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17/10/2019

The firm manages €2B across its life sciences platform, €1B of which has been raised in the last 4 years

Paris, France – October 17th, 2019 — Sofinnova Partners, a leading European venture capital firm based in Paris, London and Milan and specialized in Life Sciences, announced today the close of its latest early-stage healthcare venture capital fund Sofinnova Capital IX, oversubscribed at €333 million. The firm now has more than €2B under management with more than €1B raised in the last four years across its platform of life sciences funds.

Pursuing the strategy it has consistently applied over the years for its flagship early-stage Capital funds, Sofinnova Capital IX will invest in the healthcare industry and more specifically in the biopharmaceutical and medical device sectors. Sofinnova Partners will seek to invest as a founding and lead investor in start-ups and corporate spin-offs, and focus on therapeutic, paradigm-shifting technologies and products alongside visionary entrepreneurs. Sofinnova Capital IX will invest about two thirds of its funds in European companies, and one third outside of Europe, primarily in North America.

The new fund has commitments from leading institutional investors, predominantly endowment funds, insurance companies, pension funds, sovereign funds, corporates and family offices, many of whom are continuing a long and successful relationship with the Sofinnova family of Funds. The majority of commitments came in from Europe, including France, Italy, Ireland, Denmark, Germany, Switzerland, the United Kingdom and Luxembourg, but also from leading North American investors in the U.S. and Canada, as well as major investors from Asia.
Antoine Papiernik, Managing Partner and Chairman of Sofinnova Partners, said, “Our experienced team, stable strategy and exit track record resonated well with investors, hence the success of our fundraising for this latest Capital fund. Over the last three years, we have completed nine remarkable exits in the portfolio for a total enterprise value of almost 4 billion euros.”

The launch of Sofinnova Capital IX follows the formation, in just the last three years, of Sofinnova Crossover I, a fund investing in pre- and post-IPO companies; Sofinnova MD Start III, a medical device acceleration fund; Sofinnova Industrial Biotech I, a fund dedicated to industrial biotech; and Sofinnova Telethon Fund I, a fund dedicated to seed investments in gene and cell therapies based out of Milan, Italy. With these focused franchises managed by dedicated specialist teams, Sofinnova Partners has established a unique and comprehensive platform of investment vehicles across the life sciences investment value chain.

Triago acted as placement agent and Clifford Chance acted as legal counsel on Sofinnova Capital IX.

About Sofinnova Partners
Sofinnova Partners is a leading European venture capital firm specialized in Life Sciences. Headquartered in Paris, France, with offices in London and Milan, the firm brings together a team of 40 professionals from all over Europe, the U.S. and Asia. The firm focuses on paradigm-shifting technologies alongside visionary entrepreneurs. Sofinnova Partners invests across the Life Sciences value chain as a lead or cornerstone investor, from very early-stage opportunities to late-stage/public 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, please visit: www.sofinnovapartners.com

Media Contacts:
Kate Barrette
RooneyPartners LLC
+1.212.223.0561
kbarrette@rooneyco.com

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

17/03/2016

Une levée de fonds pour soutenir l’expansion de la plateforme de bio-polymères de Gecko Biomedical à travers le développement clinique et l’approbation de mise sur le marché pour de nombreuses applications dans la reconstruction des tissus.
L’opération a réuni un syndicat d’investisseurs qui, aux côtés de Sofinnova Partners, comprend Bpifrance et les investisseurs historiques.

Paris, France, 17 mars, 2016 – Gecko Biomedical (“Gecko”), une société de dispositifs médicaux développant des polymères innovants permettant de refermer des plaies, vient de lever €22,5 millions. Ce tour de financement de série A2 a été mené par Sofinnova Partners, qui devient le premier actionnaire, avec le soutien de Bpifrance, et les investisseurs historiques qui avaient investi dans l’entreprise en décembre 2013, Omnes Capital, CM-CIC Innovation et CapDecisif Management. En parallèle de cette levée de fonds, Antoine Papiernik de Sofinnova Partners et Chahra Louafi de Bpifrance deviennent membres du Conseil d’Administration.

Gecko a été créé en 2013 par Christophe Bancel, Bernard Gilly (tous deux membres du réseau iBionext), Prof. Jeff Karp (Harvard Medical School, Brigham and Women’s Hospital – Boston, MA, USA) et Prof. Bob Langer (Massachusetts Institut de Technology – Cambridge, MA, USA), avec le soutien du Dr. Maria Pereira, une figure internationale sélectionnée en 2015 par le magazine Forbes pour faire partie des “30 personnalités de moins de 30 ans” du secteur de la santé, qui a co-inventé la technologie et est actuellement Responsable de la Recherche chez Gecko.

Les fonds permettront d’accélérer le développement de la première plateforme de polymères, GB-02, spécialisée dans le domaine de la reconstruction cardiovasculaire, mais aussi d’autres tissus. Capitalisant sur la technologie, les fonds serviront également à déployer la plateforme sur d’autres indications, comme la reconstruction guidée de tissus et la libération localisée de médicaments.

La plateforme de Gecko est désormais complètement industrialisée, avec un niveau unique de biocompatibilité et un très large potentiel d’applications différentes. S’appuyant sur des polymères propriétaires, la technologie présente des caractéristiques chimiques et physiques uniques : une forte viscosité, des propriétés hydrophobes et une capacité à polymériser rapidement à la demande lorsque le chirurgien le décide. Une fois polymérisé, le composé forme un film élastique et biodégradable. Ces polymères peuvent être modifiés afin de faire varier leurs propriétés et donc permettre un grand nombre d’applications.

Christophe Bancel CEO de Gecko déclare : « Le soutien de nos investisseurs nous permettra de réaliser notre plan de développement clinique à l’international en chirurgie cardiovasculaire, en vue de faire les demandes d’autorisation pour notre premier produit d’ici un an. De plus, les fonds serviront à développer le polymère GB-02 sur d’autres indications en reconstruction de tissus. Nous travaillons également à la prochaine génération de polymères, GB-04, destinée à certaines procédures chirurgicales sans suture ».

Antoine Papiernik, Managing Partner chez Sofinnova Partners, ajoute : « Nous sommes heureux de travailler avec Gecko Biomedical, une société qui combine toutes les qualités que nous recherchons dans les entreprises dans lesquelles nous investissons : une solide équipe de management, et une plateforme technologique de très haut niveau, permettant des applications de rupture dans un large domaine ».
A propos de Gecko
Gecko Biomedical est une société de dispositifs médicaux privée basée à Paris, France, dédiée au développement rapide et à la commercialisation d’une plate-forme unique de biopolymères. Le premier produit de Gecko (GB02) est un polymère innovant ciblant la cicatrisation tissulaire, avec une première indication dans la reconstruction cardiovasculaire. La structure de GB02 est réglable, ce qui permet la personnalisation de ses propriétés pour diverses applications et tissus. La plate-forme de biopolymères de Gecko est entièrement industrialisée et très polyvalente, avec des applications potentielles dans d’autres domaines de la reconstruction tissulaire, tels que la réparation tissulaire guidée et un système de délivrance localisée de médicaments. La plate-forme Gecko est construite autour de biopolymères propriétaires ayant des propriétés physiques uniques. Ils sont hautement visqueux, hydrophobes, et proposent une polymérisation chimique rapide et «à la demande» permettant une délivrance localisée et une adhérence in situ. Les technologies de Gecko sont issues des travaux de recherche et de la propriété intellectuelle des laboratoires du Pr. Robert Langer (MIT) and Pr. Jeff Karp (Brigham and Women’s Hospital), qui ont co-fondé la société en 2013, aux côtés de Christophe Bancel et Bernard Gilly du réseau iBionext. Pour plus d’informations : www.geckobiomedical.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’informations : www.sofinnova.fr

A propos de Bpifrance
Bpifrance, filiale de la Caisse des Dépôts et de l’État, partenaire de confiance des entrepreneurs, accompagne les entreprises, de l’amorçage jusqu’à la cotation en bourse, en crédit, en garantie et en fonds propres. Bpifrance assure, en outre, des services d’accompagnement et de soutien renforcé à l’innovation, à la croissance externe et à l’export, en partenariat avec Ubifrance et Coface. Bpifrance propose aux entreprises un continuum de financements à chaque étape clé de leur développement et une offre adaptée aux spécificités régionales. Fort de 42 implantations régionales (90 % des décisions prises en région), Bpifrance constitue un outil de compétitivité économique au service des entrepreneurs. Bpifrance agit en appui des politiques publiques conduites par l’État et par les Régions pour répondre à trois objectifs : accompagner la croissance des PME, préparer la compétitivité de demain et contribuer au développement d’un écosystème favorable à l’entrepreneuriat. Avec Bpifrance, les entreprises bénéficient d’un interlocuteur puissant, proche et efficace, pour répondre à l’ensemble de leurs besoins de financement, d’innovation et d’investissement. Plus d’informations sur : www.bpifrance.fr – Suivez-nous sur Twitter : @bpifrance
A propos de CM-CIC Innovation
CM-CIC INNOVATION est une filiale de CM-CIC Investissement spécialisée dans les investissements capital-risque. Son objectif est d’investir dans des entreprises développant des technologies prometteuses. CM-CIC INNOVATION choisit des entreprises avec un fort potentiel de croissance sur des secteurs dynamiques comme les technologies de l’information, les télécommunications, l’électronique, les sciences de la vie, les nouveaux matériaux ou encore l’environnement.
La politique de CM-CIC INNOVATION est de fournir un appui en fonds propres à long terme à des startups innovantes pour rationaliser leurs chances de succès. Pour plus d’informations : www.cmcic-investissement.com

A propos de Omnes Capital
Omnes Capital est un acteur majeur du capital investissement et de l’investissement en infrastructure. Avec 2,1 milliards d’euros sous gestion, Omnes Capital apporte aux entreprises les fonds propres nécessaires à leur développement à travers ses expertises de référence : Capital Développement & Transmission, Dette Privée, Capital Risque, Energies Renouvelables, Co-Investissement, Fonds de fonds secondaire. Omnes Capital était une filiale de Crédit Agricole S.A. jusqu’en mars 2012. La société est aujourd’hui détenue par ses salariés. Omnes Capital est signataire des Principes pour l’Investissement Responsable des Nations Unies (PRI). Pour plus d’informations : www.omnescapital.com

A propos de CapDecisif Management
CapDecisif Management est une société de gestion agréée par l’AMF. Avec 110M€ actuellement sous gestion au travers de cinq fonds, dont le FPCI CapDecisif 3, G1J IdF et le Fonds Régional de Co-Investissement (FRCI). CapDecisif Management se concentre sur l’investissement en capital-risque dans les sociétés innovantes à fort potentiel principalement en Région Ile-de-France. CapDecisif Management intervient dans tous les champs de l’innovation tels que : les télécommunications, les technologies de l’information / logiciels, les sciences du vivant, l’énergie et l’environnement. Le FPCI CapDecisif 3 est notamment soutenu par le Fonds National d’Amorçage (FNA), géré par BPI France, pour le compte de l’Etat dans le cadre du Programme d’Investissements d’Avenir (PIA) et la Région Ile De France. Pour plus d’informations : www.cap-decisif.com

 

CONTACTS PRESSE
Pour Gecko
Christophe BANCEL Tel: +33 1 76 21 72 28 cbancel@geckobiomedical.com
twitter : @geckobiomedical
Pour Sofinnova Partners

17/03/2016

Funds to support the expansion of Gecko’s biopolymers platform through clinical development and approval for multiple applications in tissue reconstruction.
Financing includes Bpifrance, and historical investors.

Paris, France, March 17, 2016 – Gecko Biomedical (“Gecko”), a medical device company developing innovative polymers to support tissue healing, has closed a €22.5 million financing round. This series A2 round was led by Sofinnova Partners, which becomes the largest investor in Gecko, with support from Bpifranceand existing series A investors Omnes Capital, CM-CIC Innovation and CapDecisif Management, who invested in the company in December 2013. In conjunction with the financing, Antoine Papiernik at Sofinnova Partners and Chahra Louafi at Bpifrance have joined Gecko’s Board of Directors.

Gecko was co-founded by Christophe Bancel and Bernard Gilly (both from the iBionext Network), Prof Jeff Karp (Harvard Medical School, Brigham and Women’s Hospital – Boston, MA, USA) and Prof Bob Langer (Massachusetts Institute of Technology – Cambridge, MA, USA) in late 2013 to advance a state-of-the-art polymer platform. One of its lead inventors, Dr Maria Pereira, was named a Forbes 2015 “30 under 30.” Pereira is Gecko’s Head of Research.

The funds raised will be used to further advance the development of Gecko’s first platform GB-02 for cardiovascular reconstruction and beyond. In addition, the funds will be used to leverage its fully industrialized platform in novel areas including guided tissue repair and localized drug delivery.

Gecko’s platform has demonstrated its ability to be fully industrialized, with a unique level of biocompatibility and a great potential in terms of versatility.

This platform is based on proprietary polymers with unique chemical and physical properties, including high viscosity, hydrophobicity and fast “on demand” curing for precise local delivery and in situ adhesion. Upon curing, an elastic biodegradable film is formed. The structure of the polymer is tunable, allowing customization for various applications and tissues.

Christophe Bancel, Gecko’s CEO, commented: “Our investors’ support will enable us to complete our international clinical plans in cardiovascular surgery, which, if positive, will allow us to seek our first regulatory approval within one year. In addition, the funds will be used to expand our GB-02 platform to additional applications in tissue reconstruction. We will also drive the development of our next-generation polymer GB-04, for sutureless closure.”

Antoine Papiernik, Managing Partner at Sofinnova Partners, added: “We are thrilled to be involved with Gecko Biomedical, a company which combines all the key features we are looking for when investing in a company: a very strong management team and a world-class platform technology with a multitude of possible paradigm-shifting applications.”

 

About Gecko
Gecko Biomedical is a privately owned medical device company based in Paris, France that is dedicated to the rapid development and commercialization of a unique biopolymers platform.
Gecko’s first product (GB-02) is an innovative polymer for tissue healing, targeting cardiovascular reconstruction as an initial indication. The structure of GB-02 is tunable, allowing customization for various applications and tissues. Gecko’s biopolymers platform is fully industrialized and highly versatile, with potential novel applications in other fields of tissue reconstruction, such as guided tissue repair and localized drug delivery.
Gecko’s platform is based on proprietary biopolymers with unique chemical and physical properties, including high viscosity, hydrophobicity and fast “on demand” curing for precise local delivery and in situ adhesion.
The Company’s technologies are derived from world-class research and intellectual property from the laboratories of Pr Robert Langer (MIT) and Pr Jeff Karp (Brigham and Women’s Hospital), who co-founded the company in 2013, alongside Christophe Bancel and Bernard Gilly from the iBionext Network. For more information, please visit: www.geckobiomedical.com

About Sofinnova Partners
Sofinnova Partners is a leading European venture capital firm specialized in Life Sciences. Based in Paris, France, the firm brings together 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 Bpifrance
Bpifrance, a subsidiary of the Caisse des Dépôts and the French State, a trusted partner for entrepreneurs, supports companies from start-up to their listing on the stock market, through credit, guarantees and equity. Bpifrance also provides support services and enhanced support for innovation, external growth and export in partnership with Business France and Coface. Bpifrance offers companies a funding continuum for each key stage of their development together with services adapted to different regional needs. Through its 42 regional offices (90% of decisions are taken in region), Bpifrance represents a true financially competitive service for entrepreneurs. Bpifrance acts in support of public policies implemented by the State and the Regional authorities to meet three objectives: support business growth; prepare for future competitiveness; contribute to the development of an ecosystem favourable to entrepreneurship. With Bpifrance, companies have a powerful, close and efficient partner to meet all their needs for funding, innovation and investment. For more information go to: www.bpifrance.fr – Follow us on Twitter: @bpifrance

About CM-CIC Innovation
CM-CIC Innovation is a subsidiary of CM-CIC Investissement, the Crédit Mutuel – CIC group’s investment and merchant bank division. With more than 2.6 billion Euros worth of equity under management and over 600 portfolio companies, CM-CIC Investissement is a key player in capital investment in France, backed by its own equity resources. CM-CIC Innovation is specialized in investment and support for high-potential growth companies, with strong technology expertise, in the first stages of their development. It finances firms positioned on sectors such as life sciences, information technology, industrial innovations or environment. For more information go to: www.cmcic-investissement.com

About Omnes Capital
Omnes Capital is a major player in private equity and infrastructure. With €2.1 billion in assets under management, Omnes capital provides companies with the capital needed to finance their growth and with key expertise in a number of areas: Buyout & Growth Capital, Private Debt, Venture Capital, Renewable Energy, Co-Investment, Secondary Funds of Funds. Omnes Capital was a subsidiary of Crédit Agricole until March 2012. The firm is now owned by its employees. Omnes Capital is a signatory to the United Nations Principles for Responsible Investment (PRI). For more information go to: www.omnescapital.com

About CapDecisif Management
CapDecisif Management is an investment management company approved by the AMF (French Financial Markets Authority). Our team currently manages €110m over five different funds amongst which FPCI CapDecisif 3, G1J IdF and Regional Co-Investment Funds (FRCI). CapDecisif Management focuses on venture capital startups and invests mainly in upstream, innovative companies with high-growth potential, and which are located primarily in the Paris region. CapDecisif 3 is supported by the French National Seed Fund, managed by Bpifrance investment within the framework of the “Investissements d’Avenir”, and Paris Region. For more information go to: www.cap-decisif.com

 

PRESS CONTACTS
For Gecko
Christophe BANCEL Tel: +33 1 76 21 72 28 cbancel@geckobiomedical.com
Twitter: @geckobiomedical
For Sofinnova Partners
Anne REIN Tel: +33 6 03 35 92 05 anne.rein@strategiesimage.com

For Bpifrance
Nathalie POLICE Tél : + 33 1 41 79 95 26 nathalie.police@bpifrance.fr

15/03/2016

– Production and marketing of furandicarboxylic acid (FDCA) based on renewable resources, the main new building block for polyethylenefuranoate (PEF)
– Further development and licensing of Avantium’s production processes for FDCA and PEF at industrial scale
– Intention to build a reference plant for FDCA with an annual capacity of up to 50,000 tons at BASF’s Verbund site in Antwerp, Belgium

Ludwigshafen, Germany, and Amsterdam, Netherlands – March 15, 2016 – BASF and Avantium today announced that they have signed a letter of intent and entered into exclusive negotiations to establish a joint venture (JV) for the production and marketing of furandicarboxylic acid (FDCA), as well as marketing of polyethylenefuranoate (PEF), based on this new chemical building block. FDCA is produced from renewable resources.

The JV will use the YXY process® developed by Avantium in its laboratories in Amsterdam and pilot plant in Geleen, Netherlands, for the production of FDCA. It is intended to further develop this process as well as to construct a reference plant for the production of FDCA with an annual capacity of up to 50,000 metric tons per year at BASF’s Verbund site in Antwerp, Belgium. The aim is to build up world-leading positions in FDCA and PEF, and subsequently license the technology for industrial scale application.

FDCA and PEF: New materials enabling improved food packaging films and plastic bottles
FDCA is the essential chemical building block for the production of PEF. Compared to conventional plastics, PEF is characterized by improved barrier properties for gases like carbon dioxide and oxygen. This can lead to longer shelf life of packaged products. Due to its higher mechanical strength, thinner PEF packaging can be produced, thus a lower amount of packaging material is necessary. Therefore PEF is particularly suitable for the production of certain food and beverage packaging, for example films and plastic bottles. After use, PEF can be recycled.

“With the planned joint venture, we want to combine Avantium’s specific production technology and application know-how for FDCA and PEF with the strengths of BASF,” said Dr. Stefan Blank, President of BASF’s Intermediates division. “Of particular importance is our expertise in market development and large-scale production as an established and reliable chemical company in the business of intermediates and polymers,” Blank added.

“The contemplated joint venture with BASF is a major milestone in the development and commercialization of this game-changing technology. Partnering with the number one chemical company in the world, provides us with access to the capabilities that are required to bring this technology to industrialization,” said Tom van Aken, Chief Executive Officer of Avantium. “The joint venture will further strengthen the global technology and establish the market leadership for FDCA and PEF. With BASF, we plan to start production of FDCA to enable the first commercial launch of this exciting bio-based material and to further develop and grow the market to its full potential,” van Aken continued.

About Avantium
Avantium is a leading chemical technology company and a forerunner in renewable chemistry. Together with its partners around the world, Avantium develops efficient processes and sustainable products made from biobased materials. Avantium offers a breeding ground for revolutionary renewable chemistry solutions. From invention to commercially viable production processes. One of Avantium’s many success stories is YXY technology®, with which they created PEF: a completely new, high-quality plastic made from plant-based industrial sugars. PEF is 100% recyclable. It therefore offers a cost-effective solution to make anything from a wide range of plastic bottles and packaging to fibers. YXY is the most advanced technology, but Avantium is also working on a host of other ground-breaking projects and is providing advanced catalysis research services and systems to the leading chemical and petrochemical companies. Avantium’s offices and headquarters are based in Amsterdam, the Netherlands. Further information at www.avantium.com

About BASF Intermediates
The BASF Group’s Intermediates division develops, produces and markets a comprehensive portfolio of about 700 intermediates around the world. Its most important product groups include amines, diols, polyalcohols, acids and specialties. Intermediates are used for example as starting materials for coatings, plastics, pharmaceuticals, textiles, detergents and crop protectants. Innovative intermediates
from BASF help to improve both the properties of final products and the efficiency of production processes. The ISO 9001 certified Intermediates division operates plants at production sites in Europe, Asia and North America. Around the globe, the division generated sales to third parties of about €2.8 billion in 2015. Further information at www.intermediates.basf.com

About BASF
At BASF, we create chemistry for a sustainable future. We combine economic success with environmental protection and social responsibility. The approximately 112,000 employees in the BASF Group work on contributing to the success of our customers in nearly all sectors and almost every country in the world. Our portfolio is organized into five segments: Chemicals, Performance Products, Functional Materials & Solutions, Agricultural Solutions and Oil & Gas. BASF generated sales of more than €70 billion in 2015. BASF shares are traded on the stock exchanges in Frankfurt (BAS), London (BFA) and Zurich (AN). Further information at www.basf.com

Media contacts:
BASF SE
Klaus-Peter Rieser
Intermediates Division
Phone: +49 621 60 95138
E-mail: klaus-peter.rieser@basf.com

Avantium
Alex de Vries
Phone: +31 20 586 0132
Mobile: + 31 651 11 9205
E-mail: alex.de.vries@msl.nl

15/03/2016

– Production and marketing of furandicarboxylic acid (FDCA) based on renewable resources, the main new building block for polyethylenefuranoate (PEF)
– Further development and licensing of Avantium’s production processes for FDCA and PEF at industrial scale
– Intention to build a reference plant for FDCA with an annual capacity of up to 50,000 tons at BASF’s Verbund site in Antwerp, Belgium

Ludwigshafen, Germany, and Amsterdam, Netherlands – March 15, 2016 – BASF and Avantium today announced that they have signed a letter of intent and entered into exclusive negotiations to establish a joint venture (JV) for the production and marketing of furandicarboxylic acid (FDCA), as well as marketing of polyethylenefuranoate (PEF), based on this new chemical building block. FDCA is produced from renewable resources.

The JV will use the YXY process® developed by Avantium in its laboratories in Amsterdam and pilot plant in Geleen, Netherlands, for the production of FDCA. It is intended to further develop this process as well as to construct a reference plant for the production of FDCA with an annual capacity of up to 50,000 metric tons per year at BASF’s Verbund site in Antwerp, Belgium. The aim is to build up world-leading positions in FDCA and PEF, and subsequently license the technology for industrial scale application.

FDCA and PEF: New materials enabling improved food packaging films and plastic bottles
FDCA is the essential chemical building block for the production of PEF. Compared to conventional plastics, PEF is characterized by improved barrier properties for gases like carbon dioxide and oxygen. This can lead to longer shelf life of packaged products. Due to its higher mechanical strength, thinner PEF packaging can be produced, thus a lower amount of packaging material is necessary. Therefore PEF is particularly suitable for the production of certain food and beverage packaging, for example films and plastic bottles. After use, PEF can be recycled.

“With the planned joint venture, we want to combine Avantium’s specific production technology and application know-how for FDCA and PEF with the strengths of BASF,” said Dr. Stefan Blank, President of BASF’s Intermediates division. “Of particular importance is our expertise in market development and large-scale production as an established and reliable chemical company in the business of intermediates and polymers,” Blank added.

“The contemplated joint venture with BASF is a major milestone in the development and commercialization of this game-changing technology. Partnering with the number one chemical company in the world, provides us with access to the capabilities that are required to bring this technology to industrialization,” said Tom van Aken, Chief Executive Officer of Avantium. “The joint venture will further strengthen the global technology and establish the market leadership for FDCA and PEF. With BASF, we plan to start production of FDCA to enable the first commercial launch of this exciting bio-based material and to further develop and grow the market to its full potential,” van Aken continued.

About Avantium
Avantium is a leading chemical technology company and a forerunner in renewable chemistry. Together with its partners around the world, Avantium develops efficient processes and sustainable products made from biobased materials. Avantium offers a breeding ground for revolutionary renewable chemistry solutions. From invention to commercially viable production processes. One of Avantium’s many success stories is YXY technology®, with which they created PEF: a completely new, high-quality plastic made from plant-based industrial sugars. PEF is 100% recyclable. It therefore offers a cost-effective solution to make anything from a wide range of plastic bottles and packaging to fibers. YXY is the most advanced technology, but Avantium is also working on a host of other ground-breaking projects and is providing advanced catalysis research services and systems to the leading chemical and petrochemical companies. Avantium’s offices and headquarters are based in Amsterdam, the Netherlands. Further information at www.avantium.com

About BASF Intermediates
The BASF Group’s Intermediates division develops, produces and markets a comprehensive portfolio of about 700 intermediates around the world. Its most important product groups include amines, diols, polyalcohols, acids and specialties. Intermediates are used for example as starting materials for coatings, plastics, pharmaceuticals, textiles, detergents and crop protectants. Innovative intermediates
from BASF help to improve both the properties of final products and the efficiency of production processes. The ISO 9001 certified Intermediates division operates plants at production sites in Europe, Asia and North America. Around the globe, the division generated sales to third parties of about €2.8 billion in 2015. Further information at www.intermediates.basf.com

About BASF
At BASF, we create chemistry for a sustainable future. We combine economic success with environmental protection and social responsibility. The approximately 112,000 employees in the BASF Group work on contributing to the success of our customers in nearly all sectors and almost every country in the world. Our portfolio is organized into five segments: Chemicals, Performance Products, Functional Materials & Solutions, Agricultural Solutions and Oil & Gas. BASF generated sales of more than €70 billion in 2015. BASF shares are traded on the stock exchanges in Frankfurt (BAS), London (BFA) and Zurich (AN). Further information at www.basf.com

Media contacts:
BASF SE
Klaus-Peter Rieser
Intermediates Division
Phone: +49 621 60 95138
E-mail: klaus-peter.rieser@basf.com

Avantium
Alex de Vries
Phone: +31 20 586 0132
Mobile: + 31 651 11 9205
E-mail: alex.de.vries@msl.nl

09/03/2016

Burntisland, Scotland, March 10th 2016. CelluComp, a sustainable materials company, announces the closing of a £3.7 Million funding round. The funding was lead by FPCI CapAgro Innovation, with follow-on investments from Sofinnova Partners, and Scottish Enterprise through its investment arm, the Scottish Investment Bank (SIB), as well as a syndicate of angel investors.

CelluComp uses a proprietary technology to extract nano-cellulose fibres from the waste streams of root vegetables to produce a unique product called Curran®. Curran® provides a high performing, environmentally-sound and economically-viable solution for reinforcement and rheology (thickening) in multiple industries, such as paints & coatings, paper, food, home and personal care, concrete, oil drilling and composites. To-date, CelluComp has focused its attention on the coatings and paper industries. Unlike competing solutions from wood, Curran® is able to reach attractive cost targets thus enabling mass-market applications. CelluComp built its first production facility in Scotland in 2015 and plans further capacity and commercial expansion in the near future. CelluComp has benefited from its existing partnerships and will continue to work with partners to expand capacity and commercial reach.

Christian Kemp-Griffin, CEO of CelluComp, commented: “Along with founders David Hepworth and Eric Whale I am extremely pleased to have raised this round of financing with such important partners. This investment not only gives the company the needed funds to build our production capacity and commercial development but also brings a combined level of expertise and professionalism that will allow the company to accelerate its success. ”

Jean-Baptiste Cuisinier, Chairman of CapAgro, the first venture capital fund in France to be dedicated to innovation in agriculture, food and renewable chemistry and energies, expressed how pleased he was to invest in such a dynamic young company that not only showed terrific promise but also provided economic and environmental solutions for the agricultural sector.

Joško Bobanović, Partner at Sofinnova Partners, added: “Since our initial investment CelluComp has progressed significantly and surpassed our expectations. With existing production capacity, the company is ready to develop interesting markets and prepare for the next phase of growth. We look forward to continue supporting the team in the future.”

Kerry Sharp, Head of the Scottish Investment Bank, said “Scottish Enterprise has worked with CelluComp since the beginning, and we are pleased to see the company expanding globally and attracting further international investment. Last year CelluComp established Scotland’s first bio-based production facility, and this new round of investment will help support the expansion of the company’s manufacturing facilities in line with the ambition of Scotland’s National Plan for Industrial Biotechnology. We look forward to working with CelluComp as it continues to develop.”

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

Notes to Editors:

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

CapAgro is supported by eight leading industrial groups and financial institutions that are closely involved in the development of agriculture, the food industry and green chemistry. Created in September 2014, the venture capital firm focuses on projects related to sustainable farming, quality and nutrition in the food industry and biomass conversion. With nearly €60 million of funds under management, CapAgro is already supporting 11 innovative companies mostly in Europe.

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

The Scottish Investment Bank (SIB) is the investment arm of Scotland’s main economic development agency, Scottish Enterprise, operating Scotland-wide in partnership with Highlands and Islands Enterprise. It manages a suite of co- investment funds including the Scottish Co-investment Fund and the Scottish Venture Fund, which are partly funded by the European Regional Development Fund (ERDF), Renewable Energy Investment Fund and the Scottish Recycling Fund. SIB is the cornerstone investor in the privately managed Scottish Loan Fund, managed by Maven Capital Partners and an investor in Epidarex Capital’s life sciences fund. Our investment funds support Scotland’s SME funding market to ensure businesses with growth and export potential have adequate access to growth capital. We also provide a team of Financial Readiness specialists to help companies prepare for new investment and access appropriate finance.
www.scottish-enterprise.com/sib

24/02/2016

A major step forward in bionic vision for patients with retinitis pigmentosa1452269936_pixium_004

Paris, France – February 24, 2016 – Pixium Vision (FR0011950641 – PIX) a company developing innovative bionic vision systems to allow patients who have lost their sight to lead more independent lives, announces today the first implant and successful activation of IRIS® II, the only epi-retinal implant with 150 electrodes, intended for patients who have lost sight as a result of retinitis pigmentosa (RP).
The first human implant of IRIS® II was successfully performed in January, by Professor Michel Weber, Head of Ophthalmology at the University Hospital of Nantes, France. This is part of Pixium Vision’s ongoing clinical trial to assess the safety and performance of IRIS® II as a treatment to compensate for blindness by providing a form of bionic vision and enabling greater autonomy for patients.
Professor Weber commented: “This first implant was successfully completed for the 58 year old retinitis pigmentosa patient. With the implant design and its smart retinal fixation, the procedure is close to the surgical techniques familiar to the retinal surgeons.” Pr. Weber added: “After many years in darkness, the patient was activated and reported first perception of light. Per clinical protocol, the patient will now enter training to learn how to interpret the light signals.”

The implant activation and first light perception provide tangible evidence of visual perception. It precedes the normal rehabilitation process where, per protocol, the patient learns to interpret the bionic vision.
Dr Yannick Le Mer, a pioneer in retinal implant surgery at the Fondation Ophtalmologique Rothschild in Paris (a centre of excellence for ophthalmic surgery participating in the study with Hôpital des QuinzeVingts) added: “The new IRIS®II implant represents a major step forward for patients with retinitis pigmentosa: the intervention is relatively quick thanks to the design of the implant and it is now equipped with 150 electrodes, close to three time more than currently available. Epi-retinal approach is currently the less invasive and most optimal solution to allow retinitis pigmentosa patients to emerge from darkness.”
Khalid Ishaque, CEO of Pixium Vision, said: “The first implant and activation of IRIS® II, with its innovative features, is an exciting and major advance in the field of bionic vision development, interfacing the eye and the brain. Pixium Vision is dedicated to conceive, develop and bring meaningful bionic vision innovations to surgeons, enabling them to treat patients who have lost sight.” Up to 10 patients will be included in the ongoing clinical trial in several specialized centres in Europe. In December 2015, Pixium Vision filed for CE mark. Subject to CE mark approval, IRIS® II should be commercially available around mid-2016.

IRIS® II incorporates innovative characteristics:
– A smart bio-inspired camera that is intended to function like the human eye: the sensor does not take a sequence of video frames, essentially composed of redundant information, but continuously captures the changes in a visual scene with its time independent pixels;
– An epi-retinal implant with 150 electrodes, almost three times more electrodes than available today;
– An explantable design: the electrode array is secured on the retinal surface by a patented support system that allows explantation, minimizing risk of retinal damage and permitting potential for upgrade to newer therapy options.
Earlier in the year, Pixium Vision also announced promising pre-clinical safety data1 for its next generation PRIMA implant, a miniaturized wireless sub-retinal implant in preparation for the first in human feasibility study later this year.

About the IRIS® II clinical study:
Study title: “Compensation for Blindness with the Intelligent Retinal Implant System (IRIS V2) in Patients With Retinal Dystrophy (IRIS 2)”
https://clinicaltrials.gov/ct2/show/NCT02670980?term=Compensation+for+Blindness+with+the+Intelligent+R etinal+Implant+System+%28IRIS+V2%29+in+Patients+With+Retinal+Dystrophy+%28IRIS+2%29&rank=1
The IRIS® II clinical trial is a multi-centric, open label, non-randomized prospective European study to assess safety and performance of the IRIS® II bionic vision system as treatment to compensate for blindness, providing a form of perception for blind persons and enabling them greater autonomy and quality of living. Up to 10 patients suffering from retinitis pigmentosa, Cone-Rod dystrophy, choroideremia will be included and followed for a minimum of 18 months and an additional 18 months, subject to patient agreement. Clinical trials are currently underway in 7 centers below. Additional centers are being opened in United Kingdom and Spain.

– Hôpital des Quinze-Vingts et la Fondation
Ophtalmologique Rothschild, Paris (France)
Contact: Dr Saddek Mohand-Said
28, Rue de Charenton, 75012 Paris, France
Tel: +33 1 40 02 14 04

– Klinik und Poliklinik für Augenheilkunde Hamburg –
Eppendorf (Germany)
Contact: Dr. Matthias Keserü
Martinistraße 52, 20246 Hamburg, Germany
Tel: +49 40 7410 18878

– CHU de Nantes Clinique Ophtalmologique (France)
Contact: Prof. Michel Weber
1 Place Alexis Ricordeau, 44000 Nantes, France
Tel : +33 2 40 08 36 22

– Dept. of Ophthalmology, University of Bonn (Germany)
Contact: Prof. Dr. Frank G. Holz, Prof. Peter Charbel Issa
Ernst-Abbe -Str. 2, 53127 Bonn, Germany
Tel: +49 228 287 1564 7

– CHU Nimes, Service Ophtalmologie (France)
Contact: Dr. Gérard Dupeyron
Place du Pr. Robert Debré, 30029 Nimes Cedex 9, France
Tel : +33 4 66 68 32 71

– Universitäts Klinikum Klinik für Augenheilkunde
Freiburg (Germany)
Contact: Prof. Hansjürgen Agostini
Kilianstrasse 5, 79106 Freiburg, Germany
Phone: +49 761 270 40060

– Augenklinik der Medizinischen Universtaet Graz
(Austria)
Contact: Prof. Michaela Velikay – Parel
Auenbruggerplatz 4, 8036 Graz, Austria
Tel: +43 316 385 3817
About Pixium Vision (www.pixium-vision.com)
Pixium Vision’s Mission is to create a world of bionic vision for those who have lost their sight enabling them to regain partial perception and greater autonomy and improved quality of daily living. Pixium Vision is the only company today developing in parallel 2 innovative bionic retinal implant systems, which incorporate active implantable prostheses intended to treat and compensate for blindness resulting from the degeneration of retinal photoreceptor cells. The Company harnesses the rapid advances in neuroscience, neuromorphic visual processing, microelectronics / nanoelectronics, optoelectronics, neurobiology and intelligent software algorithms.
These bionic systems are intended for blind people whose optic nerve remains functional. Pixium Vision’s bionic vision systems are associated with a surgical intervention as well as a rehabilitation period. European Clinical trials are currently underway with IRIS®, the company’s first bionic vision system. Patients have tolerated their implants well so far and improvements in visual perception have been observed. Pixium Vision has filed IRIS’s CE mark dossier at the end of 2015 and expects CE mark approval by mid-2016.
Pixium Vision is, in parallel, also developing PRIMA, a sub retinal miniaturized wireless implant platform currently in preclinical studies. The Company plans to begin clinical trials with PRIMA in Europe in 2016.
The company is EN ISO 13485 certified.
Pixium Vision maintains close collaborations with academic and research partnerships spanning across the prestigious Vision Institute in Paris, the Hansen Experimental Physics Laboratory at Stanford University, as well as several global scientific, medical, clinical, and technology experts, resulting also in strong intellectual property portfolio.
Pixium Vision is listed on Euronext (Compartiment C) in Paris.
ISIN: FR0011950641; Mnemo: PIX
IRIS® is a trademark of Pixium-Vision SA

Contacts

Pixium Vision
Pierre Kemula, CFO
investors@pixium-vision.com
+33 1 76 21 47 68
@PixiumVision
Relations Presse
Newcap Media
Annie-Florence Loyer – afloyer@newcap.fr
+33 1 44 71 00 12 / +33 6 88 20 35 59
Daphné Boccara – dboccara@newcap.fr
+33 1 44 71 94 93

Disclaimer:
This press release may expressly or implicitly contain forward-looking statements relating to Pixium Vision and its activity. Such statements are related to known or unknown risks, uncertainties and other factors that could lead actual results, financial conditions, performance or achievements to differ materially from Vision Pixium results, financial conditions, performance or achievements expressed or implied by such forward looking statements.
Pixium Vision provides this press release as of the aforementioned date and does not commit to update forward looking statements contained herein, whether as a result of new information, future events or otherwise.
For a description of risks and uncertainties which could lead to discrepancies between actual results, financial condition, performance or achievements and those contained in the forward-looking statements, please refer to Chapter 4 “Risk Factors” of the company’s Registration Document filed with the AMF under number R15- 069 on September 23, 2015 which can be found on the websites of the AMF – AMF (www.amf-france.org) and of Pixium Vision (www.pixium-vision.com).