At Interpack 2026 , Mettler-Toledo Product Inspection (Hall 11 Stand A60), a global leader in precision instruments and inspection solutions, will present a portfolio of proven inspection technologies, software and global service capabilities designed to support pharmaceutical manufacturers in building more precise, compliant and connected production environments.

Under the theme “Inspect. Protect. Comply.”, the company will demonstrate how product inspection solutions are evolving to support the future of smart manufacturing in pharmaceutical production, where accuracy, traceability and data integrity are critical at every stage of the process.

Building smarter pharmaceutical manufacturing through inspection capability

As pharmaceutical production becomes increasingly digitalised, product inspection plays a central role in maintaining process control, product quality and compliance.

At Interpack, Mettler-Toledo will highlight how its technologies support core inspection capabilities including weight control, physical contamination detection, integrity checks, and label inspection.

These capabilities help manufacturers inspect every product with confidence, protect product quality and patient safety, and comply more easily with regulatory requirements, forming a strong foundation for smarter, more connected pharmaceutical manufacturing.

Accurate weight control at high speeds

The C35 AdvancedLine high performance checkweigher will be showcased for pharmaceutical applications, supporting precise weight control at high throughput rates of up to 600 packs per minute. The system conducts completeness checks, and accurately detects overfills and underfills, supporting compliance with weights and measures regulations, including FDA 21 CFR Part 11 standards and helping to maintain consistent product quality.

Its ability to operate at very high speeds while maintaining measurement accuracy makes it well suited to modern pharmaceutical production lines where both performance and precision are essential.

Metal detection for pharmaceutical applications

Mettler-Toledo will showcase its Tablex-PRO metal detector, designed specifically for the enhanced inspection of pharmaceutical tablets and capsules. The ultra-high sensitivity metal detector, identifies stainless steel contaminants less than 0.3 mm in diameter and removes the contaminated product early in the production process. This integrated system is easy to use and supports compliance with pharmaceutical standards including FDA 21 CFR parts 210, 211, and 11, and GAMP 5.

By combining precise metal detection with stable and repeatable performance, the technology provides consistent inspection results in applications where even small contaminants can present a significant risk to product safety and quality. With a compact, flexible design the metal detection system can be easily installed in environments with restricted space.

Precision x-ray inspection for regulated environments

Pharmaceutical production requires consistent, repeatable inspection performance across a wide range of dosage forms and packaging formats. Mettler-Toledo will demonstrate how its x-ray inspection portfolio supports these requirements.

Systems such as the X12 perform integrity checks including completeness verification, helping manufacturers identify missing or damaged products before they reach the end user. Simultaneously, the X12 reliably detects foreign bodies in small and medium-sized pharmaceutical packages, supporting high levels of quality control in precision-driven environments.

NEW: AI-driven inspection for enhanced quality control

At Interpack, Mettler-Toledo will introduce advanced AI capabilities within its x-ray inspection systems. These technologies are designed to improve inspection accuracy in complex scenarios, such as overlapping products, mixed product types and random product positioning on the line.

AI supports integration with conventional contamination inspection tools improving inspection reliability while reducing unnecessary product rejection, contributing to more efficient and consistent production processes.

Lifecycle support through global service

Maintaining inspection performance over time is critical in pharmaceutical production, where equipment reliability, documented performance and validation are essential.

Mettler-Toledo will highlight its global service offering, supporting manufacturers throughout the full lifecycle of their inspection systems, from installation and qualification through to maintenance and performance verification. Combining global reach with local support enables fast response times, delivered by experts on-site and remote support teams.

This approach helps maintain consistent performance, reduces unplanned downtime and supports ongoing compliance with validation and regulatory requirements.

Supporting industry knowledge and best practice

In addition to its technology portfolio, Mettler-Toledo will introduce a new pharmaceutical inspection guide, providing practical insights into inspection strategies, compliance considerations and best practices for pharmaceutical production environments.

The guide reflects the company’s focus on supporting customers not only with technology, but also with the knowledge required to apply product inspection solutions effectively in highly regulated industries.
“Pharmaceutical manufacturers are operating in a highly regulated environment where precision, documentation and consistency are critical,” said Miriam Krechlok, Segment Marketing Manager at Mettler-Toledo Product Inspection. “At Interpack, we are pleased to demonstrate to visitors how our proven inspection solutions support smarter manufacturing by combining reliable detection, precision weighing and global service expertise. This helps our customers inspect every product with confidence, protect product quality and comply more easily with regulatory requirements.”

Visitors can experience live demonstrations and explore pharmaceutical product inspection systems at Interpack 2026 in Hall 11 Stand A60. For more information, click here or visit www.mt.com/pi-pr.

The move to Vienna and the introduction of refreshed formats proved a resounding success, with record engagement, packed sessions and a strong pipeline of exhibitor announcements signalling continued momentum across the sector.

This year’s edition reflected a maturing conversation within pharmaceutical and biotech supply chains, grounded in practical application, resilience and real-world value. That was evident both on stage and across the exhibition floor, where suppliers showcased solutions designed to address today’s most pressing operational challenges.

The focus on interaction delivered tangible results. Delegates submitted 321 questions via the event app, underlining strong audience participation and the appetite for open, honest discussion. Sessions across both the Supply Chain and Logistics tracks benefited from live polling, audience-led debate and practical peer-to-peer exchange.

Reflecting on the themes that shaped discussions throughout the week, Ben Sharples, Event Director of LogiPharma, highlighted a noticeable shift in how the industry is approaching transformation:

“AI dominated the conversation again this year, but the tone was far more grounded. There’s a growing realism about what the technology can deliver right now, as well as where its limitations still lie.”

According to Sharples, true end‑to‑end visibility emerged as the single most critical capability for supply chains responding to major disruption. Survey data shared during sessions revealed that 50% of respondents felt AI had not helped at all during the recent Middle East crisis, reinforcing the message that technology alone is not a silver bullet.

Other key learnings included the increasing alignment between supply chain and commercial teams, with organisations placing greater emphasis on growth, market share and customer outcomes. Sharples also noted that while AI continues to attract attention, poor data quality remains the root cause of many failed initiatives, often overlooked amid the hype.

Crucially, people and culture continue to define success. “Even the best technology won’t deliver if it’s in the wrong hands,” Sharples added. “Digital transformation is still, at its core, a people and change challenge.”

With major disruption now viewed as inevitable rather than exceptional, the LogiPharma agenda reinforced the need for resilient networks and predictive capabilities. Looking ahead, AI‑enabled control towers were widely cited as a foundational element, increasingly acting as the nervous system of modern supply chains, shifting organisations from reactive recovery to proactive foresight.

Other highlights from across the conference

A larger exhibitor zone and wider variety of formats meant that the move to Vienna was also praised by sponsors.

“People love the interactive elements of LogiPharma and these extend from plenaries and round-tables, to the experiential activities brought by sponsors, including a F1 simulator and an A.I. photobooth,” confirmed Jake Brown, Commercial Lead at LogiPharma.

“Exhibitors used LogiPharma as a platform to launch and showcase next-generation technologies aimed at improving resilience, reducing risk, balancing cost and sustainability, and strengthening cold chain integrity,” he added.

TransVoyant announced the launch of Risk in Motion, a new solution designed to analyse multiple data sources against disruption threats. The platform enables supply chain teams to act ahead of potential issues, protecting shipments, inventory and temperature-sensitive products in real time.

Cold chain innovation continued with Peli BioThermal’s introduction of a new SmartCap for DV10 dewars, offering enhanced visibility and reliability for high‑value cell and gene therapy shipments.

Visitors to Woolcool were introduced to the LifeGUARDIAN® thermal box system, a fully passive packaging solution designed to protect temperature‑sensitive payloads for up to 120 hours. The system combines a layered design including an outer carton, fleece jacket, thermal core and ice packs to deliver consistent and reliable temperature control without the need for active components.

Innovation from emerging companies was also firmly in the spotlight. Tapp was named Start Up Village Champion, recognised for its progress in developing a simpler and more sustainable way to manage temperature-controlled shipments. The company was selected for its focus on reducing e‑waste and enabling instant data access without the need for additional hardware.

Beyond technology, the event also highlighted the importance of partnership and shared purpose. A standout moment was Yusen Logistics hosting a traditional Japanese Kagami Biraki sake barrel‑opening ceremony, symbolising new beginnings and strengthened collaboration.

The new partnership leading to global delivery of gene therapies will combine their industry-leading GMO manufacturing facilities and technical expertise as well as regional networks to speed up the development and manufacturing along with global growth of client programmes that bring next-generation gene therapies to patients around the world, the pair said in a statement. The partnership will simplify global expansion by eliminating regulatory and logistical challenges and streamline a dual-hemisphere workflow through connecting US and APAC manufacturing hubs.

Additionally, local manufacturing for clinical trials in-country will make sure regional supply chains can meet the expectations of local patients, minimising waiting times and speeding up commercialisation.

The CEO at Andelyn, Wade Macedone, said, “Our partnership with ENCell is a powerful step forward in Andelyn’s mission to help bring life-saving therapies to patients worldwide. By joining forces with such a respected leader in South Korea, we are not just expanding our global footprint; we are leveraging our unique strengths to deliver a truly seamless international manufacturing network. This collaboration reinforces our shared leadership in the cell and gene therapy space and ensures that, together, we can support our clients with the expertise and scale needed to deliver the next generation of medicines on a global stage.”

ENCell’s CEO, Dr Jong Wook Chang, added that “this partnership with Andelyn represents a significant step in expanding the global CGT ecosystem. By combining Andelyn’s expertise in viral vector development and cGMP manufacturing with ENCell’s clinical and manufacturing capabilities across APAC, we are establishing a seamless manufacturing platform connecting the United States and Asia-Pacific. Together, we will enable more efficient development and scalable production of gene therapies, supporting our clients from early-stage development through global clinical trials and commercialisation.”

• The “Factory of the Future” of pharma, biotech, and food companies must answer the most pressing industry challenges
• Automation, robotics, digitalization, and AI to enable human operators to focus on the highest value-adding tasks
• Syntegon’s contribution to “re:imagine” the Factory of the Future: neXt, SVX, SynTiso – backed by lifecycle services

At interpack 2026, Syntegon will join its customers in “re:imagining” the Factory of the Future by providing answers to their most pressing challenges. With highly innovative solutions, the company will demonstrate how operations in the pharma, biotech, and food sectors can be elevated to the next level of efficiency, flexibility and sustainability at booth A31-B31 in hall 6.

Challenges as a Driver for Innovation and Growth

The industry is facing a game-changing shift: Rising cost pressure, increased flexibility needs, and stricter regulatory requirements demand companies to “re:imagine” the Factory of the Future. Syntegon answers those challenges with innovations, co-created with its customers. The vision: a factory that is self-regulating and able to adjust to all challenges, supervised by an AI-supported human control center. At interpack 2026, Syntegon will present the building blocks allowing customers to re-imagine their Factory of the Future, with operations that are more seamless, smart, and touchless, and thereby ultimately more efficient. 

“At interpack, we demonstrate the power of our COCREATE and COSUCCEED concept. Game-changing innovations, jointly developed with pioneering customers, deliver greater business impact. Our innovation highlights, neXt and SVX, raise the bar in the food sector. For pharma operations, SynTiso sets a new standard as a first-of-its-kind high-speed gloveless liquid pharmaceutical filling line. Syntegon’s promise as a strategic lifecycle partner combines innovation leadership with best-in-class lifecycle services as the ultimate enabler for our customers’ growth,” says Torsten Türling, CEO of Syntegon.

neXt: The Factory of the Future is Seamless, Smart, and Touchless

The food industry is evolving quickly: Consumer and retailer demands are changing overnight, requiring utmost flexibility. Labor is scarce and increasingly expensive, and regulation enforces more sustainable packaging materials. The new neXt system solution from Syntegon takes on those challenges by providing seamless operation, smart performance, and touchless controls. neXt automation allows operators to focus on the highest value-adding activities. Seamless operation increases efficiency and minimizes downtime. Real-time, smart data drives fact-based action and optimized OEE. Touchless controls and an intuitive UX result in faster changeovers, less training, and higher flexibility across product portfolios. Designed with future, evolving demands in mind, neXt enables a competitive edge for food manufacturers in a highly dynamic market.

SVX: High Speed, Fast Changeovers, Low Material Consumption

The highly innovative SVX vertical packaging platform is second to none in addressing today’s and tomorrow’s customer challenges. Its immense speed of 300 bags per minute enables the lowest cost per bag. Changeovers across various bag styles are simple and fast, allowing for maximum uptime and flexibility. Patented technology reduces packaging consumption by 50 percent. SVX’s compact footprint dramatically increases productivity per square meter without facility expansion, thereby providing a boost to business growth.

SynTiso: Redefining Liquid Pharmaceutical Production

Pharma and biotech are booming sectors. Most new biologics drugs are provided in injectable format. Increasingly strict regulations aim to eliminate contamination risks in injectables. With SynTiso, Syntegon provides the solution to those challenges. Jointly developed with two Big Pharma companies, SynTiso removes the need for human interference with gloveless isolator technology and a fully robotized operation including a contactless container transport system. The benefits: benchmark-level regulatory compliance, 50 percent faster changeovers, and higher product output per batch run. SynTiso is set to revolutionize the future of liquid pharmaceutical filling operations.

“Re:imagining Your Factory of the Future” with Syntegon’s Lifecycle Services

Syntegon is the strategic lifecycle partner of its customers. The company’s deep application expertise supports customers from the first ideation of their Factory of the Future. Engineering solutions tailored to customers’ specific business needs create the best return on investment. Flawless project execution from the start to an up-and-running factory enables faster time to market. Qualified field and on-site service engineers secure reliable performance and high uptime. Constant line upgrades based on AI-powered data analytics make any investment future-proof. Syntegon’s lifecycle services turn the equipment of any Factory of the Future into a highly valuable and reliable business asset.

Women’s HealthX (WoHX) is the number one event in women’s health, unifying the full lifecycle of female healthcare through data, science, and evidence-based innovation to close the sex difference data gap and drive better clinical outcomes for women worldwide.

On December 3–4, 2026 in Boston, WoHX will bring together 750 global leaders from pharma and biotech, hospitals and health systems, health insurers, employers, investors, startups, and government, all actively seeking proven technologies, data, and partners to advance women’s health care, research, and outcomes across the life course.

Unlike any other event, WoHX goes beyond discussion to focus on implementation of representative data sets to drive meaningful change. The exhibition directly addresses the conditions that affect women differently and disproportionately, across every stage of life.

Attendees will gain clear insight into which areas are overhyped versus underfunded, where the biggest evidence gaps remain, and how data, science, and evidence can drive measurable change in policy, reimbursement, product development, and clinical practice.

Julie Rios, Division Director, Reproductive Endocrinology & Infertility at UPMC, shared why she is looking forward to attending:

“I’m looking forward to connecting with innovators across women’s health to explore new technologies, collaborations, and care models that can help us solve our most complex reproductive health cases and improve outcomes for patients who currently have limited options.”

Taking place in Boston, the global hub for healthcare innovation, research, and medical institutions, whose collaborative ecosystem aligns perfectly with WoHX’s mission to accelerate the adoption of clinical solutions, and improve outcomes for women worldwide.

Across seven dedicated stages spanning Evidence, Data & Innovation, Fertility & Reproductive Health, Menopause & Healthy Aging, Maternity & Maternal Care, Sexual Health & Wellness, Cognitive Health & Wellness, and Chronic Disease Management, attendees will benefit from:

• 100+ hours of free education from 150+ expert speakers
• Direct access to senior decision-makers and key industry leaders
• Tailored one-to-one meetings with solution providers across medical devices, CROs, and analytics software
• Hands-on exploration of AI-powered tools, digital therapeutics, wearables, telehealth, and integrated care models via the interactive HealthXpo floor, featuring live demonstrations and hands-on clinical showcases
• The Women’s Health Startup Zone, connecting founders directly with investors
• The Career Zone, linking attendees with postgraduate programs, universities, and research centres, alongside masterclasses in AI literacy, data analytics, and research innovation

Early confirmed speakers include:

• Michael Annichine, CEO, Magee-Womens Research Institute and Foundation
• David Friend, Chief Science Officer, Daré Bioscience
• Emily Lau, Director, Women’s Heart Health Program, Brigham and Women’s Hospital
• Carolee Lee, CEO & Founder, WHAM
• Suneela Vegunta, Vice Chair, Women’s Health Research Division, Mayo Clinic
• Barb DePree, Director of Women’s Health, Holland Hospital
• Jodi Neuhauser, Founder & CEO, In Women’s Health
• Julie Rios, Division Director, Reproductive Endocrinology & Infertility, UPMC
• Kesha O’Reilly, Global Director, Medical Affairs HIV Franchise, Gilead Sciences
• Katie Baca-Motes, CEO GSD, Health Research
• Catherine Monk, Founding Director, Center for the Transition to Parenthood
• Mitzi Krockover, CEO & Founder, WomanCentered

Further announcements, including speaker confirmations and agenda highlights, will be released in the coming months.

Because we believe in healthcare equity, attendance is free for any medical officers and leaders within hospitals and healthcare systems, pharma, biotech, corporate enterprises and government officials.

End-to-End LNP Insights Across Three Parallel Tracks

To support comprehensive learning and cross-functional collaboration, the 2026 program will feature three parallel end-to-end tracks, enabling companies to send different members of their team to gain targeted insights across the entire LNP lifecycle:

Analytical Development & Characterization

Exploring advanced and innovative characterization strategies to support the development of high-quality, safe, and reproducible LNPs.

Formulation & Delivery

Focusing on novel targeting strategies and next-generation LNP formulations to enable selective and specific extrahepatic delivery.

Process Development & Manufacturing

Addressing translation from research to commercial manufacturing, with a focus on robust scale-up strategies and reproducibility.

Pre-Conference Activity – Monday, April 6:

LNP 101 Day – Providing an introduction into all things LNP related to give attendees a solid foundation of core LNP principles. This is designed for LNP newcomers as well as experienced professionals who want to strengthen their understanding on concepts before diving into the main conference content.

Workshop Day – This day focuses on addressing key scientific and translational challenges through expert-led workshops, fostering hands-on learning and collaborative problem solving before the main summit begins

The 5th LNP Summit is offering group booking discounts of up to 20% for companies registering multiple delegates at the same time, to support the growing importance of team wide learnings.

• 10% discount for 2 delegates
• 15% discount for 3 delegates
• 20% discount for 4+ delegates

For full program details and registration information, visit: https://ter.li/a039ds

Riyadh, KSA: As global process industries respond to increasing pressures around sustainability, digitalisation and operational resilience, ACHEMA is extending its presence to markets where industrial transformation is advancing at scale. The launch of ACHEMA Middle East 2026 marks the first Middle East edition of the long-established process industry platform and reflects growing regional demand for integrated, knowledge-driven industrial ecosystems.

ACHEMA Middle East will take place from 26–28 October 2026 at the Riyadh International Convention & Exhibition Center (RICEC), under the patronage of the Saudi Ministry of Industry and Mineral Resources and with the support of ASAS. The event brings ACHEMA’s century-long heritage in chemical engineering, process technology and applied industrial science into a region undergoing rapid industrial diversification and downstream expansion.

For more than 100 years, ACHEMA has served as a global reference point for the chemical, pharmaceutical, biotechnology, laboratory and process industries. Its arrival in Saudi Arabia extends this role into the Middle East, Africa and South Asia (MEASA), providing a full-scale exhibition and conference platform that connects international solution providers with regional manufacturers, policymakers, researchers and technology leaders.

Organised by Messe Frankfurt and powered by DECHEMA, ACHEMA

Middle East is aligned with Saudi Vision 2030 and the Kingdom’s industrial development agenda. The event is designed to support localisation, advanced manufacturing, sustainability, digitalisation and long-term investment across sectors including chemicals, energy, pharmaceuticals, food production, water technologies and advanced materials.

The exhibition covers 6 core product groups, spanning the full process industry lifecycle — from industrial engineering and process technology to laboratory and analytical solutions, automation and digital systems, packaging and supply chain solutions, and innovation-led R&D. This integrated scope reflects the increasingly interconnected nature of modern process industries and the need for cross-disciplinary solutions.

Programme content is structured around six innovation themes — process, pharma, lab, digital, green and energy innovation — delivered through CPD-accredited conferences, technical sessions and expert-led discussions addressing current industrial challenges and future pathways, including electrification, bioprocessing, AI-enabled operations and circular economy models.

Commenting on the launch, Dr. Björn Mathes, CEO of DECHEMA Exhibitions, said: “ACHEMA Middle East is not just a regional extension – it’s a strategic evolution. By bringing ACHEMA to Riyadh, we’re creating a platform where science, engineering and industrial innovation align with the ambitions of one of the world’s most dynamic industrial economies.”

Azzan Mohammed, Managing Director, Messe Frankfurt Saudi Arabia, added: “Saudi Arabia is undergoing a significant industrial transformation. ACHEMA Middle East reflects how international collaboration and knowledge exchange can support regional progress and contribute to the development of sustainable, competitive industrial ecosystems.”

Strong early interest is reflected in confirmed international brands including Yokogawa, GMM Pfaudler, Hach, Beckhoff, Aptek, Pharmadule Morimatsu, Tofflon and Sealmatic, indicating solid market engagement ahead of the inaugural edition.

With its emphasis on technical depth, system integration and applied knowledge exchange, ACHEMA Middle East 2026 is positioned to play a meaningful role in the region’s evolving process industry landscape.

Aylward Enterprises, a recognized leader in oral solid dose (OSD) packaging automation, highlights two complementary bulk handling solutions engineered to optimize product transfer and inspection prior to feeding: the Bulk Product Conveyor (BPC) and the BPC Sorter. Designed to seamlessly integrate with upstream feeding systems, these accessories deliver reliable product transport, chip removal, and automated inspection, helping manufacturers maintain high throughput and product quality across pharmaceutical, nutraceutical, and healthcare operations.

The Bulk Product Conveyor transports bulk tablets from a 32-liter capacity hopper directly to the feed system, ensuring continuous production flow. Standard features include a vacuum attachment for chip removal and de-dusting, along with a low-level product sensor that enables automatic loading, reducing operator intervention and downtime. By maintaining consistent product delivery, the BPC enhances efficiency and supports smooth line performance in high-volume packaging environments.

Building on this functionality, the BPC Sorter incorporates an integrated sorting system for enhanced quality control. Capable of handling both tablets and softgels, it removes chipped and partial product, as well as under- and oversized units, before material reaches the feed system. By eliminating defective pieces at the source, the BPC Sorter safeguards downstream equipment, ensures uniformity, and improves overall batch integrity.

Together, the Bulk Product Conveyor and BPC Sorter provide manufacturers with scalable, user-friendly solutions that increase automation, reduce manual handling, and maintain product quality at every stage of the feeding process. With robust construction and cGMP-ready designs, these systems exemplify Aylward’s commitment to advancing efficiency and compliance in solid-dose packaging operations.

To learn more about the Bulk Product Conveyor, BPC Sorter, and other accessories that improve solid-dose packaging performance, visit www.aylwardenterprises.com.

Almac Group has announced a multi-million-pound investment to expand its facility in Singapore, as the company marks ten years of operations in the country.

The investment by Almac Clinical Services is part of a long-term commitment to expand warehouse capacity in Singapore and increase regional clinical supply management expertise to address client demand.

This initiative supports Almac’s five-year growth strategy, which has included the quadrupling of dedicated -20°C capacity, expansion of secondary cold chain packaging capabilities and enhanced temperature-controlled clinical supply services. These investments address client expectations and market demand to support clinical trials from Singapore and to provide advanced cold chain solutions.

APAC continues to be one of the fastest growing markets for clinical trials, and Almac has seen unprecedented growth over the last ten years in line with this. Singapore offers clear benefits as a strategic centre for clinical packaging, along with both regional and global logistics.

Dr Robert Dunlop, President and Managing Director of Almac Clinical Services said:

“We are proud to celebrate a decade of operations in Singapore. This investment reflects our unwavering commitment to advancing human health, not only in Asia-Pacific but globally.

“For over a decade our facilities in Japan and Singapore have played a pivotal role in enabling Almac to efficiently manage the APAC clinical supply chain, delivering significant value to our clients.  It fuels our continuous improvement across services and infrastructure to support clients with securing the best possible outcome for patients worldwide.  As we look ahead, we are committed to deepening our partnerships with existing and new clients, and we remain dedicated to our promise to Supply with Care.”

Novartis today presented new ianalumab data in Sjögren’s disease, the second most prevalent rheumatic autoimmune disease, at a late-breaker presentation during the American College of Rheumatology Convergence congress.

Ianalumab 300 mg monthly delivered a clinically meaningful benefit in the global NEPTUNUS-1 and NEPTUNUS-2 Phase III trials, showing both improvement in disease activity and reductions in patient burden. Compared to placebo, ianalumab achieved a numerically greater reduction in disease activity by Week 16 with improvements sustained through Week 52 as measured by the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI).

“Sjögren’s disease is a debilitating autoimmune condition affecting multiple organs causing a wide spectrum of symptoms such as dryness, fatigue, pain, and an increased risk of lymphoma – that together may create a substantial disease burden,” says Professor Xavier Mariette, Head of Department of Immuno-Rheumatology, Bicêtre Hospital, Assistance Publique – Hôpitaux de Paris, Paris-Saclay University, France. “The NEPTUNUS trials were the first Phase III studies in Sjögren’s in which a treatment significantly improved disease activity and demonstrated that ianalumab has the potential to provide a clinically meaningful benefit to patients.”

Ianalumab is a fully human monoclonal antibody with a novel dual mechanism of action that depletes B-cells and also inhibits their activation and survival via BAFF-R blockade. B-cell dysfunction plays a significant role in Sjögren’s disease by causing an autoimmune response that leads to inflammation and tissue damage.

“Today’s results reinforce our confidence that ianalumab has the potential to transform the treatment of this complex disease where no targeted medications currently exist,” said Shreeram Aradhye, M.D., President of Development and Chief Medical Officer at Novartis. “We look forward to working with health authorities globally to bring this innovation to people with Sjögren’s disease, the second most prevalent rheumatic autoimmune disease.”

NEPTUNUS study outcomes from 219 trial sites in 35 countries

The replicate NEPTUNUS trials showed statistically significant improvement in ESSDAI, the primary endpoint, at week 48 for ianalumab 300 mg monthly¹. Numerical improvements were observed as early as Week 16, which were sustained throughout the study¹.

Patients receiving ianalumab showed consistent numerical improvements in secondary outcome measures including:

• More patients with ESSDAI low disease activity
• Improvement in Physician Global Assessment
• Reduction in overall disease burden as early as Week 8 continuing to Week 52 as assessed by Patient Global Assessment
• Numerical improvement in dryness, pain and fatigue as assessed by Sjögren’s Syndrome Symptom Diary and EULAR Sjögren’s Syndrome Patient Reported Index
• Improvement of stimulated Salivary Flow (sSF) rate and oral dryness vs placebo in patients with sSF>0.4 mL/min at baseline, in a post-hoc analysis

Ianalumab 300 mg monthly numerically improved physician- and patient-reported outcomes. Nominal significance was observed in NEPTUNUS-1 and the pooled data set for PhGA and PaGA, as well as the number of patients achieving low disease activity based on ESSDAI in the pooled data set. The pooled and individual patient-reported secondary outcomes did not reach statistical significance.

The trial results showed favorable safety with an overall incidence of adverse events and serious adverse events comparable to placebo in both studies.