuticals (JPI), GlycoVaxyn AG, a leader in the development of innovative conjugate vaccines, today announced that it has secured a Strategic Translation Award from the Wellcome Trust to finance its Shigella program.

The award will allow the Company to advance its Shigella bioconjugate vaccine by funding human safety and challenge studies in healthy adults to confirm the efficacy of a monovalent Shigella flexneri 2a vaccine, before testing a multivalent vaccine in field studies in children. Clinical trials are scheduled to start in 2014 in the USA.
Shigella is one of the main causes of a diarrheal disease that causes illness and death among young children in low-income countries. Various serotypes of this Gram-negative bacterium are responsible for the diarrhea and, with regional differences in serotype distribution, up to 6 serotypes need to be included in a vaccine to provide broad protection and prevent Shigellosis worldwide.
GlycoVaxyn’s in vivo glycosylation technology enables the possibility to develop such a complex multivalent Shigella vaccine for the first time. Complexes of the antigenic surface polysaccharides and proteins can now be directly synthesized in genetically engineered bacterial cells. This multivalent Shigella bioconjugate vaccine can be manufactured at low costs, a distinct advantage compared to conjugate vaccines that are chemically produced.
“An estimated 1.1 million people die from Shigella infections each year, mostly children under the age of five living in low income countries,” said Richard Seabrook, Ph.D., head of Business Development at the Wellcome Trust. “With rising antibiotic resistance limiting our treatment options, we urgently need an affordable vaccine that will provide broad protection against the many strains of Shigella bacteria that cause disease.”
Dr Michael Wacker, chief scientific officer of GlycoVaxyn added, “We are very honored to work with this prestigious global charitable foundation and proud to contribute to the development of a vaccine that addresses a critical medical need among millions around the world. GlycoVaxyn has previously conducted a Phase 1 study in healthy volunteers on a single serotype Shigella conjugate vaccine. This collaboration will enable us to investigate a new vaccine against a different single serotype, moving this important program forward towards a broad acting vaccine that protects against multiple serotypes.”
Gordon Dougan, Ph.D., member of GlycoVaxyn’s Scientific Advisory Board and professor at the Wellcome Trust Sanger Institute in Cambridge commented, “GlycoVaxyn is using highly innovative technology to break open new fields in vaccinology. I am delighted to see them work together with the Wellcome Trust to apply this technology to vaccines for children suffering from dysentery”.

About GlycoVaxyn AG
GlycoVaxyn is a privately-funded company developing a portfolio of novel bio-conjugate vaccines against common severe bacterial infections produced with its unique, proprietary in vivo glycosylation platform. With this platform, the company can develop and produce immunogenic glycoprotein conjugates in a biological process that circumvents many of the challenges and uncertainties involved in currently used chemical methods. Besides Shigella, the portfolio includes preclinical programs targeting major infectious diseases such as Staphylococcus aureus and Streptococcus pneumoniae. GlycoVaxyn is funded by a top-tier group of private investors including Sofinnova Partners, Index Ventures and Edmond de Rothschild Investment Partners and recently entered collaborations with GSK and JPI. For further information, visit www.glycovaxyn.com.

About The Wellcome Trust
The Wellcome Trust is a global charitable foundation dedicated to achieving extraordinary improvements in human and animal health. It supports the brightest minds in biomedical research and the medical humanities. The Trust’s breadth of support includes public engagement, education and the application of research to improve health. It is independent of both political and commercial interests. www.wellcome.ac.uk

Robert Flamm
GlycoVaxyn AG Russo Partners, LLC
Tel: +41-44-733-8595 Tel: +1-212-845-4226
media@glycovaxyn.com robert.flamm@russopartnersllc.com


Including NDA-Ready Novel Dyslipidemia Treatment to Complement Cardiovascular Portfolio

AstraZeneca today announced that it has entered into a definitive agreement to acquire Omthera Pharmaceuticals, a specialty pharmaceutical company based in Princeton, New Jersey, focused on the development and commercialisation of new therapies for abnormal levels of lipids in the blood, referred to as dyslipidemia.

Omthera’s investigational product, EpanovaTM, for the potential treatment of patients with very high triglycerides, is a novel omega-3 free fatty acid composition that has been shown to bolster levels of eicosapentaenoic acid and docosahexaenoic acid significantly in the blood. In studies to date, it has been shown to reduce triglyceride levels and improve other key lipid parameters and is expected to increase convenience for patients by providing both two and four gram once-a-day doses with or without meals.

Under the terms of the agreement, AstraZeneca will acquire Omthera for $12.70 per share, or approximately $323 million, which has an Enterprise Value of approximately $260 million after incorporating Omthera’s cash balances of approximately $63 million. This represents a premium of 88% on Omthera’s closing price on Friday 24 May 2013. In addition to the cash payment, each Omthera shareholder will receive Contingent Value Rights (CVRs) of up to approximately $4.70 per share, equating to approximately $120 million in total, if specified milestones related to Epanova are achieved, or if a milestone related to global net sales is achieved. This will bring the total potential acquisition cost to approximately $443 million.

Omthera has completed pharmacokinetic and Phase III clinical studies to investigate the safety and efficacy profile of Epanova, a coated soft gelatin capsule containing a complex mixture of polyunsaturated free fatty acids derived from fish oils. In 2012, Omthera reported positive results from two Phase III trials (EVOLVE and ESPRIT) examining the effectiveness of Epanova in lowering very high triglycerides, and in reducing non-HDL cholesterol in combination with a statin for patients with high triglycerides. Both trials were conducted under a Special Protocol Assessment with the US Food and Drug Administration.

Omthera is expected to file a new drug application (NDA) in the US for Epanova in mid-2013 for patients with severe hypertriglyceridemia (triglyceride levels greater than or equal to 500mg/dL), with regulatory filings in other markets to follow. AstraZeneca aims to file a supplemental NDA as soon as possible for Epanova as a treatment for patients with mixed dyslipidemia (triglyceride levels of 200-499mg/dl), as well as in a fixed dose combination with CRESTOR (rosuvastatin calcium) for those mixed dyslipidemia patients at high risk of a cardiovascular event. AstraZeneca intends to pursue a large-scale cardiovascular outcomes trial for Epanova in combination with statins.

Pascal Soriot, Chief Executive Officer of AstraZeneca said: “The number of people with elevated triglyceride levels is rising rapidly across the world, due in part to the increasing prevalence of obesity and diabetes. There is a clear need for effective and convenient alternatives to some of the existing treatments. Epanova offers real potential both as a distinctive monotherapy for the treatment of hypertriglyceridemia and in combination with Crestor for patients at high risk of  adverse cardiovascular events. This is an exciting acquisition that clearly complements our existing portfolio in cardiovascular and metabolic disease, one of our core therapy areas.”

Gerald L. Wisler President amp; CEO, Board Member, and Co-Founder of Omthera, commented: “We are delighted to be joining AstraZeneca, a leading pharmaceutical company with a proven track record in the development and commercialisation of global brands in the area of cardiovascular disease. We believe strongly that AstraZeneca can maximise the value of Epanova not only as a monotherapy treatment for dyslipidemia but also as a treatment for cardiovascular disease in combination with Crestor. »

The Board of Directors of Omthera has unanimously approved the terms of the agreement, and has recommended that its shareholders approve the transaction. AstraZeneca’s Board has also approved the terms of the agreement. Subject to the approval of Omthera’s shareholders as well as other conditions including customary regulatory approvals, the transaction is expected to close in the third quarter of 2013. Omthera’s shareholders representing approximately 60% of the current total shares outstanding have entered into a voting agreement with AstraZeneca to vote in favour of the transaction, subject to the conditions set out in the voting agreement.

About Epanova™Epanova is a patent protected, novel, ultra-pure mixture of the free fatty acid forms of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) that meaningfully reduces triglycerides, improves other key lipid parameters and is expected to increase patient convenience with 2-gram once-a-day dosing with or without meals. Epanova is a coated soft gelatin capsule containing a complex mixture of polyunsaturated free fatty acids derived from fish oils, including multiple long-chain omega-3 and omega-6 fatty acids, with EPA, DHA, and docosapentaenoic acid being the most abundant forms of omega-3 fatty acids. Omthera Pharmaceuticals has completed pharmacokinetic and Phase III clinical studies to investigate the safety and efficacy profile of Epanova. In 2012 Omthera reported positive results from its Phase III EVOLVE and ESPRIT trials, both of which were conducted under a Special Protocol Assessment with the U.S. Food and Drug Administration. Omthera is expected to file an NDA for Epanova in mid-2013 for patients with triglyceride levels greater than or equal to 500mg/dL or for severe hypertriglyceridemia. Other planned indications for the monotherapy are as an adjunct to statin therapy and diet in  patients with mixed dyslipidemia and increased triglycerides  (>200 and

About hypertriglyceridemia Hypertriglyceridemia is a serum lipid disorder (dyslipidemia) defined by serum triglyceride levels of ≥150 mg/dL. It is associated with an increased risk of cardiovascular diseases, such as coronary artery disease, or acute risk of pancreatitis if triglyceride levels exceed 500 mg/dL. In 2011, dyslipidemia affected 352 million people aged 20 or older across the major pharmaceutical markets (United States, France, Germany, Italy, Spain, United Kingdom, and Japan), caused by genetic predisposition and various secondary/contributing factors, such as lifestyle and dietetic behaviour (e.g. obesity, malnutrition, metabolic syndrome), as well as by numerous diseases (e.g. diabetes, renal disease, autoimmune diseases). It is estimated that there are 5 million patients in the U.S. with TG levels > 500 mg/dL. A recent NHANES analysis of dyslipidemia in the US indicated that low-density lipoprotein levels have actually declined since the last analysis, but the percentage of patients with severe hypertriglyceridemia has risen sharply along with the dramatic increases in obesity.

About mixed dyslipidemia The second most common form of dyslipidemia is mixed dyslipidemia. Physicians estimate that between 22% and 37% of patients have this form of dyslipidemia. The term mixed dyslipidemia refers to a condition in which the patient suffers from hypercholesterolemia, low high-density lipoprotein levels and hypertriglyceridemia. Due to the nature of the condition and the fact that different classes of antidyslipidemics offer different benefits in controlling lipid abnormalities, a combination therapy is often considered the most beneficial in patients with mixed dyslipidemia. Options are a combination of a statin with either fibrate or nicotinic acid or Omega-3 fatty acids.

About Omthera Pharmaceuticals, Inc. Founded in 2008, Omthera Pharmaceuticals, Inc. is an emerging specialty pharmaceutical company that listed on NASDAQ in April 2013 (NASDAQ: OMTH). Led by a team of experts with exceptional experience in developing new therapies for lipid disorders, Omthera is dedicated to developing innovative therapies for the millions of patients who have elevated triglyceride levels and increased risk of cardiovascular disease. Omthera currently has 14 employees based in Princeton, New Jersey. For more information please visit: www.omthera.com 

About AstraZeneca AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com



Omthera Pharmaceuticals contacts

Chris Schade, Executive Vice President and Chief Financial Officer +1 908 741 6402 (US)

AstraZeneca contacts

Media Enquiries Ayesha Bharmal +44 20 7604 8034 (UK/Global) Vanessa Rhodes +44 20 7604 8037 (UK/Global) Tony Jewell +1 (302) 885 4594 (US) Jacob Lund +46 8 553 260 20 (Sweden)

Investor Enquiries James Ward-Lilley                      +44 20 7604 8122    mob: +44 7785 432613 Karl Hård                                    +44 20 7604 8123  mob: +44 7789 654364 Colleen Proctor                           + 1 302 886 1842     mob: +1 302 357 4882 Ed Seage                                    + 1 302 886 4065     mob: +1 302 373 1361


Princeton, N.J. and PARIS – May 20, 2013 – STENTYS (FR0010949404 – STNT), a medical technology company commercializing in Europe the world’s first and only Self-Apposing® Stent to treat acute myocardial infarction (AMI), announced today that the first patient was enrolled in APPOSITION V, the pivotal FDA-approved IDE trial which will enable the Company to apply for marketing approval of the Self-Apposing Stent in the United States.
APPOSITION V is a multi-center, randomized, two-arm clinical trial that will enroll up to 880 heart attack (ST-elevation myocardial infarction or STEMI) patients at 50 sites in the U.S. and worldwide. The trial is designed to compare the clinical outcome of patients treated with the STENTYS Self-Apposing Stent with a balloon-expandable stent already approved for this indication, the Abbott Multi-Link stent, at 12 months after the procedure. Principal investigators of the study are Roxana Mehran, M.D., Professor of Medicine and Director of Interventional Cardiovascular Research and Clinical Trials at Mount Sinai School of Medicine (New York), and Maurice Buchbinder, M.D., Professor of Clinical Medicine at Stanford University (Stanford, Calif.).
“The APPOSITION V trial will be a landmark study as it is the first time a novel device, that has already shown impressive clinical results in Europe, will benefit our STEMI patients here in the U.S.” said Dr. Mehran. “We would like to congratulate Dr. Karel Koch from Amsterdam Medical Center for enrolling the first patient in this study.”
“This is a historic milestone for STENTYS, as we begin the U.S. trial that will allow us to file our marketing application with the FDA,” said Gonzague Issenmann, CEO and co-founder of STENTYS. “The STENTYS Self-Apposing Stent has the potential to replace the current gold standard of conventional balloon-expandable stents in the AMI setting.”

About the STENTYS Self-Apposing® Stent
The STENTYS Self-Apposing® Stent addresses the stent-sizing dilemma that cardiologists are confronted with when treating heart attack patients. It fits into the contour of a blood vessel, and its shape and diameter adapt as the vessel dilates and the initial clot dissolves during the post-AMI phase, thus reducing the risk of malapposition and complications associated with conventional stents in this setting. The STENTYS Self-Apposing Stent has been marketed in Europe since receiving CE Mark in 2010.

About the APPOSITION V Study
APPOSITION V is an interventional, multi-center, randomized, two-arm clinical trial to evaluate the safety and effectiveness of the STENTYS Self-Apposing® Stent in the treatment of de novo stenotic lesions in coronary arteries in 880 patients undergoing primary revascularization due to ST-elevation myocardial infarction (STEMI) as compared to the Multi-Link coronary system (Abbott Vascular, Inc.). The trial’s primary endpoint is target vessel failure (TVF), which is defined as a composite of cardiac death, target vessel recurrent myocardial infarction or clinically driven target vessel revascularization (TVR), at 12 months post-procedure. The powered secondary endpoint is acute stent malapposition and will be assessed by intravascular ultrasound (IVUS) on the first 225 patients. All patients will undergo clinical follow up at 30 days, six months, nine months and 12 months, with an annual checkup through three years. Fifty sites are expected to participate in the U.S. and worldwide. More information can be found at www.clinicaltrials.gov.

STENTYS is developing and commercializing innovative solutions for the treatment of patients with acute myocardial infarction (AMI, or heart attack) and complex coronary artery disease. STENTYS’ Self-Apposing® Stents are designed to adapt to vessels with ambiguous or fluctuating diameters, particularly in the post-infarction phase, in order to prevent the malapposition problems associated with conventional stents. In the APPOSITION III clinical trial, STENTYS stents demonstrated a very low one-year mortality rate among 1,000 high-risk AMI patients when compared to recent studies with conventional stents. More information is available at www.stentys.com.

This press release contains forward looking statements about the Company’s business. Such forward looking statements are based on numerous assumptions regarding the Company’s present and future business strategies and the environment in which it will operate in the future which may not be accurate. Such forward-looking statements involve known and unknown risks which may cause the Company’s actual results, performance or achievements to differ materially from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, among others, risks associated with the development and commercialization of the Company’s products, market acceptance of the Company’s products, its ability to manage growth, the competitive environment in relation to its business area and markets, its ability to enforce and protect its patents and proprietary rights, uncertainties related to the U.S. FDA approval process, including with respect to a pre-market approval for the Company’s BMS, slower than expected rates of patient recruitment for clinical trials, the outcome of clinical trials, and other factors, including those described in the Section 4 “Risk Factors” of the Company’s 2011 Registration Document (document de référence) filed with the Autorité des marchés financiers in France on June 25, 2012 under number R.12-033 as such section may be updated from time to time.

Stanislas Piot, CFO
Tel.: +33 (0)1 44 53 99 42
STENTYS is listed on Comp. C of the NYSE Euronext Paris
ISIN: FR0010949404 – Ticker: STNT
Europe: NewCap.
Dusan Oresansky / Pierre Laurent
Tel.: +33 (0)1 44 71 94 93
US: MacDougall Biomedical Communications
Charles Liles, Tel.: 781 235 3060
Christine Labaree, Tel.: 650 339 7533