EDETEK Engages Capgemini to Support Its Global Transformation Initiative and Accelerate AI Innovation in Clinical Development




EDETEK Engages Capgemini to Support Its Global Transformation Initiative and Accelerate AI Innovation in Clinical Development

NEW YORK–(BUSINESS WIRE)–EDETEK Inc., a global provider of leading AI-driven clinical development platforms and services, has engaged Capgemini to support its ongoing advancements in digital transformation within the life sciences industry. This engagement combines EDETEK’s deep domain expertise and established platforms and services with Capgemini’s advanced AI and engineering capabilities, to enable EDETEK to deliver innovative solutions aimed at optimizing clinical development, improving operational efficiency, and accelerating the time-to-market for new therapies.

A shared vision for the future of clinical R&D

By integrating advanced digital and data capabilities—including generative AI—across all phases of clinical trials, the project will support new efficiencies for pharmaceutical companies, including:

• Dramatically reduce time-to-market for new therapies.
• Enablement of self-learning, insight-driven trials for faster, more proactive decision-making.
• Streamlined data management and trial workflows, enhancing efficiency and precision.
• Significant cost reductions and boosted drug pipeline value.

“Working with Capgemini signifies our continuing efforts to expand our global capabilities towards delivering more effective and faster clinical development,” said Dr. Shakthi Kumar, Chief Strategy & Business Officer at EDETEK. “By bringing together our AI-driven platforms with Capgemini’s leading capabilities in life science and technology, we will empower life science organizations to conduct smarter, faster, and more predictive clinical trials—ultimately improving patient outcomes at scale.”

Bringing innovation to clinical development at scale

The engagement combines EDETEK’s proven technology with Capgemini’s global network and deep domain knowledge to scale AI-powered clinical innovation across the pharmaceutical industry. Together, this will help make intelligent, agile, and data-driven clinical trials accessible to more life sciences organizations worldwide. In addition, Capgemini will leverage its robust engineering capabilities to help scale EDETEK’s platforms globally and enable continued leadership in reliability, innovation, and performance.

“Our deep expertise in next-gen clinical development methodologies and advanced AI will expand EDETEK’s R&D cloud and eClinical platform, helping its clients to unlock new levels of agility, insight, and efficiency,” said Thorsten Rall, Global Industry Head, Life Sciences at Capgemini. “Together, we are committed to redefining what’s possible for the industry—delivering measurable value, accelerating innovation, and shaping the future of healthcare through smarter, more predictive clinical trials.”

About EDETEK, Inc.

Founded in 2009, EDETEK delivers high-quality AI-powered platforms and clinical services to over one hundred biopharma clients worldwide. With a presence across four continents, EDETEK is redefining the future of clinical development through intelligent technology.

For more information about EDETEK, please visit www.edetek.com

About Capgemini

Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem. The Group reported 2024 global revenues of €22.1 billion.

Get The Future You Want | www.capgemini.com

Contacts

Capgemini press contact:
Julia Zimmerman
Tel.:+1 847-922-7951
E-mail: julia.zimmerman@capgemini.com

EDETEK press contact:
Wei Kong
Tel.: +1 609-720-0888
E-mail: wei.kong@edetek.com

Alnylam Receives European Commission Approval for AMVUTTRA® (vutrisiran) for the Treatment of ATTR Amyloidosis with Cardiomyopathy




Alnylam Receives European Commission Approval for AMVUTTRA® (vutrisiran) for the Treatment of ATTR Amyloidosis with Cardiomyopathy

− First and Only RNAi Therapeutic Approved by the European Commission for the Treatment of Wild-Type or Hereditary ATTR Amyloidosis with Cardiomyopathy –

− Novel RNAi Mechanism Delivers Rapid Knockdown of Transthyretin (TTR), Addressing the Disease at its Source –

− Approval Based on HELIOS-B Phase 3 Study, Which Showed Up to 36% Reduction in All-Cause Mortality, With Preservation of Functional Capacity and Quality of Life, with Four Quarterly Doses Per Year –

− Decision Follows Recent Authorizations in the U.S. and Brazil −

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNA interference (RNAi) therapeutics company, today announced that the European Commission (EC) has granted approval for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM) as an additional indication for its orphan RNAi therapeutic AMVUTTRA^® (vutrisiran). The approval broadens the indication for AMVUTTRA, which now becomes the first and only RNAi therapeutic approved by the EC for the treatment of the cardiomyopathy manifestations of ATTR amyloidosis and the polyneuropathy manifestations of hereditary transthyretin-mediated amyloidosis (hATTR) in adults.

“Estimates show approximately 100,000 people are affected by ATTR amyloidosis across Europe, most with cardiomyopathy, so this approval marks a critical step toward addressing this underserved patient population,” said Pushkal Garg, M.D., Chief Medical Officer at Alnylam. “AMVUTTRA is supported by a well-established efficacy and safety profile, with over 6,000 patient-years of global experience in the treatment of hATTR with polyneuropathy. By delivering rapid and sustained knockdown of TTR through convenient, quarterly dosing, it offers a clinically differentiated approach with the potential to transform outcomes for patients living with this debilitating and potentially fatal disease. We now look forward to securing access to AMVUTTRA for eligible patients across the EU as quickly as possible.”

The EC decision is based on positive results from the pivotal HELIOS-B Phase 3 study – a randomized, double-blind, placebo-controlled, multicenter, global trial that enrolled a diverse group of patients reflective of the contemporary ATTR-CM population, including those receiving substantial concurrent use of available standard-of-care therapies such as tafamidis and SGLT2 inhibitors. AMVUTTRA met all 10 pre-specified primary and secondary endpoints across both the overall and monotherapy populations. These included statistically significant reductions in all-cause mortality and recurrent cardiovascular events, as well as significant improvements in functional capacity (6-minute walk test), health status and quality of life (Kansas City Cardiomyopathy Questionnaire), and heart failure symptoms and severity (NYHA class). In the overall population, AMVUTTRA achieved a 28% reduction in the primary composite of all-cause mortality and recurrent cardiovascular events as compared to placebo. Mortality in this population was significantly reduced by 36% through 42 months in a pre-specified secondary endpoint analysis which included up to 36 months of the double-blind period plus six months of open-label extension. In HELIOS-B, rates of adverse events (AEs), serious AEs, severe AEs and AEs leading to study drug discontinuation were similar between the AMVUTTRA and placebo arms. Adverse drug reactions of AMVUTTRA include injection site reactions and increase in blood alkaline phosphatase and alanine transaminase. Detailed results from the HELIOS-B study were published in The New England Journal of Medicine.¹

“The HELIOS-B findings provide compelling evidence to support the use of vutrisiran as a first-line treatment option for patients with ATTR-CM,” said Marianna Fontana, M.D., Ph.D., HELIOS-B investigator, Professor of Cardiology, University College London, National Amyloidosis Center, Royal Free Hospital, London. “As a physician, it is a privilege to see the true impact on patients in the clinic. The trial enrolled a broad population reflective of real-world clinical practice, and that’s what makes the results so meaningful. This is a milestone for patients, who now have a new treatment option that has the potential to significantly improve outcomes of this disease.”

ATTR-CM is caused by the deposition of misfolded TTR fibrils, which drive progressive and irreversible cardiovascular damage and premature death. AMVUTTRA is an RNAi therapeutic that works upstream by delivering sustained knockdown of disease-causing TTR at its source. In the EU, it is administered as a subcutaneous injection once every three months, either by a healthcare professional, or self-administered by patients or their caregivers, offering flexibility in treatment delivery.

“Amyloidosis is a serious and progressive disease that significantly impacts not only patients’ physical health, but also their quality of life and independence. I am thrilled by the news of a new therapy for people in the EU living with ATTR-CM who often face delayed diagnosis. Having a new treatment option available marks a welcome development for the amyloidosis community,” said Giovanni d’Alessio, President of the Amyloidosis Alliance.

In May 2025, the European Medicines Agency’s Committee for Orphan Medicinal Products (COMP) adopted a positive opinion on the maintenance of the EU Orphan Designation for AMVUTTRA in ATTR amyloidosis.

AMVUTTRA was approved in March 2025 by the U.S. Food and Drug Administration (FDA) and the Brazilian Health Regulatory Agency (ANVISA) for the treatment of the cardiomyopathy of wild-type or hereditary ATTR amyloidosis in adults. Alnylam continues to pursue additional global submissions to bring vutrisiran to patients worldwide.

AMVUTTRA^® (vutrisiran) INDICATION AND IMPORTANT SAFETY INFORMATION

Indications

In the EU, AMVUTTRA^® (vutrisiran) is indicated for the treatment of:

• hereditary transthyretin amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy (hATTR-PN).
• wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM).

Important Safety Information

Reduced Serum Vitamin A Levels and Recommended Supplementation

Vutrisiran treatment leads to a decrease in serum vitamin A levels. Supplementation of approximately, but not exceeding, 2500 IU to 3000 IU vitamin A per day is advised for patients taking vutrisiran. Patients should be referred to an ophthalmologist if they develop ocular symptoms suggestive of vitamin A deficiency (e.g., night blindness).

Adverse Reactions

Commonly reported adverse reactions with vutrisiran were injection site reactions and increase in blood alkaline phosphatase and alanine transaminase.

For additional information about vutrisiran, please see the full Summary of Product Characteristics.

About AMVUTTRA^® (vutrisiran)

AMVUTTRA^® (vutrisiran) is an RNAi therapeutic that delivers rapid knockdown of variant and wild‑type transthyretin (TTR), addressing the underlying cause of transthyretin (ATTR) amyloidosis. Administered quarterly via subcutaneous injection, vutrisiran is approved and marketed in more than 15 countries for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults. It is also approved in the U.S. and Brazil for the treatment of wild-type or hereditary ATTR amyloidosis in adult patients with cardiomyopathy (ATTR-CM). In the EU, AMVUTTRA is administered once every three months, either by a healthcare professional or through self-administration by patients or their caregivers.

About ATTR

Transthyretin amyloidosis (ATTR) is an underdiagnosed, rapidly progressive, debilitating and fatal disease caused by misfolded transthyretin (TTR) proteins, which accumulate as amyloid deposits in various parts of the body, including the nerves, heart and gastrointestinal tract. Patients may present with polyneuropathy, cardiomyopathy or both manifestations of disease. There are two different forms of ATTR – hereditary ATTR (hATTR), which is caused by a TTR gene variant and affects approximately 50,000 people worldwide, and wild-type ATTR (wtATTR), which occurs without a TTR gene variant and impacts an estimated 200,000-300,000 people worldwide.^2-5

About RNAi

RNAi (RNA interference) is a natural cellular process of gene silencing that represents one of the most promising and rapidly advancing frontiers in biology and drug development today.⁶ Its discovery has been heralded as “a major scientific breakthrough that happens once every decade or so,” and was recognized with the award of the 2006 Nobel Prize for Physiology or Medicine.⁷ By harnessing the natural biological process of RNAi occurring in our cells, a new class of medicines known as RNAi therapeutics is now a reality. Small interfering RNA (siRNA), the molecules that mediate RNAi and comprise Alnylam’s RNAi therapeutic platform, function upstream of today’s medicines by potently silencing messenger RNA (mRNA) – the genetic precursors that encode for disease-causing or disease pathway proteins – thus preventing them from being made.⁶ This is a revolutionary approach with the potential to transform the care of patients with genetic and other diseases.

About Alnylam Pharmaceuticals

Alnylam (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and prevalent diseases with unmet need. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach yielding transformative medicines. Since its founding in 2002, Alnylam has led the RNAi Revolution and continues to deliver on a bold vision to turn scientific possibility into reality. Alnylam has a deep pipeline of investigational medicines, including multiple product candidates that are in late-stage development. Alnylam is executing on its “Alnylam P⁵x25” strategy to deliver transformative medicines in both rare and common diseases benefiting patients around the world through sustainable innovation and exceptional financial performance, resulting in a leading biotech profile. Alnylam is headquartered in Cambridge, MA.

Alnylam Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. All statements other than historical statements of fact regarding Alnylam’s expectations, beliefs, goals, plans or prospects including, without limitation, Alnylam’s expectations regarding the safety and efficacy of AMVUTTRA for the treatment of ATTR-CM; the potential for AMVUTTRA to be used as a first-line treatment for ATTR-CM; the potential for AMVUTTRA to address the underserved ATTR-CM patient population and to improve outcomes for ATTR-CM patients; and Alnylam’s ability to secure access to AMVUTTRA for eligible patients across the EU and the timing of such access should be considered forward-looking statements. Actual results and future plans may differ materially from those indicated by these forward-looking statements as a result of various important risks, uncertainties and other factors, including, without limitation, risks and uncertainties relating to: Alnylam’s ability to successfully execute on its “Alnylam P⁵x25” strategy; Alnylam’s ability to successfully demonstrate the efficacy and safety of its product candidates; the pre-clinical and clinical results for Alnylam’s product candidates; actions or advice of regulatory agencies and Alnylam’s ability to obtain regulatory approval for its product candidates, as well as favorable pricing and reimbursement; successfully launching, marketing and selling Alnylam’s approved products globally; and any delays, interruptions or failures in the manufacture and supply of Alnylam’s product candidates or its marketed products; as well as those risks more fully discussed in the “Risk Factors” filed with Alnylam’s 2024 Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC), as may be updated from time to time in Alnylam’s subsequent Quarterly Reports on Form 10-Q and in its other SEC filings. In addition, any forward-looking statements represent Alnylam’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Alnylam explicitly disclaims any obligation, except to the extent required by law, to update any forward-looking statements.

Contacts

Alnylam Pharmaceuticals, Inc.

Christine Regan Lindenboom

(Investors and Media)

+1-617-682-4340

Josh Brodsky

(Investors)

+1-617-551-8276

Emily Bunting

(Media, Europe)

+41 79 866 97 03

We Need to Talk About Erectile Dysfunction: 38% of Canadian Men Don’t Know You Need a Prescription for ED Medication




We Need to Talk About Erectile Dysfunction: 38% of Canadian Men Don’t Know You Need a Prescription for ED Medication

– This Men’s Health Week, Phoenix is addressing misconceptions around erectile dysfunction to raise awareness for treatment and break the social stigma –

TORONTO–(BUSINESS WIRE)–For Men’s Health Week (June 9 to 15), Phoenix, Canada’s leading digital health clinic for men, is raising awareness to break the stigma around erectile dysfunction (ED), a medical condition that affects almost half (49.4%) of Canadian men aged 40 to 88.

ED is a medical condition that prevents the ability to get and maintain an erection sufficient for sexual intercourse, with a range of potential causes that could each contribute to the condition, including age, medications, injury, and lifestyle. Despite its prevalence, Phoenix’s survey of more than 1,500 Canadians found that there is a significant lack of awareness around ED and its treatment, likely contributing to stigma surrounding the condition.

CANADIANS UNDERESTIMATE THE REACH OF ED

Despite nearly half of Canadian men over 40 being affected, ED’s prevalence is underestimated, driving undue stigma. In fact, almost half of Canadians (45%) think that ED affects less than 40 per cent of men 40+. Twenty-seven per cent of Canadians think it affects less than 30 per cent of men 40+.

While Canadians underestimate the prevalence of ED in middle-aged and older men, many are also unaware that the condition can also impact younger men. The survey found that 64 per cent of Canadians don’t know that men aged 35 and younger can experience ED. That percentage grows as you look at younger men, with 71% of Canadians unaware that men aged 18 to 25 can be affected. This common misconception can contribute to the stigma around experiencing ED as a younger man, making it more difficult for those struggling to seek care.

“ED is a medical condition that men of all ages can experience. There shouldn’t be anything awkward about it, but there is. We’re trying to change that,” says Kevin Bache, co-founder and co-CEO of Phoenix. “While it may feel uncomfortable, men need to understand what the condition entails, and not shy away from being proactive in discussing it with a doctor. The sooner you get started, the better your chances are at finding mental and physical relief.”

WIDESPREAD MISUNDERSTANDING OF ED MEDICATION

Treatment for ED and its underlying cause can vary greatly depending on a patient’s prognosis, however, medication is a common and effective treatment. Despite this fact, Phoenix’s survey found 18 per cent of men are unsure if ED is treatable with medication, revealing a lack of awareness that may leave many suffering needlessly.

The data also highlighted a concerning gap in awareness that ED medication requires a prescription. Thirty-eight per cent of men are unsure or don’t think they need a prescription to purchase medication, such as Viagra, for ED. However, the lack of awareness is most significant among younger Canadians. About three in five Gen Z (59%) don’t know that you need a prescription for ED medication: 32 per cent are unsure, and 27 per cent don’t think you need a prescription at all.

It is important that Canadians know that ED medication requires a prescription from a medical professional, as they may otherwise be vulnerable to purchasing unauthorized sexual enhancement products sold over the counter, which Health Canada warns could pose serious health risks.

“It’s no surprise that people aren’t aware of the prevalence of ED – it just doesn’t get talked about enough. But the good news is, there are treatment options, and with more openness and awareness, more people can seek support immediately,” says Gavin Thompson, co-founder and co-CEO of Phoenix. “We built Phoenix to change that. Our mission is simple: make expert care easy to access – fast, discreet, and doctor-led. We’re building a future where men take charge of their health with confidence.”

WHAT CANADIANS NEED TO KNOW ABOUT ED

• ED can affect men at any age, but it becomes more common as you get older.
• ED is more common than you may think, affecting almost half of Canadian men aged 40 to 88.
• Many factors can cause ED, including: low levels of testosterone, nervous dysfunction, blood flow complications, medications, medical conditions, lifestyle factors, obesity, diet, drug abuse, smoking, and emotional or psychological complications.
• ED is highly treatable, but the first step is consulting a medical professional. Treatment for erectile dysfunction and its underlying cause can vary greatly, making it important to consult a medical professional to receive a diagnosis and devise an effective treatment strategy.
• ED medication requires a prescription from a medical professional.

Phoenix is currently available in Ontario, Alberta, British Columbia, Saskatchewan, Manitoba, Nova Scotia, New Brunswick, PEI, and Newfoundland. To learn more about Phoenix’s ED support, visit https://www.phoenix.ca/treatments/erectile-dysfunction.

ABOUT PHOENIX

Phoenix is Canada’s leading digital health clinic for men, specializing in three areas of treatment – erectile dysfunction, weight loss, and hair loss. The telehealth platform facilitates access to licensed Canadian physicians, treatment options, and free, discreet shipping of prescription medication from coast to coast. Visit Phoenix.ca to learn more.

SURVEY METHODOLOGY

These findings are from a survey conducted by Phoenix from May 20th to May 22nd, 2025, among a representative sample of 1509 online Canadians who are members of the Angus Reid Forum. The survey was conducted in English and French. For comparison purposes only, a probability sample of this size would carry a margin of error of +/-2.53 percentage points, 19 times out of 20.

Contacts

MEDIA
Anne-Marie Tremble

Senior Account Manager, Talk Shop Media

annemarie@talkshopmedia.com
613-914-3551

Azafaros to Present at BIO International Convention 2025 Following Successful €132M Series B Financing




Azafaros to Present at BIO International Convention 2025 Following Successful €132M Series B Financing

LEIDEN, Netherlands–(BUSINESS WIRE)–#Adults–Azafaros, a clinical-stage biotechnology company developing novel therapies for rare lysosomal storage disorders (LSDs), today announced that it will present at the 2025 BIO International Convention taking place in Boston, USA, from 16-19 June. The company’s presentation is scheduled for Monday, June 16 at 16:45 ET in Room 153B.

The presentation will highlight Azafaros’ progress in developing nizubaglustat, its lead investigational compound for the treatment of rare lysosomal storage disorders with neurological involvement, including GM1 and GM2 gangliosidoses and Niemann-Pick disease type C (NPC).

This announcement follows Azafaros’ recently completed and oversubscribed €132 million Series B financing round, which will support advancing nizubaglustat into pivotal clinical development. The company is on track to initiate two Phase 3 trials in GM1/GM2 gangliosidoses and NPC in 2025.

Earlier this year, Azafaros reported positive topline results from its ongoing Phase 2 study evaluating nizubaglustat in patients with GM2 gangliosidosis and NPC. The current Ph2 extension study demonstrated a favorable safety profile after more than 12 months of treatment. In addition, preliminary improvements or stabilization in key clinical endpoints were observed in the majority of patients, underscoring promising efficacy trends for nizubaglustat.

“We are excited to share our latest progress at BIO 2025, including the continued clinical development of nizubaglustat which holds strong potential as a meaningful treatment option for patients with devastating neurodegenerative lysosomal disorders,” said Stefano Portolano, CEO at Azafaros. “With the support of our recent financing round and encouraging data from our ongoing trials, we can continue our rapid momentum to bring this product into pivotal clinical studies as we work to develop a potential new solution for this area where there is a significant unmet need.”

About nizubaglustat

Nizubaglustat is a small molecule, orally available and brain penetrant azasugar with a unique dual mode of action, developed as a potential treatment for rare lysosomal storage disorders with neurological involvement, including GM1 and GM2 gangliosidoses and Niemann-Pick disease type C (NPC).

Nizubaglustat has received Rare Paediatric Disease Designations (RPDD) for the treatment of GM1 and GM2 gangliosidoses and NPC, Orphan Drug Designations (ODD) for GM1 and GM2 gangliosidosis (Sandhoff and Tay-Sachs Diseases) and NPC, as well as Fast Track Designation and IND clearance for GM1/GM2 gangliosidoses and NPC from the US Food and Drug Administration (FDA). Additionally, nizubaglustat has been awarded Orphan Medicinal Product Designation (OMPD) for the treatment of GM1 and GM2 gangliosidoses by the European Medicines Agency (EMA) and Innovation Passport for the treatment of GM1 and GM2 gangliosidoses from the UK Medicines and Healthcare Products Regulatory Agency (MHRA).

About GM1 and GM2 gangliosidoses

GM1 gangliosidosis and GM2 gangliosidosis (Tay-Sachs and Sandhoff diseases) are lysosomal storage disorders caused by the accumulation of GM1 or GM2 gangliosides respectively, in the central nervous system (CNS). This results in progressive and severe neurological impairment and premature death. These diseases mostly affect infants and children, and no disease-modifying treatments are currently available.

About Niemann-Pick disease Type C (NPC)

Niemann-Pick disease Type C is a progressive, life-limiting neurological lysosomal storage disorder caused by mutations in the NPC1 or NPC2 gene and aberrant endosomal-lysosomal trafficking, leading to the accumulation of various lipids, including gangliosides in the CNS. The onset of disease can happen throughout the lifespan of an affected individual, from prenatal life through adulthood.

About Azafaros

Azafaros is a clinical-stage company founded in 2018 with a deep understanding of rare genetic disease mechanisms using compound discoveries made by scientists at Leiden University and Amsterdam UMC and is led by a team of highly experienced industry experts. Azafaros aims to build a pipeline of disease-modifying therapeutics to offer new treatment options to patients and their families. By applying its knowledge, network and courage, the Azafaros team challenges traditional development pathways to rapidly bring new drugs to the rare disease patients who need them. Azafaros is supported by leading healthcare investors including Jeito Capital, Forbion Growth, Seroba, Pictet Group and a syndicate of leading Dutch and Swiss existing investors including Forbion Ventures, BioGeneration Ventures (BGV), BioMedPartners, Asahi Kasei Pharma Ventures, and Schroders Capital.

Contacts

For further information:
Azafaros B.V.

Email: info@azafaros.com
www.azafaros.com

Samsung Bioepis Enters into a Strategic Partnership with NIPRO for Commercialization of Multiple Biosimilars in Japan




Samsung Bioepis Enters into a Strategic Partnership with NIPRO for Commercialization of Multiple Biosimilars in Japan

• Samsung Bioepis expands its presence in Japanese market through partnership with NIPRO Corporation
• Marks a step forward in widening treatments options across multiple therapeutic areas including immunology for patients in Japan

INCHEON, Korea–(BUSINESS WIRE)–#InnovatingAccess–Samsung Bioepis Co., Ltd. (“Samsung Bioepis”) announced today that the company has entered into a license, development and commercialization agreement with NIPRO Corporation (“NIPRO”) for multiple biosimilar candidates including SB17, ustekinumab biosimilar candidate, in Japan.

Under the terms of the agreement, Samsung Bioepis will be responsible for the development, manufacture and supply of the medicines, while NIPRO will be responsible for commercialization of the medicines in Japan.

“This partnership marks an important step towards expanding our footprint in Japan. Biosimilars have a great potential to bring cost savings and widen access to treatments for healthcare systems, providers, and patients in Japan. We look forward to collaborating with NIPRO, a company renowned for its high-quality medical devices and healthcare solutions, to accelerate access to treatments in the Japanese market,” said Kyung-Ah Kim, President and Chief Executive Officer of Samsung Bioepis. “We will continue to advance our development platform and innovate access to treatments for healthcare systems, payers, physicians, and patients around the world.”

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – LinkedIn, X.

Contacts

MEDIA CONTACT
Anna Nayun Kim, nayun86.kim@samsung.com
Yoon Kim, yoon1.kim@samsung.com

SOLVE FSHD and Modalis Announce Strategic Collaboration to Develop an Innovative CRISPR-Based Epigenome Editing Treatment for Facioscapulohumeral Muscular Dystrophy




SOLVE FSHD and Modalis Announce Strategic Collaboration to Develop an Innovative CRISPR-Based Epigenome Editing Treatment for Facioscapulohumeral Muscular Dystrophy

VANCOUVER, British Columbia & TOKYO & WALTHAM, Mass.–(BUSINESS WIRE)–SOLVE FSHD, a venture philanthropy organization dedicated to accelerating treatments for facioscapulohumeral muscular dystrophy (FSHD), and Modalis Therapeutics Corporation (TSE 4883; “Modalis”), a CRISPR-based epigenome editing therapeutics company focused on rare genetic diseases, today announced a strategic collaboration to develop an innovative therapy for FSHD, a debilitating muscular disorder affecting approximately 1 million individuals worldwide. The novel therapy leverages Modalis’s proprietary CRISPR-GNDM^® (Guide Nucleotide-Directed Modulation) technology, which can dynamically modulate gene expression without introducing double-strand DNA breaks.

SOLVE FSHD will provide strategic funding to support the development of Modalis’s MDL-103 program. MDL-103 is an innovative therapeutic solution that continuously suppresses the expression of the DUX4 gene, the toxic disease-causing gene for FSHD, which becomes abnormally activated due to epigenetic changes in the D4Z4 repeat region on chromosome 4. MDL-103 is designed to have durable activity over long periods of time under the control of a strong, muscle-specific promoter, and is delivered to the muscles of patients using a muscle-tropic AAV delivery system. Modalis’s CRISPR-GNDM^® technology has the potential to transform the treatment of FSHD by epigenetically silencing the expression of DUX4.

“SOLVE FSHD is pleased to partner with Modalis and to add them to our diverse portfolio of collaborators that are advancing potential therapies for FSHD,” stated Eva Chin, Executive Director of SOLVE FSHD. “SOLVE FSHD identified Modalis as a company committed to finding a cure for this debilitating condition. We were impressed by their unique approach to targeting the epigenetic cause of FSHD, using a platform technology that has shown promise in other neuromuscular diseases. We believe that the support from SOLVE FSHD will allow Modalis to accelerate the advancement of MDL-103 into clinical trials.”

“We are delighted to be working in partnership with SOLVE FSHD and greatly appreciate the invaluable support for the development of MDL-103,” said Haru Morita, CEO of Modalis. “This strategic collaboration is a strong validation of Modalis’s CRISPR-GNDM^® technology and our MDL-103 program. As a pioneer in this technology, we have demonstrated promising long-term drug efficacy in mouse models, shown durable target engagement and safety in non-human primates, and exhibited excellent biodistribution in neuromuscular disorders. We believe that MDL-103, which incorporates CRISPR-GNDM^® technology with a muscle tropic AAV delivery system, has significant potential as a breakthrough treatment for FSHD.”

About SOLVE FSHD

SOLVE FSHD is a venture philanthropic organization established to catalyze innovation and accelerate key research in finding a cure for FSHD. Established by renowned Canadian entrepreneur and philanthropist, Chip Wilson, the Wilson family has committed $100 million to kick-start funding into projects that support the organizations’ mission to solve FSHD by 2027. The goal of SOLVE FSHD is to find a solution that can slow down or stop muscle degeneration, increase muscle regeneration and strength, and improve the quality of life for those living with FSHD, visit https://www.solvefshd.com.

About Modalis Therapeutics Corporation

Modalis was founded in 2016 and conducts research and development activities in Massachusetts, USA. Modalis is a pioneering leader in the field of epigenetic medicine. Modalis develops therapeutics for patients suffering from serious genetic disorders such as neuromuscular diseases, CNS diseases, and cardiomyopathies. Modalis’s proprietary CRISPR-GNDM^® technology is capable of specifically up or down modulating the expression of disease-relevant genes without introducing double-strand DNA breaks. For more information, visit https://www.modalistx.com/en/.

Contacts

SOLVE FSHD

Alexandra Grant, House of Wilson

alexandrag@hofw.com

Modalis Therapeutics Corporation

Corporate Planning Department

media@modalistx.com

Aethera Biotech Forges Strategic Collaboration with China’s Shang Renée Skincare to Introduce CROP (Controlled Release of Optimized Plants) Patent Technology into Chinese Market




Aethera Biotech Forges Strategic Collaboration with China’s Shang Renée Skincare to Introduce CROP (Controlled Release of Optimized Plants) Patent Technology into Chinese Market

ROME–(BUSINESS WIRE)–Aethera Biotech officially announced a strategic partnership with Chinese premium skincare brand Shang Renée, marking the latter as Aethera Biotech’s first collaborative partner in the Chinese market. This collaboration not only introduces the internationally pioneering CROP patent technology to China but has also led to the joint establishment of the CELL Laboratory in Italy, laying a robust foundation for scientific innovation in skincare.

CROP technology is an exclusive global patent held by Aethera Biotech. This innovation utilizes 100% natural laboratory cultivation to develop plant callus tissue cells (phytocomplexes), fully preserving the highly active components and regenerative properties of plants. The CELL Laboratory will focus on cellular research of core ingredients such as EchinAge CROP-G and other rare botanical specimens for Shang Renée, providing robust scientific support for the brand’s skincare formulations.

The EchinAge CROP-G compound, cultivated through this proprietary technology, exhibits elevated concentrations of modularized polyphenols and polysaccharides. Compared to conventional Echinacea extracts, EchinAge CROP-G demonstrates significantly enhanced polyphenolic content. Its dermatological efficacy manifests through three primary mechanisms:

1. Rapid oxidative stress reduction via ROS suppression;
2. Dual-targeted anti-inflammatory action through inhibition of iNOS and COX2 expression;
3. Skin firming via attenuation of fibroblast-protective activity.

Clinically validated outcomes include measurable improvements in skin texture refinement and reduction of contour wrinkles, supported by comprehensive experimental data.

Centered on the philosophy of “Natural Regeneration,” Shang Renée is committed to delivering transformative solutions for skin repair, firming, and wrinkle reduction. This partnership will leverage Aethera Biotech’s expertise in plant cell cultivation, synergizing with active compounds like EchinAge CROP-G to develop groundbreaking skincare innovations.

The CEO of Aethera Biotech stated: “We are thrilled to deepen our collaboration with Shang Renée. Through joint research at the CELL Laboratory, we aim to translate avant-garde plant cell technologies into tangible skincare advancements, offering Chinese consumers purer and more efficacious skincare experiences.”

Contacts

Claire Chan

service@shangrenee.com

Otsuka Sibeprenlimab Phase 3 Data Show a Statistically Significant and Clinically Meaningful Proteinuria Reduction for the Treatment of Immunoglobulin A Nephropathy (IgAN)




Otsuka Sibeprenlimab Phase 3 Data Show a Statistically Significant and Clinically Meaningful Proteinuria Reduction for the Treatment of Immunoglobulin A Nephropathy (IgAN)

• In the Phase 3 VISIONARY study, sibeprenlimab achieved a statistically significant and clinically meaningful 51.2% (P<0.0001) reduction in proteinuria at nine months of treatment when compared to placebo
• The safety profile of sibeprenlimab was favorable and consistent with previously reported data
• Immunoglobulin A nephropathy is a progressive, immune-mediated, chronic kidney disease that can lead to end-stage kidney disease (ESKD) over the lifetime of most patients under current optimized standard care
• Sibeprenlimab filed its Biologics License Application (BLA) and received Priority Review designation from the U.S. Food and Drug Administration (FDA) with a target action date of November 28th, 2025

PRINCETON, N.J. & TOKYO–(BUSINESS WIRE)–Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical, Co. Ltd. (Otsuka) today presented results from a pre-specified interim analysis of the Phase 3 VISIONARY study (NCT05248646) evaluating sibeprenlimab, for the treatment of immunoglobulin A nephropathy (IgAN) in adults. Patients treated with sibeprenlimab achieved a 51.2% (P<0.0001) reduction in proteinuria (as measured by 24-hour uPCR [urine protein-to-creatinine ratio]) at nine months of treatment when compared to placebo¹. The data were presented during a late-breaking clinical trials session at the European Renal Association (ERA) Congress in Vienna, Austria. The study, the largest Phase 3 IgAN trial conducted to date, also showed the safety profile of sibeprenlimab was favorable and consistent with previously reported data¹. Specifically, 76.3% of patients treated with sibeprenlimab experienced any Treatment Emergent Adverse Event (TEAE) versus 84.5% in the placebo group.¹ Patients who experienced a serious TEAE were 3.9% treated with sibeprenlimab compared to 5.4% treated with placebo.

Sibeprenlimab received Priority Review designation from the FDA last month following its BLA filing in March. Proteinuria reduction is a recognized surrogate marker correlating with delaying progression to kidney failure and has been used as an endpoint in IgAN clinical trials to support accelerated regulatory approvals².

Sibeprenlimab is an investigational monoclonal antibody that selectively inhibits the activity of APRIL (A PRoliferation-Inducing Ligand) in adults with IgAN. APRIL plays a key role in the 4-hit process of IgAN pathogenesis and is an important initiating and sustaining factor in IgAN progression by promoting the production of pathogenic Gd-IgA1 and immune complex formation^3,4,5,6. By selectively binding and inhibiting APRIL, sibeprenlimab reduces the amount of immunoglobulin A (IgA) and Gd-IgA1 levels¹. Lower levels of Gd-IgA1 in people with IgAN provide less substrate for immune complex formation⁷. Sibeprenlimab is administered in a single-dose prefilled syringe for subcutaneous injection every four weeks intended for self-administration or administration by caregiver, providing patients the option of convenience at home.

“We are confident about the potential of sibeprenlimab and are grateful to the patients who are helping to further the science by participating in these important trials,” said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka Pharmaceutical Development & Commercialization, Inc. “Proteinuria control is an important independent predictor for long-term prognosis, and this interim data reinforces our belief that selectively targeting APRIL has the potential to be an effective and safe approach for this progressive and irreversible kidney disease.”

The VISIONARY study continues in a blinded manner to evaluate the change in kidney function over 24 months as measured by estimated glomerular filtration rate (eGFR) and is expected to be completed in early 2026. Further prespecified and exploratory analyses of the data will be conducted to determine the full potential of sibeprenlimab for the treatment of IgAN¹.

“The VISIONARY Phase 3 interim analysis shows a robust proteinuria reduction of 51.2% in the group treated with sibeprenlimab relative to placebo. These results affirm our belief in the efficacy of sibeprenlimab in the largest Phase 3 IgAN trial to date. The study enrolled a diverse patient population reflective of the disease epidemiology,” said Dr. Dana Rizk, professor of medicine in the division of nephrology at the University of Alabama at Birmingham. “The safety data emerging from VISIONARY is reassuring and adds to our existing knowledge about sibeprenlimab’s safety profile from prior programs. This is very exciting news for patients and adds a therapeutic option with a novel mechanism of action potentially targeting the immunologic pathogenesis of IgAN.”

About the VISIONARY Study

The VISIONARY study is the largest IgAN trial to date, and is a multicenter, randomized, double-blind, placebo-controlled trial consisting of approximately 510 adult patients with IgAN who were receiving standard-of-care therapy (defined as maximally tolerated ACE inhibitor or ARB +/- SGLT2 inhibitor), designed to evaluate the efficacy and safety of sibeprenlimab 400 mg administered subcutaneously every four weeks, compared to placebo¹. The primary efficacy endpoint is to evaluate the change in 24-hour uPCR at 9 months compared with baseline. The secondary endpoint is to evaluate the annualized slope of eGFR estimated over ~24 months¹.

About Sibeprenlimab

Sibeprenlimab (formerly VIS649) was designed and engineered by Visterra, Inc., a wholly owned subsidiary of Otsuka. Pre-clinical and early-stage trials of sibeprenlimab were also conducted by Visterra. Sibeprenlimab is an investigational monoclonal antibody that selectively binds to and inhibits the activity of APRIL and plays a key role in the 4-hit process. By selectively binding and inhibiting APRIL, sibeprenlimab reduces the amount of immunoglobulin A (IgA) and Gd-IgA1 levels¹. Lower levels of Gd-IgA1 in people with IgAN provide less substrate for immune complex formation⁷. Decreased immune complex formation should result in diminished deposition in the kidney, and reduced proteinuria and kidney inflammation⁸. By reducing the production of Gd-IgA1, sibeprenlimab may help slow kidney damage and progression toward ESKD^3,4,5,6. By inhibiting APRIL, sibeprenlimab may help address one of the IgAN-specific drivers for nephron loss.

About IgAN and APRIL

IgAN is a progressive, immune-mediated, chronic kidney disease that typically manifests in adults aged 20-40 years and leads to ESKD over the lifetime of most patients^9,10,11.

IgAN is characterized by the accumulation of Gd-IgA1 complexes in the kidneys. IgAN can lead to progressive loss of kidney function and, eventually, ESKD, imposing a significant burden on patients¹⁰. Despite supportive care, there is an unmet need for treatments that address the root causes of the condition. Continued research in the disease remains crucial to uncovering opportunities for advancement in our understanding and treatment of patients ⁵.

APRIL, a cytokine in the tumor necrosis factor (TNF) family, is integral to the pathogenesis and progression of IgAN. It promotes the survival and class switching of B cells to produce IgA, particularly the pathogenic galactose-deficient IgA1 (Gd-IgA1) that forms immune complexes in the kidneys⁵.

About Otsuka

Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: Otsuka–people creating new products for better health worldwide. Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.

In pharmaceuticals, Otsuka is a leader in the challenging areas of mental, renal, and cardiovascular health and has additional research programs in oncology and on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.

Otsuka established a presence in the U.S. in 1973 and today its U.S. affiliates include Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Otsuka America Pharmaceutical, Inc. (OAPI). These two companies’ 2,250 employees in the U.S. develop and commercialize medicines in the areas of mental health and nephrology, using cutting-edge technology to address unmet healthcare needs.

OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Co., Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 35,340 people worldwide and had consolidated sales of approximately USD 14.7 billion in 2024.

All Otsuka stories start by taking the road less traveled. Learn more about Otsuka in the U.S. at www.otsuka-us.com and connect with us on LinkedIn and Twitter at @OtsukaUS. Otsuka Pharmaceutical Co., Ltd.’s global website is accessible at https://www.otsuka.co.jp/en/.

About Visterra

Visterra is a biologics research and early-stage clinical development biotechnology company committed to developing innovative antibody-based therapies for the treatment of patients with immune-mediated kidney diseases and other hard-to-treat diseases. Its proprietary Hierotope® platform enables the design and engineering of precision biologics-based product candidates that specifically bind to, and modulate, key disease targets that are not adequately addressed by traditional therapeutic approaches. The platform also includes Fc engineering capabilities for half-life extension, bispecific antibodies and antibody-drug conjugates (ADCs). Visterra’s pipeline includes programs targeting kidney diseases, immunologically-driven diseases and infectious diseases. Visterra is an indirect subsidiary of Otsuka Pharmaceutical Co., Ltd. For more information, visit www.visterrainc.com.

References

1. Otsuka Pharmaceutical Development & Commercialization, Inc.Visionary Study: Phase 3 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy (IgAN). Clinicaltrials.gov. https://www.nejm.org/doi/full/10.1056/NEJMoa2305635
2. Thompson A, Carroll K, Inker LA, et al. Proteinuria Reduction as a Surrogate End Pointin Trials of IgA Nephropathy. Clin J Am Soc Nephrol. 2019;14(3):469-481.doi:10.2215/CJN.08600718
3. Mathur M, Barratt J, Suzuki Y, et al. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VIS649 (Sibeprenlimab), an APRIL-Neutralizing IgG2 Monoclonal Antibody, in Healthy Volunteers. Kidney Int Rep. 2022;7(5):993-1003.
4. Chang S, Li XK. The Role of Immune Modulation in Pathogenesis of IgA Nephropathy (nih.gov)
5. Cheung CK, Barratt J, Liew A, Zhang H, Tesar V, Lafayette R. The role of BAFF and April in IGA nephropathy: Pathogenic mechanisms and targeted therapies. Frontiers in nephrology. February 1, 2024.
6. Mathur M, Barratt J, Chacko B, et al. A Phase 2 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy Patients. NEJM. 2023 https://www.nejm.org/doi/full/10.1056/NEJMoa2305635
7. Gharavi, Ali G, et al. “Aberrant Iga1 Glycosylation Is Inherited in Familial and Sporadic IGA Nephropathy.” Journal of the American Society of Nephrology : JASN, U.S. National Library of Medicine, May 2008, pmc.ncbi.nlm.nih.gov/articles/PMC2386728
8. Kant, Sam, et al. “Advances in Understanding of Pathogenesis and Treatment of Immune-Mediated Kidney Disease: A Review – American Journal of Kidney Diseases.” American Journal of Kidney Diseases, Apr. 2022, www.ajkd.org/article/S0272-6386(21)00835-0/fulltext.
9. Pitcher, D. Braddon, et. al Long-term outcomes in IGA nephropathy. Clinical journal of the American Society of Nephrology : CJASN. https://pubmed.ncbi.nlm.nih.gov/37055195/.
10. Lai K. Iga nephropathy. Nature reviews. Disease primers. 2016
11. Cheung, Chee Kay & Boyd, JKF & Feehally, J.. (2012). Evaluation and management of IgA nephropathy. Clinical Medicine. 12. s27-s30. 10.7861/clinmedicine.12-6-s27.

Contacts

Contacts for Media

Otsuka in the U.S.

Robert Murphy

Corporate Communications

Otsuka America Pharmaceutical, Inc.

robert.murphy@otsuka-us.com

+1 609 249 7262

Otsuka in Japan

Jeffrey Gilbert

Leader, Pharmaceutical PR

Otsuka Pharmaceutical Co., Ltd.

gilbert.jeffrey.a@otsuka.jp

+81 3 6361 7379

RAD 2025: Long-Term Data on Nemluvio® (nemolizumab) Demonstrate its Favorable Safety Profile and Sustained and Increased Improvements in Itch and Skin Lesions in Patients With Atopic Dermatitis up to Two Years




RAD 2025: Long-Term Data on Nemluvio® (nemolizumab) Demonstrate its Favorable Safety Profile and Sustained and Increased Improvements in Itch and Skin Lesions in Patients With Atopic Dermatitis up to Two Years

• New interim two-year data from a long-term extension study of Nemluvio in atopic dermatitis reinforce its rapid onset of action and demonstrate its lasting impact across multiple clinical and patient reported outcomes including itch and skin lesions¹
• Results build on data from the phase III ARCADIA program, showing Nemluvio’s consistent safety profile and sustained and increased improvements in efficacy outcomes in atopic dermatitis patients during prolonged treatment up to two years^1,2
• Two-year data from a long-term extension study of Nemluvio in prurigo nodularis will also be presented later in June at the International Congress of Dermatology

ZUG, Switzerland–(BUSINESS WIRE)–Galderma (SIX: GALD) today announced two-year data from a new interim analysis of a long-term extension study investigating the safety and efficacy of Nemluvio in moderate-to-severe atopic dermatitis. The data show that Nemluvio is well tolerated, with no new safety signals identified, reinforcing its rapid onset of action and demonstrating sustained and increased improvements in symptoms including itch and skin lesions with prolonged treatment up to two years.¹ These data will be presented in a late-breaker abstract at the Revolutionizing Atopic Dermatitis (RAD) Conference, taking place from June 6-7, 2025.

Atopic dermatitis affects more than 230 million people worldwide.³ Often reported as one of patients’ most problematic symptoms, 87% of people with atopic dermatitis say they are seeking freedom from itch, with speed of itch relief therefore also prioritized by both patients and physicians.^4-7 Nemluvio is the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31.^3,8,9 IL-31 is a neuroimmune cytokine that drives itch and is involved in inflammation and skin barrier dysfunction in atopic dermatitis.^8,10 Nemluvio is also the first and only biologic approved for atopic dermatitis as well as prurigo nodularis with four-week dosing intervals from the start of treatment, and the only option to move to eight-week dosing intervals for appropriate patients with atopic dermatitis.⁹

The ARCADIA long-term extension study was designed to assess the long-term safety and efficacy of Nemluvio in patients with moderate-to-severe atopic dermatitis up to five years and includes more than 1,900 patients who either completed the initial or maintenance period in ARCADIA 1 or 2, a previous phase II/IIIb study, or were newly enrolled adolescent patients.¹

Results to be presented at the RAD Conference will show that Nemluvio is associated with sustained and increased improvements in skin lesions, itch, sleep, and quality of life during prolonged treatment up to two years.¹ At week 104 in evaluable patients, the interim analysis shows that:

• More than 85% achieved a 75% reduction in the Eczema Area and Severity Index (EASI)¹
• Approximately 85% and 70% achieved an at least four-point improvement in itch, and being itch free or nearly itch free, respectively, when assessed using the SCORing Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) Pruritus score. Improvements in sleep mirrored those in itch¹
• Approximately 60% reached clearance or almost-clearance of skin lesions when assessed using the Investigator’s Global Assessment (IGA) score¹
• Patients’ quality of life improved over time, as measured by the Dermatology Life Quality Index (DLQI)¹

Results also reinforce Nemluvio’s rapid onset of action on itch and skin at Week 4, with 49% of patients who entered the long-term extension study naïve to Nemluvio achieving a 75% reduction in the EASI, and 69% achieving an at least four-point improvement in itch when assessed using the SCORAD VAS Pruritus score.¹

Nemluvio was well tolerated in the long-term treatment of atopic dermatitis and no new safety signals were identified.¹

Additional data from both the ARCADIA program in atopic dermatitis, as well as from the OLYMPIA open-label extension study in prurigo nodularis will be presented at RAD 2025, reinforcing Nemluvio’s rapid impact on key symptoms of atopic dermatitis, and its long-term efficacy in prurigo nodularis.^11,12

Nemluvio was first approved in August 2024 by the United States Food and Drug Administration (U.S. FDA) for the treatment of adults with prurigo nodularis.⁹ In December 2024, it was also approved by the U.S. FDA for the treatment of patients 12 years and older with moderate-to-severe atopic dermatitis, in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies.⁹ To date, Nemluvio is approved for both moderate-to-severe atopic dermatitis and prurigo nodularis by multiple regulatory authorities around the world, including the European Commission. Additional regulatory submissions and reviews are ongoing.

More details on Galderma’s scientific presentations at RAD can be found here.

About Nemluvio

Nemluvio was initially developed by Chugai Pharmaceutical Co., Ltd. In 2016, Galderma obtained exclusive rights to the development and marketing of nemolizumab worldwide, except in Japan. 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.^13,14

About atopic dermatitis

Atopic dermatitis is a common, chronic, and flaring inflammatory skin disease, characterized by persistent itch and recurrent skin lesions.^3,15,16 It affects more than 230 million people worldwide.³ It is the most common inflammatory skin disease, impacting almost four times more people than psoriasis.¹⁷

Important Safety Information

Indications: NEMLUVIO^® (nemolizumab-ilto) is a prescription medicine used:

• to treat adults and children 12 years of age and older with moderate-to-severe eczema (atopic dermatitis or AD) in combination with prescription therapies used on the skin (topical) when the eczema is not well controlled by topical therapies alone. It is not known if NEMLUVIO is safe and effective in children with atopic dermatitis under 12 years of age.
• to treat adults with prurigo nodularis. It is not known if NEMLUVIO is safe and effective in children with prurigo nodularis under 18 years of age.

Do not take NEMLUVIO if you are allergic to nemolizumab-ilto or to any ingredients in NEMLUVIO. Before taking NEMLUVIO, tell your healthcare provider about all of your medical conditions, including if you:

• are scheduled to receive any vaccination. You should not receive a live vaccine right before or during treatment with NEMLUVIO.
• are pregnant or plan to become pregnant. It is not known whether NEMLUVIO will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known whether NEMLUVIO passes into your breast milk and if it can harm your baby.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

NEMLUVIO may cause serious side effects, including: allergic reactions (hypersensitivity). Stop using NEMLUVIO and tell your healthcare provider or get emergency help right away if you get any of the following symptoms:

• Breathing problems or wheezing
• Swelling of the face, lips, mouth, tongue, or throat
• Fainting, dizziness, feeling lightheaded
• Fast pulse
• Swollen lymph nodes
• Joint pain
• Fever
• Skin rash (red or rough skin)
• Nausea or vomiting
• General ill feeling
• Cramps in your stomach area

The most common side effects of NEMLUVIO include:

• Eczema: headache, joint pain, hives (itchy red rash or wheals), and muscle aches
• Prurigo Nodularis: headache and skin rashes: atopic dermatitis (a type of eczema), eczema, and eczema nummular (scattered circular patches)

These are not all of the possible side effects of NEMLUVIO.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800- FDA-1088.

Please see full Prescribing Information including Patient Information.

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. Silverberg, JI, et al. Nemolizumab long-term safety and efficacy up to 104 weeks in the ARCADIA open-label extension study in adolescents and adults with moderate-to-severe atopic dermatitis. Presented at Revolutionizing Atopic Dermatitis Conference 2025; June 6-7; Nashville, United States.
2. Silverberg J, et al. Nemolizumab with concomitant topical therapy in adolescents and adults with moderate-to-severe atopic dermatitis (ARCADIA 1 & 2): results from two replicate double-blinded, randomised controlled phase 3 trials. Lancet. 2024;404(10451):445-460. doi: 10.1016/S0140-6736(24)01203-0
3. Langan SM, et al. Atopic dermatitis [published correction appears in Lancet. 2020;396(10253):758]. Lancet. 2020;396(10247):345-360. doi: 10.1016/S0140- 6736(20)31286-1
4. Silverberg JI, et al. Patient burden and quality of life in atopic dermatitis in US adults: a population-based cross-sectional study. Ann Allergy Asthma Immunol. 2018;121(3):340-347. doi: 10.1016/j.anai.2018.07.006
5. Augustin M, et al. Real-World Treatment Patterns and Treatment Benefits among Adult Patients with Atopic Dermatitis: Results from the Atopic Dermatitis Patient Satisfaction and Unmet Need Survey. Acta Derm Venereol. 2022;7:102:adv00830. doi: 10.2340/actadv.v102.3932
6. Durno N, et al. Biologics and oral systemic treatment preferences in patients and physicians for moderate-to-severe atopic dermatitis: a discrete choice experiment in the United Kingdom and Germany. J Derm Treatment. 2024;35(1). doi: 10.1080/09546634.2024.2417966
7. Penton H, et al. Assessing Response in Atopic Dermatitis: A Systematic Review of the Psychometric Performance of Measures Used in HTAs and Clinical Trials. Dermatol Ther (Heidelb). 2023;13(11):2549-2571. doi: 10.1007/s13555-023-01038-3
8. Silverberg JI, et al. Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus. J Allergy Clin Immunol. 2020;145(1):173-182. doi: 10.1016/j.jaci.2019.08.013
9. Nemluvio U.S. Prescribing Information. Available online. Accessed May 2025
10. Kwatra SG, Misery L, Clibborn C, Steinhoff M. Molecular and cellular mechanisms of itch and pain in atopic dermatitis and implications for novel therapeutics. Clin Transl Immunology. 2022;11(5):e1390. doi: 10.1002/cti2.1390
11. Silverberg JI, et al. Nemolizumab was associated with rapid and significant improvements in itch and sleep in patients with moderate-to-severe atopic dermatitis: Results from two global phase 3 pivotal studies (ARCADIA 1 and ARCADIA 2). Presented at Revolutionizing Atopic Dermatitis Conference 2025; June 6-7; Nashville, United States.
12. Yosipovitch G, et al. Nemolizumab long-term efficacy and safety up to 52 weeks in the OLYMPIA open-label extension study in patients with prurigo nodularis: An interim analysis. Presented at Revolutionizing Atopic Dermatitis Conference 2025; June 6-7; Nashville, United States.
13. Chugai Pharmaceutical Co., Ltd. Maruho Obtained Regulatory Approval for Mitchga, the first Antibody Targeting IL-31 for Itching Associated with Atopic Dermatitis. Available online. Accessed May 2025
14. Chugai Pharmaceutical Co., Ltd. Mitchga Approved for Itching in Pediatric Atopic Dermatitis and Prurigo Nodularis, for its Subcutaneous Injection 30mg Vials. Available online. Accessed May 2025
15. Ständer S. Atopic dermatitis. N Engl J Med. 2021;384(12):1136-1143. doi:10.1056/NEJMra2023911
16. Yang G, et al. Skin Barrier Abnormalities and Immune Dysfunction in Atopic Dermatitis. Int J Mol Sci. 2020;21(8):2867. doi: https://doi.org/10.3390/ijms21082867
17. Raharja A, et al. Psoriasis: a brief overview. Clin Med (Lond). 2021;21(3):170-173. doi:10.7861/clinmed.2021-0257

Contacts

For further information:

Christian Marcoux, M.Sc.

Chief Communications Officer

christian.marcoux@galderma.com
+41 76 315 26 50

Richard Harbinson

Corporate Communications Director

richard.harbinson@galderma.com
+41 76 210 60 62

Céline Buguet 

Franchises and R&D Communications Director  

celine.buguet@galderma.com 

+41 76 249 90 87 

Emil Ivanov

Head of Strategy, Investor Relations, and ESG

emil.ivanov@galderma.com
+41 21 642 78 12

Jessica Cohen

Investor Relations and Strategy Director

jessica.cohen@galderma.com
+41 21 642 76 43

Canada’s Top Youth Scientists Awarded $1.3 Million at the 2025 Canada-Wide Science Fair in Fredericton




Canada’s Top Youth Scientists Awarded $1.3 Million at the 2025 Canada-Wide Science Fair in Fredericton

FREDERICTON, New Brunswick–(BUSINESS WIRE)–From groundbreaking schizophrenia treatment research to innovative sea turtle robots, Canada’s top young scientists showcased world-class research and innovation this week at the 63rd Canada-Wide Science Fair. At an awards ceremony this evening at the University of New Brunswick, 219 finalists were recognized with nearly $1.3 million in scholarships and awards at the country’s premier youth science, technology, engineering and mathematics (STEM) event. The fair’s Best Project Award in Discovery went to Sara Waqas from Calgary for her project, “Neurobiologically Informed Targeted Schizophrenia Treatment: A Multi-Omic, fMRI Approach”, while the Best Project in Innovation went to Evan Budz from Burlington, Ontario, for his project “Development of an Autonomous Bionic Sea Turtle Robot for Ecological Monitoring using AI”.

“This week, we’ve witnessed the power of youth curiosity in action,” said Reni Barlow, Executive Director at Youth Science Canada, organizers of the event. “Every student who undertakes a STEM project deserves to be celebrated for their dedication and creativity. Tonight’s winners are a powerful example of the impact youth can make through STEM.”

* * * * *

Top winners, selected by over 200 judges, include:

Best Project Awards

Best Project: Discovery

Sara Waqas from Calgary, Alberta, for Neurobiologically Informed Targeted Schizophrenia Treatment: A Multi-Omic, fMRI Approach.

Link to project

Best Project: Innovation

Evan Budz from Burlington, Ontario, for Development of an Autonomous Bionic Sea Turtle Robot for Ecological Monitoring using AI.

Link to project

Platinum Awards – Discovery
Best Junior (Grade 7/8)

Claire Sehn from Peterborough, Ontario, for Beat the Blaze: Preventing Wildfires and Drought With a Novel, Biodegradable Treatment.

Link to project

Best Senior (Grade 11/12/Cégep)

Hejin Wang from Saint John, New Brunswick, for Controlling Humongous Fungus: Cyanobacteria as a Biocontrol Agent for Root Rot Fungus.

Link to project

Platinum Awards – Innovation
Best Junior (Grade 7/8)

Trisha Haldar from Windsor, Ontario, for Visual Drug Interaction Checker.

Link to project

Best Senior (Grade 11/12/Cégep)

Chloe Rae Filion and Sophie Rose Filion from Fenwick, Ontario, for The Home Smog Alarm: How clean is your home’s air?

Link to project

* * * * *

The 2025 Canada-Wide Science Fair featured 390 student finalists, from Grade 7 through Cégep, showcasing 339 projects. The event drew more than 5,000 visitors and more than 30,000 online viewers. The Canada-Wide Science Fair and STEM Expo continue in person at the University of New Brunswick tomorrow, Friday, June 6, until 2:30 p.m. ADT, with projects remaining online for public viewing afterward.

The 64^th edition of the Canada-Wide Science Fair will be held at the Edmonton EXPO Centre and the University of Alberta from May 23 to 30, 2026.

Members of the public are invited to meet the best project and platinum award winners on Friday, June 6, at 8:30 a.m. ADT in the Richard J. Currie Center at the University of New Brunswick. The panel discussion will also be broadcast live.

https://cwsf-espc.link/2025-meet-the-winners
Media members are encouraged to participate.

Winners will be available for media interviews throughout the week of June 9, 2025, by contacting Mary Moniz at mary@torchiacom.com.

Photos and videos, as well as the complete list of Canada-Wide Science Fair award recipients, are available here: CWSF 2025 Media Kit

About Youth Science Canada

Youth Science Canada empowers all Canadian youth to engage their curiosity in discovering and innovating through STEM projects. A registered charity incorporated in 1966, YSC delivers on its mission through national programs, including mySTEMspace, the National STEM Fair Network, Canada-Wide Science Fair, STEM Expo, Team Canada representation at international fairs and Smarter Science professional development for teachers. Through these programs, YSC directly supports the more than 500,000 students who do STEM projects in any given year. For more information, visit youthscience.ca.

Contacts

For more information:

Mary Moniz

Torchia Communications

www.torchiacom.com
647-278-0152

mary@torchiacom.com

Aline Bedros

Torchia Communications

www.torchiacom.com
514-250-2332

aline@torchiacom.com