GenSight Biologics Announces Publication of Results from LUMEVOQ® REVERSE Pivotal Phase III Trial and Non-Human Primate Study in Science Translational Medicine

GenSight Biologics Announces Publication of Results from LUMEVOQ® REVERSE Pivotal Phase III Trial and Non-Human Primate Study in Science Translational Medicine

  • First publication based on Phase III data to document sustained and clinically meaningful bilateral improvement in visual acuity from unilateral injection of a gene therapy
  • Non-human primate study clarifies mechanism behind contralateral effect

PARIS–(BUSINESS WIRE)–
Regulatory News:

GenSight Biologics (Paris:SIGHT) (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announced that the journal Science Translational Medicine has published results from the REVERSE pivotal Phase III clinical trial of LUMEVOQ® gene therapy in ND4 Leber Hereditary Optic Neuropathy (LHON) subjects along with key results from a non-human primate study investigating the contralateral effect of the gene therapy. The paper*, published in the December issue under the title “Bilateral visual improvement with unilateral gene therapy injection for Leber hereditary optic neuropathy”, is the first peer-reviewed article based on Phase III clinical trial data to document sustained and clinically meaningful bilateral improvement in visual outcomes from a unilateral injection of a gene therapy.

The findings from the REVERSE trial and the non-human primate study were key components of the data package submitted by GenSight Biologics in September 2020 to the European Medicines Agency when it applied for marketing authorization for LUMEVOQ® as treatment for patients with visual loss due to LHON caused by a confirmed mutation in the ND4 mitochondrial gene. The agency’s decision is expected in Q4 2021.

“The treatment has been shown to be safe and the outcomes can be life changing,” said Dr. Patrick Yu-Wai-Man, MD, PhD, lead author, REVERSE principal investigator and Senior Lecturer and Honorary Consultant Ophthalmologist at the University of Cambridge, Moorfields Eye Hospital, and the UCL Institute of Ophthalmology, London, United Kingdom.

“Our study provides great hope for treating this blinding disease in young adults,” said Dr.José-Alain Sahel, MD, co-corresponding author, co-founder of GenSight and Director of the Institut de la Vision (Sorbonne-Université/Inserm/CNRS), Paris, France, where LUMEVOQ®’s underlying mitochondrial targeting technology was developed. “Our approach isn’t just limited to vision restoration: other mitochondrial diseases could be treated using the same technology,” added Dr. Sahel, who is also Chairman of the Department of Ophthalmology at Centre Hospitalier National d’Ophtalmologie des XV-XX, Paris, France, and Professor and Chairman of the Department of Ophthalmology at the University of Pittsburgh School of Medicine and UPMC (University of Pittsburgh Medical Center), USA.

REVERSE Trial outcomes

37 ND4 LHON subjects, who experienced onset of vision loss from 6 months to one year before enrollment, participated in the REVERSE trial. The results show a clinically meaningful improvement over baseline of +15 ETDRS letters (−0.308 LogMAR) in the average best-corrected visual acuity (BCVA) of injected eyes of the 37 REVERSE patients 96 weeks after treatment. The patients’ other eye, which received a sham injection, experienced an average visual acuity gain over baseline of +13 letters equivalent (−0.259 LogMAR). Against nadir, or the worst recorded BCVA, the gains were even more impressive, at +28.5 ETDRS letters for the LUMEVOQ®-injected eyes and +24.5 ETDRS letters for sham-injected eyes.

81% of subjects showed a clinically relevant recovery (CRR) from the nadir in one or both eyes. CRR, a measure of treatment response established by an international consensus meeting on the management of LHON1, is defined as either an improvement from off-chart BCVA to on-chart, or an on-chart improvement BCVA of at least -0.2 LogMAR, or +10 ETDRS letters.

The improvement in quality of life metrics relative to baseline values taken before treatment, which were evaluated using the well-established National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25), was compelling and largely above the thresholds of clinical relevance. The composite NEI VFQ-25 score showed a mean improvement of 9.5 points, exceeding the clinically relevant threshold of +3.9-+4.3 points.2

Non-human primate study outcomes

The non-human primate study, launched to investigate the mechanism behind the unexpected improvement in the contralateral eye’s visual function, was designed to mimic the REVERSE trial, with monkeys given a unilateral LUMEVOQ® injection. The study demonstrated the transfer of viral vector DNA from the injected eye to the anterior segment, retina, and optic nerve of the noninjected eye. This result, the authors conclude, provides a plausible mechanistic explanation for the bilateral improvement in visual function after unilateral LUMEVOQ® injection.

Other topics discussed

The paper also presents detailed safety data, which document the overall good safety profile of LUMEVOQ®, with no viral vector biodissemination and mostly mild ocular adverse events that were controlled with local topical therapy. Additionally, the authors discuss other results from REVERSE, such as other responder analyses and visual outcomes, and place these in context against the natural history insights found in analyses of visual acuity in non-treated patients.

The paper can be obtained from www.sciencemag.org.

*About the paper:

Bilateral visual improvement with unilateral gene therapy injection for Leber hereditary optic neuropathy

Authors: Patrick Yu-Wai-Man1,2,3,4, Nancy J. Newman5, Valerio Carelli6,7, Mark L. Moster8, Valerie Biousse5, Alfredo A. Sadun9, Thomas Klopstock10,11,12, Catherine Vignal-Clermont13,14, Robert C. Sergott8, Günther Rudolph15, Chiara La Morgia6,7, Rustum Karanjia9,16, Magali Taiel17, Laure Blouin17, Pierre Burguière17, Gerard Smits18, Caroline Chevalier17, Harvey Masonson18, Yordak Salermo18, Barrett Katz18, Serge Picaud19, David J. Calkins20, José-Alain Sahel14,19,21,22

Affiliations:

1 Cambridge Centre for Brain Repair and MRC Mitochondrial Biology Unit, Department of Clinical Neurosciences, University of Cambridge, Cambridge CB2 0PY, UK.

2 Cambridge Eye Unit, Addenbrooke’s Hospital, Cambridge University Hospitals, Cambridge CB2 0QQ, UK.

3 Moorfields Eye Hospital, London EC1V 2PD, UK.

4 UCL Institute of Ophthalmology, University College London, London EC1V 9EL, UK.5 Departments of Ophthalmology, Neurology and Neurological Surgery, Emory University School of Medicine, Atlanta, GA 30322, USA.

6 IRCCS Istituto delle Scienze Neurologiche di Bologna, UOC Clinica Neurologica, 40139 Bologna, Italy.

7 Unit of Neurology, Department of Biomedical and Neuromotor Sciences (DIBINEM), University of Bologna, 40139 Bologna, Italy.

8 Departments of Neurology and Ophthalmology, William H. Annesley, Jr. EyeBrain Center, Wills Eye Hospital and Thomas Jefferson University, Philadelphia, PA 19107, USA.

9 Doheny Eye Institute and UCLA School of Medicine, Los Angeles, CA 90086, USA.

10 Friedrich Baur Institute at the Department of Neurology, University Hospital, LMU Munich, 80336 Munich, Germany.

11German Center for Neurodegenerative Diseases (DZNE), 80336 Munich, Germany.

12 Munich Cluster for Systems Neurology (SyNergy), 80336 Munich, Germany.

13 Department of Neuro-Ophthalmology and Emergencies, Rothschild Foundation Hospital, 75019 Paris, France.

14 Centre Hospitalier National d’Ophtalmologie des Quinze Vingts, FOReSIGHT, INSERM-DGOS CIC 1423, 75012 Paris, France. 15Department of Ophthalmology, University Hospital, LMU Munich, 80336 Munich, Germany.

16 Ottawa Hospital Research Institute and University of Ottawa Eye Institute, Ottawa, Ontario K1H 8L6, Canada.

17 GenSight Biologics, 75012 Paris, France.

18 GenSight Biologics, New York, NY 10016, USA.

19 Sorbonne Université, INSERM, CNRS, Institut de la Vision, 75012 Paris, France.

20 The Vanderbilt Eye Institute, Vanderbilt University Medical Center, Nashville, TN 37232, USA.

21 Fondation Ophtalmologique A. de Rothschild, 25-29 Rue Manin, 75019 Paris, France.

22 Department of Ophthalmology, The University of Pittsburgh School of Medicine, Pittsburgh, PA 15213, USA.

Notes:

1 V. Carelli, M. Carbonell, I. F. de Coo, A. Kawasaki, T. Klopstock, W. A. Lagrèze, C. La Morgia, N. J. Newman, C. Orssaud, J. W. R. Pott, A. A. Sadun, J. van Everdingen, C. Vignal-Clermont, M. Votruba, P. Yu-Wai-Man, P. Barboni, International consensus statement on the clinical and therapeutic management of Leber hereditary optic neuropathy. J. Neuroophthalmol.37, 371–381 (2017).

2 I. J. Suñer, G. T. Kokame, E. Yu, J. Ward, C. Dolan, N. M. Bressler, Responsiveness of NEI VFQ-25 to changes in visual acuity in neovascular AMD: Validation studies from two phase 3 clinical trials. Invest. Ophthalmol. Vis. Sci. 50, 3629–3635 (2009).

About GenSight Biologics

GenSight Biologics S.A. is a clinical-stage biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders. GenSight Biologics’ pipeline leverages two core technology platforms, the Mitochondrial Targeting Sequence (MTS) and optogenetics, to help preserve or restore vision in patients suffering from blinding retinal diseases. GenSight Biologics’ lead product candidate, LUMEVOQ® (GS010; lenadogene nolparvovec), has been submitted for marketing approval in Europe for the treatment of Leber Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease affecting primarily teens and young adults that leads to irreversible blindness. Using its gene therapy-based approach, GenSight Biologics’ product candidates are designed to be administered in a single treatment to each eye by intravitreal injection to offer patients a sustainable functional visual recovery.

About Leber Hereditary Optic Neuropathy (LHON)

Leber Hereditary Optic Neuropathy (LHON) is a rare maternally inherited mitochondrial genetic disease, characterized by the degeneration of retinal ganglion cells that results in brutal and irreversible vision loss that can lead to legal blindness, and mainly affects adolescents and young adults. LHON is associated with painless, sudden loss of central vision in the 1st eye, with the 2nd eye sequentially impaired. It is a symmetric disease with poor functional visual recovery. 97% of patients have bilateral involvement at less than one year of onset of vision loss, and in 25% of cases, vision loss occurs in both eyes simultaneously. The estimated incidence of LHON is approximately 800-1,200 new patients who lose their sight every year in the United States and the European Union.

About LUMEVOQ® (GS010)

LUMEVOQ® (GS010) targets Leber Hereditary Optic Neuropathy (LHON) by leveraging a mitochondrial targeting sequence (MTS) proprietary technology platform, arising from research conducted at the Institut de la Vision in Paris, which, when associated with the gene of interest, allows the platform to specifically address defects inside the mitochondria using an AAV vector (Adeno-Associated Virus). The gene of interest is transferred into the cell to be expressed and produces the functional protein, which will then be shuttled to the mitochondria through specific nucleotidic sequences in order to restore the missing or deficient mitochondrial function. “LUMEVOQ” was accepted as the invented name for GS010 (lenadogene nolparvovec) by the European Medicines Agency (EMA) in October 2018.

About RESCUE and REVERSE

RESCUE and REVERSE are two separate randomized, double-masked, sham-controlled Phase III trials designed to evaluate the efficacy of a single intravitreal injection of GS010 (rAAV2/2-ND4) in subjects affected by LHON due to the G11778A mutation in the mitochondrial ND4 gene.

The primary endpoint measured the difference in efficacy of GS010 in treated eyes compared to sham-treated eyes based on Best‑Corrected Visual Acuity (BCVA), as measured with the ETDRS at 48 weeks post-injection. The patients’ LogMAR (Logarithm of the Minimal Angle of Resolution) scores, which are derived from the number of letters patients read on the ETDRS chart, was used for statistical purposes. Both trials were adequately powered to evaluate a clinically relevant difference of at least 15 ETDRS letters between treated and untreated eyes adjusted to baseline.

The secondary endpoints involved the application of the primary analysis to best‑seeing eyes that received GS010 compared to those receiving sham, and to worse‑seeing eyes that received GS010 compared to those that received sham. Additionally, a categorical evaluation with a responder analysis was evaluated, including the proportion of patients who maintain vision (< ETDRS 15L loss), the proportion of patients who gain 15 ETDRS letters from baseline and the proportion of patients with Snellen acuity of >20/200. Complementary vision metrics included automated visual fields, optical coherence tomography, and color and contrast sensitivity, in addition to quality of life scales, bio‑dissemination and the time course of immune response. Readouts for these endpoints were at 48, 72 and 96 weeks after injection.

The trials were conducted in parallel, in 37 subjects for REVERSE and 39 subjects for RESCUE, in 7 centers across the United States, the UK, France, Germany and Italy. Week 96 results were reported in 2019 for both trials, after which patients were invited to a long-term follow-up study that will last for three years.

ClinicalTrials.gov Identifiers:

REVERSE: NCT02652780

RESCUE: NCT02652767

GenSight Biologics

Chief Financial Officer

Thomas Gidoin

[email protected]

+33 (0)1 76 21 72 20

LifeSci Advisors

Investor Relations

Guillaume van Renterghem

[email protected]

+41 (0)76 735 01 31

RooneyPartners

Media Relations

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+1 646-537-5649

Orpheon Finance

Retail Investors

James Palmer

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+33 (0)7 60 92 77 74

KEYWORDS: France Europe

INDUSTRY KEYWORDS: Biotechnology Health Pharmaceutical Optical Clinical Trials

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Learn deep esoteric and profound ideas relevant to your daily life and work with new book

Rich Mollura shares information from his personal experience in ‘Autobiography of a New York City Salesman’

NEW YORK, Dec. 10, 2020 (GLOBE NEWSWIRE) — Rich Mollura explores how the relentless force of kundalini energy has helped him cope with grief, navigate life and contemplate the mysteries of the world in his new book, “Autobiography of a New York City Salesman: My Parallel Life of Transformation through Conscious Evolution and Kundalini Energy” (published by Balboa Press AU).

 

Featuring a theme of individual and collective conscious evolution, the book offers its reader an opportunity to appreciate the supreme intelligence of creation, life and spiritual evolution by delving into personal and universal experiences. Mollura documents and gives examples of his personal experience with kundalini energy to make each insight clear and applicable to other people’s personal evolutions.

 

Combining wisdom from Lao Tsu, to Buddha, to Jesus and connecting them to modern spiritual beings like Wayne Dyer and Eckhart Tolle, Mollura also explains how they are relevant to daily work, families, and the challenges everyone faces. The author addresses specifically how he and his family worked through diseases in his son to the grieving of the loss of parents while connecting to powerful ideas and ancient wisdom.

 

Hoping to inspire and encourage one’s own journey of inner revolution and evolution, Mollura wants each of his readers to come away from reading his book with “A transformed vision of their own evolution which they find exciting and fun.”

 

“Autobiography of a New York City Salesman” is available for purchase on Amazon at: https://www.amazon.com/Autobiography-York-City-Salesman-Transformation/dp/1982231742.

 

“Autobiography of a New York City Salesman”

By Rich Mollura

Hardcover | 6 x 9 in | 194 pages | ISBN 9781982231767

Softcover | 6 x 9 in | 194 pages | ISBN 9781982231743

E-Book | 194 pages | ISBN 9781982231750

Available at Amazon and Barnes & Noble

 

About the Author

Born in 1961, Rich Mollura lives on Long Island and has worked as a salesman for a Fortune 500 company in New York City for just under 40 years. He has a wife and two children. Mollura graduated out of Fordham University and has numerous sales accolades that helped him become one of the most successful and effective sales people for a company that will be 100 next year.

Balboa Press, a division of Hay House, Inc. – a leading provider in publishing products that specialize in self-help and the mind, body, and spirit genres. Through an alliance with the worldwide self-publishing leader Author Solutions, LLC, authors benefit from the leadership of Hay House Publishing and the speed-to-market advantages of the self-publishing model. For more information, visit balboapress.com. To start publishing your book with Balboa Press, call 844-682-1282 today.

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Deutsche Telekom and Microsoft redefine partnership to deliver high-performance cloud computing experiences

– Seven-year strategic agreement to help enterprise and midmarket customers accelerate digitalization

– Enhance productivity and digitize business operations with Microsoft 365 and Microsoft Azure as T-Systems’ preferred cloud platform in select solution areas

– Support digital education efforts in Germany

PR Newswire

BONN, Germany and REDMOND, Wash., Dec. 10, 2020 /PRNewswire/ — Deutsche Telekom Group and Microsoft Corp. announced an expansion of their partnership that will help customers of all sizes accelerate their cloud transformation initiatives.

For many companies, the cloud represents an opportunity to reduce IT costs, increase flexibility and accelerate innovation. However, to fully take advantage of cloud computing, it requires a high-performance network that can scale to meet increasing technology demands. By combining Microsoft’s cloud and AI capabilities with Telekom’s Cloud Migration Framework and telecommunications services, the companies enable customers to increase their productivity, build more agile and resilient operations, and deliver new cloud offerings faster.

“We have agreed on the framework for joint strategic growth with our long-term partner Microsoft. We are delighted,” said Adel Al-Saleh, member of the Deutsche Telekom Board of Management and CEO of T-Systems. “This partnership will enable us to enhance services for our customers. We will also be supporting each other with digitalization and network build-out.”

“The case for digital transformation has never been more urgent. We know that the next decade of economic performance for every business, whether large or small, will depend on the digital investments made today,” said Jean-Philippe Courtois, executive vice president and president, Microsoft Global Sales, Marketing and Operations. “Through this strategic partnership, which combines the power of Deutsche Telekom’s network and Microsoft’s cloud, customers will have more opportunities to become resilient, accelerate innovation and ultimately drive success.”

Trusted cloud infrastructure to accelerate business innovation

The delivery of secure and powerful software applications requires a modern IT infrastructure. To accelerate business innovation, Telekom plans to migrate the majority of its internal IT workloads to the public cloud by 2025, and Azure is a central part of that strategy. Through a companywide training program, thousands of Telekom employees will learn how to maximize the benefits of Azure.

Moving mainframe workloads to the cloud is one of the targeted areas of the partnership. Historically, mainframes were designed as scale-up servers to run high-volume online transactions and batch processing. Using cloud-based mainframes, businesses can deliver new services based on evolving customer demands without retrofitting legacy hardware. This means companies can drive scale, business continuity and energy efficiency while reducing operational and hardware costs.

Telekom will also offer its customers direct access to the Microsoft cloud through Azure ExpressRoute. By bypassing the public internet, customers will have increased agility through faster connectivity to better address regional compliance and data residency needs.

Enabling digital collaboration and streamlining business operations

To help people and businesses be more connected and productive from anywhere, Telekom will offer Microsoft 365, including Microsoft Teams. As part of this, the companies have started a project for German schools to reimagine traditional approaches to education, enabling remote learning through cloud-based IT infrastructure, modern devices and the cloud productivity and collaboration applications within Microsoft 365.

To leverage the benefits of cloud computing for critical business processes, such as enterprise resource planning and supply chain management, Telekom supports its customers with moving their SAP environments to Azure. SAP solutions on Azure offer enterprise-grade security, and business continuity and reduce hardware expenses, making it easier for startups and smaller organizations to get started.

Accelerating cloud initiatives: assessment, migration, service

Telekom’s enterprise customer unit T-Systems has migrated and securely managed large-scale applications and critical enterprise workloads. With Azure as a preferred cloud platform for select solution areas, T-Systems is providing these capabilities to companies across all industries so they can harness the global scale, security and latest advances without needing to manage installation and maintenance. This Cloud Migration Framework combines automated assessment, cloud migration and services management to help accelerate customers’ cloud initiatives.

Small and medium-sized businesses will benefit from these offerings as they can focus on their core competencies and don’t need to provide the resources and knowledge usually required to implement a comprehensive cloud strategy.

Telekom and Microsoft will work closely together to continue to address compliance needs and European regulatory requirements.

About Deutsche Telekom:
Deutsche Telekom company profile

About T-Systems:
T-Systems company profile

About Microsoft

Microsoft (Nasdaq “MSFT” @microsoft) enables digital transformation for the era of an intelligent cloud and an intelligent edge. Its mission is to empower every person and every organization on the planet to achieve more.

 

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/deutsche-telekom-and-microsoft-redefine-partnership-to-deliver-high-performance-cloud-computing-experiences-301190064.html

SOURCE Microsoft Corporation

Aegon Capital Markets Day: Leader in investment, protection, and retirement solutions

Aegon Capital Markets Day: Leader in investment, protection, and retirement solutions

 

THE HAGUE, Netherlands–(BUSINESS WIRE)–At today’s Capital Markets Day, Aegon CEO Lard Friese announces the company’s new strategy and financial targets for the period 2021 to 2023.

Financial Targets 2021 – 2023

  • Reduce gross financial leverage to EUR 5.0 to 5.5 billion
  • Implement expense savings program of EUR 400 million
  • Achieve cumulative free cash flows of EUR 1.4 to 1.6 billion
  • Grow dividend per share to around EUR 0.25 per share over 2023

Aegon’s CEO, Lard Friese will be joined by Matt Rider, Chief Financial Officer, Duncan Russell, Chief Transformation Officer and Allegra van Hövell-Patrizi, Chief Risk Officer, to outline the planned transformation of Aegon, and to discuss the steps taken to strengthen the business as well as how these actions will create value for Aegon’s customers and shareholders.

“We are taking significant steps to transform Aegon in order to change our performance trajectory and create value for our customers and shareholders”, commented Lard Friese, CEO of Aegon. “We are narrowing our strategic focus to selected core and growth markets and, within these, have made choices that allow us to focus on those areas where we believe that Aegon is well positioned to create value. We have developed an ambitious plan comprised of detailed initiatives designed to improve the operating performance of our business by reducing costs, expanding margins and growing profitably. We are simplifying our capital framework, and continuing to strengthen our balance sheet, in part by further deleveraging. In addition, we are taking proactive risk management actions to improve our risk profile and reduce the volatility of our capital ratios. We are building a high-performance culture, investing in talent development and focusing on delivery. We intend to build on our strengths: our brands, our base of 29 million customers, and our deep expertise in designing solutions, managing assets, and creating distribution networks. We are excited about the opportunities we have to better reach our customers and to help them achieve a lifetime of financial security.”

Highlights of Aegon’s new strategy include:

– Going forward, we will focus on three core markets (the United States, the Netherlands, and the United Kingdom), three growth markets (Spain & Portugal, China, and Brazil) and one global asset manager. In small markets or markets where we have sub-scale or niche positions, we will manage capital tightly and have a bias to exit. The recently announced sale of our Central & Eastern European businesses and Stonebridge in the UK are good examples of actions we are taking to increase our focus. Additionally, we have decided to separate the businesses in our core markets into Financial Assets and Strategic Assets, each requiring specific skillsets and possessing different opportunities to create value. Financial Assets are blocks of business which we have closed for new sales, and which are capital intensive with relatively low returns on capital employed. Strategic Assets are businesses with a greater potential for an attractive return on capital, where we are well positioned for growth. We aim to release capital in Financial Assets over time, and re-allocate capital to Strategic Assets and growth markets.

– In the United States, several product lines are considered to be Financial Assets. These are variable annuities with significant interest rate sensitive living and death benefit riders, stand-alone individual long-term care, and fixed annuities. We have taken the decision to stop new sales for these products. We are reviewing the potential to implement a dynamic hedging strategy for variable annuities with income and death benefit riders. Subsequently, we will consider a broad range of options for this block of business. Furthermore, we will take actions to reduce the interest rate sensitivity of our US business through asset-liability management and other management actions.

– Strategic Assets in the United States are comprised of Workplace Solutions and select life and investment products that are part of Individual Solutions. In Individual Solutions, we will leverage our affiliated distribution channels to increase sales momentum and aim to regain top-5 positions in key individual life-insurance markets. We will also continue to sell select mutual funds and individual retirement products, like accumulation variable annuities with limited interest rate sensitivity. In Workplace Solutions, we will leverage our leading position in the small and mid-sized retirement market, and further modernize our platform proposition aimed at profitable growth.

– In the Netherlands, we will no longer offer new defined benefit group pension products and individual life products, with the exception of direct annuities, while we support employers in their transition towards defined contribution solutions. We consider the existing defined benefit group pensions and individual life insurance portfolios to be Financial Assets. We are taking actions to reduce the volatility of the Dutch Solvency II capital ratio, and have implemented a new capital management policy that allows for quarterly remittance payments to the Group. We aim for profitable growth in defined contribution workplace solutions and mortgage origination, and to maintain our leadership positions in those segments. We will also expand our niche position with our bank, Knab, which will serve as a digital gateway to individual retirement solutions.

– In the United Kingdom, we will continue to invest in our market-leading platform to improve the digital experience for customers, advisers and employers, and return to profitable growth as we aim to increase our margins in both the retail and workplace businesses.

– The retirement platforms in all three core markets provide a great opportunity to offer our asset management solutions to our customers, enabling them to achieve attractive investment returns. Our asset management business will implement a new global operating platform, allowing the business to maximize synergies, and grow in third-party assets. In addition, we aim to increase the share of our proprietary investment solutions amongst the assets that we administer.

– We have developed a rigorous and granular operating plan aimed at materially improving our performance. We will operate within a stricter and more disciplined governance framework with clear accountabilities, and increase the organizational rhythm to realize our transformation ambition. We are implementing an expense savings program aimed at reducing expenses by EUR 400 million in 2023 compared with 2019, representing 13% of the addressable expense base. Of this saving, EUR 150 million will be reinvested in growth. Associated one-time investments are expected to be around EUR 650 million over the period 2021 to 2023, and will be booked as Other charges.

– Throughout our transformation, we will ensure that we maintain sufficient capital in our business units and at the Holding so that we can focus our time and energy on increasing return on capital, and distributing capital to shareholders. As part of a new capital management policy, we will manage the capital positions of our business units to their operating levels over time, and maintain them above their minimum dividend payment levels. For our business in the United States the operating level is set at an RBC ratio of 400%. For our main insurance entities in the Netherlands and in the United Kingdom, the operating levels are set at a Solvency II ratio of 150%. The minimum dividend payment level is an RBC ratio of 350% in the US, and a Solvency II ratio of 135% for our main insurance entities in the Netherlands and in the United Kingdom. The Cash Capital at Holding operating range is set at EUR 0.5 to 1.5 billion, and is available to cover holding expenses, near-term dividends and contingencies. To reduce our risk profile and strengthen our balance sheet, we will target a reduction on our gross financial leverage from EUR 6.6 billion on June 30, 2020, to EUR 5.0 to 5.5 billion by 2023.

– By improving our performance and installing more disciplined capital management, we expect to grow capital generation over the plan period and translate this into increasing free cash flows. We expect total free cash flows to amount to EUR 1.4 to 1.6 billion, cumulatively over the period 2021 to 2023. Dividends are expected to grow in line with free cash flows while allowing us to execute on our planned deleveraging, and providing room to undertake our planned management actions to improve and de-risk the company. As a result, we aim to grow our dividend per share to around EUR 0.25 over 2023, barring unforeseen circumstances. Should there be surplus free cash flow above and beyond that, then we would expect that to be returned to shareholders, most likely via share buybacks, unless we invest it in value-creating opportunities.

Lard Friese: “Today, we have announced several important strategic choices to transform Aegon and have laid out a road map on how we will achieve our goals. We have an experienced management team with a track record of managing large and cash-generating balance sheets and creating value for shareholders. And with our talented and dedicated employees, we are confident that we have what it takes to successfully execute our plans. We are excited about the opportunities ahead of us and are determined to make this transformation a success.”

Capital Markets Day details

The Capital Markets Day presentations are available at 7.00 am CET on www.aegon.com. The conference will commence at 9.00 am CET and will be livestreamed via a link on the corporate website. A replay will be available later today.

About Aegon

Aegon’s roots go back more than 175 years – to the first half of the nineteenth century. Since then, Aegon has grown into an international company, with businesses in the Americas, Europe and Asia. Today, Aegon is one of the world’s leading financial services organizations, providing life insurance, pensions and asset management. Aegon’s purpose is to help people achieve a lifetime of financial security. More information on aegon.com.

Forward-looking statements

The statements contained in this document that are not historical facts are forward-looking statements as defined in the US Private Securities Litigation Reform Act of 1995. The following are words that identify such forward-looking statements: aim, believe, estimate, target, intend, may, expect, anticipate, predict, project, counting on, plan, continue, want, forecast, goal, should, would, could, is confident, will, and similar expressions as they relate to Aegon. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Aegon undertakes no obligation to publicly update or revise any forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which merely reflect company expectations at the time of writing. Actual results may differ materially from expectations conveyed in forward-looking statements due to changes caused by various risks and uncertainties. Such risks and uncertainties include but are not limited to the following:

  • Changes in general economic and/or governmental conditions, particularly in the United States, the Netherlands and the United Kingdom;
  • Changes in the performance of financial markets, including emerging markets, such as with regard to:

– The frequency and severity of defaults by issuers in Aegon’s fixed income investment portfolios;

– The effects of corporate bankruptcies and/or accounting restatements on the financial markets and the resulting decline in the value of equity and debt securities Aegon holds; and

– The effects of declining creditworthiness of certain public sector securities and the resulting decline in the value of government exposure that Aegon holds;

  • Changes in the performance of Aegon’s investment portfolio and decline in ratings of Aegon’s counterparties;
  • Lowering of one or more of Aegon’s debt ratings issued by recognized rating organizations and the adverse impact such action may have on Aegon’s ability to raise capital and on its liquidity and financial condition;
  • Lowering of one or more of insurer financial strength ratings of Aegon’s insurance subsidiaries and the adverse impact such action may have on the written premium, policy retention, profitability and liquidity of its insurance subsidiaries;
  • The effect of the European Union’s Solvency II requirements and other regulations in other jurisdictions affecting the capital Aegon is required to maintain;
  • Changes affecting interest rate levels and continuing low or rapidly changing interest rate levels;
  • Changes affecting currency exchange rates, in particular the EUR/USD and EUR/GBP exchange rates;
  • Changes in the availability of, and costs associated with, liquidity sources such as bank and capital markets funding, as well as conditions in the credit markets in general such as changes in borrower and counterparty creditworthiness;
  • Increasing levels of competition in the United States, the Netherlands, the United Kingdom and emerging markets;
  • Catastrophic events, either manmade or by nature, including by way of example acts of God, acts of terrorism, acts of war and pandemics, could result in material losses and significantly interrupt Aegon’s business;
  • The frequency and severity of insured loss events;
  • Changes affecting longevity, mortality, morbidity, persistence and other factors that may impact the profitability of Aegon’s insurance products;
  • Aegon’s projected results are highly sensitive to complex mathematical models of financial markets, mortality, longevity, and other dynamic systems subject to shocks and unpredictable volatility. Should assumptions to these models later prove incorrect, or should errors in those models escape the controls in place to detect them, future performance will vary from projected results;
  • Reinsurers to whom Aegon has ceded significant underwriting risks may fail to meet their obligations;
  • Changes in customer behavior and public opinion in general related to, among other things, the type of products Aegon sells, including legal, regulatory or commercial necessity to meet changing customer expectations;
  • Customer responsiveness to both new products and distribution channels;
  • As Aegon’s operations support complex transactions and are highly dependent on the proper functioning of information technology, operational risks such as system disruptions or failures, security or data privacy breaches, cyberattacks, human error, failure to safeguard personally identifiable information, changes in operational practices or inadequate controls including with respect to third parties with which we do business may disrupt Aegon’s business, damage its reputation and adversely affect its results of operations, financial condition and cash flows;
  • The impact of acquisitions and divestitures, restructurings, product withdrawals and other unusual items, including Aegon’s ability to integrate acquisitions and to obtain the anticipated results and synergies from acquisitions;
  • Aegon’s failure to achieve anticipated levels of earnings or operational efficiencies, as well as other management initiatives related to cost savings, cash capital at Holding, gross financial leverage and free cash flow;
  • Changes in the policies of central banks and/or governments;
  • Litigation or regulatory action that could require Aegon to pay significant damages or change the way Aegon does business;
  • Competitive, legal, regulatory, or tax changes that affect profitability, the distribution cost of or demand for Aegon’s products;
  • Consequences of an actual or potential break-up of the European monetary union in whole or in part, or the exit of the United Kingdom from the European Union and potential consequences if other European Union countries leave the European Union;
  • Changes in laws and regulations, particularly those affecting Aegon’s operations’ ability to hire and retain key personnel, taxation of Aegon companies, the products Aegon sells, and the attractiveness of certain products to its consumers;
  • Regulatory changes relating to the pensions, investment, and insurance industries in the jurisdictions in which Aegon operates;
  • Standard setting initiatives of supranational standard setting bodies such as the Financial Stability Board and the International Association of Insurance Supervisors or changes to such standards that may have an impact on regional (such as EU), national or US federal or state level financial regulation or the application thereof to Aegon, including the designation of Aegon by the Financial Stability Board as a Global Systemically Important Insurer (G-SII); and
  • Changes in accounting regulations and policies or a change by Aegon in applying such regulations and policies, voluntarily or otherwise, which may affect Aegon’s reported results, shareholders’ equity or regulatory capital adequacy levels.

This document contains information that qualifies, or may qualify, as inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation (596/2014). Further details of potential risks and uncertainties affecting Aegon are described in its filings with the Netherlands Authority for the Financial Markets and the US Securities and Exchange Commission, including the Annual Report. These forward-looking statements speak only as of the date of this document. Except as required by any applicable law or regulation, Aegon expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Aegon’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.

Media relations

Dick Schiethart

+31(0) 70 344 8821

[email protected]

Investor relations

Jan Willem Weidema

+31(0) 70 344 8028

[email protected]

KEYWORDS: Europe United Kingdom Netherlands

INDUSTRY KEYWORDS: Finance Consulting Professional Services Other Professional Services Insurance

MEDIA:

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Toyoda Gosei Starts Operation of High Pressure Hydrogen Tanks for FCVs at Inabe Plant in Japan

Toyoda Gosei Starts Operation of High Pressure Hydrogen Tanks for FCVs at Inabe Plant in Japan

KIYOSU, Japan–(BUSINESS WIRE)–
Toyoda Gosei Co., Ltd. (TOKYO:7282) has conducted a line-off ceremony at the Inabe Plant in Inabe, Mie Prefecture, Japan for the production of high pressure hydrogen tanks, a crucial component of fuel cell vehicles (FCVs). Mie Governor Eikei Suzuki, Inabe Mayor Yasushi Hioki, Toyota Motor Corporation Motomachi Plant Manager Masamichi Okada and others were invited to the ceremony and Toyoda Gosei executives and employees attended.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201209005307/en/

High pressure hydrogen tank (Photo: Business Wire)

High pressure hydrogen tank (Photo: Business Wire)

The Inabe Plant started producing high pressure hydrogen tanks in November for the new MIRAI, which was launched by Toyota Motor Corporation in December 2020. Production capacity at the plant will continue to be built up gradually to meet growth in demand with the expected increase in number of FCV models.

Outline of Inabe Plant

Name

:

Toyoda Gosei Inabe Plant

Location

:

6-1 Fujigaoka, Fujiwaracho, Inabe, Mie Pref., Japan

Products

:

High pressure hydrogen tanks and other products

Area

:

Land approx. 130,000m2, Buildings approx. 21,000m2

Employees

 :

Approx. 100

Environmental

 

 

equipment

:

Solar energy panels

1,600kW

 

 

(scheduled to be installed on March 2021)

 

 

Wind power generation

5kW × 2

 

 

Hydrogen fuel cell power generation

3.5kW

 

 

Geothermal heating and cooling system

 

 

LED lighting (entire plant)

 

Toyoda Gosei Co., Ltd.

Takatomo Abe

[email protected]

KEYWORDS: North America United States Asia Pacific Japan Canada

INDUSTRY KEYWORDS: Automotive Manufacturing Aftermarket Automotive Technology Manufacturing Other Manufacturing Alternative Vehicles/Fuels Alternative Energy Environment Energy Hardware

MEDIA:

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Inabe Plant (Photo: Business Wire)
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High pressure hydrogen tank (Photo: Business Wire)

WISeKey Appoints Two New Members to its Advisory Committee

WISeKey Appoints Two New Members to its Advisory Committee

Zug/Geneva, Switzerland – December 10, 2020 – WISeKey International Holding (“WISeKey”, SIX: WIHN, NASDAQ: WKEY), a leading cybersecurity IoT company, today announced that it has appointed Maria Pia Aqueveque Jabbaz and Cristina Dolan to its Advisory Committee. Members of WISeKey’s Advisory Committee originate from a wide variety of sectors that are of critical importance to WISeKey’s growth strategy, including cybersecurity, IoT, blockchain, and information technology.

Maria Pia Aqueveque Jabbaz is the CEO and founder of Maqueveq & Co, a strategic and corporate advisory company focused on digital asset investments and decentralized finance (DeFi) projects. Ms. Aqueveque Jabbaz is also the founder of the spin-off DTCODE, a company dedicated to technology innovations using blockchain through collaborative R&D and has represented the Blockchain Research Institute in Hispanic America & Spain. Ms. Aqueveque Jabbaz is a board member of Olidata S.p.A (Italy) and alternate board member of UNO Pensión Fund Administrator Company (Chile).  Additionally, she advises leaders of public and private companies for the implementation of blockchain technologies and is the host of TXSWorld, a TXS Radio program focused on science & technology in Europe. Ms. Aqueveque Jabbaz currently leads the Chilean chapter of the 30% Club, a global initiative focused on increasing women’s participation on the boards of listed corporations.

Throughout her career Ms. Aqueveque Jabbaz has been a valuable collaborator of prestigious global organizations including The World Bank, Interamerican Development Bank, Government of Chile, Chilean Association of Mutual Funds, North American Chamber of Commerce in Chile, and AmericaEconomía magazine. And has been invited to speak as a guest blockchain lecturer at some of the most prestigious universities in Latin America and Europe.

Cristina Dolan is an engineer, entrepreneur and CEO of InsideChains, a company focused on building solutions and growing businesses utilizing data, blockchain, cyber security and risk quantification, FIDO2, AI, IoT, telematics and serverless cloud architectures for new digitally transformative fintech, insurtech and mobility offerings. She is a co-founder of Additum.es, an award winning European ‘Value Based Healthcare’ utilizing data to improve patient outcomes. Other connected data driven entities she co-founded include an insurance marketplace that initially offered blockchain insurance and an open investing platform. In addition to being an MIT Media Lab alumna, engineer and Internet pioneer, she has over two decades of experience building transformational data enabled businesses and products in FinTech, InsurTech, Media, Telecom and Healthtech verticals. She was a co-founder of OneMain.com, which grew to be the 10th largest ISP after a very successful IPO followed by a strategic acquisition by Earthlink.

Formerly, Ms. Dolan held executive roles at Disney, Hearst, IBM and Oracle. She is a member of Forbes Technology Council and the Vice Chair and former Chair of the MIT Enterprise Forum in New York. The award-winning student competition she founded, Dream it. Code it. Win it., was the subject of her TEDx Talk, Just Solve It. She earned a Master’s Degree from the MIT Media Lab and holds a Master of Computer Science and Bachelors of Electrical Engineering with concentrations in Computer Science, Data Communications and Business.

“I am pleased to welcome Maria Pia and Christina to our Advisory Board and look forward to their valuable input and wide counsel.  I am confident that their extensive experience in cybersecurity and implementation of blockchain technologies will be very valuable to our efforts of deploying our services, increasing our client base, and expanding our footprint worldwide,” said Carlos Moreira, WISeKey’s Founder and CEO. 

About WISeKey

WISeKey (NASDAQ: WKEY; SIX Swiss Exchange: WIHN, NASDAQ: WKEY) is a leading global cybersecurity company currently deploying large scale digital identity ecosystems for people and objects using Blockchain, AI and IoT respecting the Human as the Fulcrum of the Internet. WISeKey microprocessors secure the pervasive computing shaping today’s Internet of Everything. WISeKey IoT has an install base of over 1.5 billion microchips in virtually all IoT sectors (connected cars, smart cities, drones, agricultural sensors, anti-counterfeiting, smart lighting, servers, computers, mobile phones, crypto tokens etc.).  WISeKey is uniquely positioned to be at the edge of IoT as our semiconductors produce a huge amount of Big Data that, when analyzed with Artificial Intelligence (AI), can help industrial applications to predict the failure of their equipment before it happens.

Our technology is Trusted by the OISTE/WISeKey’s Swiss based cryptographic Root of Trust (“RoT”) provides secure authentication and identification, in both physical and virtual environments, for the Internet of Things, Blockchain and Artificial Intelligence. The WISeKey RoT serves as a common trust anchor to ensure the integrity of online transactions among objects and between objects and people. For more information, visit www.wisekey.com.

Press and investor contacts:

WISeKey International Holding Ltd 

Company Contact:  Carlos Moreira
Chairman & CEO
Tel: +41 22 594 3000
[email protected]
WISeKey Investor Relations (US) 

Contact:  Lena Cati
The Equity Group Inc.
Tel: +1 212 836-9611
[email protected]

Disclaimer:

This communication expressly or implicitly contains certain forward-looking statements concerning WISeKey International Holding Ltd and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of WISeKey International Holding Ltd to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. WISeKey International Holding Ltd is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

This press release does not constitute an offer to sell, or a solicitation of an offer to buy, any securities, and it does not constitute an offering prospectus within the meaning of the Swiss Financial Services Act (“FinSA”), the FinSA’s predecessor legislation or advertising within the meaning of the FinSA, or within the meaning of any other securities regulation. Investors must rely on their own evaluation of WISeKey and its securities, including the merits and risks involved. Nothing contained herein is, or shall be relied on as, a promise or representation as to the future performance of WISeKey.

The securities offered will not be, and have not been, registered under the United States of America Securities Act of 1933, as amended, and may not be offered or sold in the United States of America, absent registration or an applicable exemption from the registration requirements of said Act.



ObsEva Announces Additional Phase 3 PRIMROSE 1 and 2 Study Results Confirming Sustained Efficacy and Continued Safety of linzagolix in the Treatment of Uterine Fibroids

 

  • PRIMROSE 1 52-week results confirm the sustained efficacy and continued safety of linzagolix (Yselty®), with a potential best-in-class high-dose option (200 mg with add-back therapy [ABT])
  • Show the unique low-dose option (100 mg without ABT) has the potential to address the needs of up to 50% of U.S. women with uterine fibroids for whom ABT may be contraindicated
  • Support the potential value of a high-dose non-ABT option when rapid and substantial volume reduction are required
  • PRIMROSE 2 76-week results show continued pain reduction and demonstrate evidence of bone mineral density (BMD) recovery following 52 weeks of treatment

 

GENEVA, Switzerland and BOSTON, MA (December 10, 2020) – ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health, today announced topline 52-week PRIMROSE 1 and 76-week PRIMROSE 2 results of Yselty, in development for the treatment of women with heavy menstrual bleeding due to uterine fibroids.

The PRIMROSE trials evaluated 100 mg and 200 mg doses with and without ABT. If approved, Yselty will be the only GnRH antagonist addressing the needs of 3 distinct groups of women suffering from uterine fibroids, due to its flexible dose options:

 

  • 100 mg once daily for women with a contraindication to or who prefer to avoid hormonal add-back therapy (ABT)
  • 200 mg once daily with concomitant ABT for long-term use (beyond 6 months)
  • 200 mg once daily for short-term use, particularly when rapid reduction in fibroid and uterine volume is desired.

 

The Week 52 PRIMROSE 1 results showed that continued treatment with Yselty led to sustained efficacy for the primary endpoint of reduced heavy menstrual bleeding (defined as menstrual blood loss of at least 50% less than baseline and at or below 80 mL). This was seen across all doses of Yselty and was in line with the earlier findings in PRIMROSE 2. The pooled Week 52 results from the two studies showed that at Week 52, 56.4% of women on 100 mg of Yselty met the primary endpoint, and with the higher dose of 200 mg+ABT the responder rate was 89.3%.

“These additional results from our PRIMROSE studies provide further evidence of the potential for Yselty to be a best-in-class, well-differentiated GnRH antagonist with unique low- and high-dose treatment options for the management of uterine fibroids,” said Brian O’Callaghan, CEO of ObsEva. “Having recently announced our filing for approval in Europe and looking ahead to our submission in the U.S. in 1H2021, we eagerly anticipate the opportunity to make Yselty available to the diverse population of women suffering from this debilitating condition.”

Key clinically relevant secondary endpoints including pain reduction as well as improvement in anemia and quality of life, were sustained up to the 52-week time point in PRIMROSE 1, as previously observed in PRIMROSE 2. In PRIMROSE 2, following three months off-treatment, pain scores remained lower than baseline in all treatment arms, further supporting the durability of the Yselty treatment effect.

For a significant proportion of women, rapid and substantial shrinkage in uterine and fibroid volume is a primary treatment objective. The 52-week PRIMROSE study results demonstrate that in women initially treated with 200 mg without ABT, uterine and fibroid volume reduction is substantially more marked than with 200 mg+ABT, and introduction of ABT on top of 200 mg after 24 weeks clearly counteracts the GnRH antagonist volume effects. These results support the need for and potential value of a high-dose regimen without ABT; Yselty is the only GnRH antagonist developed with a high-dose, non-ABT option.

PRIMROSE 1 52-week safety results showed similar incidence of adverse events between placebo and active treatment when treatment is continued beyond week 24.  From Week 24 to 52, there was low occurrence of hot flushes, headaches, and anemia, which were the most frequently observed adverse events (incidence of >5%) up to 24 weeks. Adverse events of interest, including mood-related events, decreased libido, and alopecia, were rare and similar to placebo.  

With regard to BMD, in PRIMROSE 1, incremental decrease in lumbar spine BMD similar to placebo was observed in the 100 mg treatment arm at week 52 compared to week 24, with less change seen in the 200 mg+ABT arm. In addition, median z-scores at 52 weeks showed minimal change compared to baseline in both treatment arms, supporting that women treated with Yselty for up to one year maintain BMD similar to an age-matched reference population. PRIMROSE 2 DXA results at Week 76 showed evidence of BMD recovery for patients treated with both the 100 mg and 200 mg+ABT doses. Of note, PRIMROSE trial participants were not provided with Vitamin D or calcium, co-administration of which is expected in clinical practice to lead to even smaller changes in BMD.

ObsEva recently submitted a Marketing Authorization Application (MAA) for uterine fibroids to the European Medicines Agency (EMA) and anticipates submitting a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in 1H 2021. Additional efficacy and safety data from the clinical trial program will also be submitted for presentation at upcoming scientific conferences.

Yselty® is a registered trademark owned by Kissei for use by ObsEva. Yselty® is not yet approved for use anywhere in the world.

 

About Linzagolix

Yselty® (linzagolix) is a novel, once daily, oral GnRH receptor antagonist with a potentially best-in-class profile. Linzagolix is currently in late-stage clinical development for the treatment of heavy menstrual bleeding associated with uterine fibroids and pain associated with endometriosis. ObsEva licensed linzagolix from Kissei in late 2015 and retains worldwide commercial rights, excluding Asia, for the product. Linzagolix is not currently approved anywhere in the world.

 

About Phase 3 PRIMROSE Program in Uterine Fibroids

PRIMROSE 1 & 2 are prospective, randomized, parallel group, double-blind, placebo‑controlled Phase 3 studies investigating the efficacy and safety of two dosing regimens of Yselty, 100 mg and 200 mg once daily, alone and in combination with hormonal ABT (1 mg estradiol and 0.5 mg norethisterone acetate) for the treatment of heavy menstrual bleeding associated with uterine fibroids. Women participating in the study did not receive Vitamin D or calcium supplementation. PRIMROSE 1 is being conducted in the United States, and enrolled 574 women. PRIMROSE 2 is being conducted in Europe and the United States, and enrolled 535 women. Both trials comprised a 52-week treatment period followed by a 6-month post treatment follow-up period. Week 24 primary endpoint results were announced for PRIMROSE 2 in December 2019. Week 52 results for PRIMROSE 2 and Week 24 results for PRIMROSE 1 were announced in July 2020.

To access the PRIMROSE presentation directly, please click [here].
To access the investor presentation section of the Company’s website, please click [here].

 

About Uterine Fibroids

Uterine fibroids are common benign tumours of the muscular tissue of the uterus. Uterine fibroids affect women of childbearing age and can vary in size from undetectable to large bulky masses.  Few longterm medical treatments are available, and as a result, approximately 300,000 hysterectomies are performed for uterine fibroids every year in the US.

The symptoms of uterine fibroids are wide-ranging and include heavy menstrual bleeding, anemia, pelvic pressure and bloating, urinary frequency and pain that can be extremely debilitating with a significant impact on quality of life. These symptoms can also have an impact on mental health, creating the additional burden of anxiety and distress.

 

About
ObsEva

ObsEva is a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on treating endometriosis, uterine fibroids and preterm labor. ObsEva is listed on the NASDAQ Global Select Market and is trading under the ticker symbol “OBSV” and on the SIX Swiss Exchange where it is trading under the ticker symbol “OBSN”. For more information, please visit www.ObsEva.com.

 

About Kissei

Kissei is a Japanese pharmaceutical company with approximately 70 years of history, specialized in the field of urology, kidney-dialysis and unmet medical needs. Silodosin is a Kissei product for the treatment of the signs and symptoms of benign prostatic hyperplasia which is sold worldwide through its licensees. Yselty is a new chemical entity discovered by Kissei R&D.

 

Cautionary Note Regarding Forward-Looking Statements 

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on ObsEva’s current beliefs and expectations. These forward-looking statements include expectations regarding the timing, advancement, anticipated product profile and potential therapeutic benefits of linzagolix, the potential for linzagolix to be a commercially competitive product, the timing of data from clinical trials, expectations regarding regulatory and development milestones, including the potential timing of regulatory submissions to the FDA, and the results of interactions with regulatory authorities. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials and clinical development, including the risk that the results of earlier clinical trials may not be predictive of the results of later stage clinical trials, related interactions with regulators, ObsEva’s reliance on third parties over which it may not always have full control, the impact of the novel coronavirus outbreak, and other risks and uncertainties that are described in the Risk Factors section of ObsEva’s Annual Report on Form 20-F for the year ended December 31, 2019, the Risk Factors disclosed in ObsEva’s Report on Form 6-K filed with the Securities and Exchange Commission (SEC) on November 5, 2020 and other filings ObsEva makes with the SEC. These documents are available on the Investors page of ObsEva’s website at http://www.ObsEva.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to ObsEva as of the date of this release, and ObsEva assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

 

For further information, please contact:

CEO Office contact

Shauna Dillon
Shauna.dillon@obseva.ch
+41 22 552 1550

Investor Contact

Shauna Dillon
Shauna.dillon@obseva.ch
+41 22 552 1550

 

 

 

 

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Norsk Hydro: Capital Markets Day 2020 – Seizing opportunities where capabilities match megatrends

Hydro’s strategic direction toward 2025 will focus on two key areas: strengthening the company’s position in low-carbon aluminium and growing in recycling and new energy. These will be the key topics at Hydro’s Capital Markets Day 2020.

At this year’s Capital Markets Day, Hydro will present its strategic direction toward 2025 and provide an update on the key profitability and sustainability targets announced in 2019.

“We have generated cash, cut costs and delivered extensive operational improvements across the company, providing a solid foundation for our growth agenda. Now, we’re raising the bar, setting a new ambitious improvement target for 2025, combined with a clear strategy to make Hydro a profitable and sustainable industry leader,” says President and CEO Hilde Merete Aasheim.

Delivering on the improvement agenda

Hydro has during 2020 focused on keeping the wheels turning, maintaining a healthy and safe work environment. Despite a challenging market, Hydro has aimed at positioning the company for the future. Hydro’s improvement program remains on track to deliver its 2020 target of NOK 4.1 billion, with all business areas over delivering on their cost ambitions for the year. The improvement program, accompanied with a net operating capital release and reduction in CAPEX, have contributed to greater cash generation in 2020. The strategic review of Rolled Products is progressing.

A key driver of Hydro’s 2020 improvement has been the ramp-up and increased operational robustness of the Bauxite & Alumina operations in Brazil. Alunorte is on track to deliver alumina volumes at around 90 percent of nameplate capacity in Q4 2020. Hydro has also played an important part in the local community in Brazil during the Covid-19 pandemic this year.

“Our Brazilian organization has made good progress in increasing the asset integrity and robustness, while maintaining focus on health and safety during the global pandemic,” says Aasheim.

Hydro’s overall climate ambition to reduce CO2 emissions by 30 percent by 2030 remains on track. Hydro is committed to replace fuel oil with natural gas as energy source for the Alunorte refinery, which will contribute significantly to the climate reduction target. The next step will be to electrify coal boilers at Alunorte. Hydro has signed intentional agreements to develop solar and wind power projects to deliver renewable energy at attractive cost.

Strengthening position in low carbon aluminium

Toward 2025, Hydro will strengthen its position in low-carbon aluminium. Several of the global megatrends are supporting increased demand for aluminium. According to CRU, the demand for aluminium in the vehicle sector is expected to grow by 6.2 million tonnes by 2030 at a 5.2 percent annual growth rate. CRU expects the demand for aluminium can stock to grow by 3 million tonnes at 4.1 percent annual growth rate by 2030. Total semis demand is expected to grow by 32 million tonnes by 2030, at 3 percent annual growth rate, according to CRU.

Reduced cost and improved operational excellence within Hydro’s asset base remain a priority. Hydro has updated its original improvement program and will extend it by two years with a new improvement target of NOK 8.5 billion. The 2025 target includes the NOK 4.1 billion achieved in 2019 and 2020.

In addition, Hydro has set a commercial improvement ambition of NOK 2.0 billion coming from its current portfolio. These are market driven initiatives where Hydro will leverage its innovative solutions and customer collaboration. The commercial potential also comes from leveraging Hydro’s sustainable footprint to shape demand for Hydro’s greener product portfolio. Over the past year, Hydro has seen increased demand for low-carbon brand products Hydro CIRCAL and Hydro REDUXA, and greater demand is expected also in 2021.

Diversifying into strategic growth areas

The second pillar of the 2025 strategy diversifies and expands Hydro’s portfolio into new areas: recycling, renewables, and batteries. Growing into these areas positions Hydro to take advantage of growth from key megatrends such as sustainability, electrification and urbanization.

“We will grow in areas where our capabilities match the megatrends, first and foremost in recycling, renewable energy and batteries. Our capabilities and unique low-carbon position are enablers for growth in these areas. Our current recycling portfolio is a solid foundation for further growth, and Extruded Solutions is shaping demand through innovative solutions in combination with a strong and diversified asset base,” says Aasheim.

Hydro currently has a portfolio of 29 recyclers and an annual capacity of 2.6 million tonnes for recycled scrap. The 2025 ambition includes a doubling of Hydro’s current post-consumer scrap utilization, which could provide an EBITDA uplift of NOK 1 – 1.5 billion. A strategy has been established across the recycling value chain within Primary Metal, Rolled Products and Extruded Solutions.

In renewables, Hydro has created a new unit – Renewable Growth – which will leverage Hydro’s industrial footprint and energy competence to take positions in renewable energy projects, primarily in the Nordics and Brazil. Renewable Growth targets investments in more than 1 GW.

Hydro has also established a new Battery unit as part of Hydro Energy. Hydro has already undertaken several successful investments in the battery value chain in recent years. The strategy toward 2025 includes additional investment with battery partners in attractive areas of the value chain, resulting in pro-rata EBITDA potential of NOK 600 million to 700 million from the invested companies.

Financial priorities

“Hydro remains committed to driving long-term value for our shareholders, and I am pleased with the cash generation over the past, challenging year. Looking forward, we have reconfirmed and stretched the roadmaps to satisfactory profitability for each of our business areas within the 2025 timeframe,” says CFO Pål Kildemo.

During the Covid-19 downturn, Hydro prioritized its balance sheet and protecting the investment grade credit rating. Once conditions stabilized, Hydro paid its 2019 dividend of NOK 1.25 per share, in line with Hydro’s dividend policy.

Stringent capital allocation remains a key financial focus, to support execution of the 2025 strategy. Hydro reduced CAPEX in 2020, in response to Covid-19 to NOK 7 billion, managing to reduce NOK 2.5 billion in expected spend. Expected CAPEX for 2021-2025 is NOK 9 – 9.5 billion, which is NOK 0.5 billion lower than the long-term estimate provided one year ago, despite large reductions in 2020. In addition, Hydro has a long-term sustaining CAPEX ambition of NOK 6 – 6.5 billion annually. Hydro will continue to ensure efficient levels of working capital, following the reduced levels of inventories over the latter years.

Hydro’s ambition to deliver at least 10% RoaCE over the cycle, with all business areas delivering RoaCE above their cost of capital, remains in place. The 2025 strategy develops a roadmap to profitability for each business area which facilitates reaching this target.

Investor contact:
Line Haugetraa
+47 41406376
[email protected]

Media contact:
Halvor Molland
+47 92979797
[email protected]

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Mitsubishi Motors Launches Restyled Eclipse Cross with TomTom Connected Navigation

  • TomTom expands global navigation solution deal with Mitsubishi Motors with latest SUV
  • Includes world-first what3words offline addressing integration

AMSTERDAM, Dec. 10, 2020 (GLOBE NEWSWIRE) — TomTom (TOM2), the leading independent location technology specialist, today announced that its full stack of navigation components – maps, connected navigation, and real-time traffic services – has been chosen by Mitsubishi Motors to power the new Eclipse Cross’ infotainment system. The restyled SUV is the latest Mitsubishi model to be equipped with TomTom’s automotive-grade solution; other models include the Outlander, the ASX/Outlander Sport/RVR, and the Pajero Sport.

The new Eclipse Cross features an industry-first functionality in built-in navigation. TomTom teamed up with what3words to bring its innovative addressing technology to Mitsubishi drivers around the world, even when offline. No app, data or cellular connection is required to input or navigate to a what3words address. what3words complements TomTom’s maps perfectly, allowing people to find any location and navigate to it quickly and easily. The world is divided into a grid of 3m x 3m squares and each square is assigned a unique three-word address. For example, the address for the top of Times Square’s Red Steps, New York City, is ///crab.ticket.dive.

“We are delighted to extend our deal with Mitsubishi, satisfying more of their drivers around the world with our leading location technologies,” said Antoine Saucier, Managing Director, TomTom Automotive. “Our collaboration with what3words in the new Eclipse Cross is yet another example of our pioneering efforts in in-vehicle navigation and continued commitment to providing easy-to-use solutions to drivers everywhere.”

Minoru Uehara, Chief Product Specialist of Mitsubishi Motors Corporation, said: “TomTom continues to enhance Mitsubishi drivers’ experience around the world. The what3words addressing technology, combined with TomTom’s ever reliable navigation, maps and traffic, ensures that Eclipse Cross drivers will get to where they want to go with ease.”

Clare Jones, CCO of what3words, added, “We are thrilled with our collaboration with TomTom, and excited for Mitsubishi Eclipse Cross customers. They’ll benefit from a groundbreaking technology which will enable them to find and navigate to any address they choose in the world even when completely offline.”

About TomTom:

TomTom is the leading independent location technology specialist, shaping mobility with highly accurate maps, navigation software, real-time traffic information and services.

To achieve our vision of a safer world, free of congestion and emissions, we create innovative technologies that keep the world moving. By combining our extensive experience with leading business and technology partners, we power connected vehicles, smart mobility and, ultimately, autonomous driving.

Headquartered in Amsterdam with offices in 30 countries, TomTom’s technologies are trusted by hundreds of millions of people worldwide.


www.tomtom.com

For further Information:

Media:


[email protected]

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L&T Technology Services wins USD 100 Million plus Plant Engineering engagement from global O&G major

L&T Technology Services wins USD 100 Million plus Plant Engineering engagement from global O&G major

Under a 5-year engagement, LTTS will provide engineering services at two integrated refining and chemicals manufacturing facilities in USA

BANGALORE, India–(BUSINESS WIRE)–
L&T Technology Services Limited (BSE: 540115, NSE: LTTS), a leading global pure-play engineering services company, announced that it has been selected by a global O&G major to be the primary engineering partner to support two of their integrated refining and chemicals manufacturing facilities in USA. This is a multi-year engagement with a potential value of more than USD 100 Million.

Under the five-year engagement, LTTS will provide multi-discipline plant engineering activities including site sustenance, discipline engineering and control automation support for both facilities. LTTS will leverage its in-house digital engineering tools and new age technology & solutions to optimize project execution and drive efficiency improvements for the customer. The two sites covered under LTTS’ scope are integrated refining, chemical and polymer complexes and are currently among the top 10 biggest downstream sites in the U.S.

Dr. Keshab Panda, CEO & MD, L&T Technology Services, said,“Our focus on multi vertical, large engagements with customer intimacy, leveraging digital and new age technologies is yielding the desired outcomes. This latest instance of a major customer awarding LTTS a large multi-year program is testimony to our global plant engineering expertise.”

LTTS is delighted to partner with one of the world’s leading O&G companies who are focused on providing affordable & sustainable energy and chemical products. Having worked in the Oil & Gas industry for a long time, our engineers have a unique appreciation of the challenges and opportunities in the energy and chemical industry. This is a prestigious win for LTTS, and we are excited to engage with our customer to deliver value in improving operational efficiency,” Dr. Panda added.

About L&T Technology Services Ltd

L&T Technology Services Limited (LTTS) is a listed subsidiary of Larsen & Toubro Limited focused on Engineering and R&D (ER&D) services. We offer consultancy, design, development and testing services across the product and process development life cycle. Our customer base includes 69 Fortune 500 companies and 53 of the world’s top ER&D companies, across industrial products, medical devices, transportation, telecom & hi-tech, and the process industries. Headquartered in India, we have over 15,900 employees spread across 17 global design centers, 28 global sales offices and 52 innovation labs as of September 30, 2020. For more information please visit https://www.ltts.com/

Media Contact:

Aniruddha Basu

L&T Technology Services Limited

E: [email protected]

T: +91-80-67675173

KEYWORDS: Africa India South America North America Asia Pacific Europe

INDUSTRY KEYWORDS: Software Other Energy Professional Services Oil/Gas Energy Technology Other Manufacturing Other Professional Services Engineering Other Technology Consulting Manufacturing

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