GE HealthCare to Acquire Remaining 50% Stake in Nihon Medi-Physics (NMP), a Leading Radiopharmaceutical Company in Japan, from Sumitomo Chemical

 GE HealthCare to acquire 50% stake from Sumitomo Chemical to assume full ownership of NMP, subject to regulatory approvals

As part of GE HealthCare, NMP, already a leading radiopharmaceutical company in Japan, will enhance patient access to next-generation radiopharmaceuticals that enable detection and diagnosis of disease

Acquisition positions NMP to become partner of choice for global innovators looking to bring novel radiopharmaceuticals to Japan and other Asian markets

Transaction bolsters GE HealthCare’s Pharmaceutical Diagnostics segment and demonstrates its commitment to shaping the future of Molecular Imaging

 

(BUSINESS WIRE)--GE HealthCare (Nasdaq: GEHC) has agreed to acquire full ownership of Nihon Medi-Physics Co., Ltd (NMP), by purchasing from Sumitomo Chemical (TYO: 4005) the 50% stake it does not already own. As part of GE HealthCare, NMP can build on its expertise developing and manufacturing proprietary and in-licensed radiopharmaceuticals used in single photon emission computed tomography (SPECT) and positron emission tomography (PET) molecular imaging procedures to detect and diagnose disease. Sumitomo and GE HealthCare expect the agreement to close in early 2025, subject to regulatory approvals.

NMP’s product portfolio includes GE HealthCare radiopharmaceuticals used to enable clinical images across neurology, cardiology and oncology procedures, such as its amyloid visualization radiotracer, VIZAMYL® Injection (Flutemetamol (18F) Injection), used in the Alzheimer’s pathway; DaTSCAN® Injection (Ioflupane (¹²³I) injection) used to evaluate patients with suspected Parkinson’s Disease or Dementia with Lewy Bodies; and MYOVIEW® (Technetium (99mTc) Tetrofosmin), used in SPECT myocardial perfusion imaging for the evaluation of known or suspected coronary artery disease. NMP, headquartered in Tokyo, was formed in 1973 and generated revenues of 28.2B JPY (~$183M) in 2023. In addition to 13 manufacturing facilities, NMP also focuses on research and development, including nonclinical and clinical development of radiotracers and theranostics research. GE HealthCare has held its 50% stake in NMP since acquiring Amersham plc in 2004 and holds three positions on its Board of Directors.

Kevin O’Neill, President & CEO of the Pharmaceutical Diagnostics (PDx) segment of GE HealthCare, said: “As the third largest pharmaceutical market in the world1, and amongst the leading countries by number of cyclotrons2, Japan is on a path to becoming a leader in the $7 billion molecular imaging global market and a center of excellence for Asian markets. NMP will play a key role in that journey, including bringing its deep expertise and scale to global innovators looking to bring novel products to the Japan market and beyond. This will strengthen our precision care strategy in Asia and our existing footprint in Japan, where our contrast media and medical devices are used every day to enable imaging procedures across the country.”

Hiroshi Ueda, Executive Vise President, Sumitomo Chemical, said: “We are proud of our 50-year relationship with NMP and our partnership with GE HealthCare to ensure patients in Japan could benefit from access to molecular imaging. At a time of exciting developments in the industry, following its discussions with Sumitomo Chemical, we believe GE HealthCare is the best owner to enable NMP to continue its successful growth journey. I would like to recognize NMP’s leadership and talented team for their significant achievements to date and their commitment to patients.”

As a leading global medical technology and pharmaceutical diagnostics innovator, GE HealthCare provides both molecular imaging equipment and proprietary radiotracers used across major patient care areas. The recent U.S. FDA approval of GE HealthCare’s first-of-its-kind PET radiopharmaceutical, Flyrcado™ (flurpiridaz F 18 injection), its in-licensing of Phase II FAPI assets and broadening theranostics offerings are all examples of the company’s commitment to novel diagnostics that are shaping the future of molecular imaging to drive improved patient outcomes. GE HealthCare’s PDx segment is a global leader in imaging agents used to support over 120 million patient procedures per year globally, equivalent to four patient procedures every second.

The Company expects this transaction to be neutral to Adjusted EPS3,4 in year one and accretive thereafter.

GE HealthCare was advised by Solomon Partners Securities, LLC.

Forward-Looking Statements

This release contains forward-looking statements. These forward-looking statements might be identified by words, and variations of words, such as “will,” “expect,” “may,” “would,” “could,” “plan,” “believe,” “anticipate,” “intend,” “estimate,” “potential,” “position,” “forecast,” “target,” “guidance,” “outlook,” and similar expressions. These forward-looking statements may include, but are not limited to, statements about the transaction, the completion and expected results of the transaction, and GE HealthCare Technologies Inc.’s (the “Company’s”) performance, growth opportunities, and strategy. These forward-looking statements involve risks and uncertainties, many of which are beyond the control of the Company. Factors that could cause the Company’s actual results to differ materially from those described in its forward-looking statements include, but are not limited to, the conditions to the completion of the transaction may not be satisfied; closing of the transaction may not occur or may be delayed; the Company may be unable to achieve the anticipated benefits of the transaction; operating costs and business disruptions (including, without limitation, difficulties in maintaining relationships with employees, customers, and suppliers) may be greater than expected; the Company may assume unexpected risks and liabilities; and completing the transaction may distract the Company’s management from other important matters. Other factors that may cause such a difference also include those discussed in the "Risk Factors" section of the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission and any updates or amendments it makes in future filings. There may be other factors not presently known to the Company or which it currently considers to be immaterial that could cause the Company’s actual results to differ materially from those projected in any forward-looking statements the Company makes. The Company does not undertake any obligation to update or revise its forward-looking statements except as required by applicable law or regulation.

About GE HealthCare Technologies Inc.

GE HealthCare is a leading global medical technology, pharmaceutical diagnostics, and digital solutions innovator, dedicated to providing integrated solutions, services, and data analytics to make hospitals more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 125 years, GE HealthCare is advancing personalized, connected, and compassionate care, while simplifying the patient’s journey across the care pathway. Together our Imaging, Advanced Visualization Solutions, Patient Care Solutions, and Pharmaceutical Diagnostics businesses help improve patient care from diagnosis, to therapy, to monitoring. We are a $19.6 billion business with approximately 51,000 colleagues working to create a world where healthcare has no limits.

Follow us on LinkedIn, X, Facebook, Instagram, and Insights for the latest news, or visit our website https://www.gehealthcare.com for more information.

1 https://www.trade.gov/country-commercial-guides/japan-pharmaceuticals, accessed on October 29, 2024

2 https://nucleus.iaea.org/sites/accelerators/Pages/Cyclotron.aspx, accessed on October 29, 2024

3 See our latest earnings release dated October 30, 2024 for the definition of Adjusted EPS.

4 Non-GAAP financial measure

 

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Contacts

 

GE HealthCare Media Contact:

David Morris

M +44 7920 591370

david.j.morris@gehealthcare.com

Mathilde Bouscaillou

M +33 647 008271

mathilde.bouscaillou@gehealthcare.com

 

NetApp Announces Integrated Solution with AWS Outposts for Hybrid Cloud Deployments

SAN JOSE, Calif. - Monday, 02. December 2024

New integration simplifies the use of NetApp block storage with AWS Outposts

 

(BUSINESS WIRE)--NetApp® (NASDAQ: NTAP), the intelligent data infrastructure company, today announced NetApp on-premises enterprise storage arrays for AWS Outposts, a new integrated solution allowing AWS Outposts customers to simplify the use of external block data volumes running on NetApp on-premises enterprise storage arrays in AWS Outposts deployments directly through the Amazon Web Services (AWS) Management Console. AWS Outposts is a family of fully managed solutions delivering AWS infrastructure and services to virtually any on-premises or edge location for a truly consistent hybrid experience. This solution simplifies hybrid cloud deployments by combining NetApp’s unified data storage and intelligent services with powerful cloud infrastructure offered by AWS Outposts, helping customers optimize cloud deployments on-premises and at the edge.

“Whether customers are looking to use hybrid cloud infrastructure to increase resiliency or improve compliance, leveraging NetApp storage in AWS Outposts can help customers run applications securely and efficiently at the edge,” said Jonsi Stefansson, Senior Vice President and Chief Technology Officer at NetApp. “This solution makes it simpler for customers to leverage NetApp intelligent data infrastructure to manage their data in AWS Outposts deployments. By automating volume attachments, IT teams can now tap into the efficiency and power of NetApp on-premises storage arrays to power critical workloads.”

Customers with Outpost servers or racks can now use the AWS Management Console to simplify the use of external block data volumes for enterprise applications and database workloads running on Outposts and NetApp on-premises enterprise storage arrays. Customer benefits include:

Simplified User Experience: With this solution, customers can attach block data volumes backed by NetApp on-premises enterprise storage arrays to Amazon Elastic Compute Cloud (Amazon EC2) instances on Outposts directly from the AWS Management Console. This simplifies the user experience by automating volume attachments.

Resilient and Optimized Infrastructure: The solution allows customers to use the capabilities of NetApp’s intelligent data infrastructure such as NetApp SnapMirror® and NetApp Snapshot™ while tapping into the storage efficiencies in Outpost deployments for a resilient, compliant, and optimized infrastructure.

Seamless Hybrid Cloud: By leveraging NetApp’s unified approach to data storage, AWS Outposts users will have a seamless and certified hybrid cloud experience that uses industry-leading tools and services to manage and protect their data in Outposts deployments, AWS Local Zones deployments using Cloud Volumes ONTAP®, the rest of their own data centers, and the cloud when using services such as Amazon FSx for NetApp ONTAP.

Additionally, Spot by NetApp is releasing new capabilities for its automated infrastructure optimization solution for containers and Kubernetes, Spot Ocean. As organizations scale their cloud Kubernetes operations to meet increasing application workload demands, they need a solution that helps them optimize their infrastructure while controlling costs. The new capabilities in Spot Ocean help organizations achieve those goals with a new fast-response auto-scaler that ensures clusters have the infrastructure to meet workload requirements, a dynamic commitment utilization process that uses available resources before provisioning on-demand or preemptive instances, and a new dashboard that provides more visibility and insights into cost optimization efforts and infrastructure efficiency.

To explore these new capabilities and learn how NetApp can enhance your AWS environment, visit the NetApp booth #1748 at AWS re:Invent in Las Vegas from December 2-6, 2024.

Additional Resources

AWS Outposts

NetApp Storage Integration with AWS Outposts

Continuous Infrastructure Optimization—A Cornerstone to a Successful FinOps Strategy

About NetApp

NetApp is the intelligent data infrastructure company, combining unified data storage, integrated data services, and CloudOps solutions to turn a world of disruption into opportunity for every customer. NetApp creates silo-free infrastructure, harnessing observability and AI to enable the industry’s best data management. As the only enterprise-grade storage service natively embedded in the world’s biggest clouds, our data storage delivers seamless flexibility. In addition, our data services create a data advantage through superior cyber resilience, governance, and application agility. Our CloudOps solutions provide continuous optimization of performance and efficiency through observability and AI. No matter the data type, workload, or environment, with NetApp you can transform your data infrastructure to realize your business possibilities. Learn more at www.netapp.com or follow us on X, LinkedIn, Facebook, and Instagram.

NETAPP, the NETAPP logo, and the marks listed at www.netapp.com/TM are trademarks of NetApp, Inc. Other company and product names may be trademarks of their respective owners.

 

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Contacts

 

Media Contact:

Kenya Hayes

NetApp

kenya.hayes@netapp.com

Investor Contact:

Kris Newton

NetApp

kris.newton@netapp.com

VeriSilicon Partners With LVGL to Enable Advanced GPU Acceleration for Wearable Devices and Beyond

 

SHANGHAI -

LVGL adds VeriSilicon’s 3D and VGLite 2.5D GPUs support to its library for a wide range of embedded applications

 

(BUSINESS WIRE)--VeriSilicon (688521.SH) today announced a strategic partnership with LVGL, the leading open-source graphics library for embedded systems, to support VeriSilicon’s low-power 3D and VGLite 2.5D GPU technology within the LVGL library. This partnership aims to optimize performance and expand graphic processing capabilities for a wide range of embedded applications. As one of the first providers of 3D GPU technology for the LVGL ecosystem, VeriSilicon will contribute to advancing 3D rendering capabilities within the LVGL library.

LVGL is the most popular free and open-source embedded graphics library to create beautiful User Interfaces (UIs) for any Microcontroller Units (MCUs), Micro Processor Units (MPUs), or display type. By integrating VeriSilicon’s low-power and high-performance GPU solutions into LVGL’s graphics ecosystem, it offers developers the ability to rapidly deliver improved visual experiences, while maintaining power efficiency on compact, resource-constrained devices.

Actions Technology, a low-power AIoT fabless semiconductor company, is among the first to adopt this integrated solution in their smart watch System-on-Chips (SoCs). The company recognizes the potential of VeriSilicon’s low-power GPU technology, which, in conjunction with LVGL’s graphics library, will enhance the user experience of next-generation wearable devices.

Gabor Kiss-Vamosi, CEO of LVGL, said, “VeriSilicon’s VGLite 2.5D GPU technology has pioneered a new era in the embedded world, enabling complex vector graphics with exceptional speed and low power consumption. Now, we stand at the edge of a new revolution: the arrival of 3D GPUs to MCUs. This breakthrough will transform the embedded UI landscape, unlocking never-before-seen possibilities for user interfaces on small, resource-constrained, and battery-powered devices. At LVGL, we are excited to embrace this technology and harness its potential across a wide range of platforms. Our goal is to provide a great developer experience for VeriSilicon’s 3D GPUs, enabling seamless integration of 2D, 2.5D, and 3D content that will no doubt lead to some remarkable embedded applications.”

Tim Zhang, Wearable and Sensing Business Unit General Manager of Actions Technology, said, “LVGL’s flexible and powerful graphics solutions are essential to enhance the user interfaces of our wearable products. As the wearable industry embraces 3D graphics, the adoption of VeriSilicon’s powerful and energy-efficient technologies enables us to push the boundaries of innovation, delivering rich 3D graphics with low power consumption.”

“Wearable products are experiencing rapid growth, offering extended functionalities that go far beyond traditional watches. They have evolved into accessible information devices with integrated health monitoring features,” said Weijin Dai, Executive Vice President and General Manager of VeriSilicon’s IP Division. “With this growth, delivering a powerful user interface to effectively communicate information on small displays, while maintaining low power consumption, has become essential. At VeriSilicon, we work closely with our customers to integrate 3D GPU technology into their next-generation products. As a leading provider of wearable GPUs for both 2.5D and 3D applications, we collaborate with LVGL and partners like Actions to drive innovation and achieve this mission.”

About LVGL

LVGL Kft. is the creator of LVGL, the leading free and open-source graphics library for embedded systems, enabling high-quality UIs on any Microcontroller Unit (MCU), Micro Processor Unit (MPU), or display type. With a global community and industry partnerships, LVGL empowers developers to build visually rich, responsive, and efficient UIs for resource-constrained devices from wearables to industrial equipment. For more information, visit www.lvgl.io.

About Actions Technology

Actions Technology (688049.SH) is a leading low-power AIoT fabless semiconductor company in China. We excel in providing high-quality and low-latency wireless audio experiences while prioritizing power efficiency. Our core expertise includes high-performance audio ADC/DAC, voice pre-processing, audio encoding/decoding, and audio post-processing technologies, enabling a superior audio signal chain. Additionally, we specialize in low-latency wireless connectivity with Bluetooth RF, baseband, and protocol stack technologies at the core. For more information about Actions® high-quality, low-latency platform, visit www.actionstech.com.

About VeriSilicon

VeriSilicon is committed to providing customers with platform-based, all-around, one-stop custom silicon services and semiconductor IP licensing services leveraging its in-house semiconductor IP. For more information, please visit: www.verisilicon.com.

 

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Contacts

Media Contact:

press@verisilicon.com

28th World Investment Conference in Riyadh Concludes with Calls for International Collaboration, Innovation, and Sustainability.

 Riyadh, Saudi Arabia - Thursday, 28. November 2024 AETOSWire Print 

International collaboration, innovation and sustainability were the key themes of the 28th World Investment Conference (WIC28), hosted by Invest Saudi and the World Association of International Promotion Agencies (WAIPA) that concluded in Riyadh this week.

Commenting on the success of the event, H.E. Khalid A. Al-Falih, Saudi Minister of Investment said, "This event was held under the auspicious patronage of His Royal Highness Crown Prince and Prime Minister, Mohammed bin Salman bin Abdulaziz Al Saud to whom we extend our deepest gratitude for his visionary leadership and unwavering support.

“Over the past three days, we discussed the critical challenges facing global investment and reviewed  the boundless opportunities that investment offers. From the robust discussions on harnessing digital transformation and sustainable growth to the landmark agreements announced under Saudi Arabia’s Global Supply Chain Resilience Initiative, WIC28 has reaffirmed our collective commitment to shaping a future defined by collaboration, innovation, and resilience.

"Guided by the principles of Vision 2030, Saudi Arabia has emerged as a global economic growth leader, fostering partnerships that transcend borders and sectors. Together, we have showcased the power of strategic alliances, localized value chains, and cutting-edge technologies to drive meaningful economic impact.

“I extend my thanks to the World Association of Investment Promotion Agencies for partnering with us in hosting this event and I am confident that the insights, connections, and agreements forged here will resonate far beyond this event, inspiring transformative investments and sustainable growth across the globe."

Across three days, WIC28, under the theme of “Harnessing Digital Transformation and Sustainable Growth”,  addressed challenges and opportunities that included digital transformation, sustainability, and localized value chains. The conference highlighted Saudi Arabia’s Vision 2030 as a transformative framework for aligning global partnerships, technological innovation, and sustainable development.

H.E. Bandar Ibrahim Alkhorayef, Saudi Minister of Industry and Mineral Resources, speaking on the ‘Strategic Alliances: Leveraging Partnerships for Investment Success’ panel on Day 3 underscored the Kingdom’s commitment to fostering global partnerships, stating: “It has been part of how we design most of the activities that we plan and are executing today.”

He told his panel: “The question about international collaboration is not whether to do it but how to do it, and where to find the right attractive concepts that make it interesting for different parties to collaborate and connect.”

Saudi Arabia’s incentives, he noted, include its advanced infrastructure – both digital and physical – focused on manufacturing, supply chain, and logistics, which enable investors to reduce costs significantly. “And we have approved three economic zones, offering additional benefits for those targeting not only the local market but also the global market,” he added.

Other sessions at the event included the ‘Bridging Borders’ discussion, which focused on transparent collaboration and regulatory cohesion, while ‘To Finish First, First You Have to Finish’ examined operational excellence in Investment Promotion Agencies (IPAs), emphasizing governance, efficiency, and leveraging technology to enhance investor experiences. Meanwhile, ‘Ready, Set, Go’ delved into Saudi Arabia’s efforts to attract investments in specialized industries, particularly advanced manufacturing and renewable energy, by showcasing the Kingdom’s competitive advantages.

The event was held 25-27 November in Riyadh, Saudi Arabia. It is yet to be decided where the next edition will be held.

About WIC: https://waipa.org/wic-info

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Contacts

For media inquiries:

WIC28media@apcoworldwide.com

Leading Travel Marketplace Wingie Unveils Key Destinations Before 2025

 

DUBAI, United Arab Emirates and RIYADH, Saudi Arabia, Nov. 28, 2024 (GLOBE NEWSWIRE) -- WINGIE has revealed its list of key destinations for travelers seeking memorable experiences before 2025. Drawing insights from its vast user base, WINGIE, the leading travel marketplace in the MENA region, highlights some of the most sought-after locations that promise exceptional cultural, historical, and natural allure.

Riyadh, Saudi Arabia

Riyadh in December offers a unique experience as the city hosts Riyadh Season, a celebration of culture, entertainment, and food. Visitors can enjoy concerts, performances, outdoor festivals, local markets, themed events, and famous landmarks, which add to the city’s charm. Flights to Riyadh start from 80 USD, making it an ideal destination for cultural exploration and seasonal festivities.

London, United Kingdom

London remains a popular choice for travelers worldwide, particularly in winter. Home to iconic landmarks such as the Tower of London and Buckingham Palace, the city offers a variety of experiences to explore. Its unique blend of culture and seasonal festivities makes it an ideal destination to visit before the new year. Flights to London start from 182 USD, allowing travelers to explore the city during the holiday season.

Istanbul, Türkiye

Visiting Istanbul in winter offers a unique and delightful experience. The city is much less crowded, allowing visitors to explore iconic attractions like the Hagia Sophia and Topkapı Palace. Despite the mild winter weather, the city's charm remains, providing a comfortable atmosphere for sightseeing and exploring historic sites. Flights to Istanbul start from 76 USD, making December the perfect time for a budget-friendly yet authentic experience of this multicultural city.

About Wingie Enuygun Group

Wingie Enuygun Group is a leading travel marketplace in the MENA region, specializing in flights through its platforms wingie.com, sa.wingie.com, wingie.ae and enuygun.com. The company offers a comprehensive range of travel products including flights, hotels, rental cars and bus tickets. Recognized for its innovation, Wingie Enuygun Group is at the forefront of the MENA online travel space, pioneering technological advancements and driving digital transformation within the industry.

Wingie leverages advanced AI technology to provide a seamless user experience, featuring virtual interlining for flights and a diverse array of airline tickets and travel content. The platform is available in six languages, employs over 400 people, and attracts approximately 200 million visitors annually, reaffirming its position as a premier choice for travelers.

Contact: marketing@wingie.com

Copyright © 2024 GlobeNewswire, Inc.

amana Introduces amanainvest: A Zero-Fee Solution for Effortless, Automated Wealth Building

 

DUBAI, United Arab Emirates, Nov. 28, 2024 (GLOBE NEWSWIRE) -- amana, a leading neobroker in the MENA region, introduces amanainvest, an automated wealth-building product designed for all experience levels. It allows clients to invest effortlessly in line with individual financial goals and risk preferences in a true ‘set it and forget it’ model. With zero management or subscription fees, amanainvest sets a new standard in the MENA investment landscape, ensuring that every dollar invested directly benefits the client.

With amanainvest, whether you're a first-time investor or a seasoned trader, you can start building your wealth immediately and without complexity. amanainvest offers options tailored to every investment strategy, including:

• Pre-built plans with curated portfolios organized by asset class or risk level.
• Customizable plans that allow investors to modify existing plans to align with personal financial goals.
• Build-Your-Own plans enabling users to create a unique portfolio with up to 20 assets, including stocks, ETFs, and crypto.
  

With its range of flexible plans and straightforward management, amanainvest offers the control, convenience, and customization that all modern investors need.

“Our mission is to make investing accessible and seamless,” said Muhammad Rasoul, CEO of amana. “With amanainvest, clients benefit from sophisticated but simplified tools that keep investing easy, automated, transparent, and rewarding—and entirely free of fees. This launch strengthens our position as the go-to partner for investment and trading in the MENA region.”

Key benefits of amanainvest include:

• Zero fees: No management, subscription, or exit fees—100% of returns go to the investor.
• Flexible recurring deposits: Choose from weekly, monthly, or one-time options with no lockup periods.
• Pause or adjust anytime: Investors retain complete control over their funds.
• Sharia-compliant choices: Accessible investment options to suit diverse needs.

amanainvest is an extension of amana’s mission to democratize access to financial markets. By launching amanainvest, amana cements its role as a trusted broker with one of the most comprehensive ranges of investment and trading solutions in the MENA region.

Explore amanainvest at www.amana.app.

About amana

amana is a leading neobroker. It provides retail investors and active traders with direct access to the global financial markets, serving clients across MENA. It operates multiple offices across Dubai, London, Limassol, and Beirut.

CONTACT: Contact: Karolina Slowikowska, Director of Communications, at karolina.slowikowska@amanacapital.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/fdbeac6a-7775-4c95-9185-eed801037881

Copyright © 2024 GlobeNewswire, Inc.

Galderma’s Phase III OLYMPIA 1 Data Published in JAMA Dermatology Demonstrate That Nemolizumab Improves Core Signs and Symptoms of Prurigo Nodularis

 ZUG, Switzerland - Thursday, 28. November 2024

Full results from the phase III OLYMPIA 1 trial evaluating the efficacy and safety of nemolizumab in adults with moderate-to-severe prurigo nodularis have been published in JAMA Dermatology, showing the trial met all primary and key secondary endpoints1

Data were consistent with OLYMPIA 2 trial results, reinforcing the potential of nemolizumab monotherapy to demonstrate rapid and sustained improvements in core signs and symptoms of prurigo nodularis: skin lesions, itch and sleep disturbance – at Week 16 and Week 241,2

In the OLYMPIA 1 trial, a significantly higher proportion of nemolizumab-treated patients achieved an itch-free or nearly itch-free state as early as Week 4 compared to those receiving placebo1

Nemolizumab is a first-in-class monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31. IL-31 is a neuroimmune cytokine that is known to drive key signs and symptoms of prurigo nodularis3,4

 

(BUSINESS WIRE)--Galderma (SWX:GALD) today announced that full results from the phase III OLYMPIA 1 trial, a 24-week study which evaluated the efficacy and safety of nemolizumab monotherapy in adults with moderate-to-severe prurigo nodularis, were published in JAMA Dermatology.1 The trial met both primary and all key secondary endpoints, showing that nemolizumab-treated patients had significantly higher improvements in itch and skin lesions when compared to those receiving placebo at Week 16, with a rapid and clinically meaningful response on itch and sleep disturbance observed as early as Week 4.1 Nemolizumab was well-tolerated, and its safety profile was generally consistent with previous studies.1

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20241127699136/en/

 

“These results, alongside the OLYMPIA 2 trial data, formed the basis of nemolizumab’s recent U.S. Food and Drug Administration approval for the treatment of adults with prurigo nodularis. They demonstrate the potential of this treatment to rapidly and significantly provide relief from the most burdensome symptom for people with prurigo nodularis – itch. We are committed to bringing this treatment option to patients in other parts of the world as soon as possible.”

 

BALDO SCASSELLATI SFORZOLINI, M.D., Ph.D.

GLOBAL HEAD OF R&D

GALDERMA

 

The phase III OLYMPIA 1 trial enrolled 286 adult patients with moderate-to-severe prurigo nodularis.1,5 Results demonstrated that patients treated with nemolizumab monotherapy (without background topical corticosteroids or topical calcineurin inhibitors) showed clinically meaningful and statistically significant improvements in both primary endpoints, compared to placebo.1 After 16 weeks of treatment, more than three times as many nemolizumab-treated patients:1

Achieved an at least four-point improvement in itch intensity, as measured by the peak-pruritus numerical rating scale (PP-NRS), when compared to the placebo group (58.4% vs 16.7%; P<0.001).

Reached clearance or almost-clearance of skin lesions, when assessed using the investigator’s global assessment (score of 0 or 1 and a ≥2-point improvement from baseline), compared to the placebo group (26.3% vs 7.3%; P<0.01).

The trial also met all key secondary endpoints confirming rapid responses on itch and sleep disturbance as early as Week 4:1

More than six times as many nemolizumab-treated patients achieved itch response when compared to the placebo group (41.1% vs 6.3%; P<0.001), as measured by a four-point or greater reduction in PP-NRS score.

More than twenty times as many nemolizumab-treated patients achieved a PP-NRS score of less than two, when compared to the placebo group (21.6% vs 1.0%; P<0.001). Results improved through to Week 16 (34.2% vs 4.2%; P<0.001).

Almost six times as many nemolizumab-treated patients demonstrated a four-point improvement in sleep disturbance, as measured by the sleep disturbance numerical rating scale, when compared to the placebo group (31.1% vs 5.2%; P<0.001). Results improved through to Week 16 (50.0% vs 11.5%; P<0.001).

These full results reinforce previous findings from the phase III OLYMPIA 2 trial, published in the New England Journal of Medicine, which demonstrated that nemolizumab rapidly and significantly improved itch and skin lesions in patients with prurigo nodularis, with clinically meaningful responses on itch observed as early as Week 4.2 The OLYMPIA trial program is the largest phase III program in prurigo nodularis completed to date, and the only one to include an open-label, long-term extension study.5-7

 

“The full phase III OLYMPIA 1 trial results add to the extensive body of evidence supporting nemolizumab’s potential to significantly and safely improve some of the most debilitating symptoms for people with prurigo nodularis – chronic itch, skin nodules, and poor sleep quality – which can be all consuming and have a knock-on effect on patients’ overall quality of life and mental health.”

 

PROF. SONJA STÄNDER

LEAD INVESTIGATOR AND PROFESSOR, DERMATOLOGY

UNIVERSITY HOSPITAL MüNSTER, GERMANY

 

Based on data from the OLYMPIA clinical trial program, nemolizumab has been approved by the U.S. Food and Drug Administration for the treatment of adults with prurigo nodularis under the name Nemluvio®.8 Galderma also has marketing authorization applications for nemolizumab in both prurigo nodularis and atopic dermatitis under review by multiple additional regulatory authorities, including the European Medicines Agency and via the Access Consortium framework in countries such as Australia, Singapore, and Switzerland, as well as Canada, Brazil, and South Korea.9,10 Submissions to regulatory authorities in additional countries are ongoing.

Media can find more information about prurigo nodularis in this media toolkit.

About prurigo nodularis

Prurigo nodularis is a chronic, debilitating, and distinct neuroimmune skin disease characterized by the presence of intense itch and thick skin nodules covering large body areas.11 It is an underrecognized and underdiagnosed skin condition, and while there are limited studies investigating its prevalence, current estimates indicate that up to 181,000 people are living with prurigo nodularis in the United States.4,12-14 The majority of patients report that the persistent itch negatively impacts their quality of life.15 Furthermore, the intense itch associated with prurigo nodularis results in significant sleep disturbance and further contributes to reduced quality of life.16,17

About nemolizumab

Nemolizumab is a monoclonal antibody developed by Galderma. Under the name Nemluvio®, it was approved by the U.S. Food and Drug Administration (FDA) for the treatment of prurigo nodularis in adults in August 2024, becoming the first approved monoclonal antibody specifically inhibiting the signaling of IL-31, a neuroimmune cytokine that drives multiple disease mechanisms in prurigo nodularis.3,4,8

The U.S. FDA has also accepted for review Galderma’s Biologics License Application for nemolizumab for the treatment of adolescents and adults with moderate-to-severe atopic dermatitis, with a decision expected by the end of the year.10 Galderma also has marketing authorization applications for nemolizumab in both prurigo nodularis and atopic dermatitis under review by multiple additional regulatory authorities, including the European Medicines Agency and via the Access Consortium framework in countries such as Australia, Singapore, and Switzerland, as well as in Canada, Brazil, and South Korea.9,10

Nemolizumab was initially developed by Chugai Pharmaceutical Co., Ltd., and subsequently licensed to Galderma in 2016 – worldwide except Japan and Taiwan. In Japan, nemolizumab is marketed as Mitchga® and is approved for the treatment of prurigo nodularis, as well as pruritus associated with atopic dermatitis in pediatric, adolescent, and adult patients.18,19

About the OLYMPIA 1 trial

OLYMPIA 1 was a randomized, double-blind, placebo-controlled phase III clinical trial designed to assess the efficacy and safety of nemolizumab monotherapy compared with placebo in patients aged at least 18 years with prurigo nodularis over a 24-week treatment period.1 OLYMPIA 1 included 286 patients with moderate-to-severe prurigo nodularis.1,5

About Galderma

Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com.

References:

1. Ständer S, et al. Nemolizumab in Patients with Moderate-to-Severe Prurigo Nodularis: A Randomized Controlled Phase 3 Trial. JAMA Derm. 2024;160. doi: 10.1001/jamadermatol.2024.4796

2. Kwatra SG, et al. Phase 3 trial of nemolizumab in patients with prurigo nodularis. N Engl J Med. 2023;389:1579-89. doi: 10.1056/NEJMoa2301333

3. Ständer S, et al. Trial of nemolizumab in moderate-to-severe prurigo nodularis. N Engl J Med. 2020; 382:706-716. doi:10.1056/NEJMoa1908316

4. Bewley A, et al. Prurigo Nodularis: A Review of IL-31RA Blockade and Other Potential Treatments. Dermatol Ther (Heidelb). 2022;12(9):2039–2048. doi: 10.1007/s13555- 022-00782-2

5. ClinicalTrials.Gov. A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN). Available online. Last accessed: September 2024

6. ClinicalTrials.Gov. A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN). Available online. Last accessed: September 2024

7. ClinicalTrials.Gov. A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN). Available online. Last accessed September 2024

8. Galderma. Galderma receives U.S. FDA approval for Nemluvio® (nemolizumab) for adult patients living with prurigo nodularis. Available online. Last accessed: September 2024

9. Galderma. Galderma receives filing acceptances for nemolizumab in prurigo nodularis and atopic dermatitis in four additional countries. Available online. Last accessed: September 2024

10. Galderma. Galderma announces regulatory filing acceptance for nemolizumab in prurigo nodularis and atopic dermatitis in the U.S. and EU. Available online. Last accessed: September 2024

11. Pereira MP, et al. European Academy of Dermatology and Venereology European prurigo project: expert consensus on the definition, classification and terminology of chronic prurigo. J Eur Acad Dermatol Venereol. 2018;32(7):1059-1065. doi: 10.1111/jdv.14570

12. Kwatra SG, et al. Prevalence of prurigo nodularis in the United States. J Am Acad Dermatol Int. 2024. doi: 10.1016/j.jdin.2023.12.013

13. Ständer S, et al. Prevalence of prurigo nodularis in the United States of America: A retrospective database analysis. J Am Acad Dermatol Int. 2021;2:28-30. doi: 10.1016/j.jdin.2020.10.009

14. Huang AH, et al. Real-world prevalence of prurigo nodularis and burden of associated diseases. J Invest Dermatol. 2020;140(2):480-483.e4. doi: 10.1016/j.jid.2019.07.697

15. Todberg T, et al. Treatment and burden of disease in a cohort of patients with prurigo nodularis: a survey-based study. Acta Derm Venereol. 2020;100(8):adv00119. doi: 10.2340/00015555-3471

16. Kwatra SG. Breaking the itch–scratch cycle in prurigo nodularis. N Engl J Med. 2020;382(8):757-758. doi: 10.1056/NEJMe1916733

17. Aggarwal P, et al. Clinical characteristics and disease burden in prurigo nodularis. Clin Exp Dermatol. 2021;46(7):1277-1284. doi: 10.1111/ced.14722

18. Chugai Pharmaceutical Co., Ltd. Maruho Obtained Regulatory Approval for Mitchga, the first Antibody Targeting IL-31 for Itching Associated with Atopic Dermatitis. Available online. Last accessed September 2024

19. Chugai Pharmaceutical Co., Ltd. Mitchga Approved for Itching in Pediatric Atopic Dermatitis and Prurigo Nodularis, for its Subcutaneous Injection 30mg Vials. Available online. Last accessed September 2024

 

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Contacts

 

For further information:

Christian Marcoux, M.Sc.

Chief Communications Officer

christian.marcoux@galderma.com

+41 76 315 26 50

Emil Ivanov

Head of Strategy, Investor Relations, and ESG

emil.ivanov@galderma.com

+41 21 642 78 12

Sébastien Cros

Corporate Communications Director

sebastien.cros@galderma.com

+41 79 529 59 85

Jessica Cohen

Investor Relations and Strategy Director

jessica.cohen@galderma.com

+41 21 642 76 43