What's new?
04/04/2018

• Sofinnova Crossover 1 est le plus grand fonds crossover dédié à la santé en Europe.
• Avec ce nouveau fonds, Sofinnova Partners poursuit activement sa stratégie visant à élargir sa plateforme d’investissements en sciences de la vie sur l’ensemble de la chaîne de valeur, de l’amorçage aux sociétés de croissance.
• Bpifrance* et CNP Assurances sont co-sponsors du fonds.

Paris, France – 4 avril 2018 — Sofinnova Partners, un leader du capital-risque en Europe spécialisé dans les sciences de la vie, annonce le lancement de son premier fonds crossover dédié à la santé en Europe, d’un montant de 275 millions d’euros (340 millions de dollars), au-delà de l’objectif du premier closing à 250 millions d’euros. Avec ce nouveau fonds, Sofinnova Partners franchit une étape supplémentaire dans le déploiement de son projet de croissance visant à étendre son champ d’intervention dans les différents segments de l’investissement dans les sciences de la vie, grâce à des équipes dédiées.

Dans la continuité de la stratégie appliquée avec succès depuis plusieurs décennies avec ses fonds Capital intervenant en early-stage, Sofinnova Crossover I investira dans la biopharmacie et l’instrumentation médicale. Il ciblera en priorité des technologies de rupture permettant des innovations thérapeutiques portées par des équipes managériales expérimentées. Sofinnova Partners investira comme chef de fil ou investisseur de référence dans une quinzaine d’entreprises privées ou cotées. Environ 80% du fonds seront investis en Europe, et les 20% restants ailleurs, principalement en Amérique du Nord. Une équipe de quatre associés très expérimentés investira le fonds, en s’appuyant sur l’expérience élargie de Sofinnova Partners, son track record et son organisation. Ce nouveau fonds a su attirer la confiance d’investisseurs internationaux de premier plan, notamment des fonds souverains, compagnies d’assurance, corporate, et family offices. La majorité des fonds levés viennent d’Europe, en particulier de France, d’Italie, du Danemark, d’Irlande et de Suisse, mais aussi d’Asie avec des investisseurs originaires de Chine et de Singapour. En plus de BPIfrance* et de CNP Assurances, une société pharmaceutique chinoise de premier plan, le fonds public d’investissement danois, et des family offices tels que Fidim et KCK représentant de grandes familles industrielles d’Europe et d’Asie figurent parmi les investisseurs du nouveau fonds.

Antoine Papiernik, Président de Sofinnova Partners, déclare : “Avec le lancement de l’activité crossover, Sofinnova Partners construit sur son track record unique en early-stage. Beaucoup des entreprises que nous avons financées dès leur démarrage sont devenues au cours des années de grandes entreprises, certaines valorisées plusieurs milliards d’euros ; nous avons ainsi acquis une expérience unique sur la façon de les accompagner au stade d’après. Ce fonds complète notre plateforme d’investissement dans les sciences de la vie, nous permettant d’être actifs tout au long de la chaîne de valeur depuis l’investissement d’amorçage jusqu’aux phases plus avancées.”

Jacques Theurillat, Partner dans l’équipe crossover de Sofinnova Partners, poursuit : “Le marché européen de la santé est devenu mature avec des centaines d’entreprises privées et cotées à la recherche de fonds pour financer leur croissance, et Sofinnova Partners, avec son image de marque, son track record, et son expérience, est idéalement positionnée pour identifier les meilleures opportunités en Europe et accompagner leur transformation en leaders internationaux.”

Sur ce fonds Sofinnova Crossover I, Triago a agi en tant qu’agent de placement et Clifford Chance Europe LLP en tant que conseil juridique.

*Bpifrance intervient pour son compte propre et pour le compte du SGPI dans le cadre du Programme d’investissements d’Avenir (PIA)

Contact presse pour SOFINNOVA PARTNERS
Anne REIN Tel: +33 (0)6 03 35 92 05 @: anne.rein@strategiesimage.com

A propos de Sofinnova Partners
Sofinnova Partners est un des leaders du capital risque en Europe spécialisé dans les sciences de la vie. Basée à Paris, l’équipe est composée de professionnels issus d’Europe, des Etats Unis et de Chine. La société investit dans les technologies de changement de paradigme aux côtés d’entrepreneurs visionnaires. Sofinnova Partners intervient en priorité dans les start up et spin-off d’entreprises en tant qu’investisseur fondateur et chef de file. Depuis 45 ans, la société a accompagné plus de 500 entreprises à travers le monde devenues des leaders sur leur marché. Sofinnova Partners gère aujourd’hui 1,9 milliard d’euros.

09/01/2017

Paris, January 5th, 2017. DNA Script, a company focused on the manufacturing of synthetic DNA using a proprietary enzymatic technology, today announced it will present at the Biotech Showcase Conference on Tuesday, January 10th at 5:15 p.m PT in San Francisco, USA. The Biotech Showcase Conference is a financial investor and strategic business partnering event focused on early stage companies in the life science field.

DNA Script manufactures synthetic DNA using a proprietary template-free enzymatic technology. The company technology leverages nature’s most powerful catalysts – enzymes – to overcome current inefficiencies in synthetic DNA production, and enable affordable, rapid, high-quality and high-throughput production of synthetic biology tools, such as oligonucleotides, genes, pathways and genomes. « Our long-term goal is to render DNA and gene synthesis as simple and as affordable as DNA sequencing is today », states Thomas Ybert, President and CEO.

Created in 2014 and based in Paris, France, DNA Script develops its technology in partnership with Institut Pasteur (www.pasteur.fr/en) and Institut Pierre Gilles de Gennes (www.institut-pgg.com). The technology has the potential to greatly accelerate the development of new therapeutics, sustainable chemicals production, improved crops as well as data storage. The company completed its first institutional funding round in May 2016 led by Sofinnova Partners (www.sofinnova.fr) and with participation of Kurma Partners (www.kurmapartners.com/en) and Idinvest Partners (www.idinvest.com/en).

About DNA Script.
DNA Script is a Paris-based company focused on the manufacturing of synthetic DNA using a proprietary template-free enzymatic technology. The company aims at accelerating innovation in life sciences and technology through rapid, affordable and high-quality DNA synthesis. DNA Script leverages nature’s billions of years of evolution in synthesizing DNA to enable genome scale synthesis.

Its technology has the potential to greatly accelerate the development of new therapeutics, sustainable chemicals production, improved crops as well as data storage. DNA Script develops its technology in partnership with Institut Pasteur and Institut Pierre Gilles de Gennes with the support of key investors such as Sofinnova Partners, Kurma Partners and Idinvest Partners.

www.dnascript.co

Contact
Sylvain Gariel, COO
sg@dnascript.co
+33.6.28.04.53.11
www.dnascript.co

09/01/2017

26/12/2016

Montreal, Canada, December 22, 2016. BioAmber Inc. (NYSE: BIOA), a leader in renewable materials, today announced that it has priced an underwritten offering of 1,748,750 shares of its common stock at a price of $4.00 per share.  The gross proceeds to the Company will be approximately $7.0 million, and net proceeds, after underwriting discounts and commissions and other estimated fees and expenses payable by BioAmber, will be approximately $5.6 million.

Additionally, BioAmber announced today that it has conducted a registered direct offering to “permitted investors” in Canada of warrants to purchase an aggregate of 2,224,199 shares of common stock for gross proceeds of approximately $8.9 million.  Each warrant entitles the holder thereof to receive one share of our common stock on the exercise or deemed exercise of the warrant. The warrants are exercisable by the holders thereof at any time for no additional consideration and all unexercised warrants shall be deemed to be automatically exercised following the satisfaction of certain conditions specified in the warrants.  Until such warrants are exercised or automatically exercised following the satisfaction of such conditions, the subscription proceeds from this registered offering of warrants will be placed in escrow.

Rodman & Renshaw, a unit of H.C. Wainwright & Co., is acting as the sole bookrunning manager for both offerings.  AltaCorp Capital Inc. is acting as financial advisor to BioAmber.

BioAmber intends to use the net proceeds of the underwritten offering and the registered offering of warrants for working capital and other general corporate purposes.  The underwritten offering is expected to close on or about December 29, 2016, subject to customary closing conditions and the closing of the registered direct offering.

The shares of common stock, the warrants and the shares of common stock issuable upon exercise of the warrants described above are being sold by BioAmber pursuant to a shelf registration statement on Form S-3 (No. 333-196470) including a base prospectus, which was declared effective by the Securities and Exchange Commission (the « SEC ») on July 9, 2014, and a related registration statement on Form S-3 filed pursuant to Rule 462(b) under the Securities Act of 1933, as amended (Registration No. 333-162379), which became effective upon filing with the SEC on December 23, 2016. Prospectus supplements relating to the offerings of the securities will be filed by the Company with the SEC. Copies of the prospectus supplements and the accompanying prospectuses relating to the securities being sold, when available, will be available on the SEC’s website located at www.sec.gov and may also be obtained by contacting Rodman & Renshaw, a unit of H.C. Wainwright & Co., at placements@hcwco.com.

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

About BioAmber
BioAmber (NYSE: BIOA) is a renewable materials company. Its innovative technology platform combines biotechnology and catalysis to convert renewable feedstock into building block materials that are used in a wide variety of everyday products including plastics, paints, textiles, food additives and personal care products.  For more information visit www.bio-amber.com.

Forward-Looking Statements
This press release contains « forward-looking statements » within the meaning of the Private Securities Litigation Reform Act of 1995 that involve significant risks and uncertainties about BioAmber, including but not limited to statements with respect to BioAmber’s plans to consummate its proposed underwritten offering of common stock and its registered direct offering of warrants. BioAmber may use words such as « expect, » « anticipate, » « project, » « intend, » « plan, » « aim, » « believe, » « seek, »  » estimate, » « can, » « focus, » « will, » and « may » and similar expressions to identify such forward-looking statements. Among the important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are risks relating to, among other things, whether or not BioAmber will be able to raise capital, the final terms of the underwritten offering of common stock, market and other conditions, the satisfaction of customary closing conditions rel ated to the underwritten offering of common stock, the satisfaction of the conditions triggering the automatic exercise of the warrants from the warrants offering and the release of the proceeds from such offering, BioAmber’s business and financial condition, and the impact of general economic, industry or political conditions in the United States or internationally. For additional disclosure regarding these and other risks faced by BioAmber, see disclosures contained in BioAmber’s public filings with the SEC, including the “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended December 31, 2015, and under the heading « Risk Factors » of the prospectus supplements for these offerings.  You should consider these factors in evaluating the forward-looking statements included in this press release and not place undue reliance on such statements. The forward-looking statements are made as of the date hereof, and BioAmber undertakes no obligation to update such statements as a result of new information.

BioAmber Investor Contact
Roy McDowall
Sr. VP Communication & Strategy
514-844-8000 Ext. 260
roy.mcdowall@bio-amber.com

26/12/2016

Intent is to produce cost competitive bio-succinic acid in China to accelerate sales growth

in conditions, including technical and commercial due diligence, with the definitive agreements expected to be signed by July 2017. As part of the letter of intent, BioAmber will be selling CJCJ bio-succinic acid manufactured at its Sarnia, Ontario plant, so that CJCJ can undertake market development in China and South Korea in the first half of 2017.
“While we remain focused on ramping up our Sarnia plant and building a second plant in North America, this JV is an opportunity for BioAmber to accelerate the deployment of its bio-succinic acid technology on a global scale without capital investment,” stated Jean-Francois Huc, BioAmber’s CEO. “This joint venture would allow us to quickly penetrate the Chinese and broader Asian market and accelerate cash flow and earnings for our shareholders. It would also serve as a blueprint for the build-out of additional bio-succinic acid production with very limited capital investment.”
“This JV is an opportunity for CJCJ to leverage BioAmber’s unique, low pH yeast technology and utilize our existing fermentation assets more effectively in order to competitively supply the growing market for bio-succinic acid in Asia,” added Dr. Hang Duk Roh, Head of CJ CheilJedang BIO.
Fabrice Orecchioni, BioAmber’s COO, added: “CJCJ has visited our Sarnia facility and we have visited their intended plant in China. Both partners are confident that the China plant can be reconfigured to quickly produce bio-succinic acid, for a fraction of what it cost us to build our Sarnia facility.”

About CJ CheilJedang Corporation
CJ CheilJedang (CJCJ) is a Korean-based food, feed and bioscience company, and a subsidiary of the CJ Group. CJCJ is a global leader in the area of industrial biotechnology, with innovations in fermentation and purification technologies. CJCJ is also a leading producer of fermentation-based products such as feed amino acids, monosodium glutamate and nucleotides, with global manufacturing and business operations in six continents. As a socially responsible company, CJCJ strives towards practicing carbon-neutral manufacturing operations by utilizing renewable raw materials and developing value-added co-products to minimize waste into the environment. CJCJ BIO is a division of CJ CheilJedang and operates world-scale fermentation facilities in the United States, China, Indonesia, Malaysia and Brazil.

About BioAmberMontreal, December 19, 2016. BioAmber Inc. (NYSE:BIOA) has signed a non-binding letter of intent with South Korean-based CJ CheilJedang Corporation (KRX:097950) (“CJCJ”). Under the terms of the agreement, BioAmber and CJCJ plan to establish a joint venture in China to produce up to 36,000 metric tons of bio-succinic acid annually and commercialize the output in Asia.
The goal is to competitively produce bio-succinic acid in China and quickly penetrate the world’s largest succinic acid market. This can be achieved rapidly, cost effectively and with limited capital investment by retrofitting an existing CJCJ fermentation facility with BioAmber’s succinic acid technology. CJCJ would incur all capital costs required to retrofit their fermentation facility, including the capital needed during plant commissioning and startup, and production would begin in Q1 2018.If market demand were to subsequently exceed production capacity, the joint venture could expand production through debottlenecking and/or additional investment. The partners would also have a mutual right-of-first-refusal to retrofit additional CJCJ fermentation facilities globally.
CJCJ would own 65% of the JV and BioAmber would own 35%. The JV would pay BioAmber a technology royalty for having access to BioAmber’s proven bio-succinic acid technology, and would pay CJCJ a tolling fee for producing bio-succinic acid on behalf of the JV. Both partners would be entitled to a share of the profits equal to their respective equity ownership positions.
The proposed joint venture is subject to certa
BioAmber (NYSE: BIOA) is a renewable materials company. Its innovative technology platform combines biotechnology and catalysis to convert renewable feedstock into building block materials that are used in a wide variety of everyday products including plastics, paints, textiles, food additives and personal care products. For more information visit www.bio-amber.com.

Forward-Looking Statements
This press release contains forward-looking statements, which are subject to substantial risks, uncertainties and assumptions, including, without limitation, statements related to (i) the potential joint venture with CJCJ which remains subject to several conditions, including due diligence, the negotiation of key considerations and definitive agreements, (ii) the projected capital costs and scheduled completion of the retrofit of CJCJ’s plant located in China, (iii) the use of our technology in such plant with the goal to produce high quality bio-based succinic acid, and (iv) future sales projections of products produced at such plant. These statements often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” “seek,” “will,” “may” or similar expressions. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the events and circumsta nces reflected in the forwardlooking 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 forwardlooking statements, whether as a result of new information, future events or otherwise. For additional disclosure regarding these and other risks faced by BioAmber, see disclosures contained in BioAmber’s public filings with the SEC including, the « Risk Factors » section of BioAmber’s most recent Annual Report on Form 10-K and the recent quarterly reports on Form 10-Q.

BioAmber Investor Contact
Roy McDowall
Sr. VP Communication & Strategy
514-844-8000 Ext. 260
roy.mcdowall@bio-amber.com

16/12/2016

Berlin, Allemagne, le 15 décembre 2016 – NOXXON Pharma N.V. (Alternext Paris : ALNOX), société biopharmaceutique qui développe principalement des traitements contre le cancer, annonce la signature d’un accord de collaboration avec Merck & Co., Inc., Kenilworth, New Jersey, États-Unis (« MSD » hors des États-Unis et du Canada), selon lequel les deux sociétés collaboreront sur une étude clinique de phase 1/2 utilisant le produit anti-CXCL12 de NOXXON, NOX-A12, et l’anticorps monoclonal de MSD, Keytruda® (pembrolizumab), chez des patients atteints de tumeurs solides métastatiques qui généralement ne répondent pas à un inhibiteur de point de contrôle immunitaire en monothérapie.
L’objectif de l’étude de phase 1/2 ouverte en deux parties est d’évaluer les effets pharmacodynamiques et la sécurité de NOX-A12 en monothérapie, ainsi que la sécurité et l’efficacité de NOX-A12 en association avec le Keytruda® chez des patients souffrant d’un cancer métastatique colorectal ou pancréatique. Au total, vingt patients seront recrutés, dix pour chaque type de cancer. NOXXON sera le promoteur de l’étude qui sera menée en Europe.
Le plan de l’étude clinique a été conçu conjointement par NOXXON et MSD. La première partie de l’étude, au cours de laquelle les patients recevront NOX-A12 en monothérapie pendant jusqu’à deux semaines, évaluera les modifications de l’infiltrat immunitaire dans le microenvironnement tumoral induites par l’inhibition de la chimiokine CXCL12 par NOX-A12, en comparant des échantillons de biopsie prélevés avant et après le traitement, ainsi que la sécurité et la tolérance de NOX-A12 chez des patients atteints d’un cancer colorectal ou pancréatique métastatique (stade IV). La deuxième partie de l’étude, au cours de laquelle NOX-A12 sera associé au Keytruda®, évaluera la sécurité et la tolérance de l’association thérapeutique, ainsi que son efficacité.
NOX-A12, un inhibiteur de la chimiokine CXCL12 qui joue un rôle essentiel dans le microenvironnement tumoral, pourrait être un partenaire clé pour une grande variété de médicaments utilisés en immuno-oncologie. NOXXON a rassemblé des données précliniques et cliniques prometteuses, notamment dans des études récentes sur les animaux, qui mettent en avant une synergie avec un inhibiteur de point de contrôle immunitaire, ainsi que des données issues d’études de phase 2a récentes dans le myélome multiple et un second cancer hématologique, présentant un profil de sécurité justifiant la poursuite du développement de NOX-A12, et montrant des premiers signes d’efficacité. NOXXON estime que l’étude clinique programmée positionnera le médicament pour une administration en association avec différentes classes de médicaments immuno-oncologiques, y compris ceux agissant sur ou par l’intermédiaire des cellules T et/ou NK.
Selon les conditions de cet accord de collaboration, MSD fournira le Keytruda® à NOXXON pour les besoins de l’étude, dont il a approuvé le plan. Plusieurs voies d’exploration sont envisagées dans cet accord pour développer l’association thérapeutique dans le cadre d’études cliniques pivot, mais l’accord n’octroie aucun droit commercial à l’une ou l’autre partie sur le composé de l’autre partie. Aucune information supplémentaire n’a été communiquée.
Aram Mangasarian, PhD, Président-Directeur Général de NOXXON commente : « Cette collaboration avec MSD nous permet d’initier une étude clinique sur NOX-A12 chez des patients atteints de tumeurs solides métastatiques, avec les conseils et le soutien de l’un des acteurs clés dans le domaine de l’immuno-oncologie. Nous sommes heureux que MSD partage notre intérêt pour la voie de la CXCL12 pour moduler le microenvironnement tumoral afin d’augmenter l’efficacité du traitement par inhibiteur de point de contrôle immunitaire. »
KEYTRUDA® est une marque déposée de Merck Sharp & Dohme Corp., une filiale de Merck & Co., Inc., Kenilworth, New Jersey, États-Unis.

Pour plus d’informations, merci de contacter :

NOXXON Pharma N.V.
Aram Mangasarian, Ph.D., Président Directeur Général
Tél. +49 (0) 30 726 2470
amangasarian@noxxon.com

NewCap
Florent Alba
Tél. +33 (0) 14 471 98 55
falba@newcap.eu

À propos de NOXXON
NOXXON Pharma N.V. est une société biopharmaceutique développant principalement des traitements contre le cancer. L’objectif de NOXXON est d’améliorer significativement l’efficacité des traitements anticancéreux, notamment les approches immuno-oncologiques (inhibiteurs de point de contrôle immunitaire) et les traitements actuels plus courants (chimiothérapie et radiothérapie). La plateforme de Spiegelmers de NOXXON a permis le développement d’un portefeuille exclusif de produits candidats au stade clinique, dont son candidat médicament anticancéreux phare, NOX-A12. NOXXON est soutenu par des investisseurs internationaux de renom, dont TVM Capital, Sofinnova Partners, Edmond de Rothschild Investment Partners, DEWB, NGN et Seventure. Son siège social se situe à Amsterdam, aux Pays-Bas et ses bureaux à Berlin, en Allemagne. De plus amples informations peuvent être consultées sur www.noxxon.com.

08/12/2016

Paris, France, 7 décembre 2016. Sofinnova Partners, un des leaders du capital risque en Europe spécialisé dans les sciences de la vie, annonce la vente de Creabilis, une société de dermatologie médicale de son portefeuille, à Sienna Biopharmaceuticals, pour une valeur totale pouvant aller jusqu’à 150 M$, avec un paiement initial et un paiement additionnel conditionné à la réalisation de certaines étapes de développement.

Sofinnova Partners était le principal investisseur de Creabilis depuis son entrée au capital en 2008, à l’occasion du tour de financement de série A, jusqu’au à la cession d’aujourd’hui, et a constamment soutenu le développement de la société sur la période. A partir d’une innovation scientifique italienne émanant du BioIndustry Park Silvano Fumero à Ivrea (Italie), Creabilis a développé sa plateforme technologique propriétaire, “Topical by Design”. Sous la direction d’Alex Leetch, PDG, la société a utilisé cette plateforme pour bâtir un portefeuille diversifié de molécules destinées au traitement des maladies de peau telles que le psoriasis, prurit et dermatite. Creabilis est basée dans le Kent (Royaume Uni), et déploie ses activités de recherche et développement depuis Ivrea en Italie.

Sienna Biopharmaceuticals est une société médicale spécialisée dans la dermatologie et l’esthétique basée à Westlake Village (Californie, Etats Unis). Elle est dirigée par une équipe expérimentée ayant à son actif de nombreux succès, tels que le développement et la commercialisation de marques dermatologiques comme KYBELLA®, BOTOX®, DYSPORT®, JUVEDERM® ou ACZONE®.

Graziano Seghezzi, Partner chez Sofinnova Partners et membre du Conseil d’administration de Creabilis, déclare : « Nous sommes ravis de cet accord qui atteste de la capacité du capital risque à développer en Italie des belles et attrayantes entreprises de biotech. En associant leurs forces, Sienna et Creabilis créent une entreprise véritablement globale, disposant d’une présence solide en Amérique du Nord et en Europe ».

Alex Leech, PDG de Creabilis, indique : « le succès d’aujourd’hui doit beaucoup à Sofinnova Partners : en tant qu’investisseurs historiques et de référence, ils ont soutenu notre vision, financé notre croissance, contribué à faire venir d’autres investisseurs internationaux, et joué un rôle décisif dans la réussite de ce build up ». Il poursuit : “Nous ciblons des domaines dans lesquelles les besoins sont encore largement insatisfaits, et nous sommes désormais en position pour apporter des traitement dermatologiques innovants aux patients européens et américains».

BOTOX® Cosmetic, JUVÉDERM®, KYBELLA® et ACZONE® sont des marques de la société Allergan, Inc.

POUR PLUS D’INFORMATION, VEUILLEZ CONTACTER :

SOFINNOVA PARTNERS
Anne REIN
+33 6 03 35 92 05
anne.rein@strategiesimage.com
A propos de Sofinnova Partners
Sofinnova Partners est un des leaders du capital risque en Europe spécialisé dans les sciences de la vie. Basée à Paris, l’équipe est composée de 12 professionnels de l’investissement issus d’Europe, des Etats Unis et de Chine. La société investit dans les technologies de changement de paradigme aux côtés d’entrepreneurs visionnaires. Sofinnova Partners intervient en priorité dans les start up et spin-off d’entreprises en tant qu’investisseur fondateur et chef de file. Depuis plus de 40 ans, la société a accompagné plus de 500 entreprises à travers le monde devenues des leaders sur leur marché. Sofinnova Partners gère aujourd’hui 1,5 milliard d’euros.
Pour plus d’information : www.sofinnova.fr

A propos de Creabilis plc
Creabilis est une société de pharmacie spécialisée dans le traitement topical des maladies dermatologiques. S’appuyant sur sa plateforme technologique propriétaire, « Topical by Design », Creabilis développe des traitements innovants, avec effets localisés et exposition systémique réduite. Creabilis est dirigée par une équipe managériale expérimentée et soutenue par un consortium d’investisseurs de premier plan dans les sciences de la vie, Sofinnova Partners, Neomed, et AbbVie Biotech Ventures. Creabilis est basée au Royaume Uni, et a installé ses activités de R&D en Italie.

07/12/2016

PARIS, France – le 7 décembre 2016 – Lysogene, société biopharmaceutique spécialisée dans la thérapie génique ciblant les maladies rares du système nerveux central, annonce la nomination de David Schilansky au Conseil d’administration en tant que membre indépendant, non exécutif. Actuellement Directeur des Opérations et Directeur Général Délégué de DBV Technologies, société biopharmaceutique (Euronext : DBV ; NASDAQ : DBVT), M. Schilansky possède vingt années d’expérience managériale dans les domaines de la biotechnologie et de la finance.

« Nous sommes heureux d’accueillir David au sein de notre Conseil d’administration, où il veillera à la bonne mise en œuvre de la stratégie de développement de Lysogene » a déclaré Karen Aiach, CEO et fondatrice de Lysogene. « Ses solides compétences de direction et de gestion d’entreprise vont être cruciales alors que nous engageons le développement de nos programmes de thérapie génique dans la Mucopolysaccharidose de type A, la gangliosidose à GM1, ainsi que d’autres maladies potentiellement mortelles. »

En qualité de membre du comité exécutif de DBV Technologies, M. Schilansky supervise la mise en œuvre de la stratégie depuis janvier 2015, après avoir été Directeur Financier de la société en 2011. Auparavant, M. Schilansky a occupé différentes fonctions clés chez Ipsen Pharma, dont celle de Directeur Financier par intérim. Il a également travaillé chez Thomson Inc. (aujourd’hui Technicolor S.A.) en tant que co-responsable des relations investisseurs et chez Warburg Dillon Read (aujourd’hui UBS Investment Bank) dans le domaine des fusions et acquisitions.

« Lysogene est une société innovante, à croissance rapide, qui a déjà franchi des étapes importantes et dispose d’un solide potentiel de développement » commente M. Schilansky. « Je suis fier de rejoindre le Conseil d’administration de Lysogene durant cette phase de transformation pleine de promesses que connaît actuellement la société. »

À propos de la mucopolysaccharidose de type A (ou maladie de Sanfilippo A) et de la gangliosidose à GM1
La MPS IIIA est une maladie de surcharge lysosomale associée à des atteintes neurologiques sévères. Elle est due à une anomalie du gène SGSH transmise de manière autosomique et récessive et touche environ une pour 100.000 naissances. La MPS IIIA apparaît dans la petite enfance, provoquant une neurodégénerescence progressive associée à des troubles du comportement insolubles et à une régression du développement. Cette maladie est dévastatrice pour les patients et pour leur famille. Il n’existe aujourd’hui aucun traitement, et les patients meurent de façon précoce.
La gangliosidose à GM1 est une maladie rare neurodégénérative caractérisée par de graves retards de développement cognitif et moteur, entraînant la mort précoce des patients. La maladie est causée par une mutation du gène GLB1 qui code pour la bêta-galactosidase, une enzyme nécessaire au recyclage de la molécule GM1-gangliosidose dans les neurones. Ce lipide du cerveau est essentiel pour un fonctionnement normal, mais son accumulation entraine une neurodégénerescence et des symptômes neurologiques sévères. Il n’existe actuellement aucun traitement

À propos de Lysogene
Lysogene est une société de biotechnologie au stade clinique, pionnière dans la recherche fondamentale et le développement clinique de thérapies géniques utilisant des vecteurs dérivés de virus adéno-associés (AAV) dans des maladies du SNC pour lesquelles il existe d’importants besoins médicaux non satisfaits. Depuis 2009, Lysogene a mis en place une plate-forme et un réseau sans équivalent, avec des produits de pointe dans la MPS III A et dans la gangliosidose à GM1, pour s’affirmer comme un leader mondial dans les maladies orphelines du SNC.

Pour plus d’informations : www.lysogene.com.

Contact media France:
Annie-Florence Loyer
NewCap
afloyer@newcap.fr
+33 (0)1 44 71 00 12 + 33 (0)6 88 20 35 59
Contact media USA:

Marion Janic
RooneyPartners
mjanic@rooneyco.com
+1 (212) 223-4017

06/12/2016

Lausanne, Switzerland, December 6, 2016 – Asceneuron SA, an emerging leader in the development of innovative small molecules for neurodegenerative diseases, today announced the appointment of J. Michael Ryan, M.D. as Chief Medical Officer. With over 15 years of Central Nervous System (CNS) clinical research experience, Michael brings extensive drug development expertise to Asceneuron. He will be responsible for advancing Asceneuron’s pipeline of innovative small molecules and progressing tau modifiers through the clinic.
Michael joins Asceneuron from Novartis Pharmaceuticals Corporation, where he was Vice President in the Neuroscience Development Franchise and Therapeutic Area Head for Neurodegeneration for five years. At Novartis, he worked on the clinical development strategy and led programmes in a number of CNS indications including Alzheimer’s disease, Parkinson’s disease and Schizophrenia. He has also held a number of senior clinical research and development positions at several multi-national companies including Pfizer, Wyeth Research, and MSD Research Laboratories (known as Merck Research Laboratories in the United States).
Michael completed training in geriatric psychiatry and neuropsychiatry at Dartmouth Medical School and has published over 30 scientific articles on neurodegenerative diseases. He has held academic positions at Dartmouth Medical School and the University of Rochester, where he co-directed the Geriatric Neurology & Psychiatry Clinic until 2004. Michael holds an M.D. in Medicine from the Medical University of South Carolina and a B.S. in Biology from Georgetown University.
Dirk Beher, CEO of Asceneuron, commented: “We are delighted to welcome Michael to the Asceneuron team. His outstanding track record and expertise in neurodegenerative disease are crucial as we are about to progress our first highly brain penetrant and orally bioavailable tau modifier into the clinic for the treatment of a number of orphan CNS disorders. We look forward to working with Michael in addressing this high unmet medical need and developing our pipeline to bring our innovative small-molecule therapeutics to patients.”
Michael Ryan, newly appointed CMO of Asceneuron, added: “Asceneuron is at an exciting stage of development as it looks to take its tau modifiers into the clinic. I look forward to working with such a highly experienced board and dynamic team as we progress the pipeline and develop important treatment options for patients with neurodegenerative diseases.”

For further information, please contact:
Asceneuron
Dirk Beher, CEO
Email: info@asceneuron.com
Hume Brophy
Conor Griffin, Alexia Faure, Alex Protsenko
Tel: +44 (0)20 7862 6395
Email: asceneuron@humebrophy.com

About Asceneuron
Asceneuron is an emerging biotech company excelling in the development of orally bioavailable therapeutics for debilitating neurodegenerative disorders with high unmet medical needs such as orphan tauopathies, Alzheimer’s and Parkinson’s diseases. The lead product, an O-GlcNAcase inhibitor that in preclinical studies has been demonstrated to modulate tau pathology, is currently completing the critical regulatory studies to initiate human clinical testing. The O-GlcNAcase inhibitor is being developed for the orphan tauopathy progressive supranuclear palsy (PSP). Asceneuron is a privately held company financed by a strong syndicate of investors consisting of Sofinnova Partners, SR One, Johnson & Johnson Innovation – JJDC, Inc. (JJDC), Kurma Partners and Merck Ventures. For more information, please visit www.asceneuron.com.

24/11/2016

Support from Financial and Strategic Investors Will Advance
Product Development and Commercialization Efforts

Fremont, Calif.— November 22, 2016 — Shockwave Medical, a pioneer in the treatment of calcified cardiovascular disease, today announced the closing of $45 million in Series C financing led by Sectoral Asset Management, with participation from mutual funds advised by T. Rowe Price Associates, Inc. and returning investors including Sofinnova Partners, Venrock, RA Capital, Deerfield, Ally Bridge Group and others.

Proceeds from the financing will be used to advance development of the company’s Lithoplasty® balloon catheter platform into new therapeutic areas and to expand commercialization of the technology for the treatment of peripheral vascular disease in both the United States and the European Union. The company’s near-term plans also include further study of Peripheral Lithoplasty devices in conjunction with drug coated balloons in a 300+ patient randomized controlled study called DISRUPT PAD III.

“When you consider the treatment challenges created by calcified lesions, it is clear there is a large market opportunity for Lithoplasty. The strong clinical results generated using a device built on a balloon-based platform offer a unique and compelling alternative to currently available therapies,” said Michael Sjöström, co-founder and Chief Investment Officer, Sectoral Asset Management and lead investor of this funding. “We look forward to supporting the management team as they take the company, and technology, to the next level.”

“We are very pleased to have Sectoral lead this financing with returning participation from our high quality investor base,” said Shockwave Medical CEO and co-founder Daniel Hawkins. “Lithoplasty is poised to be a paradigm-changing technology for the treatment of advanced cardiovascular disease. This financing will enable the company to continue taking the steps necessary to ensure the technology reaches its fullpotential.”

Shockwave Medical recently achieved of a series of important milestones including:
– FDA clearance of the company’s Lithoplasty System for lithotripsy-enhanced balloon dilation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries.
– Announcement of the upcoming DISRUPT PAD III study, the largest ever multicenter randomized study designed to exclusively enroll patients with calcified peripheral artery disease (PAD). The study will provide physicians foundational Level I evidence to guide therapy in this difficult-to-treat patient cohort.
– Presentation of positive results from the first study of Lithoplasty technology in the treatment of patients with calcified coronary artery disease.
“Shockwave is on a very successful trajectory to address the growing burden of calcium in cardiovascular disease using Lithoplasty,” said Antoine Papiernik, managing partner of Sofinnova Partners. “We are very pleased to add our continued support to that provided by a very strong investment syndicate. Collectively, this investor base offers the breadth of resources and depth of commitment needed to support the company’s vision of changing the treatment of advanced cardiovascular disease.”

About Shockwave Medical’s Lithoplasty® System
The Shockwave Medical Lithoplasty System is the first-ever device designed to selectively target hardened calcium in patients with cardiovascular disease. The system integrates the calcium-disrupting power of lithotripsy with the familiarity and simplicity of a balloon angioplasty. Built on a deliverable balloon catheter platform, the device emits intermittent sound waves (lithotripsy) that target and disrupt calcified plaques, which then require only a low-pressure balloon inflation to dilate the blockage and restore blood flow. The result is an effective and consistent revascularization of calcified lesions while minimizing complications.
The Peripheral Lithoplasty System is commercially available in the European Union and the United States for the treatment of peripheral vascular disease. To view an animation of the Lithoplasty System visit: http://shockwavemedical.com.

About Shockwave Medical
Shockwave Medical, based in Fremont, Calif., is working to reshape interventional therapy with Lithoplasty® Technology for the treatment of calcified peripheral vascular, coronary vascular and heart valve disease. For more information, visit www.shockwavemedical.com.

Media Contact:
Jessica Volchok
ir@shockwavemedical.com
310 849-7985

 

14/11/2016

LEIDEN, the Netherlands, Nov. 14, 2016 – ProQR Therapeutics N.V. (Nasdaq:PRQR), a company dedicated to changing lives through the creation of transformative RNA medicines for the treatment of severe orphan diseases such as cystic fibrosis (CF) and Leber’s congenital amaurosis Type 10 (LCA10), today announced results for the third quarter of 2016.
“This quarter we completed our QR-010 nasal potential difference study and in October, we reported positive results from this study in homozygous ∆F508 patients. The outcomes were both statistically significant and clinically meaningful, marking an important step for about half of the global CF population.” said Daniel de Boer, Chief Executive Officer of ProQR “I’m proud of the team that has designed and executed this study in the most rigorous way leading to robust clinical proof of concept in the early phase of our development program. I also want to thank the patients that participated, and the clinical investigators that supported this unique and important trial”.

Financial Highlights
At September 30, 2016, ProQR held cash and cash equivalents of €64.9 million, compared to €76.3 million at June 30, 2016. Net cash used in operating activities during the three month period ended September 30, 2016 was €10.8 million, compared to €6.3 million for the same period last year.
Research and development costs increased to €8.3 million for the quarter ended September 30, 2016 from €6.0 million for the same period last year and comprised of allocated employee costs including share-based payments, the costs of materials and laboratory consumables, outsourced activities for our clinical studies, license and intellectual property costs and other allocated costs. The increase in expenses was primarily due to the advancement of our pipeline, which included clinical development of QR-010 for CF, preparations for the start of the first clinical trial of QR-110 for LCA10, and preclinical development activities of QR-313 for epidermolysis bullosa.
General and administrative costs increased to €2.0 million for the quarter ended September 30, 2016 from €1.5 million for the same period last year, primarily due to increased investments in our facilities and our support organization.
Net result for the three month period ended September 30, 2016 was a €10.1 million loss or €0.43 per share, compared to a €6.3 million loss or €0.27 per share for the same period last year. For further financial information for the period ending September 30, 2016, please refer to the financial statements appearing at the end of this release.

Corporate Highlights
• In July 2016, QR-010 received a Fast Track designation by the US Food and Drug Administration (FDA). Drugs that are under development for serious conditions and have the potential to fulfill an unmet medical need can receive this designation. It was established with the intention to bring promising drugs to patients sooner by facilitating the development with more frequent FDA interactions and expediting the review process.
• During the 12th Annual Meeting of the Oligonucleotide Therapeutics Society (OTS) September 25 – 28, 2016 the company presented a poster titled: ‘QR-010 Restores CFTR Function in Models of ∆F508 mediated Cystic Fibrosis’. The poster summarized some of the exciting pre-clinical work published earlier and new data showing that repeated nebulization of QR-010 did not change the diffusion speed of QR-010 in in vitro models of CF-like mucus. The poster also featured new data showing that QR-010 was stable in the presence of clinically relevant levels of several CF standard-of-care therapies.
• During OTS, the company also presented a poster titled ‘QR-110 Treatment for Leber’s Congenital Amaurosis Type 10 due to the p.Cys998X Mutation in CEP290’. This data shows that QR-110 can restore CEP290 mRNA and protein levels in primary LCA10 compound heterozygous patient cells and homozygous optic cups in a dose dependent manner. Based on this data, and other extensive preclinical work, the company plans to start a first-in-human study in adult and pediatric subjects in the first half of 2017.
• This quarter, the company advanced QR-313 (previously named QRX-313) into pre-clinical development for the treatment of dystrophic epidermolysis bullosa (DEB). QR-313 is an RNA oligonucleotide designed to induce the exclusion of a part of the COL7A1 RNA (exon skipping) that contains a disease causing mutation with the aim to restore functional collagen type VII (C7) protein and with that the anchoring fibrils that bind the layers of skin together. The clinical program for QR-313 is expected to start in 2018.

Subsequent events
• During the North American Cystic Fibrosis conference (NACFC) October 26 – 29, 2016 the company presented positive results from PQ-010-002, a proof-of-concept study demonstrating that QR-010 restores CFTR function in patients homozygous for ∆F508. CFTR is the protein channel that is defective in patients with CF, and presence or absence of function of CFTR can be measured with the nasal potential difference (NPD) assay. Following 4 weeks of topical therapy, QR-010 improved the CFTR-mediated total chloride response, a direct measure of CFTR function. QR-010 also restored other indicators of CFTR function. In subjects that were compound heterozygous for the ∆F508 mutation, no meaningful difference was measured. QR-010 was observed to be safe and well-tolerated in all subjects.
• During NACFC the company also announced that clinical study PQ-010-001 completed all four single-dose cohorts and blinded safety data from all cohorts was shared. PQ-010-001 is a placebo-controlled Phase 1b study in subjects with CF homozygous for ∆F508. QR-010 was observed to be safe and well-tolerated in all cohorts. The multiple dose cohorts in this study are ongoing and topline safety, tolerability and exploratory efficacy data from this study are expected in mid-2017.

About ProQR
ProQR Therapeutics is dedicated to changing lives through the creation of transformative RNA medicines for the treatment of severe orphan diseases such as cystic fibrosis and Leber’s congenital amaurosis. Based on our unique proprietary RNA repair platform technologies we are growing our pipeline with patients and loved ones in mind.
*Since 2012*

About QR-010
QR-010 is a first-in-class RNA-based oligonucleotide designed to address the underlying cause of the disease by targeting the mRNA in CF patients that have the ∆F508 mutation. The ∆F508 mutation is a deletion of three of the coding base pairs, or nucleotides, in the CFTR gene, which results in the production of a misfolded CFTR protein that does not function normally. QR-010 is designed to bind to the defective CFTR mRNA and to restore CFTR function. QR-010 is designed to be self-administered via an optimized eFlow® Nebulizer (PARI Pharma GmbH). eFlow® is a small, handheld aerosol delivery device which nebulizes QR-010 into a mist inhaled directly into the lungs. QR-010 has been granted orphan drug designation in the United States and the European Union and fast-track status by the FDA. The QR-010 project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 633545.

About QR-110
QR-110 is a first-in-class RNA-based oligonucleotide designed to address the underlying cause of Leber’s congenital amaurosis Type 10 due to the p.Cys998X mutation in the CEP290 gene. The p.Cys998X mutation is a substitution of one nucleotide in the pre-mRNA that leads to aberrant splicing of the mRNA and non-functional CEP290 protein. QR-110 is designed to restore wild-type CEP290 mRNA leading to the production of wild-type CEP290 protein by binding to the mutated location in the pre-mRNA causing normal splicing of the pre-mRNA. QR-110 is intended to be administered through intravitreal injections in the eye and has been granted orphan drug designation in the United States and the European Union.

About QR-313
QR-313 is a first-in-class RNA-based oligonucleotide designed to address the underlying cause of dystrophic epidermolysis bullosa (DEB) due to mutations in exon 73 of the COL7A1 gene. Mutations in this exon can cause loss of functional collagen type VII (C7) protein. Absence of C7 results in the loss of anchoring fibrils that normally link the dermal and epidermal layers of the skin together. QR-313 is designed to exclude exon 73 from the mRNA (exon skipping) and produce truncated but functional C7 protein and thereby restores functionality of the anchoring fibrils.

FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to”, “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. Forward-looking statements are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. These forward-looking statements include, but are not limited to, statements regarding QR-010, QR-110 and QR-313, and the clinical development and the therapeutic potential thereof, statements regarding our ongoing and planned discovery and development of product candidates and the timing thereof, including those in our innovation pipeline, statements regarding release of clinical data, and statements regarding the Horizon 2020 program. Our actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, risks associated with our clinical development activities, including that positive results observed in our prior and ongoing studies may not be replicated in later trials or guarantee approval of any product candidate by regulatory authorities, manufacturing processes and facilities, regulatory oversight, product commercialization, intellectual property claims, and the risks, uncertainties and other factors in our filings made with the Securities and Exchange Commission, including certain sections of our annual report filed on Form 20-F. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future, except as required by law.

ProQR Therapeutics N.V.:
Smital Shah
Chief Financial Officer
T: +1 415 231 6431
ir@proqr.com