Dupixent® (dupilumab) approved by European Commission as first and only biologic medicine for children aged 6 to 11 years with severe atopic dermatitis

Dupixent® (dupilumab) approved by European Commission as first and only biologic medicine for children aged 6 to 11 years with severe atopic dermatitis




Dupixent® (dupilumab) approved by European Commission as first and only biologic medicine for children aged 6 to 11 years with severe atopic dermatitis

Dupixent® (dupilumab) approved by European Commission as first and only biologic medicine for children aged 6 to 11 years with severe atopic dermatitis

  • Pivotal trial showed more than four times as many children achieved itch reduction and more than three times as many children achieved clear or almost clear skin with Dupixent plus topical corticosteroids (TCS) compared to TCS alone
  • Nearly three in four children achieved a 75% improvement in disease extent and severity, with an average improvement of approximately 80%
  • Approximately 80% of children experienced clinically meaningful improvements in a composite of health-related quality of life measures that include sleep, school, emotional well-being and relationships
  • Expanded approval of Dupixent for these children reinforces well-established, long-term safety profile

PARIS and TARRYTOWN, N.Y. – November 30, 2020 – The European Commission (EC) has extended the marketing authorization for Dupixent® (dupilumab) in the European Union (EU) to include children 6 to 11 years of age with severe atopic dermatitis who are candidates for systemic therapy. Dupixent is the only systemic medicine approved in the EU to treat these patients.

“As the parent of a child with atopic dermatitis, and someone who works with families impacted by this condition daily, I’ve seen first-hand the enormous physical and mental health burden of this disease, and the toll it can take on the entire family,” said Korey Capozza, MPH, Founder and Executive Director of Global Parents for Eczema Research (GPER). “Young children with severe atopic dermatitis currently have few treatment choices and significant unmet needs. We welcome the addition of new medicines for these underserved patients.”

Atopic dermatitis is a chronic inflammatory disease of the skin that can be debilitating, and severe disease can significantly impact many aspects of life for both children and their families. The current standard of care for children with severe atopic dermatitis in Europe is limited to topical treatments, leaving those with poorly controlled disease to cope with intense, unrelenting itch and skin lesions that can cover much of the body, resulting in skin cracking, redness or darkening, crusting and oozing. In addition, uncontrolled severe atopic dermatitis can have a substantial emotional and psychosocial impact, causing sleep disturbance, symptoms of anxiety and depression and feelings of isolation in children.

 “The approval of Dupixent for children in Europe marks another significant milestone for atopic dermatitis patients and their families, broadening the availability of a first-in-class medicine that offers a proven safe and effective treatment for this debilitating skin disease,” said John Reed, M.D., Ph.D., Global Head of Research and Development at Sanofi. “Dupixent’s ability to provide significantly clearer skin, and clinically meaningful reduction of persistent itch, addresses important unmet needs for these children. In addition to atopic dermatitis, we continue to investigate the potential of Dupixent in younger age groups and across a variety of type 2 inflammatory diseases.”

Dupixent is a fully-human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins, and is not an immunosuppressant. Data from Dupixent clinical trials have shown that IL-4 and IL-13 are key drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP).

“This approval for Dupixent in the EU represents a major advancement for children with severe atopic dermatitis and their families, who spend countless days and nights tending to their child’s disease with few treatment options to help alleviate the debilitating symptoms,” said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. “Dupixent is a novel therapy that addresses a root cause of atopic dermatitis by specifically targeting the underlying type 2 inflammation of the disease. Dupixent has already been used by hundreds of thousands of patients around the world, including those with atopic dermatitis as well as other type 2 inflammatory diseases such as asthma and adults with chronic rhinosinusitis with nasal polyps.  We are pleased to bring this paradigm-changing medicine to even younger patients in the EU who need new options beyond steroids or immunosuppressants.”

In children aged 6-11 years weighing 15 to <60 kg, Dupixent 300 mg is administered as an injection under the skin (subcutaneous injection) every four weeks following the initial loading dose given as two injections 14 days apart. For those weighing >60 kg, Dupixent 300 mg is administered every two weeks following the initial loading dose given the same day. The dose may be increased to 200 mg every two weeks in patients weighing 15 to <60 kg based on physician’s assessment.

Pivotal trial data

The EC decision is based primarily on data that includes pivotal Phase 3 efficacy and safety results of Dupixent combined with topical corticosteroids (TCS) compared to TCS alone (placebo) in children 6-11 years with severe atopic dermatitis. At 16 weeks, patients in treatment groups of Dupixent 300 mg every four weeks (N=122) or 200 mg every two weeks (N=59) with TCS experienced:

  • Improved disease extent and severity: 82% and 80% average improvement from baseline with Dupixent every four and two weeks, respectively, compared to 49% and 48% for placebo. In addition, 70% and 75% of Dupixent patients achieved at least a 75% improvement in the four-week and two-week treatment groups, respectively, compared to 17% and 26% for placebo.
  • Skin clearance: 33% and 39% of patients achieved clear or almost clear skin with Dupixent every four and two weeks respectively, compared to 11% and 10% for placebo.
  • Reduced itch: 51% and 61% of patients achieved clinically significant reduction with Dupixent every four and two weeks, respectively, compared to 12% and 13% for placebo. A significantly greater proportion of Dupixent patients achieved improvement in itch as early as four weeks.
  • Improved health-related quality of life (HR-QoL): 77% and 81% of patients experienced clinically meaningful improvement in patient-reported HR-QoLwith Dupixent every four and two weeks, respectively, compared to 39% and 36% for placebo. Dupixent patients also experienced improvements in additional HR-QoL measures assessing disease severity and patient-reported measures such as itch and sleep.

The safety profile of Dupixent in children 6-11 years of age followed through week 52, based on an open-label extension trial, was similar to the safety profile observed at week 16 and consistent with the safety profile seen in adults and adolescents with atopic dermatitis. Overall rates of adverse events (AEs) were 65% and 61% for Dupixent every four and two weeks respectively, and 73% and 75% for placebo. AEs that were more commonly observed with Dupixent included upper respiratory tract infections (11% and 9% for Dupixent every four and two weeks, 10% and 12% for placebo), injection site reactions (10% and 14% for Dupixent every four and two weeks, 6% and 5% for placebo), nasopharyngitis (13% and 3% for Dupixent every four and two weeks, 7% and 10% for placebo), conjunctivitis (7% and 9% for Dupixent every four and two weeks, 4% and 5% for placebo), and fever (3% for both Dupixent groups, 2% and 0% for placebo). Additional prespecified AEs included skin infections (6% and 9% for Dupixent every four and two weeks, 13% for both placebo groups), and herpes viral infections (2% for both Dupixent groups, 5% for both placebo groups).

About the pediatric trial

The co-primary endpoints in the pediatric trial were skin clearance, as measured by a score of 0 or 1 on the Investigator’s Global Assessment (IGA), and disease extent and severity, as measured by Eczema Area and Severity Index score (EASI-75).

Secondary endpoints included the average change in EASI score from baseline, and itch as measured by at least a 4-point reduction in itch intensity on a 0 to 10-point scale (weekly average of daily Peak Pruritus Numerical Rating Scale). Additionally, HR-QoL was measured by the proportion of patients who achieved at least six points on the patient-reported Children’s Dermatology Life Quality Index (CDLQI), as well as additional measures from Patient Oriented Eczema Measure (POEM) and SCORing Atopic Dermatitis (SCORAD).

About Dupixent

Dupixent is approved for specific patients with atopic dermatitis, asthma and/or in adults with CRSwNP in a number of countries around the world, including the European Union, U.S. and Japan. Dupixent is currently approved in more than 60 countries, and more than 200,000 patients have been treated globally.

Dupixent is intended for use under the guidance of a healthcare professional and can be given in a clinic or at home by self-administration after training by a healthcare professional. In children younger than 12 years of age, Dupixent should be administered by a caregiver. No initial lab testing or ongoing lab monitoring is required with Dupixent treatment in any approved indication or age group.

Dupilumab development program

To date, dupilumab has been studied in more than 10,000 patients across 50 clinical trials in various chronic diseases driven by type 2 inflammation.

In addition to the currently approved indications, Sanofi and Regeneron are also studying dupilumab in a broad range of diseases driven by type 2 inflammation and other allergic pathways, including pediatric atopic dermatitis (6 months to 5 years of age, Phase 3), pediatric asthma (6 to 11 years of age, Phase 3), eosinophilic esophagitis (Phase 3), chronic obstructive pulmonary disease (Phase 3), bullous pemphigoid (Phase 3), prurigo nodularis (Phase 3), chronic spontaneous urticaria (Phase 3), and food and environmental allergies (Phase 2). These potential uses are investigational, and the safety and efficacy of dupilumab in these conditions have not been evaluated by any regulatory authority. Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.

About Regeneron

Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, infectious diseases and rare diseases.

Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune®, which uses unique genetically-humanized mice to produce optimized fully-human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.

 

About Sanofi

 

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

 

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

 

Sanofi, Empowering Life

 

 

Sanofi Media Relations Contact 
Sally Bain
Tel.: +1 (781) 264-1091
Sally.Bain@sanofi.com

 

                         
Regeneron Media Relations Contact
Hannah Kwagh
Tel: +1 (914) 847-6314

Hannah.Kwagh@regeneron.com 

 

Sanofi Investor Relations Contacts Paris
Eva Schaefer-Jansen
Arnaud Delepine
Yvonne Naughton

 

Sanofi Investor Relations Contacts North America
Felix Lauscher
Fara Berkowitz
Suzanne Greco

 

Sanofi IR main line:
Tel.: +33 (0)1 53 77 45 45
ir@sanofi.com
https://www.sanofi.com/en/investors/contact

 

Regeneron Investor Relations
Contact
Mark Hudson
Tel: +1 (914) 847-3482

Mark.Hudson@regeneron.com

 

 

Sanofi Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole.  Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2019. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

 

Regeneron Forward-Looking Statements and Use of Digital Media
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words.  These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regeneron’s business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regeneron’s and its collaborators’ ability to continue to conduct research and clinical programs, Regeneron’s ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators (collectively, “Regeneron’s Products”), and the global economy; the nature, timing, and possible success and therapeutic applications of Regeneron’s Products and Regeneron’s product candidates and research and clinical programs now underway or planned, including without limitation Dupixent® (dupilumab); uncertainty of market acceptance and commercial success of Regeneron’s Products and product candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) on the commercial success of Regeneron’s Products (such as Dupixent) and product candidates; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s product candidates and new indications for Regeneron’s Products, such as dupilumab for the treatment of pediatric atopic dermatitis, pediatric asthma, eosinophilic esophagitis, chronic obstructive pulmonary disease, bullous pemphigoid, prurigo nodularis, chronic spontaneous urticaria, food and environmental allergies, and other potential indications; safety issues resulting from the administration of Regeneron’s Products (such as Dupixent) and product candidates in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and product candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and product candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regeneron’s Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron’s Products and product candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates; the ability of Regeneron’s collaborators, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and product candidates; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated companies, as applicable), to be cancelled or terminated; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection, Dupixent, and Praluent® (alirocumab)), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2019 and its Form 10-Q for the quarterly period ended September 30, 2020.  Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.

 

Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron’s media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron).

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ABN AMRO presents outcome of strategy review and hosts virtual Investor Update

ABN AMRO presents outcome of strategy review and hosts virtual Investor Update




ABN AMRO presents outcome of strategy review and hosts virtual Investor Update

ABN AMRO presents outcome of strategy review and hosts virtual Investor Update

Clear vision of the bank we want to be

  • ‘A personal bank in the digital age’ serving clients where we have scale in the Netherlands and Northwest Europe
  • Our clients’ first choice partner in sustainability in climate change, circular economy and social impact
  • A future-proof bank, rigorously simplifying and centralising the operating model, enabling us to focus on clients and work more efficiently
  • Committed to our moderate risk profile; culture and licence to operate are clear priorities

Financial targets reflecting economic outlook

  • Safeguarding income by increasing market share in our focus growth segments
  • Costs no higher than EUR 4.7 billion in 2024, reflecting EUR 700 million savings
  • Execution discipline and CIB non-core wind-down underpin moderate risk profile; cost of risk reconfirmed at 25 to 30 basis points through-the-cycle
  • ROE target for 2024 of around 8%; ROE ambition of 10% remains, subject to interest rate normalisation
  • Basel IV CET1 target of 13%. Threshold for share buybacks above 15% (subject to regulatory approval), to be recalibrated when uncertainties reduce
  • Dividend pay-out ratio of 50% of reported net profit

Today, ABN AMRO is hosting a virtual Investor Day. Its theme: ‘A personal bank in the digital age’.

Robert Swaak, CEO, comments: ‘Today we present the outcome of the strategy review and our vision for the bank. Our strategic pillars – customer experience, sustainability and future-proof bank – remain our guiding principles in acting on our purpose ‘Banking for better, for generations to come’. With our strong brand and attractive market positions across all segments we have a strong foundation. Our strategy review now gives us a distinct profile and focus. The wind-down of the CIB non-core portfolio as announced in August was a first step. Today we announce we will be a personal bank in the digital age, serving clients where we have scale in the Netherlands and Northwest Europe.

A personal bank in the digital age with a focus on segments where we have scale
We will focus on attractive segments in the Netherlands and Northwest Europe where we can grow profitably. In the Netherlands we will grow in the segments wealthy clients, affluent clients and mid-to large corporates, where we leverage our expertise. We will further develop our leading positions in mortgages and SMEs with new propositions, aiming to increase our market share in both segments to above 20%. In Northwest Europe we will leverage our domestic expertise in the energy, digital and mobility transition, aiming for a top 3 market position in selected niches. We remain open to bolt-on acquisition opportunities, especially in private banking.

We are a personal bank in the digital age, engraining the customer experience. Our trusted relationships with clients, together with our capabilities across all client segments, enable us to support them at all important financial steps in their lives. We offer both convenience and expertise. We deliver a convenient daily banking experience increasingly digitally. At moments that matter we support our clients with sector and sustainability expertise.

Sustainability is core to our purpose  
Our clients increasingly need expertise to support them in the sustainability shift. We are their first choice partner in climate change, the circular economy and social impact. We aim to increase the volume of sustainable client loans and investments from around one-fifth to one-third in 2024. We will lead by example and make our office buildings more energy efficient. We will redevelop one of our locations in Amsterdam into a Paris-proof workplace designed to facilitate the trend of remote working. Alongside this we will sell our head office building and lease back part of it. The transaction is expected to result in a book gain.

Future-proof bank enables client focus and efficiency
We are building a future-proof bank by rigorously simplifying and centralising our operating model, enabling us to focus on clients and work more efficiently. Around 90% of high volume processes will be digitalised end-to-end by 2024. We will further streamline the product portfolio by around 60% by 2024. As clients make the shift to digital we will continue to reduce the number of branches. Our financial coaches will continue to be available to clients who need support to ensure they maintain access to banking services.

We are fully committed to our moderate risk profile and our role as a gatekeeper of the financial system. Our culture and licence to operate remain clear priorities. We place great value on fostering a culture within the bank in which everyone feels respected and valued. Taking ownership, clear targets and accountability are key to execution and our licence to operate.

Guidance and targets reflect current cautious economic outlook
Safeguarding income in low-rate environment
The low interest rate environment and wind-down of the CIB non-core portfolio will continue to impact net interest income. We aim to safeguard income by growing market share in focus segments by 2 to 5 percentage points by 2024. We expect fees to recover when lockdowns lift and to grow strongly after that as we increasingly charge for our convenience and expertise.

Continued cost focus
We have a good track record of cost control. We are targeting costs no higher than EUR 4.7 billion in 2024, reflecting EUR 700 million of further cost savings. Costs in 2021 at around EUR 5.3 billion are expected to be higher than in 2020 at around EUR 5.1 billion (excluding restructuring costs in both years) due to an increase in regulatory levies, AML costs and strategic investments. We expect a further reduction of staff of around 15% by 2024, mostly from 2022 onwards. We will reduce the impact on staff through natural attrition and reskilling in roles where we expect shortages. We expect EUR 300 million of strategic investments and a restructuring provision of around EUR 150 million through 2023.

Cost of risk 
We reconfirm our through-the-cycle cost of risk of 25 to 30 basis points. The non-core CIB activities were an important cause of disappointing cost of risk in recent years. The wind-down of the CIB non-core portfolio is well on track and will improve the bank’s risk profile of the bank. Discipline in the execution of the sharpened risk framework will contribute to lower volatility in impairments.

Return on equity
We target a return on equity (‘ROE’) of around 8% by 2024 when the cost of risk is expected to normalise, cost-savings programmes are completed and growth initiatives are delivering. Our ROE ambition remains 10% and this will require some normalisation over time of current low interest rates.

Capital framework
We have set out our capital framework despite current uncertainties. We are committed to resuming payment of dividends, sustainably, conditions permitting and taking into account ECB recommendations. We will resume dividend pay-out at a ratio of 50% of net profit, after deduction of AT1 coupon payments and minority interests. We will adopt Basel IV as the primary capital metric with a Basel IV CET1 target of 13%. When our Basel IV CET1 ratio is above the threshold of 15% we will consider share buybacks subject to conditions and regulatory approval, not before FY2021. The threshold will be recalibrated as uncertainties reduce. Pay-out of the accrued full-year 2019 dividend will be considered prudently at full-year 2020, taking into account the status of the ECB dividend recommendation as well as conditions and prospects at that time.’

Webcast
The Investor Update reference documents are available online.  A one-hour management presentation, led by Robert Swaak (CEO), followed by Q&As can be followed live via webcast from 10.00 am to 12.00 noon CET on https://www.abnamro.com/ir.   

ABN AMRO Press Office
Jeroen van Maarschalkerweerd
Head of Media Relations & PR
pressrelations@nl.abnamro.com
+31 20 6288900
ABN AMRO Investor Relations
Ferdinand Vaandrager
Head of Investor Relations investorrelations@nl.abnamro.com
+31 20 6282282

 

 

This press release is published by ABN AMRO Bank N.V. and contains inside information within the meaning of article 7 (1) to (4) of Regulation (EU) No 596/2014 (Market Abuse Regulation]

Thin Film Electronics ASA – Warrant Exercise

Thin Film Electronics ASA – Warrant Exercise




Thin Film Electronics ASA – Warrant Exercise

Oslo, 30 November 2020

Reference is made to the announcement by Thin Film Electronics ASA (the “Company”) on 20 May 2020 regarding an Extraordinary General Meeting where the shareholders resolved to issue warrants to participants in a Private Placement and Subsequent Offering of shares, and on 30 June 2020 regarding the result of the Subsequent Offering.

The Company has received notices of exercise of a total of 182,619,709 Warrants A and a total of 7,435,524 Warrants B, and has subsequently resolved to increase the Company’s share capital with NOK 20,906,075.63 in connection with the issuance of shares upon said exercises.

Following this warrant exercise, 75.17% of the total issued Warrants A have now been exercised.

Any unexercised Warrants A will expire on 31 December 2020 without compensation to the holder.

Upon registration of the share capital increase, the Company’s share capital will be NOK 108,410,300.46 divided into 985,548,186 shares, each share having a par value of NOK 0.11.

Contact:
Kevin Barber – Chief Executive Officer
Email: kevin.barber@thinfilmsystems.com

This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.

La Commission européenne approuve Dupixent® (dupilumab), le premier et le seul médicament biologique indiqué pour le traitement de la dermatite atopique sévère de l’enfant âgé de 6 à 11 ans

La Commission européenne approuve Dupixent® (dupilumab), le premier et le seul médicament biologique indiqué pour le traitement de la dermatite atopique sévère de l’enfant âgé de 6 à 11 ans




La Commission européenne approuve Dupixent® (dupilumab), le premier et le seul médicament biologique indiqué pour le traitement de la dermatite atopique sévère de l’enfant âgé de 6 à 11 ans

La Commission européenne approuve Dupixent® (dupilumab), le premier et le seul médicament biologique indiqué pour le traitement de la dermatite atopique sévère de l’enfant âgé de 6 à 11 ans

  • Dans le cadre d’un essai pivot, Dupixent en association avec des corticoïdes topiques, a permis d’obtenir une réduction des démangeaisons chez quatre fois plus d’enfants qu’un traitement par corticoïdes topiques seulement et une cicatrisation complète ou quasi complète de la peau chez trois fois plus d’enfants.
  • Chez près de trois enfants sur quatre, l’étendue et la sévérité de la maladie se sont améliorées de 75 %, avec une amélioration moyenne d’environ 80 %. 
  • Chez environ 80 % des enfants, des améliorations cliniquement significatives de différents paramètres de la qualité de vie en lien avec la santé (sommeil, scolarité, bien-être psychologique et relations sociales) ont été observées.
  • L’extension des indications de Dupixent à ces enfants conforte son profil de tolérance bien établi à long terme.

PARIS et TARRYTOWN (New York) – Le 30 novembre 2020 – La Commission européenne (CE) a étendu l’autorisation de mise sur le marché de Dupixent® (dupilumab) dans l’Union européenne (UE) aux enfants âgés de 6 à 11 ans présentant une forme sévère de dermatite atopique et nécessitant un traitement systémique. Dupixent est le seul médicament systémique approuvé dans l’UE pour le traitement de cette catégorie de patients.

« Ayant moi-même un enfant souffrant de dermatite atopique et côtoyant chaque jour dans mon travail des familles touchées par cette maladie, je sais combien son fardeau physique et mental peut être lourd à porter et connais l’impact qu’elle peut avoir sur l’ensemble de la famille », a déclaré Korey Capozza, MPH, Fondatrice et Directrice générale de Global Parents for Eczema Research (GPER). « Les jeunes enfants atteints de dermatite atopique sévère disposent actuellement de très peu d’options thérapeutiques et présentent des besoins médicaux non satisfaits importants. L’approbation de nouveaux médicaments répondant aux besoins non pourvus de cette catégorie de patients est donc particulièrement bienvenue. »  

La dermatite atopique est une maladie inflammatoire chronique de la peau qui peut être invalidante et dont la gravité peut avoir de lourdes répercussions sur plusieurs dimensions de la vie des enfants et de leur famille. La prise en charge standard des enfants souffrant de dermatite atopique sévère en Europe se limite à la prescription de corticoïdes topiques, laissant ceux dont la maladie est inadéquatement contrôlée aux prises avec des démangeaisons intenses et persistantes et des lésions sur pratiquement toute la surface du corps, entraînant une peau craquelée, rouge ou foncée et couverte de croûtes qui finissent par suinter. Non contrôlée, la dermatite atopique sévère peut avoir un impact émotionnel et psychosocial non négligeable, provoquer des troubles du sommeil, des symptômes d’anxiété et de dépression et un sentiment d’isolement pour les enfants.

« L’approbation de Dupixent chez l’enfant en Europe représente une nouvelle étape importante pour les patients atteints de dermatite atopique et leur famille car elle étend la disponibilité d’un médicament qui, en plus d’être le premier de sa classe pharmacothérapeutique, constitue un traitement à la fois sûr et efficace de cette maladie invalidante de la peau », a précisé le Dr John Reed, Ph.D., Responsable Monde de la Recherche et Développement de Sanofi. « La mise à disposition de Dupixent à ces enfants répond à un besoin médical important et permettra à leur peau de cicatriser et de soulager leurs démangeaisons persistantes. Outre la dermatite atopique, nous continuons d’étudier le potentiel de Dupixent auprès de populations plus jeunes et dans le traitement de plusieurs autres maladies porteuses d’une signature inflammatoire de type 2. »  

Dupixent est un anticorps monoclonal entièrement humain qui inhibe spécifiquement la signalisation de l’interleukine 4 (IL-4) et de l’interleukine 13 (IL-13). Il ne s’agit pas d’un médicament immunosuppresseur. Les données des essais cliniques consacrés à Dupixent ont montré que les protéines IL-4 et IL-13 jouent un rôle central dans la dermatite atopique, l’asthme et la polypose nasosinusienne.

« L’approbation de Dupixent dans l’UE représente un progrès majeur pour les enfants atteints de dermatite atopique sévère et pour les membres de leur famille qui consacrent souvent un nombre incalculable de jours et de nuits à les soigner et disposent de très peu de solutions thérapeutiques pour soulager les symptômes invalidants de cette maladie », a ajouté le Dr George D. Yancopoulos, Ph.D., Président et Chief Scientific Officer de Regeneron. « Dupixent est un nouveau médicament qui s’attaque aux causes profondes de la dermatite atopique en ciblant spécifiquement l’inflammation de type 2 sous-jacente à cette maladie.  Dupixent a déjà été utilisé par plusieurs centaines de milliers de patients dans le monde, y compris par des patients atteints de dermatite atopique ainsi que d’autres maladies inflammatoires de type 2 telles que l’asthme et comme l’asthme et les adultes atteints de rhinosinusite chronique avec polypes nasaux. Ce médicament incarne un véritable changement de paradigme et nous sommes heureux de le mettre à la disposition de patients encore plus jeunes dans l’UE ayant besoin d’options thérapeutiques autres que des corticoïdes ou des immunosuppresseurs. »

Chez l’enfant âgé de 6 à 11 ans pesant de 15 à <60 kg ’administration de Dupixent 300 mg se fait par injection sous-cutanée (injection sous la peau) toutes les quatre semaines après une dose de charge fractionnée en deux injections à 14 jours d’intervalle. Pour les enfants pesant plus de 60 kg, Dupixent 300 mg est administré toutes les deux semaines après la dose de charge initiale ou le jour même. La dose peut être portée à 200 mg toutes les deux semaines chez les patients dont le poids corporel est compris entre 15 et <60 kg, sur la base d’une évaluation du médecin. La dose peut être augmentée à 200 mg toutes les deux semaines chez les patients dont le poids est compris entre 15 kg et moins de 60 kg, en fonction de l’évaluation du médecin.  

Données de l’essai pivot

La décision de la CE repose principalement sur des données qui incluent les résultats d’un essai pivot de phase III de l’efficacité et de la tolérance de Dupixent en association avec des corticoïdes topiques, comparativement à un traitement par corticoïdes topiques (placebo) seulement chez des enfants âgés de 6 à 11 ans atteints de dermatite atopique sévère. Après 16 semaines, les patients traités par Dupixent 300 mg toutes les quatre semaines (n=122) ou par Dupixent 200 mg toutes les deux semaines (n=59), en association avec des corticoïdes topiques, ont obtenu les résultats suivants :

  • Amélioration du score d’étendue et de sévérité de la maladie : amélioration moyenne de respectivement 82 % et 80 % par rapport au score initial, avec Dupixent toutes les quatre et deux semaines, comparativement à respectivement 49 % et 48 % pour le placebo. De plus, respectivement 70 % et 75 % des patients traités par Dupixent ont obtenu une amélioration d’au moins 75 % de leur score dans le groupe des patients traités toutes les quatre semaines et toutes les deux semaines, contre respectivement 17 % et 26 % pour ceux traités par placebo.
  • Cicatrisation de la peau : respectivement 33 % et 39 % des patients ont obtenu une cicatrisation complète ou quasi complète de leur peau, avec Dupixent toutes les quatre et deux semaines, comparativement à 11 % et 10 % pour ceux traités par placebo.
  • Réduction des démangeaisons : respectivement 51 % et 61 % des patients ont obtenu une réduction cliniquement significative des démangeaisons, avec Dupixent toutes les quatre et deux semaines, comparativement à 12 % et 13 % pour ceux traités par placebo. Une proportion significativement plus importante de patients traités par Dupixent a obtenu une amélioration des démangeaisons dès la quatrième semaine de traitement.
  • Amélioration de la qualité de vie en lien avec la santé : chez respectivement 77 % et 81 % des patients, la qualité de vie en lien avec la santé rapportée par les patients a enregistré des améliorations cliniquement significatives, avec Dupixent toutes les quatre et deux semaines, comparativement à 39 % et 36 % chez ceux traités par placebo. Chez les patients traités par Dupixent, les scores de sévérité de la maladie et certaines mesures rapportées par les patients, évaluant par exemple les démangeaisons et le sommeil, se sont également améliorés.   

Le profil de tolérance de Dupixent chez les enfants âgés de 6 à 11 ans, évalué pendant 52 semaines, sur la base d’un essai de prolongation en ouvert, a été comparable au profil de tolérance observé après 16 semaines et cohérent avec celui observé chez les adultes et adolescents atteints de dermatite atopique. Les taux globaux d’événements indésirables se sont établis à 65 % pour Dupixent toutes les quatre semaines et à 61 % pour Dupixent toutes les deux semaines, contre respectivement 73 % et 75 % pour le placebo. Les événements indésirables qui ont été observés plus fréquemment chez les patients traités par Dupixent ont été les infections des voies respiratoires supérieures (11 % pour Dupixent toutes les quatre semaines, 9 % pour Dupixent toutes les deux semaines et respectivement, 10 % et 12 % pour le placebo), des réactions au site d’injection (10 % pour Dupixent toutes les quatre semaines, 14 % pour Dupixent toutes les deux semaines et respectivement, 6 % et 5 % pour le placebo), les rhinopharyngites (13 % pour Dupixent toutes les quatre semaines, 3 % pour Dupixent toutes les deux semaines et respectivement, 7 % et 10 % pour le placebo), les conjonctivites (7 % pour Dupixent toutes les quatre semaines, 9 % pour Dupixent toutes les deux semaines et respectivement, 4 % et 5 % pour le placebo) et la fièvre (3% pour les deux groupes Dupixent, 2% et 0% pour le placebo). Parmi les autres événements indésirables pré-spécifiés observés figuraient les infections cutanées (6 % pour Dupixent toutes les quatre semaines, 9 % pour Dupixent toutes les deux semaines et 13 % pour les deux groupes placebo), ainsi que les infections par le virus de l’herpès (2% pour les deux groupes Dupixent, 5% pour les deux groupes placebo).

À propos de l’essai pédiatrique

Les co-critères d’évaluation principaux de l’essai pédiatrique étaient la cicatrisation de la peau, mesurée par un score IGA (ou Évaluation globale de l’investigateur) de 0 ou de 1 et l’étendue et la sévérité de la maladie, mesurée au moyen du score EASI-75 (Eczema Area and Severity Index – Indice d’étendue et de gravité de l’eczéma).

Les critères d’évaluation secondaires incluaient la variation moyenne du score EASI par rapport au score à l’inclusion dans l’étude, de même que les démangeaisons évaluées par une réduction d’au moins 4 points sur une échelle allant de 0 à 10 mesurant l’intensité des démangeaisons (moyenne hebdomadaire du score journalier de l’intensité du prurit). La qualité de vie en lien avec la santé a également été évaluée en mesurant la proportion de patients ayant obtenu un score d’au moins six points sur l’indice de qualité de vie en dermatologie (Children’s Dermatology Life Quality Index [CDLQI]), et en prenant en compte d’autres scores comme le score POEM (Patient Oriented Eczema Measure) et le score SCORAD (SCORing Atopic Dermatitis).

À propos de Dupixent

Dupixent est approuvé dans un certain nombre de pays, dont ceux de l’Union européenne, les États-Unis et le Japon, pour le traitement de la dermatite atopique et de l’asthme chez certaines catégories de patients et pour le traitement de la polypose nasosinusienne de l’adulte. Dupixent est actuellement approuvé dans plus de 60 pays et, à ce jour, plus de 200 000 patients dans le monde ont été traités par ce médicament.

Dupixent doit être administré sous la surveillance d’un professionnel de santé et peut être administré dans un établissement de santé ou à domicile, par le patient lui-même, avoir reçu des instructions adaptées. Chez l’enfant de moins de 12 ans, Dupixent doit être administré par une personne aidante. Aucune analyse biologique ou suivi biologique n’est requise en cas de traitement par Dupixent dans ses indications approuvées, quel que soit l’âge des patients.

Programme de développement du dupilumab

À ce jour, Dupixent a été étudié chez plus de 10 000 patients dans le cadre de 50 essais cliniques consacrés au traitement de diverses maladies chroniques portant une signature inflammatoire de type 2.

En plus des indications actuellement approuvées, Sanofi et Regeneron consacrent plusieurs programmes de développement clinique au dupilumab et l’étudient dans le traitement de maladies portant une signature inflammatoire allergique ou de type 2, comme la dermatite atopique pédiatrique (6 mois à 5 ans, phase II/III), l’asthme pédiatrique (6 à 11 ans, phase III), l’œsophagite à éosinophiles (phase III), la bronchopneumopathie chronique obstructive (phase III), la pemphigoïde bulleuse (phase III), le prurigo nodulaire (phase III), l’urticaire chronique spontanée (phase III) et les allergies alimentaires et environnementales (phase II). Ces indications potentielles du dupilumab sont expérimentales et aucun organisme de réglementation n’a encore évalué ses profils de sécurité et d’efficacité dans ces indications. Le dupilumab est développé conjointement par Sanofi et Regeneron dans le cadre d’un accord de collaboration global.

À propos de Regeneron

Regeneron (NASDAQ: REGN) est une grande société de biotechnologie qui invente des médicaments aptes à transformer la vie des personnes atteintes de maladies graves. Fondée il y 30 ans et dirigée par des médecins-chercheurs, l’entreprise possède la capacité unique de transformer ses recherches en médicaments, dont huit ont été approuvés par la FDA ainsi que des produits-candidats issus de ses activités de recherche interne. Ses médicaments et son portefeuille de développement sont conçus pour aider les patients souffrant de maladies oculaires, de maladies allergiques et inflammatoires, de cancer, de maladies cardiovasculaires et métaboliques, de maladies infectieuses de douleurs et de maladies rares.

Regeneron accélère et améliore le processus de développement traditionnel des médicaments grâce à VelociSuite®, une suite unique de technologies dont fait partie VelocImmune®, qui fait appel à une souris humanisée unique pour le développement optimal d’anticorps entièrement humains et d’anticorps bispécifiques, ainsi qu’à des initiatives ambitieuses comme le Regeneron Genetics Center, l’un des plus grands centres de séquençage génétique du monde. Pour plus d’informations sur Regeneron, voir le site www.regeneron.com ou suivre @Regeneron on Twitter.

 

À propos de Sanofi

 

La vocation de Sanofi est d’accompagner celles et ceux confrontés à des difficultés de santé. Entreprise biopharmaceutique mondiale spécialisée dans la santé humaine, nous prévenons les maladies avec nos vaccins et proposons des traitements innovants. Nous accompagnons tant ceux qui sont atteints de maladies rares, que les millions de personnes souffrant d’une maladie chronique.

 

Sanofi et ses plus de 100 000 collaborateurs dans 100 pays transforment l’innovation scientifique en solutions de santé partout dans le monde.

 

Sanofi, Empowering Life, donner toute sa force à la vie.

 

Relations Médias Sanofi
Sally Bain
Tél. : +1 (781) 264-1091
Sally.Bain@sanofi.com

 

Relations Médias Regeneron
Hannah Kwagh
Tél. : +1 (914) 847-6314

Hannah.Kwagh@regeneron.com 

Relations Investisseurs Sanofi – Paris
Eva Schaefer-Jansen
Arnaud Delepine
Yvonne Naughton

 

Relations Investisseurs Sanofi – Amérique du Nord
Felix Lauscher
Fara Berkowitz
Suzanne Greco

 

Tél. : +33 (0)1 53 77 45 45
ir@sanofi.com
https://www.sanofi.com/en/investors/contact

 

Relations Investisseurs Regeneron
Mark Hudson
Tél. : +1 (914) 847-3482

Mark.Hudson@regeneron.com

Déclarations prospectives – Sanofi
Ce communiqué contient des déclarations prospectives. Ces déclarations ne constituent pas des faits historiques. Ces déclarations comprennent des projections et des estimations concernant la mise sur le marché et autre potentiel de ce produit, ou concernant les recettes futures envisagées pour ce produit. Ces déclarations prospectives peuvent souvent être identifiées par les mots « s’attendre à », « anticiper », « croire », « avoir l’intention de », « estimer », « planifier » ou « espérer», ainsi que par d’autres termes similaires. Bien que la direction de Sanofi estime que ces déclarations prospectives sont raisonnables, les investisseurs sont alertés sur le fait que ces déclarations prospectives sont soumises à de nombreux risques et incertitudes, difficilement prévisibles et généralement en dehors du contrôle de Sanofi, qui peuvent impliquer que les résultats et événements effectifs réalisés diffèrent significativement de ceux qui sont exprimés, induits ou prévus dans les informations et déclarations prospectives. Ces risques et incertitudes comprennent notamment les actions et contretemps réglementaires inattendus, ou généralement des réglementations étatiques, qui peuvent affecter la disponibilité ou le potentiel commercial de ce produit, le fait que ce produit pourrait ne pas rencontrer un succès commercial, les incertitudes inhérentes à la recherche et développement, les futures données cliniques et l’analyse des données cliniques existantes relatives à ce produit, y compris postérieures à la mise sur le marché, les problèmes inattendus de sécurité, de qualité ou de production, la concurrence de manière générale, les risques associés à la propriété intellectuelle, à tout litige futur en la matière et à l’issue de ces litiges, l’instabilité des conditions économiques et de marché, l’impact que le COVID-19 aura sur Sanofi, ses clients, fournisseurs et partenaires et leur situation financière, ainsi que sur ses employés et sur l’économie mondiale. Tout impact significatif sur ces derniers pourrait négativement impacter Sanofi. La situation évolue rapidement et d’autres conséquences que nous ignorons pourraient apparaitre et exacerber les risques précédemment identifiés. Ces risques et incertitudes incluent aussi ceux qui sont développés ou identifiés dans les documents publics déposés par Sanofi auprès de l’AMF et de la SEC, y compris ceux énumérés dans les rubriques « Facteurs de risque » et « Déclarations prospectives » du Document d’enregistrement universel 2019 de Sanofi, qui a été déposé auprès de l’AMF ainsi que dans les rubriques « Risk Factors » et « Cautionary Statement Concerning Forward-Looking Statements » du rapport annuel 2019 sur Form 20-F de Sanofi, qui a été déposé auprès de la SEC. Sanofi ne prend aucun engagement de mettre à jour les informations et déclarations prospectives sous réserve de la réglementation applicable notamment les articles 223-1 et suivants du règlement général de l’Autorité des marchés financiers.

 

Déclarations prospectives et utilisation des médias numériques – Regeneron
Ce communiqué de presse contient des déclarations prospectives concernant des risques et des incertitudes liés à des événements futurs et à la performance future de Regeneron Pharmaceuticals, Inc. («Regeneron» ou la «Société»). Les événements ou résultats réels peuvent différer considérablement de ces informations prospectives. Des termes tels que « anticiper », « s’attendre à », « avoir l’intention », « planifier », « croire », « rechercher », « estimer », des variantes de ces termes et des expressions similaires ont pour but d’identifier ces déclarations prospectives, bien que toutes les déclarations prospectives ne contiennent pas ces termes explicites. Ces déclarations concernent, et ces risques et incertitudes incluent, entre autres, l’impact que le SARS-CoV-2 (le virus à l’origine de la pandémie de COVID-19) peut avoir sur les activités, les employés, les collaborateurs et les fournisseurs de Regeneron, ainsi que sur les autres tiers sur lesquels compte l’entreprise, sur l’aptitude de Regeneron et de ses collaborateurs à poursuivre la conduite des programmes de recherche et cliniques, sur la capacité de Regeneron à gérer sa chaîne d’approvisionnement, les ventes nettes des produits mis sur le marché ou commercialisés par Regeneron et (ou) ses collaborateurs (ci-après, les « produits de Regeneron »), et sur  l’économie mondiale ; la nature, le calendrier, ainsi que le succès et les applications thérapeutiques possibles des produits et produits-candidats de Regeneron et des programmes de recherche et cliniques en cours ou prévus, y compris, sans limitation, ceux consacrés à Dupixent® (dupilumab) ; l’incertitude de l’acceptation sur le marché et du succès commercial des produits et produits-candidats de Regeneron et l’impact des études (qu’elles soient conduites par Regeneron ou autres et qu’elles soient mandatées ou volontaires) sur le succès commercial de tels produits (comme Dupixent) et produits- candidats ; la probabilité, le moment et l’étendue d’une éventuelle approbation réglementaire et du lancement commercial des produits-candidats et des nouvelles indications pour les produits de Regeneron, comme celle du dupilumab pour le traitement de la dermatite atopique pédiatrique, l’asthme pédiatrique, l’œsophagite à éosinophiles, la bronchopneumopathie chronique obstructive, le pemphigoïde bulleuse, le prurigo nodulaire, l’urticaire chronique spontanée, les allergies alimentaires et environnementales et pour d’autres indications potentielles) ; les problèmes de sécurité résultant de l’administration des produits et produits candidats de Regeneron (comme Dupixent), chez des patients, y compris des complications graves ou des effets indésirables liés à l’utilisation des produits et produits-candidats de Regeneron dans le cadre d’essais cliniques ; les décisions des autorités réglementaires et administratives susceptibles de retarder ou de limiter la capacité de Regeneron à continuer de développer ou de commercialiser ses produits (comme Dupixent) et ses produits-candidats ; les obligations réglementaires et la surveillance en cours ayant une incidence sur les produits de Regeneron, les programmes de recherche et cliniques et les activités commerciales, y compris celles relatives à la vie privée des patients ; la disponibilité et l’étendue du remboursement des produits de Regeneron par les tiers payeurs, HMO, organismes de gestion des soins et régimes  publics tels que Medicare et Medicaid ; les décisions  en  matière  de  prise  en  charge  et  de  remboursement  par  ces  tiers payeurs  et  les  nouvelles  politiques  et  procédures  qu’ils  sont  susceptibles  d’adopter ; la possibilité que des médicaments ou candidats-médicaments concurrents soient supérieurs aux produits et produits-candidats de Regeneron ou présentent un profil coût-efficacité supérieur ; la mesure dans laquelle les résultats des programmes de recherche et développement menés par Regeneron ou ses collaborateurs peuvent être répliqués dans le cadre d’autres études et (ou) conduire à des essais cliniques, à des applications thérapeutiques ou des approbations réglementaires ; la capacité de Regeneron à fabriquer et à gérer des chaînes d’approvisionnement pour plusieurs produits et produits-candidats ; la capacité des collaborateurs, fournisseurs ou autres tierces parties de Regeneron (le cas échéant) d’effectuer la fabrication, le remplissage, la finition, l’emballage, l’étiquetage, la distribution et d’autres étapes liées aux produits et produits-candidats de Regeneron ; les dépenses imprévues ; les coûts de développement, de production et de vente de produits ; la capacité de Regeneron à respecter ses prévisions ou ses prévisions financières et à modifier les hypothèses sous-jacentes ; la possibilité que tout accord de licence, de collaboration ou d’approvisionnement, y compris les accords de Regeneron avec Sanofi, Bayer et Teva Pharmaceutical Industries Ltd. (ou leurs sociétés affiliées respectives, le cas échéant), soient annulés ou résiliés ; et les risques liés à la propriété intellectuelle d’autres parties et aux litiges en cours ou futurs, y compris, sans limitation, les litiges en matière de brevets et autres procédures connexes relatives à Eylea® (aflibercept), solution injectable, Dupixent® et Praluent® (alirocumab), tout autre contentieux et toute autre procédure et enquête gouvernementale sur l’entreprise et (ou)  ses activités, l’issue de toute procédure de ce type et l’impact que ce qui précède peut avoir sur les activités, les perspectives, les résultats d’exploitation et la situation financière de Regeneron. Une description plus complète de ces risques, ainsi que d’autres risques importants, figure dans les documents déposés par Regeneron auprès de la Securities and Exchange Commission des États-Unis, en particulier dans son Form 10-K pour l’exercice clos le 31 décembre 2019 et dans son Form 10-Q pour le trimestre clos le 30 septembre 2020 .Toutes les déclarations prospectives sont fondées sur les convictions et le jugement  actuels  de  la  direction  et  le  lecteur  est  prié  de  ne  pas  se  fier  aux  déclarations  prospectives  formulées  par  Regeneron. Regeneron n’assume aucune obligation de mise à jour publique ou autre des déclarations prospectives, y compris, notamment, des projections ou des prévisions financières, que ce soit à la suite de nouvelles informations, d’événements futurs ou autrement.

 

Regeneron utilise son site Web dédié aux relations avec les investisseurs et aux relations avec les médias ainsi que ses réseaux sociaux pour publier des informations importantes sur la Société, y compris des informations qui peuvent être considérées comme importantes pour les investisseurs. Les informations financières et autres concernant Regeneron sont régulièrement publiées et accessibles sur son site Web dédié aux relations avec les investisseurs et aux relations avec les médias (http://newsroom.regeneron.com) et sur son fil Twitter (http://twitter.com/regeneron).

Pièce jointe

EIB supports AB Science in its COVID-19 development programme

EIB supports AB Science in its COVID-19 development programme




EIB supports AB Science in its COVID-19 development programme

Paris, 30 November 2020, 7am 

EIB supports AB Science in its COVID-19 development programme

  • Financing deal worth €15.0 million signed to support clinical development programme for masitinib
  • Masitinib developed as a credible candidate for treating COVID-19 in addition to other diseases for which no therapeutic solutions are available

AB Science SA (Euronext – FR0010557264 – AB) and the European Investment Bank (the EIB) are pleased to announce the signing of a loan agreement totalling €15.0 million (the COVID-19 loan) today.

This agreement will enable AB Science to fund the clinical development programme evaluating masitinib as a treatment for COVID-19.

Masitinib might be an effective treatment for COVID-19 due to its recently discovered dual mechanism allowing it to act as both an anti-inflammatory and an antiviral agent. Masitinib directly inhibits the 3CL protease, the main protease of SARS-CoV-2 directly involved in the replication of the virus.

This initial partnership with the EIB might be expanded in the future, as discussions are already underway about additional financing for other indications in which masitinib is or could be evaluated, for a maximum budget of €30.0 million.

This financing is supported by the European Fund for Strategic Investments, the financial centrepiece of the Investment Plan for Europe under which the EIB and European Commission have joined forces to kick-start priority investments in the European Union. It is also backed by the InnovFin risk-sharing mechanism which targets corporate research initiatives supported by Horizon 2020, the European Union’s framework programme for research and innovation.

The combination of the EIB’s expertise and the European Commission’s support with the InnovFin guarantee has made it possible to set up an innovative financing package tailor-made to the needs of AB Science.

The COVID-19 loan consists of two tranches of €6 million each, and a third tranche worth €3 million. The first tranche is expected to be released in the coming weeks. The remaining two tranches will be made available at a later stage, subject to certain milestones, including clinical progress in AB Science’s study regarding the treatment of COVID-19 and the company’s future equity funding.

The COVID-19 loan is supplemented by an agreement to issue warrants for the EIB. The number of warrants to be issued by AB Science each time a tranche of the COVID-19 loan is drawn will depend on its reference price prior to the disbursement and the amount of the tranche in question. Purely as an illustration, a reference price of €10.0 would mean that AB Science should issue 162,162 warrants when it draws the first tranche. Each warrant will entitle the EIB to subscribe to one ordinary share in AB Science at the reference price (discount of 5.0%) for a period of 15 years.

Each time a tranche of the COVID-19 loan is drawn, AB Science will issue a press release specifying the terms and conditions and the final number of warrants issued on the occasion.

Alain Moussy, co-founder and chief executive of AB Science, said: “This is an important agreement because this major loan is a sign of a leading European institution’s interest in the development of masitinib. The EIB loan supporting masitinib’s development as a treatment for COVID-19 demonstrates that masitinib is a credible candidate thanks to its dual antiviral and anti-inflammatory mechanism. We hope that this first agreement is only the beginning of a long partnership with the European Investment Bank, allowing us to move faster in developing new medicines for diseases where therapeutic solutions are not available or insufficient.”

“I am delighted to announce this funding agreement with AB Science. The fight against COVID-19 is a priority for the European Union’s bank, which is why we support the development of therapeutic options that could provide an effective response to the health crisis,” said EIB Vice-President Ambroise Fayolle. He added, “Small and medium-sized enterprises are a major source of medical innovation that we need to build on. That’s why it is important that we support and work with them.”

Against the backdrop of the health crisis, this new financing reflects the EIB’s strong mobilisation to support the development of new and effective treatments for COVID-19. This new funding takes total European investment to €600 million in support of 19 biotechs and medtechs involved in the fight against the epidemic.

Note to editors

About the European Investment Bank
Created by the Treaty of Rome and founded in 1958, the EIB is the European Union’s bank, which, together with its dedicated SME support subsidiary the European Investment Fund (EIF), forms the EIB Group. The EIB Group is a key player in reviving Europe’s – including France’s – economy through investment. Thanks to its reliable expertise and the financial attractiveness of its AAA rating, the EIB Group has strengthened its activities in France since 2012 (reaching €8.5 billion of investment in 2019), not only supporting businesses and innovation but also financing projects in strategic sectors such as climate action, energy, healthcare, housing, education for young people and training infrastructure. The EIB Group is the operator of the Investment Plan for Europe, commonly known as the Juncker Plan.

To find out more about the EIB: www.eib.org

InnovFin – EU Finance for Innovators Under Horizon 2020, the EU research and innovation programme for 2014-2020, the European Commission and the European Investment Bank Group (EIB and EIF) launched a new generation of financial instruments and advisory services in 2014 to help innovative firms access finance more easily. Until the end of 2020, the InnovFin – EU Finance for Innovators programme is offering a range of customised products providing financing support for research and innovation projects conducted by small, medium-sized and large companies and promoters of research infrastructure.

About masitinib
Masitinib is a new orally administered tyrosine kinase inhibitor that targets mast cells and macrophages, which are important cells for immunity, by inhibiting a limited number of kinases. Thanks to its unique mechanism, masitinib can be developed for a large number of medical conditions including cancer, inflammatory diseases, and certain diseases of the central nervous system. In oncology, masitinib has the potential to improve survival when administered alone or in combination with chemotherapy, thanks to its immunotherapeutic properties.

Masitinib can alleviate symptoms in certain inflammatory disorders and central nervous system diseases by acting on mast cells and microglia, thereby inhibiting the activation of the inflammatory process.

About AB Science
Founded in 2001, AB Science is a pharmaceutical company specialising in the research, development and commercialisation of protein kinase inhibitors (PKIs), a class of targeted proteins whose action is key in signalling pathways within cells. Our programmes only target diseases which have high unmet medical needs, are often lethal with short-term survival, or are rare or refractory to a previous line of treatment. AB Science has developed a proprietary portfolio of molecules and the company’s lead compound, masitinib, has already been registered for veterinary medicine and is developed in human medicine in oncology, neurological diseases, and inflammatory diseases. The company is headquartered in Paris, France, and listed on Euronext Paris (ticker: AB).

To find out more about AB Science: www.ab-science.com

Press contacts

AB Science
Financial communication and press relations
investors@ab-science.com
European Investment Bank
Anne-Cécile Auguin: +352 621 361948
a.auguin@eib.org
Press Office: +352 4379 21000
press@eib.org

 

Forward-looking statements – AB Science

This press release contains forward-looking statements. These statements are not historical facts. These statements include projections and estimates, as well as the assumptions on which they are based, statements based on projects, objectives, intentions and expectations regarding financial results, events, operations, future services, product development and their potential or future performance. These forward-looking statements can often be identified by the words “expect,” “anticipate,” “believe,” “intend,” “estimate,” or “plan” as well as other similar terms. While AB Science believes these forward-looking statements are reasonable, investors are cautioned that these forward-looking statements are subject to numerous risks and uncertainties that are difficult to predict and generally beyond the control of AB Science and which may imply that results and actual events significantly differ from those expressed, induced or anticipated in the forward-looking information and statements. These risks and uncertainties include the uncertainties related to product development of the Company which may not be successful or to the marketing authorisations granted by competent authorities or, more generally, any factors that may affect marketing capacity of the products developed by AB Science, as well as those developed or identified in the public documents filed by AB Science with the Autorité des Marchés Financiers (AMF), including those listed in the Chapter 4 “Risk Factors” of AB Science reference document filed with the AMF on November 22, 2016, under the number R. 16-078. AB Science disclaims any obligation or undertaking to update the forward-looking information and statements, subject to the applicable regulations, in particular articles 223-1 et seq. of the AMF General Regulations.

 

This press release and the information contained therein do not constitute an offer for subscription or purchase, or the solicitation of a purchase or subscription order, of AB Science securities in the United States or in any other jurisdiction in which the transaction may be subject to restrictions. This press release is a promotional communication and not a prospectus within the meaning of Directive 2003/71/EC of the European Parliament and of the Council, as amended. The distribution or publication of this press release in certain countries may be subject to restrictions under the legal and regulatory provisions in force. Accordingly, persons present in these countries where this press release is distributed or published must inform themselves of and comply with these laws and regulations.

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Xuan Quynh LLC Joins PHILUX Global Funds to Participate in Luxembourg-based Infrastructure Fund for Vietnam and Laos

Xuan Quynh LLC Joins PHILUX Global Funds to Participate in Luxembourg-based Infrastructure Fund for Vietnam and Laos




Xuan Quynh LLC Joins PHILUX Global Funds to Participate in Luxembourg-based Infrastructure Fund for Vietnam and Laos

New York, Nov. 29, 2020 (GLOBE NEWSWIRE) — PHI Group, Inc. (www.phiglobal.comPHIL), announced today that Xuan Quynh Limited Liability Company, a Vietnamese infrastructure construction and development company, has signed an agreement with PHI Luxembourg Development SA, the mother holding company for PHILUX Global Funds SCA, SICAV-RAIF, to join its “PHILUX Infrastructure Fund” compartment as a new partner in the first-ever Luxembourg-based infrastructure fund initiated for investment in Vietnam and Laos.

As one of the fastest growing economies in ASEAN, Vietnam is currently demanding for more foreign financial investment and technical assistance to narrow its infrastructure gap. According to the Global Infrastructure Outlook, Vietnam requires an investment of US$605 billion to meet 83 per cent of its infrastructure goals by 2040. Among the sectors that have been given utmost priorities are the urban transportation, road, rail and port infrastructure.

Currently, just 20 per cent of the country’s national roads are paved, and a recently approved plan to build Vietnam’s North-South high-speed railway, which allows passengers to travel between capital Hanoi and Ho Chi Minh City in about eight hours, will cost about 26 billion U.S. dollars.

The rising population in major cities in recent years has strained and exceeded capacity of the existing connectivity networks and utilities systems. With 50% of Vietnam’s population expected to be living in cities, Hanoi and Ho Chi Minh are building rapid transit systems exceeding US$22 billion in the hope of reducing private vehicle ownership and improving air quality.

Various expressway projects are planned and underway to improve connectivity within major cities. Similarly, development and upgrading of urban utilities infrastructure are announced and there are 44 planed PPP projects with total investment value worth up to US$ 120 billion in the road and power sectors.

Besides supporting infrastructure development for industrial zones, transportation, urban areas, seaports and airports in Vietnam, Xuan Quynh LLC intends to utilize the Luxembourg infrastructure fund for a number infrastructure projects in Laos as well.

Laos is one of the fastest growing economies in Southeast Asia region, with its average GDP growth rate for the last 20 years exceeding the level of 7 percent annually, one of the highest among ASEAN states. Nonetheless, inadequate infrastructure has been usually referred to as a major constraint to socio-economic development in Laos. Rapid economic growth has come with an increase in energy demand while power infrastructure in Laos is still under development. Telecommunication is another issues that needs to be addressed. But the most critical issue of Laos’ infrastructure is the road transportation system. As a completely landlocked country, road transport is the only means for improving socio-economic development through infrastructure. Unfortunately, road infrastructure in Laos is still limited, and according to the World Bank, only 56% of the rural population in Laos has access to all-season road. Thus, turning the country from a land-locked into a land-linked one is one of the most priorities of the Lao government, and this will see Laos as a connection hub among neighboring countries, bridging the more advanced economies of China, Thailand and Vietnam.

PHILUX Global Funds SCA, SICAV-RAIF (www.philux.eu), is a Luxembourg-based bank fund with multiple sub-fund compartments for investment in real estate, infrastructure, renewable energy and healthcare as well as the proposed Chu Lai Multiple Commodities Center (CMCC) and the Asia Diamond Exchange (ADE) in the Chu Lai Open Economic Zone, Quang Nam Province, Vietnam. This will be the first rough diamond exchange in Southeast Asia, comparable with diamond exchanges in Antwerp (https://www.awdc.be/) and Dubai (https://www.dmcc.ae/gateway-to-trade/commodities/diamonds).

Mr. Nguyen Canh Doat, Director of Xuan Quynh LLC, commented: “ We are very pleased to partner with PHILUX Infrastructure Fund to respond to the growing needs of infrastructure development in Vietnam and Laos and strongly believe that we will be able to achieve significant goals together through our cooperation.”

Henry Fahman, Chairman of PHILUX Global Funds SCA, SICAV-RAIF, stated: “We are delighted to work with Xuan Quynh to implement PHILUX Infrastructure Fund for Vietnam and Laos. By capitalizing on our combined experience and networks we will be well positioned to serve the needs of infrastructure development in Vietnam and Laos as well as create significant benefits for both companies, our shareholders and all other stakeholders involved.”

About PHILUX Global Funds and PHI Group, Inc.

PHILUX Global Funds SCA, SICAV-RAIF is a Luxembourg-based bank fund (www.philux.eu) with multiple sub-fund compartments for investment in real estate, infrastructure, renewable energy and healthcare as well as the proposed Chu Lai Multiple Commodities Center (CMCC) and the Asia Diamond Exchange (ADE) in the Chu Lai Open Economic Zone, Quang Nam Province, Vietnam.

PHI Group, Inc.(www.phiglobal.com), (PHIL), primarily focuses on mergers and acquisitions and invests in select industries and special situations that may substantially enhance shareholder value. In addition, the Company’s wholly-owned subsidiary, PHILUX Capital Advisors, Inc. (www.philuxcap.com) provides M&A consulting services and assists companies to go public and access international capital markets while also serving as the investment adviser to PHILUX Global Funds.

About Xuan Quynh LLC

Established in 1995, Xuan Quynh LLC is a multidisciplinary business operating mainly in the fields of construction – housing and resort real estate, road and bridge system, hydroelectricity, mining and a number of services including wholesale, retail, transport and accommodation.

With 25 years of establishment and development, Xuan Quynh LLC is operated by a team of experienced and dedicated managers and well-trained, professional and motivated staff with modern and advanced construction equipment and machinery. Xuan Quynh LLC has been the prestigious partner of several large-scale, high-quality construction projects in Vietnam.

Safe Harbor Act and Forward-looking Statements

This news release contains “forward-looking statements” pursuant to the “safe-harbor” provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “may,” “future,” “plan” or “planned,” “will” or “should,” “expected,” “anticipates,” “draft,” “eventually” or “projected,” which are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements as a result of various factors.

Contact:

PHI Group, Inc.
+1-714-642-0571
info@phiglobal.com

Telix Pharmaceuticals Limited Acquires TheraPharm GmbH, Broadening Reach to Hematologic Cancers and Transplant Medicine

Telix Pharmaceuticals Limited Acquires TheraPharm GmbH, Broadening Reach to Hematologic Cancers and Transplant Medicine




Telix Pharmaceuticals Limited Acquires TheraPharm GmbH, Broadening Reach to Hematologic Cancers and Transplant Medicine

MELBOURNE, Australia and BAAR, Switzerland, Nov. 29, 2020 (GLOBE NEWSWIRE) — Telix Pharmaceuticals Limited (ASX: TLX, ‘Telix’, the ‘Company’) announces it has entered into an agreement with Scintec Diagnostics GmbH (‘Scintec’) to acquire TheraPharm GmbH (‘TheraPharm’), a Swiss-German biotechnology company developing innovative diagnostic and therapeutic solutions in the field of hematology.

The acquisition of TheraPharm provides Telix with access to a portfolio of patents, technologies, production systems, clinical data and know-how in relation to the use of Molecularly Targeted Radiation (MTR) in hematology and immunology. TheraPharm is developing antibody MTR technology against CD66, a cell surface target highly expressed by neutrophils (a type of white blood cell) and tumor-infiltrating lymphocytes. As such, the technology has potentially very broad applications in the diagnosis and treatment of hematologic diseases (e.g. blood cancers), lymphoproliferative disorders and immune-mediated diseases (e.g. lupus, and multiple sclerosis). Of particular interest is the demonstrated use of the technology to safely and effectively perform bone marrow conditioning (BMC) prior to bone marrow stem cell transplant.

Telix CEO, Dr. Christian Behrenbruch stated, “Telix is committed to extending and improving the lives of patients with serious diseases. As such, the acquisition of TheraPharm and its MTR assets are uniquely aligned to Telix’s mission and technical strengths in antibody engineering and radiochemistry. TheraPharm’s technology has a significant role to play in BMC and stem cell transplantation across a broad range of blood cancers and rare diseases. The current approach to BMC employs highly toxic drugs that have a poor morbidity and mortality profile, and for which many patients are ineligible. MTR offers an excellent safety profile that may greatly expand the number of patients able to undergo life prolonging stem cell transplantation while greatly reducing the hospitalisation burden and cost associated with such procedures.”

TheraPharm co-founder and Managing Director, Dr. Klaus Bosslet added, “Over the past 5 years, TheraPharm, in collaboration with Dr. Kim Orchard from the University of Southampton (UK), has made excellent progress developing 90Y-besilesomab for the treatment of hematologic cancers and several related conditions including multiple myeloma, leukemia and amyloidosis. This unique asset is a logical addition to Telix’s portfolio, offering a potentially rapid development path to a first commercial indication for the treatment of patients with SALA, while at the same time having potentially broad applications for stem cell transplantation in patients with more common cancers of the blood, including multiple myeloma and leukemia. We look forward to joining the Telix team in order to expedite the development of products for this under-served field.”

Full transaction details, including financial terms, can be found via the Telix website and ASX portal here.

About Hematopoietic Stem Cell Transplant (HSCT)

Bone marrow conditioning (BMC) followed by hematopoietic stem cell transplantation (HSCT) is presently performed to treat patients with hematologic malignancies (blood cancers), with the objective of extending patient survival or achieving cure. HSCT is also performed for a broad range of non-cancer conditions. HSCT is preferentially performed in countries of high income (Europe >30,000, Americas >20,000, worldwide >65,000 p.a., respectively) and is growing at around 5% annually.

About Systemic Amyloid Light-Chain Amyloidosis (SALA)

SALA is a rare, but serious protein deposition disease, caused by a protein known as ‘amyloid’ that is produced by abnormal plasma cells residing in the bone marrow. As amyloid accumulates in the organs of the body, organ function will eventually deteriorate, ultimately causing organ failure. SALA has an estimated prevalence of 30,000 and 45,000 in United States and Europe, respectively and while a rare disease, SALA portends a very poor prognosis, with a median survival from diagnosis of ~11 months if untreated.

The current standard of care comprises of induction therapy (typically cyclophosphamide, bortezomib, dexamethasone) plus high dose melphalan BMC, followed by HSCT. This approach is typically only accessible to a small proportion of patients (<20%) who are able to tolerate induction therapy and melphalan BMC.

About Telix Pharmaceuticals Limited

Telix is a clinical-stage biopharmaceutical company focused on the development of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix is headquartered in Melbourne, Australia with international operations in Belgium, Japan and the United States. Telix is developing a portfolio of clinical-stage oncology products that address significant unmet medical needs in prostate, kidney and brain cancer. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit www.telixpharma.com.

About TheraPharm GmbH

TheraPharm is a biotechnology company specialised in the research, development and manufacturing of monoclonal antibodies for targeted radiation of hematopoietic malignant and non-malignant diseases, lymphoproliferative diseases, conditioning for allogeneic stem cells as well as in diagnostics of inflammatory diseases and bone marrow metastases.                

Telix Corporate Contact   Telix Investor Relations
Dr. Christian Behrenbruch Dr. David N. Cade
Telix Pharmaceuticals Limited Telix Pharmaceuticals Limited
CEO  CBO and Head of Investor Relations
Email: Christian@telixpharma.com Email: david.cade@telixpharma.com

Sorrento to Participate in the 32nd Piper Sandler Healthcare Investor Conference

Sorrento to Participate in the 32nd Piper Sandler Healthcare Investor Conference




Sorrento to Participate in the 32nd Piper Sandler Healthcare Investor Conference

SAN DIEGO, Nov. 29, 2020 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc. (NASDAQ: SRNE, “Sorrento”), is pleased to announce that Dr. Henry Ji, Chairman and CEO, will be participating in the Piper Sandler 32nd Annual Virtual Healthcare Conference.

A pre-recorded presentation is made available to participants and the public, in addition to 1 on 1 virtual meetings with selected investors taking place between 11/30/20 and 12/03/20.

Dr. Ji Pre-Recorded Investor Presentation can be accessed at the following Link: https://pipersandler.zoom.us/rec/play/7p6ebIhHbRkmmBaXffNQeGXSsRkhriEV56NBSFVTRQ9IBnxL6C4uvSfjlZXAayBAeewv7zWyCwLtr2XR.qMOgbDXGYEyaZYt2

(Note: Link expires 90 days after date of recording).

For more information visit www.sorrentotherapeutics.com

Forward-Looking Statements

This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sorrento Therapeutics, Inc. under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties that could cause actual results to differ materially from those projected. Certain statements contained in this presentation or in other documents of Sorrento Therapeutics, Inc. (the “Company” or “Sorrento”) and of any of its affiliates, along with certain statements that may be made by management of the Company orally in presenting this material, are or may be considered “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. These statements can be identified by the fact that they do not relate strictly to historic or current facts. They use words such as “estimate,” “expect,” “intend,” “believe,” “plan,” “anticipate,” “potential,” “projected” and other words and terms of similar meaning in connection with any discussion of future operating or financial performance or condition. Sorrento cautions that these statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks and uncertainties. Statements regarding future action, future performance and/or future results including, without limitation, those relating to the timing for completion, and results of, scheduled or additional clinical trials and the FDA’s or other regulatory review and/or approval and commercial launch and sales results (if any) of the Company’s formulations and products and regulatory filings related to the same, and receipt by the Company of milestone and royalty payments may differ from those set forth in the forward-looking statements. Peak sales and market size estimates have been determined on the basis of market research and comparable product analysis, but no assurances can be given that such sales levels will be achieved, if at all, or that such market size estimates will prove accurate.

The Company assumes no obligation to update forward-looking statements as circumstances change. Investors are advised to consult further disclosures that the Company makes or has made on related subjects in the Company’s most recent periodic reports filed with the Securities and Exchange Commission, including Sorrento’s Annual Report on Form 10-K for the year ended December 31, 2019 and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth in those filings.

In presenting this material or responding to inquiries in connection with a presentation, management may refer to results, projections or performance measures that are not prepared in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”) as reported in the Company’s SEC filings. These results, projections or performance measures are non-GAAP measures and are not intended to replace or substitute for results measured under GAAP and are supplemental to GAAP reported results.

Because actual results are affected by these and other potential risks, contingencies and uncertainties, the Company cautions investors that actual results may differ materially from those expressed or implied in any forward-looking statement. It is not possible to predict or identify all such risks, contingencies and uncertainties. The Company identifies some of these factors in its SEC filings on Forms 10-K, 10-Q and 8-K, including Sorrento’s Annual Report on Form 10-K for the year ended December 31, 2019 and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth in those filings. Investors are advised to consult the Company’s filings for a more complete listing of risk factors, contingencies and uncertainties affecting the Company and its business and financial performance.

Media and Investor Relations

Contact: Alexis Nahama, DVM (SVP Corporate Development)

Telephone: 1.858.203.4120

Email: mediarelations@sorrentotherapeutics.com

ZTlido® and G-MAB™ are trademarks owned by Scilex Pharmaceuticals Inc. and Sorrento, respectively.

Seprehvir®, is a registered trademark of Virttu Biologics Limited, a wholly owned subsidiary of TNK Therapeutics, Inc. and part of the group of companies owned by Sorrento Therapeutics, Inc.

All other trademarks are the property of their respective owners.
© 2020 Sorrento Therapeutics, Inc. All Rights Reserved. 

Nexans Press Release

Nexans Press Release




Nexans Press Release

Nexans – Press Release

Paris La Défense, November 29, 2020 – Further to its earlier disclosure, Nexans informs that all contacts with Cenergy Holdings S.A. have now been terminated.  

About Nexans

Nexans is a key driver for the world’s transition to a more connected and sustainable energy future. For over 120 years, the Group has brought energy to life by providing customers with advanced cable technologies for power and data transmission. Today, Nexans goes beyond cables to offer customers a complete service that leverages digital technology to maximize the performance and efficiency of their critical assets. The Group designs solutions and services along the entire value chain in four main business areas: Building & Territories (including utilities and e­mobility), High Voltage & Projects (covering offshore wind farms, subsea interconnections, land high voltage), Telecom & Data (covering data transmission, telecom networks, hyperscale data centers, LAN), and Industry & Solutions (including renewables, transportation, oil and gas, automation, and others).

Corporate Social Responsibility is a guiding principle of Nexans’ business activities and internal practices. In 2013 Nexans was the first cable provider to create a Foundation supporting sustainable initiatives bringing access to energy to disadvantaged communities worldwide. The Group’s commitment to developing ethical, sustainable and high-quality cables also drives its active involvement within leading industry associations, including Europacable, the NEMA, ICF and CIGRE.

Nexans employs nearly 26,000 people with an industrial footprint in 34 countries and commercial activities worldwide. In 2019, the Group generated 6.7 billion euros in sales.

Nexans is listed on Euronext Paris, compartment A.

For more information, please visit: www.nexans.com  

Additional information:

Financial Communication Communications
Aurélia Baudey-Vignaud
Tel: +33 (0)1 78 15 03 94
e-mail: aurelia.baudey-vignaud@nexans.com

 

Catherine Garipoglu
Tel: +33 (0)1 78 15 04 78
e-mail: catherine.garipoglu@nexans.com

 

   

 

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