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16/05/2019

Oversubscribed round to bring first products powered by enzymatic DNA synthesis technology to market

Paris, May 16, 2019. Sofinnova Partners, a leading European venture capital firm specialized in the life sciences, today announced that its portfolio company DNA Script, an industry leader in the manufacturing of synthetic nucleic acids using proprietary enzymatic technology, has raised $38.5 million in Series B financing. New shareholders LSP and BPIFrance joined the round, alongside existing shareholders Kurma Partners, Idinvest Partners, Illumina Ventures, and M Ventures (the corporate venture arm of Merck KGaA). Sofinnova Partners was the first institutional investor in DNA Script in 2016.

DNA Script is the world’s leading company in manufacturing synthetic nucleic acids using enzymatic technology. Founded in 2014 in Paris, the company aims to accelerate innovation in life sciences and technology delivering rapid, affordable, and high-quality DNA. Sixty years after the discovery of DNA, DNA Script’s revolutionary approach leverages billions of years of nature’s evolution in synthesizing DNA to enable genome scale synthesis.

The company offers a novel biochemical process for DNA and RNA synthesis, a fundamental tool used in biology research. At a recent academic conference, DNA Script presented its ability to synthesize 200nt of DNA with remarkable accuracy. This innovation may be used in numerous applications, including electronic data storage, by leveraging unprecedented capabilities of the molecule to store information. The fundraising allows DNA Script to further develop its unique enzymatic technology and nucleotide chemistry platform, and deliver the promise of same-day results.

Joško Bobanović, Partner at Sofinnova Partners, said: “We are excited that DNA Script, which we have backed from its first round of financing, was able to raise such a significant round. The company continues to deliver on its plan, and is now funded by a group of likeminded investors who support the team’s vision of creating a business that enables new applications for synthetic DNA and RNA in areas including drug discovery and development, agriculture, and industrial and food technologies.”

“Sofinnova Partners has been an excellent partner from a very early stage, just after the inception of our company,” said Thomas Ybert, CEO of DNA Script. “Since then, they have helped us on a daily basis to build DNA Script from the ground up. The team brings a strong expertise in the technology as well as one of the broadest global networks in the industry. Importantly, they also provide unconditional support and coaching to our entrepreneurs – whatever the challenge at hand,” he said.

This new funding reaffirms Sofinnova Partners’ investment strategy in the industrial biotech field, initiated in 2009. As a pioneer in this emerging and rapidly growing sector, Sofinnova Partners has a portfolio of 14 industrial biotech companies, backed through two dedicated funds: Sofinnova Green Seed Fund, which raised €22.5M in 2012, and Sofinnova IB I, which raised €125M in 2017.

About DNA Script
Founded in 2014 in Paris, DNA Script is the world’s leading company in manufacturing de novo synthetic nucleic acids using an enzymatic technology. The company aims to accelerate innovation in life sciences and technology through rapid, affordable and high-quality DNA synthesis. DNA Script’s approach leverages billions of years of natural evolution to enable genome-scale synthesis. The company’s technology has the potential to greatly accelerate the development of new therapeutics, enhanced diagnostics, sustainable chemical production, improved crops and DNA data storage.
www.dnascript.co

About Sofinnova Partners
Sofinnova Partners is a leading European venture capital firm specialized in Life Sciences. Headquartered in Paris, France, the firm brings together a team of professionals from all over Europe, the U.S. 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 €2 billion under management.
For more information: http://sofinnovapartners.com/.

Press contact for Sofinnova Partners

International
Kate Barrette
RooneyPartners LLC
kbarrette@rooneyco.com

France
Anne Rein
S&I
+ 33 6 03 35 92 05
anne.rein@strategiesimage.com

19/04/2016

Toulouse, April 19, 2016. EnobraQ, a biotechnology company developing CO2-based industrial fermentation processes, announces it has secured a 2.9 M€ seed financing round lead by Auriga Partners and Sofinnova Partners. Also participating in the round were IRDInov and CEA Investissement. Proceeds will be allocated towards EnobraQ’s research and development plan targeting an advanced proof of concept before the end of 2017.
Founded in 2015 by Sofinnova Partners, following a research project financed by the Toulouse White Biotechnology cluster, EnobraQ is developing a fermentation process using CO2 as its sole carbon source for the production of molecules of interest for the chemical industry. New technological solutions are needed to fight climate change through substituting petroleum products for cleaner alternatives. In this context, EnobraQ’s disruptive approach is to use yeast for CO2 capture and production of chemical compound, thereby significantly reducing greenhouse gases. It provides a unique, innovative response for reducing the threat and seizing the opportunity: feeding the yeasts from its technology with CO2 and decarbonized hydrogen to carry out customized chemical syntheses on an industrial scale
«This successful financing is a major milestone for the company. We are very pleased and honored to have been able to convince several prestigious seed funds to help us in our prospective development” said Leopold Demiddeleer, EnobraQ’s chairman. “Even though we are still very early stage, and hence a very risky proposition, the exceptional potential of the company has convinced our investors” adds Leopold Demiddeleer.

Contact : Michael KREL
mkrel@enobraq.com
+33 (0)6 31 92 53 56

About EnobraQ
EnobraQ is a biotechnology company that develops carbon dioxide based fermentation processes to provide bio-based alternatives to fossil fuel-derived chemicals. The company was founded in 2015 following a research project within the Toulouse White Biotechnology cluster.
About Sofinnova Partners
Sofinnova Partners is a leading European venture capital firm specialized in Life Sciences. Based in Paris, France, the firm brings together 12 highly experienced investment 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 founding and lead investor in start-ups and corporate spin-offs, and has backed nearly 500 companies over more than 40 years, creating market leaders around the globe. Today, Sofinnova Partners has over €1.5 billion under management. For more information, please visit: www.sofinnova.fr
Contact : Anne Rein, anne.rein@strategiesimage.com

About AURIGA IV Bioseeds:
AURIGA IV Bioseeds is a seed investment fund of more than €40M, supported by the Banque Publique d’Investissement and the European Investment Fund. The fund is focused on supporting technological companies emerging from knowledge and know-how developed in Infectiology and Microbiology. AURIGA IV Bioseeds is managed by AURIGA Partners, an independent venture firm based in 18 avenue de Matignon 75008 Paris France and registered with the register of commerce and companies of Paris under number 419 156 351. AURIGA Partners invests in high technology projects bringing innovation to market.
Contact : Franck Lescure, Partner AURIGA Partners – lescure@aurigapartners.com

About IRDInov:
IRDInov is a seed-capital Fund managed by IRDI Gestion based in Toulouse (France). Since its launch in 2012, with financial backing from FNA (French National Seed Fund) managed by BPI France, IRDI, Midi-Pyrénées and Aquitaine regions, and regional banks and industrial actors, IRDInov focuses its investments on seed-capital for technological projects generated from private and public research institutions. IRDInov has the capability to invest up to 3 M€ by project in the south-west of France.
http://www.irdi.fr | Contact : Jean-Michel Petit, CEO – jean-michel.petit@irdi.fr

About CEA Investissement
CEA Investissement, a subsidiary of the CEA, is a specialist in seed investment in technology companies. Its proximity to public research laboratories and the venture capital industry has made it a key player in launching and financing startup companies in France. To date, it has funded over 50 companies. With 15 years’ experience in seed investment, CEA Investissement has generated several successful exits, including companies such as TRACIT, ULIS, MOVEA and FERMENTALG. The investment in EnobraQ was made through the Amorçage Technologique Investissement (ATI) fund, managed by CEA Investissement. The CEA, BPI (using the FNA), EDF, SAFRAN and BIOMERIEUX are investors in ATI.
www.cea-investissement.com | Contact : Celia Hart, Investment Director, Life Sciences, celia.hart@cea.fr Mis en forme : Anglais (États Unis)

19/04/2016

Toulouse, 19 avril 2016. EnobraQ, une entreprise de biotechnologies développant des procédés de fermentations industrielles à partir de CO2, vient de finaliser un premier tour de financement de 2,9 million d’euros mené par Auriga Partners et Sofinnova Partners. IRDInov et CEA investissement ont aussi participé à ce tour d’amorçage. Les fonds levés permettront à la société de développer son programme de recherche visant à obtenir une preuve de concept avancée d’ici fin 2017.
Créée fin 2015 par Sofinnova Partners, suite à un projet de recherche du démonstrateur Toulouse White Biotechnology, EnobraQ développe un procédé fermentaire utilisant du CO2 comme source de carbone pour la production de précurseurs de synthèses organiques et de polymérisation. Dans un contexte où les solutions technologiques sont attendues pour lutter contre le réchauffement climatique et trouver des substituts au pétrole, l’approche d’EnobraQ est révolutionnaire. Grâce un procédé biologique de capture du CO2 par des levures, sa technologie vise à réduire un des principaux gaz à effet de serre en l’utilisant comme source de carbone renouvelable. Elle apporte une réponse unique et innovante pour réduire la menace et saisir l’opportunité : nourrir des levures issues de sa technologie avec du CO2 et de l’hydrogène décarbonné pour opérer des synthèses chimiques sur mesure à une taille industrielle.

«Le succès de ce financement marque une étape importante ; c’est un grand honneur et une grande satisfaction d’avoir pu convaincre plusieurs fonds d’amorçage prestigieux de nous aider dans notre développement prospectif » commente Leopold Demiddeleer, Président d’EnobraQ. «Alors que la société est à un stade de développement encore très amont, et donc très risqué, nos investisseurs ont été convaincus par l’exceptionnel potentiel de la société » ajoute-t-il.

Contact : Michael KREL
mkrel@enobraq.com
+33 (0)6 31 92 53 56

À propos d’EnobraQ
EnobraQ est une société de biotechnologie qui développe des procédés fermentaires utilisant le dioxyde de carbone comme matière première pour apporter des alternatives biosourcées aux molécules d’origine fossile et particulièrement pétrolière. La société a été fondée en 2015 à la suite d’un projet précompétitif au sein du démonstrateur Toulouse White Biotech.

À 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’informations : www.sofinnova.fr
Contact : Anne Rein, anne.rein@strategiesimage.com

À propos d’AURIGA IV Bioseeds :
AURIGA IV Bioseeds est un fonds d’amorçage, doté de plus de 40M€, soutenu par la Banque Publique d’Investissement et le Fonds Européen d’Investissement. Le fonds soutient des sociétés technologiques développées à partir des connaissances et du savoir-faire en Infectiologie et en Microbiologie. AURIGA IV Bioseeds est géré par AURIGA Partners, société de gestion indépendante de capital innovation technologique, basée 18 avenue Matignon 75008 Paris et
enregistrée au code du commerce sous le numéro RCS 419 156 351. AURIGA Partners investit en fonds propres dans des projets technologiques innovants à fort potentiel.
Contact : Franck Lescure, Partner AURIGA Partners – lescure@aurigapartners.com

À propose de IRDInov :
IRDInov, géré par IRDI Gestion, est un fonds d’amorçage dédié au financement de sociétés innovantes en phase d’amorçage ou de démarrage. La stratégie d’investissement de ce fonds est centrée sur les projets de spin off d’entreprises issues des organismes de recherche publique ou privée dans tous les secteurs d’activité innovants (agro-industrie, aérospatial, santé, informatique, télécoms, chimie, énergie, environnement…), sur un espace géographique composé de l’Aquitaine, de Midi-Pyrénées et du Limousin.
http://www.irdi.fr | Contact : Jean-Michel Petit, Directeur Général d’IRDInov – jean-michel.petit@irdi.fr

À propos de CEA Investissement
Créée en 1999, CEA Investissement se consacre au financement d’entreprises de haute technologie. Ses investissements s’appuient sur deux fonds : le Fonds « Amorçage Technologique Investissement” (ATI) (dont les souscripteurs sont BPI France au travers du Fonds National d’Amorçage, EDF, SAFRAN et BIOMERIEUX et le CEA) et le Fonds Stratégique CEA intervenant à tout type de stade de développement au capital de sociétés partenaires du CEA. Depuis sa création, CEA Investissement a financé le démarrage de plus de 50 start-up.
L’investissement dans ENOBRAQ a été réalisé avec le fonds ATI.
www.cea-investissement.com/ Contact : Celia Hart, Directeur d’Investissement Sciences du Vivant, celia.hart@cea.fr

14/04/2016

Financing Will Support Commercialization of the First Biology-Guided Radiotherapy System for Targeted, Personalized Cancer Treatment

HAYWARD, Calif., April 14, 2016 – RefleXion Medical, a medical equipment company developing the first biology-guided radiotherapy system for targeted, personalized cancer treatment, announced today that it has closed a $46 million Series B round of funding. The financing was led by new investor KCK Group, a family investment fund. Also participating in the round were existing investors Pfizer Venture Investments, Venrock and Sofinnova Partners, RefleXion’s largest shareholder.

In conjunction with the financing, Nael Kassar and Greg Garfield from KCK Group will join the RefleXion Board of Directors. Current Board members include Antoine Papiernik, Bill Burkoth, Colin Cahill, Dr. Fred Moll, Jay Watkins, Dr. Samuel Mazin and Akshay Nanduri.

“KCK is extremely excited to partner with RefleXion, and is committed to seeing their technology transform care for patients suffering from cancer,” said Greg Garfield, Head -Medical Technologies Division at KCK Group.

Radiotherapy is a non-invasive cancer treatment procedure, often used in conjunction with medical and surgical oncology therapies. In the United States, approximately 1 million patients receive some form of radiotherapy every year. RefleXion’s biology-guided radiotherapy system (BgRT) could redefine the category by utilizing both anatomic (Computed Tomography) and functional (Positron Emission Tomography) imaging data to guide personalized radiotherapy. Delivering targeted treatment based on the patient’s individual biology, PET-CT guided radiotherapy has the potential to deliver a higher dose of therapeutic radiation to cancerous lesions while sparing surrounding healthy tissue.

“In just two years, the RefleXion team has mitigated the core technical risks in developing a disruptive biology-guided radiotherapy system,” said Dr. Samuel Mazin, Co-Founder/President of RefleXion and inventor of the company’s core technology. “PET has been an effective tool to help diagnose and stage cancer using a radiotracer to map the higher metabolic activity of cancerous lesions. With this metabolic map, we could track multiple tumors in real time and precisely deliver targeted therapy based on that patient’s individual biology.”

In addition to the potential of improving treatment efficacy for primary lesions and tracking of multiple tumors, the RefleXion biology-guided radiotherapy system may also enable several compelling applications of precision medicine. This may include the use of novel PET tracers to adapt treatment based on relevant biological tumor characteristics such as tumor hypoxia, cellular proliferation, DNA synthesis and genetic markers.

Proceeds from the Series B financing will be allocated towards expanding RefleXion’s Engineering, Regulatory and Commercial organizations. “On behalf of the company and existing investors, I would like to welcome KCK Group as we work together to advance cancer care in a significant way. This major financing, along with the collective support, vision and guidance of Sofinnova Partners, Pfizer and Venrock, will allow the Company to achieve the development and regulatory milestones preceding a commercial launch of this paradigm-changing technology,” said Jay Watkins, Chairman of RefleXion.

About KCK Group
KCK is a family investment fund that invests in a diverse set of industries, including medical technologies.

About RefleXion Medical
RefleXion Medical is a privately held medical device company developing the first biology-guided radiotherapy (BgRT) system for cancer treatment. By leveraging Positron Emission Tomography (PET) in a novel way, RefleXion’s patented technology will allow tumors to continuously signal their location during treatment and potentially revolutionize the practice of radiation oncology. RefleXion is backed by premier investment firms Sofinnova Partners, KCK Group, Pfizer Venture Investments and Venrock. The company has also received grant funding from the National Cancer Institute (NCI) Small Business Innovation Research (SBIR) Program. For more information, visit www.reflexionmedical.com and follow @reflexionmed on Twitter.

RefleXion Medical Contact
press[at]reflexionmedical.com

14/04/2016

Financing Will Support Commercialization of the First Biology-Guided Radiotherapy System for Targeted, Personalized Cancer Treatment

HAYWARD, Calif., April 14, 2016 – RefleXion Medical, a medical equipment company developing the first biology-guided radiotherapy system for targeted, personalized cancer treatment, announced today that it has closed a $46 million Series B round of funding. The financing was led by new investor KCK Group, a family investment fund. Also participating in the round were existing investors Pfizer Venture Investments, Venrock and Sofinnova Partners, RefleXion’s largest shareholder.

In conjunction with the financing, Nael Kassar and Greg Garfield from KCK Group will join the RefleXion Board of Directors. Current Board members include Antoine Papiernik, Bill Burkoth, Colin Cahill, Dr. Fred Moll, Jay Watkins, Dr. Samuel Mazin and Akshay Nanduri.

“KCK is extremely excited to partner with RefleXion, and is committed to seeing their technology transform care for patients suffering from cancer,” said Greg Garfield, Head -Medical Technologies Division at KCK Group.

Radiotherapy is a non-invasive cancer treatment procedure, often used in conjunction with medical and surgical oncology therapies. In the United States, approximately 1 million patients receive some form of radiotherapy every year. RefleXion’s biology-guided radiotherapy system (BgRT) could redefine the category by utilizing both anatomic (Computed Tomography) and functional (Positron Emission Tomography) imaging data to guide personalized radiotherapy. Delivering targeted treatment based on the patient’s individual biology, PET-CT guided radiotherapy has the potential to deliver a higher dose of therapeutic radiation to cancerous lesions while sparing surrounding healthy tissue.

“In just two years, the RefleXion team has mitigated the core technical risks in developing a disruptive biology-guided radiotherapy system,” said Dr. Samuel Mazin, Co-Founder/President of RefleXion and inventor of the company’s core technology. “PET has been an effective tool to help diagnose and stage cancer using a radiotracer to map the higher metabolic activity of cancerous lesions. With this metabolic map, we could track multiple tumors in real time and precisely deliver targeted therapy based on that patient’s individual biology.”

In addition to the potential of improving treatment efficacy for primary lesions and tracking of multiple tumors, the RefleXion biology-guided radiotherapy system may also enable several compelling applications of precision medicine. This may include the use of novel PET tracers to adapt treatment based on relevant biological tumor characteristics such as tumor hypoxia, cellular proliferation, DNA synthesis and genetic markers.

Proceeds from the Series B financing will be allocated towards expanding RefleXion’s Engineering, Regulatory and Commercial organizations. “On behalf of the company and existing investors, I would like to welcome KCK Group as we work together to advance cancer care in a significant way. This major financing, along with the collective support, vision and guidance of Sofinnova Partners, Pfizer and Venrock, will allow the Company to achieve the development and regulatory milestones preceding a commercial launch of this paradigm-changing technology,” said Jay Watkins, Chairman of RefleXion.

About KCK Group
KCK is a family investment fund that invests in a diverse set of industries, including medical technologies.

About RefleXion Medical
RefleXion Medical is a privately held medical device company developing the first biology-guided radiotherapy (BgRT) system for cancer treatment. By leveraging Positron Emission Tomography (PET) in a novel way, RefleXion’s patented technology will allow tumors to continuously signal their location during treatment and potentially revolutionize the practice of radiation oncology. RefleXion is backed by premier investment firms Sofinnova Partners, KCK Group, Pfizer Venture Investments and Venrock. The company has also received grant funding from the National Cancer Institute (NCI) Small Business Innovation Research (SBIR) Program. For more information, visit www.reflexionmedical.com and follow @reflexionmed on Twitter.

RefleXion Medical Contact
press[at]reflexionmedical.com

08/04/2016

Edmond de Rothschild Investment Partners led the Series B financing alongside existing investors Sofinnova Partners and InnoBio. Large Venture also participated in the operation.
Funds will drive a confirmatory phase 3 study in US to treat progressive multiple sclerosis with MedDay’s wholly-owned lead candidate, MD1003

Paris, France, 8 April 2016 – MedDay, a biotechnology company focused on the treatment of nervous system disorders, today announces that it has raised €34 Million ($38.5M) of new capital in a Series B financing round. Edmond de Rothschild Investment Partners (EDRIP) led the new investment round alongside existing investors Sofinnova Partners and InnoBio (Bpifrance). Large Venture (Bpifrance) also participated in the operation.

The new funds will enable MedDay to conduct a confirmatory phase-3 study in United States “SPI2”, following the successful phase-3 MS-SPI study in 2015 in progressive multiple sclerosis, with its wholly-owned lead candidate, MD1003. The funds will also accelerate pre-launch activities of MD1003 in Europe where the drug is currently being supplied by MedDay on a named patient basis, the development of other pipeline candidates as well as the advancement of a research platform aimed at identifying new metabolic targets in neurological diseases.

Frédéric Sedel, CEO of MedDay, commented: “This series B round will support the international development of our lead candidate MD1003. The €34M comes in addition to current sales under “named patient use”. Together with world-leading key opinion leaders, we believe MD1003 represents a very promising drug for patients with progressive MS. The SPI2 study is expected to confirm, in a large North American population, the results of our prior European MS-SPI study and will further advance MedDay in the field of progressive MS worldwide. We are pleased to welcome additional specialist investors to MedDay.”

Raphaël Wisniewski, Edmond de Rothschild Investment Partners, said: “We are delighted to invest in MedDay at such an important time and to be able to provide funding alongside such strong and supportive current investors. MedDay has the potential to be a game-changing biotech company in the major area of progressive MS. Due to the existing data and current use of MD1003, MedDay’s platform and pipeline opportunities and strength of the management team, we are highly confident that MedDay will create major value for patients worldwide.”

On behalf of the founding investors, Rafaèle Tordjman, Managing Partner at Sofinnova Partners, and Chahra Louafi, Senior Investment Director at Bpifrance added: “We are excited that MedDay was able to raise a significant financing. The company is funded by a group of investors who share a collective vision of creating a standalone business that will deliver medicines of exceptional benefit to patients in areas of high unmet need.”
In association with the financing, Raphaël Wisniewski, Partner at EDRIP, has joined Rafaèle Tordjman and Chahra Louafi on MedDay’s Board of Directors.

About MedDay
MedDay is a privately held biotechnology company developing new drugs targeting brain metabolism to treat diseases of the nervous system. The company was founded in 2011 by Frédéric Sedel, MD, PhD (Chief Executive Officer); and Guillaume Brion, MD (Chief Operating Officer). The Company’s most advanced pipeline candidate, MD1003, is in phase 3 for the treatment of primary and secondary progressive multiple sclerosis. For more information, please see: www.medday-pharma.com.

About Edmond de Rothschild Investment Partners
Edmond de Rothschild Investment Partners is a leading investor in minority investments into privately-owned companies. Affiliate of the Edmond de Rothschild Group, the fund management employs 41 employees and has approximately €1.3 billion under management. Its Life Sciences team of nine professionals brings together over 60 years of experience in the Life Science industry and more than 100 years of private equity and venture capital experience. The team has raised more than €450 million through its Biodiscovery franchise and is currently completing the investment of BioDiscovery 4 fund. Since their inception, BioDiscovery Funds have invested in 53 privately-held companies, of which 14 have been sold and 16 listed on public financial markets, while 21 are active in the portfolios.

About Sofinnova Partners
Sofinnova Partners is a leading European venture capital firm specialized in Life Sciences. Based in Paris, France, the firm brings together 12 highly experienced investment 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 founding and lead investor in start-ups and corporate spin-offs, and has backed nearly 500 companies over more than 40 years, creating market leaders around the globe. Today, Sofinnova Partners has over €1.5 billion under management. For more information, please visit: www.sofinnova.fr

About InnoBio (Bpifrance)
The public investment bank Bpifrance is the result of the merger of business funding and investment organizations OSEO, FSI, CDC Entreprises and FSI Regions. It was established by French law on Dec. 31 2012. It has two shareholders, the French State and the Caisse des Depo^ts (The French Deposits and Consignments Fund). The aim of Bpifrance is to support businesses, (SMEs, mid-cap companies and larger entities of strategic importance to the French economy), from their seed capital stages up to stock market listing. They offer access to credit, collateral and equity funding. Bpifrance also provides assistance and enhanced support services for innovation, export and external growth. They act as a single point of contact regarding the funding and investment needs of entrepreneurs in every region. InnoBio is a EUR 173 million venture capital fund managed by Bpifrance, which is also an investor in the fund. Sanofi, GSK, Roche, Novartis, Pfizer, Lilly, Ipsen, Takeda and Boeringer-Ingelheim are among the other investors. The main aim of the fund is to make equity investments in innovative companies providing technology, products and services for health care. For more information, please visit: www.bpifrance.fr

About Large Venture (Bpifrance)
Bpifrance Large Venture is a €600M fund investing in the healthcare, digital and green technology spaces. It funds high-growth companies with significant capital requirements for their international, industrial, or commercial development. Large Venture is the next step in the financing cycle for venture-backed or revenue-generating companies, after early-stage VCs. Its goal is to help French national champions emerge, and help them scale globally. Large Venture is a long-term, active minority investor and has the ability to invest in both the private and public markets.

About progressive MS
MS is the most common disabling neurological disease among young adults, with first symptoms typically manifesting between 20 and 40 years of age. In the majority (85%) of cases, patients experience an initial phase of relapsing-remitting neurological dysfunction (RRMS), which typically evolves into a secondary progressive disease at a later point in the clinical course (SPMS). Once MS is in the progressive phase, individuals experience a gradual worsening of neurological disability. Primary progressive MS (PPMS) characterized by disease progression from onset is less common, affecting 10–15% of patients. Progressive disease (either SPMS or PPMS) can be further divided into active or not-active progressive disease based on the existence or not of superimposed inflammatory activity. Immunosuppressive and immunomodulatory drugs have been shown to decrease the frequency of relapses and CNS lesions in relapsing remitting MS. These drugs may also delay progression in the subgroup of patients with active progressive MS. However, there is currently no drug targeting not-active progressive MS which represents the larger and most difficult to treat population.

About MD1003
MD1003 is a highly dosed pharmaceutical grade biotin that has already shown efficacy in patients with progressive multiple sclerosis. MD1003 has a mode of action which potentially influences two targets related to progressive MS: (1) it activates acetyl-CoA carboxylases (ACC1 and ACC2), the rate-limiting enzymes in the synthesis of fatty acids required for myelin synthesis, and (2) it activates the Krebs cycle in demyelinated axons to avoid hypoxia-driven axonal degeneration responsible for disease’s progression. Results from two phase 3 studies, MS-SPI and MS-ON already demonstrated the unique capability of the drug to reverse disease progression in a subset of patients in addition to decreasing the overall disease’s rate of progression. The effects were specifically observed in not-active progressive forms of the disease where there is no current drug approved. The drug is already commercialized in some European countries under “named patient use”.

About MS-SPI
The MS-SPI study is a randomized 2:1, double-blinded, placebo-controlled study in patients with not-active progressive MS. Treatment duration was one year followed by a pre-planned 12 months-extension phase where the placebo was switched to the active. The primary endpoint of the study was defined as the proportion of patients who improved at 9 months (M9), with a confirmation of the improvement at 12 months (M12). The primary endpoint was met (p=0.0051). The mean change of EDSS between M0 and M12 decreased in the MD1003 group (-0.03) compared to progression in the placebo group (+0.13, p=0.014). Clinical Global Impression of change assessed by the clinician (CGI) and by the patient (SGI) after 12 months of treatment were significantly better in the intervention group compared to the placebo (p<0.0001 and p=0.0094, respectively).

For more information, please contact:

MedDay Pharmaceuticals
Email: contact@medday-pharma.com

Consilium Strategic Communications
Mary-Jane Elliott, Jonathan Birt, Laura Thornton
Tel: +44 (0)20 3709 5700
Email: medday@consilium-comms.com

08/04/2016

Edmond de Rothschild Investment Partners a mené le financement de série B aux côtés des investisseurs existants Sofinnova Partners et InnoBio. Large Venture a également participé à l’opération.
Les fonds serviront à mener une étude clinique confirmatoire de phase III aux États-Unis avec le médicament MD1003 dont les droits appartiennent exclusivement à Medday, chez les patients atteints de sclérose en plaques progressive.

Paris, France, le 7 avril 2016 – MedDay, une société de biotechnologie spécialisée dans le traitement des maladies neurologiques, annonce aujourd’hui une levée de fonds de 34 millions d’euros à l’occasion d’un tour de financement de série B. Edmond de Rothschild Investment Partners (EDRIP) a mené le nouveau tour d’investissement aux côtés des investisseurs historiques Sofinnova Partners et InnoBio (Bpifrance). Large Venture (Bpifrance) a également participé à l’opération.

Les nouveaux fonds permettront notamment à MedDay de conduire une étude confirmatoire de phase III aux Etats-Unis avec son principal candidat MD1003 (biotine pharmaceutique fortement dosée) chez les patients atteints de sclérose en plaques (SEP) progressive. Cette étude baptisée « SPI2 » fait suite à la réussite d’une première étude de phase III « MS-SPI » conduite en France entre 2013 et 2015. Les fonds permettront également de préparer le lancement commercial du MD1003 en Europe où le traitement est déjà disponible dans certains états membres dont la France selon la procédure d’autorisation temporaire d’utilisation. Medday poursuivra en parallèle le développement d’autres produits candidats et continuera à développer une plateforme de recherche destinée à identifier de nouvelles cibles métaboliques dans les maladies neurologiques.

Frédéric Sedel, directeur général de MedDay, commente : « Ce nouveau tour de financement permet de sécuriser le développement international de notre principal médicament candidat. Avec les experts internationaux, nous estimons que le MD1003 constitue un traitement extrêmement prometteur pour les patients atteints de SEP progressive, une forme de la maladie particulièrement difficile à traiter aujourd’hui. L’étude SPI2 a pour objet de confirmer, auprès d’une large population de patients nord-américains, les résultats de notre étude européenne MS-SPI et de permettre l’obtention d’une autorisation commerciale aux Etats-Unis. Nous sommes fiers d’accueillir d’autres investisseurs spécialisés de renom.»

Raphaël Wisniewski, Edmond de Rothschild Investment Partners, commente : « Nous sommes heureux d’investir dans MedDay à un moment essentiel de la vie de la société aux côtés des investisseurs historiques qui continuent à apporter leur soutien. MedDay a tout pour devenir une société de biotechnologie capable de changer la donne notamment dans le domaine de la SEP progressive. En raison des résultats cliniques déjà obtenus, de la plateforme de recherche, des opportunités en cours de développement et de la force de son équipe de direction, nous sommes convaincus que MedDay apportera à brève échéance des solutions aux patients atteints de maladies neurologiques».

Au nom des investisseurs fondateurs, Rafaèle Tordjman, Managing Partner chez Sofinnova Partners, et Chahra Louafi, Directrice d’investissement senior chez Bpifrance, ajoutent : « Nous sommes ravies de participer à la seconde levée de fonds de MedDay. La société est soutenue par un groupe d’investisseurs qui partagent une vision commune : celle de créer une société solide capable de proposer aux patients des médicaments aux bénéfices exceptionnels dans des domaines où les besoins restent encore largement insatisfaits ».
Raphaël Wisniewski, Directeur Associé chez EDRIP, rejoint Rafaèle Tordjman et Chahra Louafi au conseil d’administration de MedDay.

 

À propos de MedDay
MedDay est une société de biotechnologie privée, qui développe de nouveaux médicaments ciblant le métabolisme cérébral dans le but de traiter des maladies neurologiques graves. La société a été fondée en 2011 par le Dr Frédéric Sedel (directeur général) et le Dr Guillaume Brion (directeur des opérations). Le produit le plus avancé est le MD1003 (biotine pharmaceutique à très forte dose) actuellement en phase III pour le traitement de la SEP progressive primaire et secondaire. Pour plus d’informations, rendez-vous sur le site : www.medday-pharma.com.

À propos d’Edmond de Rothschild Investment Partners
Edmond de Rothschild Investment Partners est un investisseur de référence dans l’investissement minoritaire dans des sociétés non cotées. Filiale du groupe Edmond de Rothschild basée à Paris, la société de gestion rassemble 41 collaborateurs, dont 29 professionnels de l’investissement, et gère environ 1,3 milliard d’euros. Son équipe spécialisée dans les sciences de la vie est composée de neuf professionnels qui bénéficient d’une expérience cumulée de plus de soixante ans dans les sciences de la vie et de plus de cent ans dans l’investissement non coté. L’équipe a levé plus de 450 millions d’euros à travers les différentes générations des fonds BioDiscovery, et termine actuellement l’investissement du fonds BioDiscovery 4. Depuis leur création, cette famille de fonds a investi dans 53 sociétés non cotées, dont 15 ont fait l’objet d’une cession industrielle, 14 ont été cotées sur les marchés financiers et 21 sont actives dans les portefeuilles des fonds.

Les fonds BioDiscovery, y compris BioDiscovery 4, sont des fonds professionnels de capital investissement bénéficiant d’une procédure allégée. A ce titre, ils ne sont pas soumis à l’agrément de l’Autorité des Marchés Financiers et peuvent adopter des règles d’investissement dérogatoires. Plus d’informations sont disponibles sur le site www.edrip.fr

À 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’informations : www.sofinnova.fr

À propos d’InnoBio (Bpifrance)
La banque d’investissement publique, Bpifrance, est le résultat de la fusion des organismes professionnels de financement et d’investissement OSEO, FSI, CDC Entreprises et FSI Régions. Elle a été établie en vertu du droit français le 31 décembre 2012. Elle compte deux actionnaires : l’État français et la Caisse des Dépôts. Bpifrance a pour objectif de soutenir des entreprises (PME, sociétés de moyenne capitalisation et grandes entreprises ayant une importance stratégique dans l’économie française), depuis leur phase initiale de capitalisation jusqu’à leur introduction en bourse. Elle offre un accès au crédit, aux garanties et au financement par émission d’actions. Bpifrance offre également une assistance et des services de soutien avancés dans les domaines de l’innovation, de l’exportation et de la croissance externe. Elle fait office d’interlocuteur unique pour les besoins en financement et en investissement des entrepreneurs de chaque région. InnoBio est un fonds de capital-risque de 173 millions d’euros dirigé par Bpifrance, qui investit également dans ce fonds. Sanofi, GSK, Roche, Novartis, Pfizer, Lilly, Ipsen, Takeda et Boeringer-Ingelheim comptent parmi ses autres investisseurs. L’objectif principal de ce fonds est de réaliser des investissements en actions dans des entreprises innovantes proposant des technologies, des produits et des services dans le domaine des soins de santé. Pour plus d’informations, rendez-vous sur le site : www.bpifrance.fr

À propos de Large Venture (Bpifrance)
Doté de 600 M€, Large Venture a vocation à investir dans les sociétés innovantes en hypercroissance ayant de forts besoins capitalistiques. Il accompagne les entreprises des secteurs prioritaires de la santé, du numérique et de l’environnement dans l’accélération de leur développement commercial, leur déploiement à l’international ou l’industrialisation de leur technologie. Large Venture investit au capital de sociétés déjà financées par des VCs ou ayant déjà un chiffre d’affaires significatif et a pour objectif de favoriser l’émergence de champions français, futurs leaders mondiaux de leurs marchés. Large Venture est un investisseur minoritaire ayant la capacité de soutenir ses participations sur le long terme.

À propos de la SEP progressive
La SEP est la maladie neurologique handicapante la plus fréquente chez l’adulte jeune, les premiers symptômes se manifestant généralement entre 20 et 40 ans. Dans la majorité (85 %) des cas, les patients connaissent une phase initiale de troubles neurologiques évoluant par poussées, dite forme récurrente-rémittente (SEP-RR), qui se transforme généralement avec le temps en forme secondairement progressive de la maladie (SEP-SP). Lorsque la SEP entre dans la phase progressive, les patients présentent une aggravation lente de leur handicap neurologique. La SEP progressive primaire (SEP-PP) caractérisée par une progression dès le début de la maladie est moins fréquente et ne touche que 10 à 15 % des patients. La SEP progressive qu’elle soit secondaire ou primaire (SEP-PS ou SEP-PP) peut être subdivisée en SEP progressive « active » ou « non active », selon qu’il existe ou non une activité inflammatoire surajoutée (poussées ou nouvelles lésions IRM). Les traitement actuels, immunosuppresseurs et immunomodulateurs, permettent de réduire la fréquence des poussées et le nombre de lésions détectables en IRM. Ces médicaments sont surtout efficaces dans la SEP-RR et, à moindre degré, dans le sous-groupe de patients atteints d’une SEP progressive active. A l’inverse, il n’existe pas de médicament ciblant la SEP progressive « non active » qui constitue la population la plus difficile à traiter.

À propos de MD1003
Le MD1003 est une biotine de grade pharmaceutique très fortement dosée qui a déjà démontré son efficacité chez les patients souffrant d’une sclérose en plaques progressive. Le MD1003 a un mécanisme d’action susceptible d’agir sur deux cibles associées à la SEP progressive : (1) il active les acétyl-CoA carboxylases (ACC1 et ACC2), des enzymes impliquées dans la synthèse des acides gras à longue chaîne nécessaires à la synthèse de la myéline ; et (2) il active des enzymes impliquées dans le fonctionnement du cycle de Krebs, principale voie de production énergétique indispensable au fonctionnement des axones démyélinisés et ce afin d’éviter la dégénérescence axonale. Les résultats de deux études de phase III, MS-SPI et MS-ON, ont déjà démontré la capacité unique de ce médicament à inverser l’évolution de la maladie chez certains patient, en plus de réduire le taux de progression global de la maladie. Les effets ont plus spécifiquement été observés sur les formes progressives « non actives » de la maladie, pour lesquelles aucun médicament n’a encore démontré d’efficacité. Ce médicament est déjà disponible dans certains pays européens et notamment en France sous autorisation temporaire d’utilisation.

À propos de l’étude MS-SPI
L’étude MS-SPI est une étude randomisée 2:1, en double insu, contrôlée contre placebo menée chez des patients atteints d’une SEP progressive non active. La durée du traitement était de 12 mois, suivi d’une phase d’extension de 12 mois au cours de laquelle le placebo a été remplacé par le traitement actif. Le critère d’évaluation principal de l’étude a été défini comme la proportion de patients ayant présenté une amélioration à neuf mois (M9), avec une confirmation de l’amélioration à 12 mois (M12). Le critère principal a été atteint (p = 0,0051). La variation moyenne du score EDSS (score de handicap) entre M0 et M12 a diminué dans le groupe MD1003 (-0,03) alors qu’il s’est aggravé dans le groupe placebo (+0,13, p = 0,014). L’Impression clinique globale évaluée par le clinicien (CGI) et par le patient (SGI), après 12 mois de traitement, était significativement meilleure dans le groupe MD1003 que dans le groupe placebo (p < 0,0001 et p = 0,0094, respectivement).

Pour plus d’informations, veuillez contacter :

MedDay Pharmaceuticals
Email : contact@medday-pharma.com

Consilium Strategic Communications
Mary-Jane Elliott, Jonathan Birt, Laura Thornton
Tél : +44 (0)20 3709 5700
Email : medday@consilium-comms.com

07/04/2016

Palo Alto, CA, USA and Amsterdam, The Netherlands, 7 April 2016  – ReCor Medical announced today the enrollment of the first subjects in the FDA IDE-approved RADIANCE-HTN clinical trial to evaluate the effect of the ReCor Paradise® Renal Denervation System on blood pressure in patients with hypertension.

RADIANCE-HTN is a blinded, randomized and sham-controlled trial designed to evaluate the blood pressure lowering effect of the Paradise System in two patient populations: the SOLO cohort will evaluate subjects with essential hypertension on two or fewer antihypertensive medications, and the TRIO cohort will evaluate subjects with treatment-resistant hypertension on a minimum of 3 antihypertensive medications.
The first TRIO patient was enrolled at the Erasmus University Medical Center in Rotterdam, the Netherlands by Dr. Joost Daemen. “We are excited to have enrolled the first patient in this very important study,” commented Dr. Daemen. “We have significant experience using the Paradise System and believe that the RADIANCE-HTN study is well designed to demonstrate the System’s treatment effect. If RADIANCEHTN is positive, then, given the existing CE-marking, we would consider Paradise as an essential tool to treat patients with resistant hypertension here at Erasmus.”
The first SOLO patient was enrolled at Sutter Health, Sacramento, CA, USA by Dr. Pei-Hsiu Huang. “The SOLO cohort represents a large population of hypertension patients, many of whom are seeking alternative methods to manage a lifetime of hypertension treatment,” added Dr. Huang. “We are excited to be part of this important study and by the possibility that RADIANCE-HTN could demonstrate the efficacy of renal denervation with the Paradise System, and open a path to new treatment options for our hypertension patients.”
RADIANCE-HTN is approved to enroll 292 subjects at up to 40 investigational sites, and will be conducted in the US, UK, France, Germany, and The Netherlands.

More information on RADIANCE-HTN can be found at:
https://clinicaltrials.gov/ct2/show/NCT02649426?term=radiance&rank=3

About ReCor Medical, Inc.
ReCor Medical is a private, venture-backed, medical device company that designs and manufactures 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 3 clinical trials, and has been used in over 200 patients.

For more information about ReCor Medical, please visit
www.recormedical.com or contact Andrew M. Weiss, President & CEO,
ReCor Medical at aweiss@recormedical.com / +1-650-542-7700.

07/04/2016

Palo Alto, CA, USA and Amsterdam, The Netherlands, 7 April 2016  – ReCor Medical announced today the enrollment of the first subjects in the FDA IDE-approved RADIANCE-HTN clinical trial to evaluate the effect of the ReCor Paradise® Renal Denervation System on blood pressure in patients with hypertension.

RADIANCE-HTN is a blinded, randomized and sham-controlled trial designed to evaluate the blood pressure lowering effect of the Paradise System in two patient populations: the SOLO cohort will evaluate subjects with essential hypertension on two or fewer antihypertensive medications, and the TRIO cohort will evaluate subjects with treatment-resistant hypertension on a minimum of 3 antihypertensive medications.
The first TRIO patient was enrolled at the Erasmus University Medical Center in Rotterdam, the Netherlands by Dr. Joost Daemen. “We are excited to have enrolled the first patient in this very important study,” commented Dr. Daemen. “We have significant experience using the Paradise System and believe that the RADIANCE-HTN study is well designed to demonstrate the System’s treatment effect. If RADIANCEHTN is positive, then, given the existing CE-marking, we would consider Paradise as an essential tool to treat patients with resistant hypertension here at Erasmus.”
The first SOLO patient was enrolled at Sutter Health, Sacramento, CA, USA by Dr. Pei-Hsiu Huang. “The SOLO cohort represents a large population of hypertension patients, many of whom are seeking alternative methods to manage a lifetime of hypertension treatment,” added Dr. Huang. “We are excited to be part of this important study and by the possibility that RADIANCE-HTN could demonstrate the efficacy of renal denervation with the Paradise System, and open a path to new treatment options for our hypertension patients.”
RADIANCE-HTN is approved to enroll 292 subjects at up to 40 investigational sites, and will be conducted in the US, UK, France, Germany, and The Netherlands.

More information on RADIANCE-HTN can be found at:
https://clinicaltrials.gov/ct2/show/NCT02649426?term=radiance&rank=3

About ReCor Medical, Inc.
ReCor Medical is a private, venture-backed, medical device company that designs and manufactures 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 3 clinical trials, and has been used in over 200 patients.

For more information about ReCor Medical, please visit
www.recormedical.com or contact Andrew M. Weiss, President & CEO,
ReCor Medical at aweiss@recormedical.com / +1-650-542-7700.

04/04/2016

• Positive data from Zilretta Phase 2b and Phase 3 clinical trials demonstrate consistent efficacy across both studies with substantial and persistent pain relief
• In the Phase 3 trial Zilretta, in contrast to immediate-release triamcinolone acetonide (TCA), exceeds American Academy of Orthopedic Surgeons (AAOS) criteria for clinically important effects on pain and function
• Safety data from these studies are comparable to placebo and immediate-release TCA
• CONFERENCE CALL TODAY APRIL 4, 2016 AT 9:00 A.M. EDT

BURLINGTON, Mass., April 04, 2016 – Results from two Flexion Therapeutics, Inc. (Nasdaq:FLXN) sponsored pivotal clinical trials showed that its lead drug candidate Zilretta (also known as FX006) provided sustained and significant pain relief in patients with moderate to severe osteoarthritis (OA) knee pain. Professor Philip Conaghan, M.B., B.S., Ph.D., F.R.A.C.P., F.R.C.P., Chair of Musculoskeletal Medicine at the University of Leeds, presented the results at the OARSI 2016 World Congress in Amsterdam in a podium presentation that is available at http://flexiontherapeutics.com/programs-pipeline/scientific-publications.

Following the presentation Professor Conaghan said, “Consistent results across two pivotal clinical trials with Zilretta suggest that, at last, we have a long-lasting intra-articular therapy that is highly effective and has the potential to change the treatment paradigm for osteoarthritis.”
“We are delighted to be able to now share the detailed data from these studies which clearly demonstrate clinically meaningful and statistically significant pain relief in patients with knee OA. In addition, we are especially gratified by the Phase 3 data that demonstrate clear differentiation of Zilretta from immediate-release TCA,” said Michael Clayman, M.D., Flexion Therapeutics’ President and CEO. “Based on these data we have scheduled a pre-New Drug Application (NDA) meeting in May with the U.S. Food and Drug Administration (FDA) with the intent to gain the Agency’s endorsement to submit an NDA in the second half of 2016.”

The Phase 3 trial was a randomized, double-blind, placebo-controlled, active-comparator trial that enrolled 486 patients at approximately 40 centers worldwide. Patients were randomized to one of three treatment groups (1:1:1) and received either a single intra-articular injection of 40 mg of Zilretta, normal saline (placebo) or 40 mg of immediate-release TCA. Each patient was evaluated for efficacy and safety during seven outpatient visits over 24 weeks after receiving an injection. The primary objective of the study was to assess the magnitude of pain relief of Zilretta at 12 weeks against placebo as measured by the weekly mean of the average daily pain (ADP) score. The secondary objectives of the study assessed the magnitude and duration of pain relief and effect of Zilretta against placebo and immediate-release TCA in additional pre-specified measures.

Phase 3 study data from the OARSI podium presentation and from additional company analyses are summarized below and posted to the Flexion website at http://flexiontherapeutics.com/programs-pipeline/scientific-publications.
In the Phase 3 study, Zilretta:
• Met its primary endpoint at week 12, demonstrating highly significant (p < 0.0001, 2-sided) and clinically meaningful pain relief against placebo as measured by the weekly mean of the ADP score.
• Achieved statistically significant pain relief against placebo as measured by the weekly mean of the ADP score at weeks 1 through 16 and demonstrated, on average, an approximately 50 percent reduction in pain from baseline over weeks 1 through 12.
• Achieved numerically superior pain relief against immediate-release TCA at weeks 2 through 12 as measured by the weekly mean of the ADP score, but did not achieve statistical significance in that measure.
• Achieved statistical significance against placebo and immediate-release TCA at each time point through 12 weeks on WOMAC A (pain), WOMAC B (stiffness) and WOMAC C (function) and the Knee injury and Osteoarthritis Outcome Score (KOOS) quality of life subscale.
• Demonstrated in a pre-specified subset analysis of patients with unilateral knee pain (35 percent of subjects in the study), substantially magnified effects in the weekly mean of the ADP score, WOMAC A, B and C and KOOS quality of life and significantly enhanced separation from placebo and immediate-release TCA in all of these measures.
• Demonstrated reduced rescue medicine consumption compared with placebo and immediate-release TCA.

The Phase 3 data were also evaluated for clinical relevance by applying established AAOS criteria. In its 2013 publication, “Evidence-Based Guideline: Treatment of Osteoarthritis of the Knee,” the AAOS comprehensively reviewed the available literature on existing treatments and determined a minimal relative improvement in WOMAC A, B and C measures that would be meaningful to patients. This is referred to as the Minimal Clinically Important Improvement (MCII). The Phase 3 data show that Zilretta exceeds the MCII in WOMAC A, B and C and thus demonstrates a clinically important effect, whereas immediate-release TCA in this study does not.
The Phase 2b trial enrolled 310 participants in a multi-center, randomized, double-blind study, in which the participants received an injection of either 40 mg or 20 mg of FX006, or a placebo (saline). The 40 mg arm of Zilretta, compared to placebo, demonstrated statistical significance in average pain relief over weeks 1 through 12 (p = 0.0012; 2-sided) and over weeks 1 through 24 (p = 0.0209; 2-sided). At weekly time points, 40 mg of Zilretta also demonstrated superiority to placebo in pain relief beginning at week 1, continuing to week 11 and also at week 13 (p < 0.05 at each time point; 2-sided). The primary endpoint of the trial, superiority in pain relief at 12 weeks, did not reach statistical significance (p = 0.0821; 2-sided). A pre-specified, commonly applied sensitivity analysis (Baseline Observation Carried Forward/Last Observation Carried Forward (BOCF/LOCF)) that addresses patient dropouts, however, did demonstrate statistical significance for the primary endpoint at 12-weeks (p = 0.042).
Across both the Phase 2b and Phase 3 studies, there were no drug related serious adverse events for Zilretta and the frequency of treatment-related side effects was comparable across all study arms.

Conference Call
Flexion’s management will host a conference call today at 9:00 a.m. EDT. The dial-in number for the conference call is (855) 770-0022 for domestic participants and (908) 982-4677 for international participants, with Conference ID # 84943960. A live webcast of the conference call can also be accessed through the “Investors” tab on the Flexion Therapeutics website. A webcast replay will be available online after the call.

About Osteoarthritis of the Knee
OA is a common joint disease that affects 27 million Americans, and the prevalence of the disease is expected to significantly grow as a result of aging, obesity and sports injuries. OA is a type of degenerative arthritis that is caused by the progressive breakdown and eventual loss of cartilage in one or more joints. OA is characterized by pain, swelling, stiffness and decreased mobility of the affected joint. While OA is being diagnosed at increasingly younger ages, prevalence rises after age 45, and the knee is one of the most commonly affected joints. In 2014, more than 12 million Americans were diagnosed with OA of the knee. OA has a significant impact on the daily lives of patients, and it commonly affects large weight-bearing joints like the knees and hip but also occurs in the shoulders, hands, feet and spine. As the disease progresses, it becomes increasingly painful and debilitating, culminating, in many cases, in the need for total joint replacement.
Each year, at least five million OA patients in the U.S. receive immediate-release corticosteroid and hyaluronic acid IA injections for knee pain, but these injections generally provide limited relief, and no alternative injectable therapy has been approved in more than a decade. Opioids are another treatment option, and as many as 40 percent of Medicare patients are prescribed opioids for chronic OA pain.

About Zilretta
Zilretta is being investigated as the first intra-articular (IA) sustained-release, non-opioid treatment for patients with moderate to severe OA pain. Zilretta employs proprietary microsphere technology combining TCA — a commonly administered, short-acting corticosteroid — with a polymer (PLGA) intended to provide persistent concentrations of drug locally to both amplify the magnitude and prolong the duration of pain relief.
To date, over 600 patients have been treated with Zilretta in clinical trials. No drug-related serious adverse events have been observed in these trials and adverse events have typically been localized, mild and comparable to those observed with immediate-release TCA and placebo. The data from these trials are consistent with Zilretta providing meaningful and durable pain relief.

About Flexion Therapeutics
Flexion is a specialty pharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with OA. The company’s lead product candidate, Zilretta, is being investigated for its potential to provide improved analgesic therapy for the millions of U.S. patients who receive IA injections for knee OA annually. The company is also investigating another product candidate, FX007, a locally administered TrkA receptor antagonist for post-operative pain.

Forward-Looking Statements
Statements in this press release regarding matters that are not historical facts, including, but not limited to, statements relating to the future of Flexion; our ongoing development of Zilretta and our other product candidates; our interpretation of the data and results from our Zilretta clinical trials; our plans for, and the expected timing of, our Zilretta NDA submission with the FDA; Zilretta’s market potential; and the potential therapeutic and other benefits of Zilretta and our other product candidates, are forward-looking statements. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, risks associated with the process of discovering, developing, manufacturing and obtaining regulatory approval for drugs that are safe and effective for use as human therapeutics; the fact that results of past clinical trials may not be predictive of subsequent trials; our reliance on third parties to manufacture and conduct clinical trials of Zilretta and our other product candidates, which could delay or limit their future development or regulatory approval; our ability to meet anticipated clinical trial commencement, enrollment and completion dates and regulatory filing dates for Zilretta; the fact that we will require additional capital, including prior to commercializing Zilretta or any of our other product candidates, and may be unable to obtain such additional capital in sufficient amounts or on terms acceptable to us; the risk that we may not be able to maintain and enforce our intellectual property, including intellectual property related to Zilretta and our other product candidates; competition from alternative therapies; regulatory developments and safety issues, including difficulties or delays in obtaining regulatory approvals to market Zilretta or our other product candidates; the risk that the FDA and foreign regulatory authorities may not agree with our interpretation of the data from our clinical trials of Zilretta and may require us to conduct additional clinical trials; Zilretta may not receive regulatory approval or be successfully commercialized, including as a result of the FDA’s or other regulatory authorities’ decisions regarding labeling and other matters that could affect its availability or commercial potential; risks related to key employees, markets, economic conditions, health care reform, prices and reimbursement rates; and other risks and uncertainties described in our filings with the Securities and Exchange Commission (SEC), including under the heading « Risk Factors » in our most recent Annual Report on Form 10-K and subsequent filings with the SEC. The forward-looking statements in this press release speak only as of the date of this press release, and we undertake no obligation to update or revise any of the statements. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.

Investor Relations Contact
David Carey
Lazar Partners LTD
T: 212-867-1768
dcarey@lazarpartners.com

Media Relations Contact
Mariann Caprino
TogoRun
T : 917.242.1087
M.Caprino@togorun.com

Corporate Contact
Fred Driscoll
Chief Financial Officer
Flexion Therapeutics, Inc.
T: 781-305-7763
fdriscoll@flexiontherapeutics.com

04/04/2016

• Positive data from Zilretta Phase 2b and Phase 3 clinical trials demonstrate consistent efficacy across both studies with substantial and persistent pain relief
• In the Phase 3 trial Zilretta, in contrast to immediate-release triamcinolone acetonide (TCA), exceeds American Academy of Orthopedic Surgeons (AAOS) criteria for clinically important effects on pain and function
• Safety data from these studies are comparable to placebo and immediate-release TCA
• CONFERENCE CALL TODAY APRIL 4, 2016 AT 9:00 A.M. EDT

BURLINGTON, Mass., April 04, 2016 – Results from two Flexion Therapeutics, Inc. (Nasdaq:FLXN) sponsored pivotal clinical trials showed that its lead drug candidate Zilretta (also known as FX006) provided sustained and significant pain relief in patients with moderate to severe osteoarthritis (OA) knee pain. Professor Philip Conaghan, M.B., B.S., Ph.D., F.R.A.C.P., F.R.C.P., Chair of Musculoskeletal Medicine at the University of Leeds, presented the results at the OARSI 2016 World Congress in Amsterdam in a podium presentation that is available at http://flexiontherapeutics.com/programs-pipeline/scientific-publications.

Following the presentation Professor Conaghan said, “Consistent results across two pivotal clinical trials with Zilretta suggest that, at last, we have a long-lasting intra-articular therapy that is highly effective and has the potential to change the treatment paradigm for osteoarthritis.”
“We are delighted to be able to now share the detailed data from these studies which clearly demonstrate clinically meaningful and statistically significant pain relief in patients with knee OA. In addition, we are especially gratified by the Phase 3 data that demonstrate clear differentiation of Zilretta from immediate-release TCA,” said Michael Clayman, M.D., Flexion Therapeutics’ President and CEO. “Based on these data we have scheduled a pre-New Drug Application (NDA) meeting in May with the U.S. Food and Drug Administration (FDA) with the intent to gain the Agency’s endorsement to submit an NDA in the second half of 2016.”

The Phase 3 trial was a randomized, double-blind, placebo-controlled, active-comparator trial that enrolled 486 patients at approximately 40 centers worldwide. Patients were randomized to one of three treatment groups (1:1:1) and received either a single intra-articular injection of 40 mg of Zilretta, normal saline (placebo) or 40 mg of immediate-release TCA. Each patient was evaluated for efficacy and safety during seven outpatient visits over 24 weeks after receiving an injection. The primary objective of the study was to assess the magnitude of pain relief of Zilretta at 12 weeks against placebo as measured by the weekly mean of the average daily pain (ADP) score. The secondary objectives of the study assessed the magnitude and duration of pain relief and effect of Zilretta against placebo and immediate-release TCA in additional pre-specified measures.

Phase 3 study data from the OARSI podium presentation and from additional company analyses are summarized below and posted to the Flexion website at http://flexiontherapeutics.com/programs-pipeline/scientific-publications.
In the Phase 3 study, Zilretta:
• Met its primary endpoint at week 12, demonstrating highly significant (p < 0.0001, 2-sided) and clinically meaningful pain relief against placebo as measured by the weekly mean of the ADP score.
• Achieved statistically significant pain relief against placebo as measured by the weekly mean of the ADP score at weeks 1 through 16 and demonstrated, on average, an approximately 50 percent reduction in pain from baseline over weeks 1 through 12.
• Achieved numerically superior pain relief against immediate-release TCA at weeks 2 through 12 as measured by the weekly mean of the ADP score, but did not achieve statistical significance in that measure.
• Achieved statistical significance against placebo and immediate-release TCA at each time point through 12 weeks on WOMAC A (pain), WOMAC B (stiffness) and WOMAC C (function) and the Knee injury and Osteoarthritis Outcome Score (KOOS) quality of life subscale.
• Demonstrated in a pre-specified subset analysis of patients with unilateral knee pain (35 percent of subjects in the study), substantially magnified effects in the weekly mean of the ADP score, WOMAC A, B and C and KOOS quality of life and significantly enhanced separation from placebo and immediate-release TCA in all of these measures.
• Demonstrated reduced rescue medicine consumption compared with placebo and immediate-release TCA.

The Phase 3 data were also evaluated for clinical relevance by applying established AAOS criteria. In its 2013 publication, “Evidence-Based Guideline: Treatment of Osteoarthritis of the Knee,” the AAOS comprehensively reviewed the available literature on existing treatments and determined a minimal relative improvement in WOMAC A, B and C measures that would be meaningful to patients. This is referred to as the Minimal Clinically Important Improvement (MCII). The Phase 3 data show that Zilretta exceeds the MCII in WOMAC A, B and C and thus demonstrates a clinically important effect, whereas immediate-release TCA in this study does not.
The Phase 2b trial enrolled 310 participants in a multi-center, randomized, double-blind study, in which the participants received an injection of either 40 mg or 20 mg of FX006, or a placebo (saline). The 40 mg arm of Zilretta, compared to placebo, demonstrated statistical significance in average pain relief over weeks 1 through 12 (p = 0.0012; 2-sided) and over weeks 1 through 24 (p = 0.0209; 2-sided). At weekly time points, 40 mg of Zilretta also demonstrated superiority to placebo in pain relief beginning at week 1, continuing to week 11 and also at week 13 (p < 0.05 at each time point; 2-sided). The primary endpoint of the trial, superiority in pain relief at 12 weeks, did not reach statistical significance (p = 0.0821; 2-sided). A pre-specified, commonly applied sensitivity analysis (Baseline Observation Carried Forward/Last Observation Carried Forward (BOCF/LOCF)) that addresses patient dropouts, however, did demonstrate statistical significance for the primary endpoint at 12-weeks (p = 0.042).
Across both the Phase 2b and Phase 3 studies, there were no drug related serious adverse events for Zilretta and the frequency of treatment-related side effects was comparable across all study arms.

Conference Call
Flexion’s management will host a conference call today at 9:00 a.m. EDT. The dial-in number for the conference call is (855) 770-0022 for domestic participants and (908) 982-4677 for international participants, with Conference ID # 84943960. A live webcast of the conference call can also be accessed through the “Investors” tab on the Flexion Therapeutics website. A webcast replay will be available online after the call.

About Osteoarthritis of the Knee
OA is a common joint disease that affects 27 million Americans, and the prevalence of the disease is expected to significantly grow as a result of aging, obesity and sports injuries. OA is a type of degenerative arthritis that is caused by the progressive breakdown and eventual loss of cartilage in one or more joints. OA is characterized by pain, swelling, stiffness and decreased mobility of the affected joint. While OA is being diagnosed at increasingly younger ages, prevalence rises after age 45, and the knee is one of the most commonly affected joints. In 2014, more than 12 million Americans were diagnosed with OA of the knee. OA has a significant impact on the daily lives of patients, and it commonly affects large weight-bearing joints like the knees and hip but also occurs in the shoulders, hands, feet and spine. As the disease progresses, it becomes increasingly painful and debilitating, culminating, in many cases, in the need for total joint replacement.
Each year, at least five million OA patients in the U.S. receive immediate-release corticosteroid and hyaluronic acid IA injections for knee pain, but these injections generally provide limited relief, and no alternative injectable therapy has been approved in more than a decade. Opioids are another treatment option, and as many as 40 percent of Medicare patients are prescribed opioids for chronic OA pain.

About Zilretta
Zilretta is being investigated as the first intra-articular (IA) sustained-release, non-opioid treatment for patients with moderate to severe OA pain. Zilretta employs proprietary microsphere technology combining TCA — a commonly administered, short-acting corticosteroid — with a polymer (PLGA) intended to provide persistent concentrations of drug locally to both amplify the magnitude and prolong the duration of pain relief.
To date, over 600 patients have been treated with Zilretta in clinical trials. No drug-related serious adverse events have been observed in these trials and adverse events have typically been localized, mild and comparable to those observed with immediate-release TCA and placebo. The data from these trials are consistent with Zilretta providing meaningful and durable pain relief.

About Flexion Therapeutics
Flexion is a specialty pharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with OA. The company’s lead product candidate, Zilretta, is being investigated for its potential to provide improved analgesic therapy for the millions of U.S. patients who receive IA injections for knee OA annually. The company is also investigating another product candidate, FX007, a locally administered TrkA receptor antagonist for post-operative pain.

Forward-Looking Statements
Statements in this press release regarding matters that are not historical facts, including, but not limited to, statements relating to the future of Flexion; our ongoing development of Zilretta and our other product candidates; our interpretation of the data and results from our Zilretta clinical trials; our plans for, and the expected timing of, our Zilretta NDA submission with the FDA; Zilretta’s market potential; and the potential therapeutic and other benefits of Zilretta and our other product candidates, are forward-looking statements. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, risks associated with the process of discovering, developing, manufacturing and obtaining regulatory approval for drugs that are safe and effective for use as human therapeutics; the fact that results of past clinical trials may not be predictive of subsequent trials; our reliance on third parties to manufacture and conduct clinical trials of Zilretta and our other product candidates, which could delay or limit their future development or regulatory approval; our ability to meet anticipated clinical trial commencement, enrollment and completion dates and regulatory filing dates for Zilretta; the fact that we will require additional capital, including prior to commercializing Zilretta or any of our other product candidates, and may be unable to obtain such additional capital in sufficient amounts or on terms acceptable to us; the risk that we may not be able to maintain and enforce our intellectual property, including intellectual property related to Zilretta and our other product candidates; competition from alternative therapies; regulatory developments and safety issues, including difficulties or delays in obtaining regulatory approvals to market Zilretta or our other product candidates; the risk that the FDA and foreign regulatory authorities may not agree with our interpretation of the data from our clinical trials of Zilretta and may require us to conduct additional clinical trials; Zilretta may not receive regulatory approval or be successfully commercialized, including as a result of the FDA’s or other regulatory authorities’ decisions regarding labeling and other matters that could affect its availability or commercial potential; risks related to key employees, markets, economic conditions, health care reform, prices and reimbursement rates; and other risks and uncertainties described in our filings with the Securities and Exchange Commission (SEC), including under the heading « Risk Factors » in our most recent Annual Report on Form 10-K and subsequent filings with the SEC. The forward-looking statements in this press release speak only as of the date of this press release, and we undertake no obligation to update or revise any of the statements. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.

Investor Relations Contact
David Carey
Lazar Partners LTD
T: 212-867-1768
dcarey@lazarpartners.com

Media Relations Contact
Mariann Caprino
TogoRun
T : 917.242.1087
M.Caprino@togorun.com

Corporate Contact
Fred Driscoll
Chief Financial Officer
Flexion Therapeutics, Inc.
T: 781-305-7763
fdriscoll@flexiontherapeutics.com