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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/

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

03/12/2013

Parallèlement, la société finalise le protocole d’accord en vue de l’acquisition d’une usine de bioéthanol aux Etats Unis d’une capacité de production de 23 M gal/an dans la perspective de la transformer en la première installation industrielle de butanol bio-sourcé.

Abingdon, Royaume Uni – 2 décembre 2013. Green Biologics Ltd. (“GBL”), société spécialisée dans la chimie du renouvelable, basée à côté d’Oxford au Royaume Uni, qui développe du biobutanol et d’autres produits C4 biosourcés, a levé 15,4 M£ (18,5 M€) lors du tour de financement de Série B mené par Sofinnova Partners, avec une participation stratégique de Swire Pacific Group. Les fonds existants conseillés par Capricorn Venture Partners et Oxford Capital Partners ainsi que par Morningside Ventures et ConvergInce Holdings LLC ont participé au financement.

Sean Sutcliffe, CEO de GBL, déclare : “Nous sommes ravis d’accueillir Sofinnova Partners en tant qu’actionnaire principal, ainsi que Swire Pacific comme investisseur stratégique avec le soutien de nos investisseurs existants”. Il poursuit : “ L’expérience et l’implication de ces nouveaux investisseurs vont nous permettre d’accélérer le développement de notre plateforme technologique ainsi que la commercialisation de nos solutions ; avec un démarrage de nos activités commerciales aux Etats Unis prévu pour 2016 ”.

Denis Lucquin, Managing Partner chez Sofinnova Partners commente : « Nous sommes heureux de mener ce tour de financement. Green Biologics a développé une plateforme technologique exceptionnelle pour fabriquer des produits chimiques biosourcés comme le biobutanol et le bioacétone. Sa position sur le marché, associée à la vision industrielle et au talent de l’équipe managériale, confèrent à Green Biologics un formidable potentiel de création de valeur ».

Philippe Lacamp, Responsable développement durable de Swire ajoute : « Swire Pacific s’attache à identifier des équipes de haut niveau capables de développer des substituts écologiques aux dérivés de pétrole. Avec les autres investisseurs, nous sommes ravis de favoriser le déploiement opérationnel de la stratégie de Green Biologics ».

En parallèle du tour de financement, Green Biologics annonce la finalisation du protocole d’accord en vue de l’acquisition de l’usine de bioéthanol, CMEC (Central MN Ethanol Co-op). Le 27 novembre dernier, les actionnaires de CMEC ont formalisé leur accord à la suite de la lettre d’intention d’achat par Green Biologics datée du 2 juin. Grace à une capacité de production de bioéthanol de 23 millions de gallons par an, cette usine renforce l’outil industriel de Green Biologics et consolide son positionnement stratégique sur le marché de la chimie du renouvelable. Cette unité a vocation a devenir, par « retrofit » du process industriel, la première installation de production de butanol bio-sourcé à une échelle réellement commerciale.

A propos de Green Biologics
Green Biologics Ltd. (“GBL”) est une société de biotechnologie industrielle basée au Royaume Uni. Créée en 2003 à Oxford, GBL opère depuis ses bureaux et ses laboratoires de recherche installés à Abingdon (Oxfordshire, Royaume Uni). Aux Etats Unis, les bureaux, laboratoires et installations industrielles de GBL sont basés à Gahanna, dans l’Ohio. GBS est spécialisée dans la fabrication de substituts aux dérivés de pétrole à partir de produits d’origine végétale. Son produit principal est le biobutanol, un composant utilisé dans les peintures, les adhésifs, les enduits, les encres, les plastiques, la pharmacie, les ingrédients alimentaires ou encore les produits d’entretien ; soit un marché global supérieur à 6 milliards de dollars. GBL a développé une technologie de fermentation innovante pour produire du biobutanol à base de matière première végétale, comme le maïs mais également à partir de biomasse de seconde génération, notamment des déchets végétaux issus de l’agriculture. GBL opère mondialement en Europe, en Amérique du Nord, en Chine, en Inde et au Brésil. Pour en savoir plus, consultez www.greenbiologics.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

A propos de Swire
Le Groupe Swire a été crée à Liverpool (Royaume Uni) en 1816. Actif sur cinq continents, le coeur de ses activités se situe dans la région Asie Pacifique, avec un rayonnement principal autour de la Chine, et des intérêts significatifs au Royaume Uni, aux Etats Unis, en Afrique de l’Est, au Sri Lanka, en Papouasie Nouvelle Guinée et en Australie. Basée à Hong Kong, Swire Pacific qui est une société cotée, a été créée en 1974 à partir d’une des filiales cotée du Groupe Swire. Elle est la holding des principales activités du Groupe à Hong Kong, en Chine Continentale, à Taiwan, à Singapour et ailleurs. Swire Pacific s’organise autour de cinq divisions : Immobilier, Aviation, Boissons, Services Maritimes et Négoce & Industries. La société est l’actionnaire majoritaire de trois société cotées à Hong Kong : Swire Properties, Cathay Pacific Airways et Hong Kong Aircraft Engineering Company (HAECO). Cathay Pacific et HAECO sont les sociétés holding des autres activités de la division Aviation du Groupe. Ses intérêts industriels vont de la fabrication de peinture à l’emballage et la distribution de sucre, notamment pour la marque historique Taikoo Sugar, créée par Swire en 1881.

Contact Iinformation

Pour Green Biologics Ltd
Sean Sutcliffe – CEO
+44 1235 435710
www.greenbiologics.com

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

Pour Swire Pacific Ltd
Philippe Lacamp – Responsable du développement durable
+852 2840 8881
sd@swirepacific.com

27/11/2013

Burntisland, Scotland, November 27th 2013. CelluComp, a sustainable materials company, announces the close of a £2.4 Million funding round. Sofinnova Partners’ Green Seed Fund led the financing, and was joined by Scottish Enterprise through its investment arm, the Scottish Investment Bank (SIB), Claridge and a syndicate of angel investors.
CelluComp uses a proprietary technology to extract nano-cellulose fibres from the waste streams of root vegetables to produce a unique product called Curran®. Curran® provides a highly performant, environmentally-sound and economically-viable solution to rheology (thickening) and reinforcement in multiple industries, such as paints & coatings, home and personal care, concrete, oil drilling and composites. CelluComp is in the process of scaling-up its production and commercialising its product globally.

Christian Kemp-Griffin, CEO of CelluComp, commented: « Along with founders David Hepworth and Eric Whale I am extremely pleased to have raised this round of financing with such important partners. This investment not only gives the company the needed funds but also brings a combined level of expertise and professionalism that will allow the company to be successful quickly.”
Joško Bobanović, Partner at Sofinnova Partners responsible for the fund, added: « CelluComp’s approach changes the paradigm in commercial use of nano-cellulose and opens up a range of new applications. We were attracted by its innovative product portfolio, numerous applications verticals and multi-billion dollar markets. Green Seed Fund focuses on European investments in renewable chemistry and I am thrilled to have the opportunity to work with CelluComp team.”

“Across Scottish Enterprise, we have been working with CelluComp since 2005,” said Head of SIB Kerry Sharp. “We’re pleased to see them preparing to expand into the global marketplace and look forward to working with CelluComp as they continue to push their business forward.”

For further details, please contact:
Christian Kemp-Griffin
Tel: + 33 (0)6 82 83 00 32,
e-mail: ckgriffin@cellucomp.com

Notes to Editors:
CelluComp is Scottish-based materials start-up company that manufactures and markets sustainable products produced from the waste streams of the food industry. CelluComp launched its business in 2004 with the research and development of Curran®, a material derived from nano-cellulose of carrots and sugar beets. Curran® provides multiple solutions for many industries such as paints & coatings, concrete, home & personal care, oil drilling and composites. CelluComp’s vision is to activate change in the way the world uses materials by creating Material Change for Good.
More information is available at www.www.cellucomp.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

The Scottish Investment Bank is the investment arm of Scottish Enterprise, operating Scotland-wide in partnership with Highlands and Islands Enterprise. It manages a suite of funds including the Scottish Co-investment Fund and the Scottish Venture Fund, which are partly funded by the European Regional Development Fund (ERDF); the Scottish Seed Fund, the Scottish Plastics Loan Fund and the Renewable Energy Investment Fund. SIB is also the cornerstone investor in the privately-managed Scottish Loan Fund and an investor in the Rock Spring Ventures Life Sciences Fund. These support Scotland’s SME funding market to ensure businesses with growth and export potential have adequate access to capital. SIB also provides a team of financial readiness specialists to help companies prepare for new investment and more easily access finance.

Claridge, founded in 1987 by Charles Bronfman, is an investment firm headquartered in Montréal. Today, the firm represents the interests of the Stephen Bronfman family and manages a diverse portfolio of third-party investments, as well as direct equity participations in the food industry, real estate, clean technology, renewable energy and entertainment sectors.

 

26/11/2013

PRINCETON (Etats-Unis) et PARIS – Le 26 novembre 2013 – STENTYS (FR0010949404 – STNT), société de technologie médicale qui commercialise le premier et le seul stent auto-apposant® pour le traitement de l’infarctus du myocarde, a reçu le 1er Prix « Deloitte Technology Fast 50 », le palmarès de référence pour les entreprises technologiques en France, dans la catégorie Biotech – Sciences de la Vie pour la région Ile-de-France.
« Deloitte Technology Fast 50 » récompense les entreprises technologiques innovantes en très forte croissance.
Pour le secteur des Sciences de la Vie, la croissance est jugée par le montant des capitaux levés au cours de l’exercice 2012 : avec près de 45 M€, dont 8,3 M€ par placement privé en janvier 2012 et 36,4 M€ par augmentation de capital avec maintien du DPS, STENTYS remporte la première place.
Créée en 2006, la Société développe et commercialise des solutions innovantes pour les patients atteints d’infarctus du myocarde aigu (crise cardiaque). Son stent auto-apposant a montré d’excellents résultats cliniques au travers de nombreuses études, notamment l’étude APPOSITION III. Commercialisé en Europe depuis 2010, STENTYS étend progressivement sa couverture à d’autres régions : la Société est présente au Moyen-Orient depuis avril 2013. Aux Etats-Unis, l’étude clinique APPOSITION V en cours de recrutement, devrait permettre l’obtention de l’agrément de la FDA (Food and Drug Administration) dès 2016.
« Ce trophée témoigne du soutien continu de nos actionnaires, mais rappelle surtout que STENTYS est devenu un acteur incontournable de la cardiologie interventionnelle et que l’essentiel de la croissance est encore devant nous », déclare Gonzague Issenmann, Directeur General de STENTYS.

A propos du stent auto-apposant® de STENTYS
Le stent auto-apposant® de STENTYS résout le dilemme du calibre du stent auquel sont confrontés les cardiologues pour la prise en charge des patients victimes d’une crise cardiaque ou présentant une anatomie artérielle atypique. Son design flexible et auto-expansif lui permet d’épouser la forme du vaisseau propre à chaque patient et adhère parfaitement aux parois irrégulières des vaisseaux sanguins, notamment après l’infarctus du myocarde quand le vaisseau se dilate et le caillot se dissout. Il réduit ainsi le risque de mal-apposition et des complications liées à l’utilisation de stents conventionnels. Le stent auto-apposant® de STENTYS est commercialisé en Europe depuis l’obtention du marquage CE en 2010. Le stent STENTYS à élution de Sirolimus devrait recevoir le marquage CE au 2nd semestre 2014.

A propos de STENTYS
STENTYS développe et commercialise des solutions innovantes pour le traitement des patients ayant subi un infarctus du myocarde aigu (crise cardiaque) et présentant une coronaropathie complexe. Les stents auto-apposants de STENTYS sont conçus pour s’adapter aux vaisseaux de diamètre ambigu ou variable, en particulier après un infarctus, afin d’éviter les problèmes de mal-apposition liés aux stents conventionnels. L’étude clinique APPOSITION III a montré un très faible taux de mortalité à 1 an sur 1 000 patients à haut risque traités pour un infarctus, par rapport aux études récentes menées sur des stents conventionnels. Plus d’informations sur www.stentys.com.

A propos de Deloitte Technology Fast 50
Créé en 2001, le palmarès Deloitte Technology Fast 50 récompense 50 sociétés technologiques innovantes françaises dont le taux de croissance est le plus élevé. Considéré comme une référence au plan national, il s’inscrit dans la dynamique de croissance des entreprises technologiques dans les régions à travers sept palmarès régionaux et un palmarès national.

Ce communiqué contient des déclarations prévisionnelles portant sur les activités de la Société et ses perspectives. Ces déclarations prévisionnelles sont basées sur de nombreuses hypothèses concernant la stratégie présente et future de la Société et l’environnement dans lequel elle évolue qui pourraient ne pas être exactes. Ces déclarations prévisionnelles reposent sur des risques connus et inconnus, des incertitudes et d’autres éléments qui pourraient faire en sorte que les résultats, la performance ou les réalisations réels de la Société diffèrent substantiellement des résultats, de la performance ou des réalisations énoncés ou sous-entendus par ces déclarations prévisionnelles. Ces éléments incluent, entre autres, les risques associés au développement et à la commercialisation des produits de la Société, l’acceptation par le marché des produits de la Société, sa faculté à gérer sa croissance, l’environnement compétitif relatif à son secteur d’activité et aux marchés dans lesquels elle évolue, sa faculté à faire respecter ses droits et à protéger ses brevets et les autres droits dont elle est propriétaire, les incertitudes liées à la procédure d’autorisation auprès de la U.S. FDA, y compris en ce qui concerne la procédure de Pre-Market Approval du stent BMS de la Société, le rythme de recrutement des patients pour le besoin des études cliniques plus lent que prévu, les résultats des études cliniques et d’autres facteurs, notamment, ceux décrits à la section 4 « Facteurs de risque » du document de référence de la Société enregistré auprès de l’Autorité des marchés financiers le 27 août 2013 sous le numéro R.13-040, telle que modifiée le cas échéant.

STENTYS
Stanislas Piot
Directeur financier
Tél. : +33 (0)1 44 53 99 42
stan.p@stentys.com

NewCap.
Communication financière / Relations Investisseurs
Dusan Oresansky / Pierre Laurent
Tél. : +33 (0)1 44 71 94 93
stentys@newcap.fr
STENTYS est coté sur le Compartiment B d’Euronext Paris
ISIN : FR0010949404 – Mnémonique : STNT
Yucatan

Relations Presse
Annie-Florence Loyer / Nadège Le Lezec
afloyer@yucatan.fr / nlelezec@yucatan.fr
Tél. : +33 (0)1 53 63 27 27

25/11/2013

Pixium développe un système d’implants rétiniens pour restaurer la vision de patients aveugles.
Bpifrance, via le fonds InnoBio, participe au financement

Paris, France, 25 novembre 2013 – Pixium Vision (“Pixium”), qui développe des implants rétiniens électroniques pour des personnes ayant perdu la vue, a levé 15 M€ lors de l’extension d’un tour de table série A. Le financement a été mené par Sofinnova Partners, qui devient le premier actionnaire, avec le soutien actif de Bpifrance, via le fonds InnoBio, aux côtés des investisseurs existants de la série A Omnes Capital et Abingworth LLP. A cette occasion, Antoine Papiernik, de Sofinnova Partners, et Chahra Louafi, de Bpifrance, rejoignent le Conseil d’administration de la société.

Pixium a été co-cofondé par Bernard Gilly et José-Alain Sahel en novembre 2011 en étroite coopération avec l’Institut de la Vision, au sein du Centre Hospitalier National d’Ophtalmologie. Avec Pixium, le Dr. Gilly et le Pr. Sahel s’associent de nouveau à Sofinnova Partners après le succès de Fovea Pharmaceuticals, une société spécialisée dans les maladies oculaires qu’ils ont créée en 2005 et revendue avec succès à Sanofi en 2009.

Les fonds levés vont permettre de poursuivre le développement de IRIS, un dispositif d’implants rétiniens intelligents qui vise à permettre de recouvrer une vision proche de la normale pour les personnes ayant perdu la vue suite à des troubles dégénératifs de l’œil comme la rétinopathie pigmentaire, les autres dystrophies rétiniennes ou la dégénérescence maculaire liée à l’âge (DMLA). Pixium s’appuie sur les dernières découvertes et les avancées scientifiques dans les domaines du traitement neuronal, de la micro-électronique et de l’informatique. Les systèmes IRIS comprennent un implant intraoculaire placé dans l’œil du patient. Le patient porte une paire de lunettes dotée d’une mini-caméra intégrée et d’un émetteur sans fil. Les lunettes sont connectées à un ordinateur de poche, de la taille d’un smartphone, qui traite les images prises par la caméra en les convertissant en un signal que les lunettes transfèrent à l’implant rétinien pour stimuler les cellules ganglionnaires, qui envoient un signal au cerveau via le nerf optique afin de produire une image. Le patient suit un programme de rééducation qui apprend à son cerveau à interpréter les signaux émis par l’implant. Le système le plus avancé, IRIS1, est entré en essai clinique en avril 2013. Les résultats sur les premiers patients implantés sont attendus courant 2014 et seront à la base d’une demande de marquage CE.

Dr Gilly, Fondateur et CEO de Pixium, déclare : “Le soutien de nos investisseurs nous donne les moyens de finaliser les essais cliniques d’IRIS1, et d’envisager une autorisation réglementaire dans les deux prochaines années. Les fonds levés seront aussi utilisés pour développer les prochaines générations du système IRIS, dont le potentiel d’amélioration de la vision est encore plus grand, pouvant permettre aux patients d’accéder à une autonomie de vie bien supérieure au quotidien”.

Antoine Papiernik, Partenaire associé chez Sofinnova Partners, ajoute : “Au fil des ans, nous avons tissé des liens solides avec Bernard Gilly et José-Alain Sahel. Après Fovea Pharmaceuticals, que Sofinnova Partners a soutenu dès sa création, nous sommes ravis de rejoindre Pixium et de continuer à soutenir une équipe d’une telle qualité. La technologie de Pixium a le potentiel d’avoir un impact profond sur la vie des patients aveugles souffrants de rétinopathie pigmentaire ou de DMLA. C’est un privilège d’être associé à une entreprise développant un tel projet de rupture ».

Chahra Louafi, Directrice d’investissement chez Bpifrance, déclare : “Nous sommes ravis de pouvoir contribuer au développement de Pixium ; la technologie IRIS est extrêmement innovante et devrait représenter un progrès important pour les patients souffrants de cécité”.

Pour en savoir plus, consultez www.pixium-vision.com

Contacts pour Pixium Vision
Bernard Gilly, Chairman and CEO
bgilly@pixium-vision.com
+33 1 76 21 47 30

Citigate Dewe Rogerson 
Mark Swallow (London) / Lucie Larguier (Paris)
mark.swallow@citigatedr.co.uk / lucie.larguier@citigate.fr
+44 20 7282 2948 / +33 1 53 32 84 75

Contacts pour Sofinnova Partners
STRATEGIES & IMAGE 
Anne Rein 
anne.rein@strategiesimage.com
+33 (0)6 03 35 92 05

A propos de Pixium Vision
Pixium Vision développe des implants rétiniens électroniques innovants pour les personnes ayant perdu la vue. L’objectif est de restaurer la vision de ces patients et de leur permettre ainsi d’être plus autonomes. Pixium Vision s’appuie sur les toutes dernières découvertes scientifiques dans les domaines du traitement neuronal, de la micro-électronique et de l’informatique pour développer des systèmes d’implants rétiniens qui pourraient permettre aux personnes aveugles de retrouver une vision proche de la normale.

Le premier dispositif de Pixium Vision, IRIS1 (Intelligent Retinal Implant Systems), utilise un implant épi-rétinien et est actuellement en phase d’essais cliniques, qui seront à la base d’une demande de marquage CE. La société développe également un système de deuxième génération (IRIS2), construit sur le même modèle que le premier mais offrant une meilleure acuité visuelle. De plus, Pixium travaille actuellement sur IRIS3, un système d’implant sous-rétinien fondé sur des technologies encore plus innovantes.

Pixium Vision a été créé à Paris en novembre 2011 et est un spin-out de l’Institut de la Vision et de l’Université Pierre et Marie Curie à Paris. Le projet Pixium Vision repose sur le travail collaboratif de plusieurs équipes de recherche de haut niveau à travers l’Europe. Pixium Vision est soutenu par un syndicat d’investisseurs européens, incluant Sofinnova Partners, Omnes Capital, Abingworth, Global Life Sciences Ventures, Seventure et Polytechnos.

Pour en savoir plus, consultez www.pixium-vision.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

A propos de Bpifrance et d’InnoBio
Les investissements en fonds propres de Bpifrance sont opérés parBpifrance Investissement. Bpifrance investit en minoritaire, directement via des fonds généralistes ou sectoriels, et indirectement via des fonds partenaires, dans les entreprises françaises, PME, ETI et grandes entreprises. InnoBio est un FCPR, de 139 millions d’euros, géré par Bpifrance qui en est également souscripteur (37 %) aux côtés des principaux laboratoires pharmaceutiques mondiaux (Sanofi Aventis, GSK, Roche, Novartis, Pfizer, Lilly, Ipsen, Takeda, Boehringer-Ingelheim) opérant sur le territoire national. L’objectif principal du fonds est d’investir directement en fonds propres et quasi fonds propres au capital de sociétés fournissant des produits et services technologiques et innovants dans le domaine de la santé. InnoBio, composé d’une équipe d’investisseurs spécialistes du secteur, a réalisé son premier investissement janvier 2010. Pour en savoir plus, consultez www.bpifrance.fr

A propos d’Omnes Capital (anciennement Crédit Agricole Private Equity)
Omnes Capital est un acteur majeur du capital investissement, dédié au financement des PME. Avec 1,8 milliard d’euros d’actifs sous gestion et 160 sociétés accompagnées, Omnes Capital apporte aux entreprises les fonds propres nécessaires à leur développement à travers ses expertises de référence : Capital Développement & Transmission Small et Mid Cap, Capital Risque sur les segments des NTIC et des Sciences de la vie, Energies Renouvelables, Mezzanine,Fonds de fonds secondaire, Co-Investissement. Omnes Capital, anciennement Crédit Agricole Private Equity, était une filiale de Crédit Agricole S.A. jusqu’en mars 2012, date à laquelle la société a pris son indépendance. Omnes Capital est signataire des Principes pour l’Investissement Responsable des Nations Unies (PRI). Pour en savoir plus, consultez www.omnescapital.com

A propos de Abingworth
Abingworth est un groupe d’investissement international spécialisé dans les secteurs des sciences de la vie et de la santé. Le groupe investit en fonds propres dans des entreprises à tous les stades de leur développement, notamment en capital risque, en capital développement et dans des entreprises cotées.
Créé en 1973, Abingworth a accompagné de nombreuses entreprises reconnues sur leur marché. Les équipes d’Abingworth comptent 19 professionnels disposant d’expertises variées et d’un large réseau de contacts dans les secteurs des sciences de la vie et de la santé. Avec 1,25 milliard de dollars d’actifs sous gestion, Abingworth est présent à Londres, Menlo Park (Californie) et Boston. Pour en savoir plus, consultez www.abingworth.com

A propos de l’Institut de la Vision
Construit au cœur du Centre Hospitalier des Quinze-Vingts, l’Institut de la Vision (Paris, France) est l’un des plus importants centres de recherche européens sur les maladies de la vision. Conçu comme un lieu de rassemblement et d’échanges, il réunit dans un même lieu les trois acteurs majeurs de la lutte contre les déficiences visuelles – chercheurs, cliniciens et partenaires industriels – dont le but est identique : découvrir, tester et développer des traitements et des technologies innovantes pour prévenir ou limiter les maladies de la vision et améliorer l’autonomie et la qualité de vie des patients. 

Pour en savoir plus, consultez www.institut-vision.org.

 

20/11/2013
  • 50 percent response rate seen in heavily-pretreated FGF
  • aberrant breast cancer patients – Activity observed in other solid tumors with FGFR/VEGFR pathway activation
  • Servier partnership to fund majority of lucitanib R&D expenditures over the next 2-3 years
  • Adds third compound to portfolio with focus on patient selection and companion diagnostics

BOULDER, Colo., November 19, 2013 – Clovis Oncology (NASDAQ:CLVS) announced today that it has acquired EOS (Ethical Oncology Science) S.p.A., a privately-held Italian biopharmaceutical company developing a novel targeted therapy to treat cancer. EOS owns the exclusive global (excluding China) development and commercialization rights for lucitanib, an oral, dual-selective inhibitor of the tyrosine kinase activity of fibroblast growth factor (FGF) receptors 1 and 2 (FGFR1/2) and vascular endothelial growth factor (VEGF) receptors 1-3 (VEGFR1-3). In 2012, EOS sublicensed lucitanib rights in Europe and the rest-of-world (ROW) markets, excluding China, to Les Laboratoires Servier (Servier). Clovis holds exclusive rights for lucitanib in the U.S. and Japan, and will collaborate with Servier on the global clinical development of lucitanib.

In an ongoing Phase I/IIa clinical study, lucitanib has demonstrated multiple objective responses in FGF-aberrant breast cancer patients, and objective responses have also been observed in patients with tumors often sensitive to angiogenesis inhibitors, such as renal cell and thyroid cancer. FGF-aberrations include amplification of the FGFR1 gene as well as amplification of a region of chromosome 11q that contains several FGF ligands, specifically FGF-3, -4 and -19.The initial development program for lucitanib will focus on the approximately 25 percent of women with breast cancer who have FGF-aberrant disease.

FGFs and VEGFs each play a role in tumor growth and angiogenesis and both are validated targets in oncology. Clovis believes lucitanib is unique in its pattern of clinical inhibition of both FGFR and VEGFR tyrosine kinases. As a result, lucitanib has potential to provide benefit to cancer patients by simultaneously targeting two relevant tumor growth pathways in selected patients identified by FGF aberrations. In particular, Clovis believes FGF-aberrant tumors are driven by both FGF and VEGF pathways, and that by inhibiting both, lucitanib can provide more meaningful benefit than single pathway inhibitors.

“We have been interested in lucitanib for some time and are pleased to have acquired EOS to add this program to our portfolio,” said Patrick J. Mahaffy, Clovis Oncology’s president and CEO. “It is highly consistent with our focus on developing targeted therapies that provide meaningful benefit to specific patient populations. We are extremely encouraged with lucitanib’s 50 percent response rate seen to date in heavily pre-treated targeted patients and we intend to develop it aggressively, in collaboration with our partner Servier.” Lucitanib Clinical Development

The first clinical trial of lucitanib was initiated in Europe in July 2010 and is currently ongoing at Institute Gustave-Roussy in Paris with Professor Jean-Charles Soria and at Vall d’Hebron Institute of Oncology in Barcelona with Professor Josep Tabernero. This trial is an open-label, dose-escalation, Phase I/IIa study to determine the maximum tolerated dose (MTD), recommended Phase II dose, efficacy, pharmacokinetics and pharmacodynamics of lucitanib in adult patients with advanced solid tumors.

Doses evaluated in the study ranged from 5mg to 30mg given once per day. Twenty milligrams once per day was identified as the MTD. Overall, the toxicity profile observed to date is consistent with what was expected from preclinical studies and with VEGF inhibitors generally, with hypertension, proteinuria, asthenia and subclinical hypothyroidism being commonly observed. Other common treatment-related adverse events include gastrointestinal symptoms such as diarrhea, abdominal pain, nausea and vomiting.

Subsequent to MTD identification, a dose expansion phase was initiated in defined populations expected to derive benefit from lucitanib, and initial data show encouraging activity in patients who were either FGFaberrant or angiogenesis inhibitor-sensitive. Six of 12 evaluable FGF-aberrant breast cancer patients achieved RECIST partial responses and the median progression-free survival was 9.4 months in these 12 patients. These patients were heavily pre-treated, with at least three or as many as 14 prior treatment regimens. Importantly, two of the responders had previously failed to achieve a response with a selective FGFR inhibitor. Responses were also observed in other tumor types.

A broad Phase II program is being initiated to explore lucitanib in multiple indications including a U.S. study in patients with treatment-refractory FGF-aberrant breast cancer and a global study in patients with metastatic squamous NSCLC. In parallel with these planned Clovis-sponsored studies, a Servier-sponsored Phase II study of lucitanib monotherapy in patients with advanced breast cancer will begin enrolling this month. This ex- US study is expected to enroll approximately 120 patients and will seek to determine whether the activity of lucitanib is limited to a defined population of breast cancer tumors with FGF-aberrations or if a more broadly defined population may benefit as well.

If these Phase II monotherapy studies in breast cancer are successfully completed, Clovis and Servier intend to pursue future development of lucitanib as monotherapy and/or in combination with estrogen antagonists. Other potential indications that may be considered for development include squamous NSCLC, bladder, head and neck cancer, and other solid tumors with FGF-aberrancies.

Clinical development of lucitanib in patients with FGF-aberrant tumors will be accompanied by development of a diagnostic test designed to identify a selected patient population most likely to benefit.

Composition of matter patent protection for lucitanib and a group of structurally related compounds is issued in the United States and is pending in Japan. In the United States, the composition of matter patent will expire in 2030.

Financial Terms
Under the terms of the deal, Clovis is acquiring EOS for an up-front payment of $200 million, which includes $190 million in Clovis common stock (3,713,731 shares) and $10 million in cash. Clovis will pay an additional $65 million in cash upon the initial approval of lucitanib by the U.S. Food and Drug Association (FDA). Pursuant to the license agreement with Servier, Clovis is entitled to receive up to €350 million (approximately $470 million) upon the achievement of development and commercial milestones, as well as royalties on sales of lucitanib in the Servier territories. Clovis will also pay the EOS shareholders up to an additional €115 million in cash (approximately $155 million) upon the receipt by Clovis of certain of the milestone payments pursuant to the Servier license agreement.

Clovis and Servier will collaborate on the development of lucitanib pursuant to a mutually-agreed upon global development plan. Servier is responsible for the initial €80 million (approximately $108 million) of costs under the global development plan and costs above €80 million will be shared equally between the companies.

Clovis intends to host an R&D Day and webcast for institutional investors and analysts to detail its clinical development programs for CO-1686, lucitanib and rucaparib next January in New York City. Slide Presentation and Conference Call Details Clovis will post a lucitanib slide presentation on the Company’s website at www.clovisoncology.com which can be accessed via the following link: http://phx.corporate-ir.net/phoenix.zhtml?c=247187&p=irol-presentations.Clovis will also hold a conference call to discuss this announcement Wednesday morning, November 20, 2013 at 8:30 a.m. ET. The conference call and slide presentation will be simultaneously webcast on the Company’s web site and archived for future review. Dial-in numbers for the conference call are as follows: US participants 877 703 6110, International participants 857 244 7309, passcode: 12815948.

About Clovis Oncology
Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer 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.

About Servier 
Servier is a privately-run French research-based pharmaceutical company. Current therapeutic domains for Servier medicines are cardiovascular, metabolic, neurological, psychiatric and bone and joint diseases, as well as oncology. Servier is established in 140 countries worldwide with over 20,000 employees and a 2012 turnover of €3.9 billion. Servier invests 25% of its turnover in R&D. More information is available at: www.servier.com

Contact: Anna Sussman Breanna Burkart 303.625.5022 303.625.5023 asussman@clovisoncology.com bburkart@clovisoncology.com

To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in our clinical development programs, including the uncertainties inherent in the initiation of future clinical trials, availability of data from ongoing clinical trials, expectations for regulatory approvals, and other matters that could affect the availability or commercial potential of the drug product candidates because the relate to events, competitive dynamics, and industry change and depend on economic circumstances that may or may not occur in the future or may occur on longer or shorter timelines than anticipated. Clovis Oncology does not undertake to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Clovis Oncology’s Annual Report on Form 10-K for the year ended December 31, 2012 and its other reports filed with the Securities and Exchange Commission.