Establishment Labs Receives U.S. FDA Approval for Motiva Implants




Establishment Labs Receives U.S. FDA Approval for Motiva Implants

NEW YORK–(BUSINESS WIRE)–Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, announced it has received approval from the U.S. Food and Drug Administration (FDA) for the use of Motiva^® SmoothSilk^® Ergonomix^® and Motiva^® SmoothSilk^® Round breast implants in primary and revision breast augmentation.

“Today’s approval is transformative for breast aesthetics in the United States. This is a new era, in which women now have a choice of highly differentiated technology that is backed by rigorous scientific and clinical research,” commented Juan José Chacón-Quirós, Founder and Chief Executive Officer. “Motiva implants have changed the paradigm by proving that women do not have to compromise when it comes to their aesthetic goals. We have never wavered in our commitment to women’s health and our entire organization is ready to bring this passion and technology to the United States.”

Motiva^® SmoothSilk^® Round and Ergonomix^® Implants represent state of the art innovation in plastic surgery. These devices feature the patented SmoothSilk^® surface, designed for enhanced biocompatibility and scientifically shown to promote low inflammation. The Motiva^® SmoothSilk Ergonomix^® device is the first breast implant in the world that embodies the science of ergonomics, as it is designed to adapt, react, feel, and move like natural breast tissue. Motiva^® SmoothSilk^® Ergonomix^® implants are unique to the implant market, as their shape can adapt as the body changes position, maintaining a round shape when lying down and a teardrop shape when standing up. The Motiva^® SmoothSilk^® Round implants provide increased upper breast fullness and softness while keeping a round full form regardless of position.

“The Motiva U.S. IDE Study is the most rigorous breast implant clinical trial ever performed under FDA guidelines and it shows that Motiva implants are not only safe and effective but also that women had exceptional results, with less than one percent rates of capsular contracture and rupture in the primary augmentation cohort,” said board-certified plastic surgeon Dr. Caroline A. Glicksman. “As the Medical Director of the Motiva study and an investigator, I am proud of the quality of the data and the patient follow-up rates of this study. Motiva implants were designed to reduce device related complications, and they will be welcomed by the plastic surgery community and women seeking breast augmentation in the United States.”

The Motiva U.S. IDE Study was conducted at 32 centers in the U.S. and three centers in Western Europe. At the study endpoint of three years post-implantation, patient compliance in the primary augmentation cohort of the trial was 92.4%. The three-year, by-patient, Kaplan-Meier risk rates of first occurrence of complications for patients (95% confidence interval) in the primary augmentation cohort (N=451) were as follows: Capsular Contracture: 0.5%; Rupture, Confirmed or Suspected: 0.6% (MRI Cohort N=176); Breast Pain: 0.7%; Infection: 0.9%. Any reoperation, including an implant size change, was reported at 6.1% and any complication, including reoperations, was reported at 8.4%.

“There has been a real lack of innovation in the U.S. breast implant market for well over a decade,” added board-certified plastic surgeon and study investigator Dr. M. Bradley Calobrace. “Motiva should transform breast augmentation, both in how we operate and in what we can achieve for our patients. A safer, next generation viscoelastic implant with a uniquely designed low inflammatory surface will undoubtedly improve clinical and aesthetic outcomes. I am pleased to finally be able to offer Motiva implants to my patients in the United States.”

Since first becoming commercially available in 2010, nearly four million Motiva^® devices have been delivered to plastic and reconstructive surgeons in over 85 countries. The company’s technologies and products are covered by over 200 patent applications in 20 separate patent families worldwide and are supported by over 100 clinical and scientific studies and peer reviewed publications. The Motiva^® Implant approval announced today is the first new breast implant PMA approved by the U.S. FDA since 2013.

“Motiva is the first and only implant purposefully designed for women and their lifestyles,” said Dr. Kamakshi R. Zeidler, a board-certified plastic surgeon and member of the Establishment Labs Femtech Advisory Board. “These implants move and feel like natural breast tissue. The rates of complications in the clinical trial were also much lower than we have seen with any other implant in a U.S. PMA study. This is true Femtech. I could not be happier that women in the United States now have access to this revolutionary technology.”

About Establishment Labs

Establishment Labs Holdings Inc. is a global medical technology company dedicated to improving women’s health and wellness through the power of science, engineering, and technology. The Company offers a portfolio of Femtech solutions for breast health, breast aesthetics and breast reconstruction. The nearly four million Motiva^® devices Establishment Labs has delivered to plastic and reconstructive surgeons since 2010 have created a new standard for safety and patient satisfaction in the over 85 countries in which they are available. The Motiva Flora^® tissue expander is used to improve outcomes in breast reconstruction following breast cancer and it is the only regulatory-approved expander in the world with an integrated port using radio-frequency technology that is MRI conditional. Mia Femtech™, Establishment Lab’s unique minimally invasive experience for breast harmony, is the Company’s most recent breakthrough innovation. These solutions are supported by over 200 patent applications in 20 separate patent families worldwide and over 100 scientific and clinical studies and publications in peer reviewed journals. Establishment Labs manufactures at two facilities in Costa Rica compliant with all applicable regulatory standards under ISO13485:2016 and FDA 21 CFR 820 under the MDSAP program. Please visit our website for additional information at www.establishmentlabs.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). You can find many (but not all) of these statements by looking for words such as “approximates,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “intends to,” “would,” “will,” “may” or other similar expressions in this press release. Any statements that refer to projections of our future financial or operating performance, anticipated trends in our business, our goals, strategies, focus and plans, including related product development and commercialization and regulatory approvals, and other characterizations of future events or circumstances, including statements expressing general optimism about future operating results, related to the company’s performance are forward-looking statements. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995. We caution investors that any forward-looking statements presented in this report, or that we may make orally or in writing from time to time, are expressions of our beliefs and expectations based on currently available information at the time such statements are made. Such statements are based on assumptions, and the actual outcome will be affected by known and unknown risks, trends, uncertainties, and factors that are beyond our control. Although we believe that our assumptions are reasonable, we cannot guarantee future performance, and some will inevitably prove to be incorrect. As a result, our actual future results and the timing of events may differ from our expectations, and those differences may be material. Factors, among others, that could cause actual results and events to differ materially from those described in any forward-looking statements include risks and uncertainties relating to: our ability to successfully, timely and cost-effectively develop, seek and obtain regulatory clearance for and commercialize our product offerings; the rate of adoption of our products by healthcare providers or other customers; the success of our marketing initiatives; the safe and effective use of our products; our ability to protect our intellectual property; our future expansion plans and capital allocation; our ability to expand upon and/or secure sources of credit or capital; our ability to develop and maintain relationships with qualified suppliers to avoid a significant interruption in our supply chains; our ability to attract and retain key personnel; our ability to scale our operations to meet market demands; the effect on our business of existing and new regulatory requirements; and other economic and competitive factors. These and other factors that could cause or contribute to actual results differing materially from our expectations include, among others, those risks and uncertainties discussed in the company’s annual report on Form 10-K filed on March 4, 2024 and will be discussed in the company’s quarterly report on Form 10-Q filed on August 7, 2024, which risks and uncertainties may be updated in the future in other filings made by the company with the Securities and Exchange Commission. The risks included in those documents are not exhaustive, and additional factors could adversely affect our business and financial performance. We operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for us to predict all such risk factors, nor can we assess the impact of all such risk factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. We are not undertaking any obligation to update any forward-looking statements. Accordingly, investors should use caution in relying on past forward-looking statements, which are based on known results and trends at the time they are made, to anticipate future results or trends.

Contacts

Investor/Media Contact:
Raj Denhoy

415 828-1044

rdenhoy@establishmentlabs.com

AbCellera to Report Third Quarter 2024 Financial Results on November 4, 2024




AbCellera to Report Third Quarter 2024 Financial Results on November 4, 2024

VANCOUVER, British Columbia–(BUSINESS WIRE)–$ABCL—AbCellera (Nasdaq: ABCL) will announce its third quarter 2024 financial results on Monday, November 4, 2024, and hold an earnings conference call at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time) the same day.

A live audio webcast of the earnings conference may be accessed through a link that will be posted on AbCellera’s Investor Relations website. A replay will be available through the same link following the conference call.

About AbCellera Biologics Inc.

AbCellera (Nasdaq: ABCL) discovers and develops antibody medicines for indications across therapeutic areas including cancer, metabolic and endocrine conditions, and autoimmune disorders. AbCellera’s engine integrates technology, data science, infrastructure, and interdisciplinary teams to solve the most challenging antibody discovery problems. AbCellera is focused on advancing an internal pipeline of first-in-class and best-in-class programs and collaborating on innovative drug development programs with partners. For more information, please visit www.abcellera.com.

Contacts

Inquiries

Media: Kathleen Reid; media@abcellera.com, +1(236)521-6774

Business Development: Murray McCutcheon, Ph.D.; bd@abcellera.com, +1(604)559-9005

Investor Relations: Melanie Solomon; ir@abcellera.com, +1(778)729-9116

Ossium Health’s OssiGraft Prime™ Wins Spine Technology Award Presented by Orthopedics This Week




Ossium Health’s OssiGraft Prime™ Wins Spine Technology Award Presented by Orthopedics This Week

Company Announces Award at North American Spine Society (NASS) Meeting in Chicago

OssiGraft Prime™ Highlighted at Booth No. 4633 in NASS Exhibition Hall

CHICAGO–(BUSINESS WIRE)–Ossium Health, a clinical-stage bioengineering company that built a first-of-its-kind organ donor-derived bone marrow bank, today announced from the North American Spine Society (NASS) Annual Meeting that OssiGraft Prime™ has won the highly coveted Spine Technology Award from Orthopedics This Week. The award recognizes groundbreaking advancements in spine surgery products and honors the engineering teams and inventors behind these innovations.

OssiGraft Prime™, Ossium Health’s next-generation viable bone matrix allograft, designed for use in spinal fusions and other orthopedic procedures, was commended for its contributions to spinal fusion procedures, for pushing the boundaries of innovation, and improving patient outcomes. The Spine Technology Awards selection committee is composed of renowned spine specialists and neurosurgeons including Juan Uribe, MD, Kris Radcliff, MD, Isaac Moss, MDCM, MASc, FRCSC, Stephen Hochschuler, MD, Michael Wang, MD, FACS, and Peter Derman, MD, MBA.

“This award highlights the unique benefits that OssiGraft Prime brings to surgeons and patients alike, allowing for faster healing for spine surgery patients, more precise surgical applications, and the use of high-quality bone sourced from donors,” said Kevin Caldwell, CEO, Co-Founder & President of Ossium Health. “It is gratifying for this to be announced at the NASS Annual Meeting where attendees seek to learn about advancements in patient care. We are seeing strong interest in OssiGraft from surgeons as we ramp-up our commercial efforts.”

OssiGraft Prime™ is the latest addition to the OssiGraft™ product line, which consists of the leading commercially available allografts produced from vertebral bone. The product is featured at Ossium Health’s booth, No. 4633, at the NASS Annual Meeting.

Key Advantages of OssiGraft Prime™:

• High Composition of Cancellous Bone: Containing the natural ratios of cancellous bone in vertebral bodies (~80%), OssiGraft Prime offers an unparalleled porous scaffold rich in growth factors that accelerate bone revascularization.
• Superior Handling Properties: With a soft and cohesive consistency, OssiGraft Prime enables precise molding and maintains its integrity during irrigation, providing surgeons with enhanced control and precision during complex spinal fusion procedures.
• Sourced from Younger, Healthier Donors: The average age of OssiGraft Prime donors is 35, ensuring a more robust source of viable bone for surgical use.
• Same Anatomical Location Usage: OssiGraft Prime presents a unique opportunity for spine surgeons to use allogeneic bone grafts in the same anatomical location in both donor and recipient, an innovation in the field.

The Spine Technology Awards continue to highlight industry-leading products that enhance the capabilities of surgeons and improve patient care. Ossium Health is proud to contribute to this legacy through its continuous development of cutting-edge bioengineering solutions.

About Ossium Health

Ossium Health is a bioengineering company that leverages its proprietary organ donor bone marrow banking platform to develop stem cell therapies for patients with blood, immune, and orthopedic diseases. Founded in 2016, the company is led by Kevin Caldwell, CEO, Co-Founder & President, and Erik Woods, Chief Science Officer, Co-Founder & EVP. Ossium Health’s manufacturing facility is registered with the FDA and its laboratory is certified under the Clinical Laboratory Improvement Amendment (CLIA). For more information, please visit https://ossiumhealth.com.

Follow the company on X at https://x.com/ossiumhealth and LinkedIn at https://www.linkedin.com/company/ossiumhealth/.

Contacts

Jane Griffin

Ossium Health, Inc.

415-513-5535

press@ossiumhealth.com

David Schull

Russo Partners

858-717-2310

david.schull@russopartnersllc.com

CleanNA introduces CE-IVD compliant CleanNGS Dx




CleanNA introduces CE-IVD compliant CleanNGS Dx

WADDINXVEEN, Netherlands–(BUSINESS WIRE)–CleanNA, a leading Dutch manufacturer of magnetic bead-based nucleic acid extraction kits and systems, launched a CE-IVD compliant version of their flagship product, CleanNGS. The single-component reagent CleanNGS Dx is highly suitable for nucleic acid (library) cleanup and (double-sided) size selection in preparation for Next-Generation Sequencing (NGS) applications in clinical diagnostic settings.

Next-Generation Sequencing is rapidly becoming more prevalent in clinical diagnostics due to its advancements and decreasing costs. This powerful technology is used for applications such as identifying genetic disorders, detecting cancer mutations, and tracking infectious diseases. Before NGS can be successfully performed, nucleic acid size selection and cleanup processes are essential to ensure the quality and accuracy of sequencing results.

Over the years, CleanNGS has proven to be a reliable product for the purpose of size selection and cleanup of nucleic acids. The brand-new CleanNGS Dx combines all the experience of CleanNGS with a CE-IVD certification, making it perfectly suitable for use in NGS applications within diagnostic workflows. The In Vitro Diagnostic Regulations of the European Union aim to ensure that products are safe, effective, and reliable, and they apply to all in vitro diagnostic medical devices on the EU market.

“The CE-IVD certification of CleanNGS not only ensures compliance with European regulations and market access but, above all, guarantees the safety, effectiveness, and quality of the product. These factors are crucial for reliable human molecular diagnostics.”

– Glenn Nohar, CEO of CleanNA

CleanNGS Dx is CleanNA’s third CE-IVD compliant product launched over the course of a year, after the Clean Cell Free DNA Kit (CE-IVD) and Clean Quick Viral DNA/RNA (CE-IVD). The Dutch company is steadily building its portfolio with products for in vitro diagnostic use.

About CleanNA:

CleanNA is a Dutch manufacturer of nucleic acid extraction kits that are based on an easy bind-wash-elute principle using magnetic beads. Their quality management system is EN-ISO 13485 certified by Bureau Veritas. The company’s product portfolio exists of extraction kits for nucleic acids from clinical samples for research and diagnostics, and for sample cleanup during PCR or Next Generation Sequencing procedures. Due to the use of magnetic beads, the products are ideally suited for use in automated extraction procedures.

Contacts

marketing@cleanna.com
phone: +31 (0) 182 22 33 50

LEO Pharma Unveils Most Extensive EADV Program To Date with 5 Late Breaking Abstracts and 23 Posters Sharing Clinical and Real-World Data




LEO Pharma Unveils Most Extensive EADV Program To Date with 5 Late Breaking Abstracts and 23 Posters Sharing Clinical and Real-World Data

• LEO Pharma will demonstrate true leadership in medical dermatology by presenting one of its largest ever scientific programs to date at this year’s EADV congress, with 5 late-breaking presentations and 23 scientific posters in total.^1-28
• New late-breaking Anzupgo^® (delgocitinib) cream data will include the full results of the Phase 3 head-to-head DELTA FORCE trial, as well as a wide range of associated clinical and real-world findings on delgocitinib cream and moderate to severe chronic hand eczema (CHE).^1-6
• Additional late-breaking data includes a presentation of Adtralza^® (tralokinumab)/Adbry^® (tralokinumab-ldrm) interim data from the real-world TRACE study on the effectiveness of Adtralza/Adbry in adults with moderate to severe head and neck atopic dermatitis (AD).²⁷
• Finally, a late-breaking presentation will discuss the first randomized trial comparing clinical and molecular effects of temtokibart and dupilumab in moderate to severe AD.²⁸

BALLERUP, Denmark–(BUSINESS WIRE)–NOT FOR UK USE – NOT INTENDED FOR UK MEDIA

LEO Pharma A/S, a global leader in medical dermatology, will present new clinical and real-world data from across its portfolio of products at the upcoming 33^rd European Academy of Dermatology and Venereology (EADV) Congress.

The event will be held from the 25^th to the 28^th of September in Amsterdam, Netherlands, where LEO Pharma will present 5 coveted late-breaking presentations in addition to 23 scientific posters for a range of skin conditions, forming the largest collection of data LEO Pharma has ever shared at the EADV congress.^1-28

“It is extraordinary to witness the breadth and variety of LEO Pharma’s scientific contribution at this year’s EADV Congress. It is a record-breaking presence for us – and we cannot wait to share this ground-breaking data with the medical dermatology community,” said Christophe Bourdon, CEO of LEO Pharma.

The first late-breaking presentation for Anzupgo^® (delgocitinib) cream will provide data from the 24-week DELTA FORCE trial that compared the efficacy and safety of topical delgocitinib cream with oral alitretinoin capsules in adults with severe CHE.¹ An additional late-breaking oral presentation will provide data from the matching-adjusted indirect comparison (MAIC) of the efficacy of delgocitinib and dupilumab in the treatment of moderate to severe atopic hand eczema.²⁵ The third delgocitinib cream late-breaking presentation will provide information on biomarker and efficacy data from the randomized vehicle-controlled clinical trial with delgocitinib cream in patients with frontal fibrosing alopecia.²⁶

A late-breaking presentation will also be presented for Adtralza/Adbry, highlighting the interim real-world effectiveness results of tralokinumab in adult patients with head and neck atopic dermatitis after up to 9 months of treatment in the TRACE real world evidence (RWE) study.²⁷

Finally, a late-breaking presentation for temtokibart will also be presented, comparing clinical and molecular responses in the targeting of IL-22RA1 with temtokibart vs dupilumab in patients with moderate to severe atopic dermatitis.²⁸

“The 2024 EADV Congress marks a pivotal moment for LEO Pharma as we unveil a wealth of new data,” said Kreesten Meldgaard Madsen, Chief Development Officer, LEO Pharma. “Our presentations at EADV showcase our most comprehensive research portfolio to date, underscoring our unwavering commitment to developing innovative dermatological therapies and helping to bring new hope to patients grappling with challenging skin conditions.”

The company’s full roster at the 2024 EADV Congress, encompassing new research, encore abstracts, and 3 symposiums,^1-28 includes:

Anzupgo^® (delgocitinib) cream

• DELTA FORCE trial: A 24-week head-to-head phase 3 trial comparing the efficacy and safety of topical delgocitinib cream with oral alitretinoin capsules in adults with severe chronic hand eczema
  
  Author: Ana Maria Giménez-Arnau
  
  Presentation ID: D1T01.1F
  
  LB presentation: Wednesday, 25 Sep, 15:30 – 15:45
  
  Location: Auditorium

• Matching-adjusted indirect comparison of the efficacy of delgocitinib and dupilumab in the treatment of moderate to severe atopic hand eczema
  
  Author: David Cohen
  
  Presentation ID: D3T01.4B
  
  LB presentation: Friday, 27 Sep, 16:15 – 16:30
  
  Location: Auditorium

• Randomized vehicle-controlled clinical trial with the topical JAK inhibitor delgocitinib in patients with frontal fibrosing alopecia demonstrates biomarker and clinical efficacy
  
  Author: Maryanne Makredes Senna
  
  Presentation ID: D3T01.4F
  
  LB presentation: Friday, 27 Sep, 17:15 – 17:30
  
  Location: Auditorium

• Treatment response of delgocitinib cream according to Chronic Hand Eczema (CHE) subtypes in adults with moderate to severe CHE: results from the Phase 3 DELTA 1, DELTA 2, and DELTA 3 trials
  
  Author: Robert Bissonnette
  
  Presentation ID: FC07.04
  
  Oral presentation: Friday, 27 Sep, 14:45 – 14:55
  
  Location: G104-G105

• Topical pan-JAK inhibition with delgocitinib restores the molecular signature of lesional skin in patients with Chronic Hand Eczema
  
  Author: Sonja Molin
  
  Poster ID: P0572
  
  ePoster presentation

• Health-related quality of life in people with Chronic Hand Eczema – Findings from the multi-national CHECK study
  
  Author: Anthony Bewley
  
  Poster ID: P3443
  
  ePoster presentation

• Clinical trial exit interviews in patients with moderate to severe Chronic Hand Eczema: perspectives on disease burden and its impact on quality of life from participants in the phase 3 DELTA 1 trial
  
  Author: Padma Mohandas
  
  Poster ID: P0532
  
  ePoster presentation

• Patient characteristics and comorbidities in moderate-to-severe CHE: Results from the RWEAL study
  
  Author: Maria Concetta Fargnoli
  
  Poster ID: P2559
  
  ePoster presentation

• The multifactorial and heterogenous nature of Chronic Hand Eczema in clinical practice: Results from the RWEAL study
  
  Author: Maria Concetta Fargnoli
  
  Poster ID: P0608
  
  ePoster presentation

• Delgocitinib cream reduces itch and pain in adults with moderate to severe Chronic Hand Eczema: pooled analyses of the Phase 3 DELTA 1 and 2 trials
  
  Author: Andrea Bauer
  
  Poster ID: P0564
  
  ePoster presentation

• Efficacy and safety of delgocitinib cream in adults with moderate to severe Chronic Hand Eczema: pooled results of the Phase 3 DELTA 1 and 2 trials
  
  Author: Marie Louise Schuttelaar
  
  Poster ID: P0569
  
  ePoster presentation

• Systemic exposure and safety profile of delgocitinib cream in adults with moderate to severe Chronic Hand Eczema in the Phase 3 DELTA 2 trial
  
  Author: Melinda Gooderham
  
  Poster ID: P0581
  
  ePoster presentation

• Long-term safety and efficacy of delgocitinib cream for up to 36 weeks in adults with Chronic Hand Eczema: results of the Phase 3 open-label extension DELTA 3 trial
  
  Author: Sonja Molin
  
  Poster ID: P0565
  
  ePoster presentation

• Association and impact of Chronic Hand Eczema on occupational and household/leisure activities– results from the multinational CHECK study
  
  Author: Marie Noelle Crepy
  
  Poster ID: P1076
  
  ePoster presentation

• Prevalence of Chronic Hand Eczema in adults: A cross-sectional multi-national study of over 60,000 respondents in the general population
  
  Author: Christian Apfelbacher
  
  Poster ID: P1901
  
  ePoster presentation

• Treatment patterns in moderate to severe Chronic Hand Eczema – Results from the multinational RWEAL medical chart review
  
  Author: Ana Maria Giménez-Arnau
  
  Poster ID: P3568
  
  ePoster presentation

• Self-reported disease severity and treatment of Chronic Hand Eczema from the CHECK study – A multinational study in six countries
  
  Author: Sonja Molin
  
  Poster ID: P3526
  
  ePoster presentation

Adtralza^® (tralokinumab)/Adbry^® (tralokinumab-ldrm)

• Real-world effectiveness of tralokinumab in adults with atopic dermatitis: Interim data on improvements in patients with head and neck atopic dermatitis after up to 9 months of treatment in the TRACE study
  
  Author: April Armstrong
  
  Presentation ID: D3T01.3C
  
  LB presentation: Friday, 27 Sep, 14:45 – 15:00
  
  Location: Auditorium

• Real-world effectiveness of tralokinumab in adults with atopic dermatitis: Interim data on improvements in physician-assessed disease severity after up to 9 months of follow-up in the TRACE study
  
  Author: Elena Pezzolo
  
  Poster ID: P0689
  
  ePoster presentation

• Real-world effectiveness of tralokinumab in adults with atopic dermatitis: Interim data on improvements in patient-reported outcomes after up to 9 months of follow-up in the TRACE study
  
  Author: Antonio Costanzo
  
  Poster ID: P0690
  
  ePoster presentation

• Long-term safety and efficacy of tralokinumab in patients 65 years or older with moderate-to-severe atopic dermatitis
  
  Author: Andrew Blauvelt
  
  Poster ID: P0479
  
  ePoster presentation

• Improvement of the head and neck regions with continuous tralokinumab treatment for up to 4 years in adults with moderate-to-severe atopic dermatitis
  
  Author: Raj Chovatiya
  
  Poster ID: P0595
  
  ePoster presentation

• Tralokinumab formulated as a pre-filled pen was efficacious and well-tolerated in adults and adolescents with moderate-to-severe atopic dermatitis
  
  Author: Jennifer Soung
  
  Poster ID: P0574
  
  ePoster presentation

• Stability of long-term therapeutic responses to tralokinumab in adults with moderate-to-severe atopic dermatitis
  
  Author: Andrew Blauvelt
  
  Poster ID: P0596
  
  ePoster presentation

Kyntheum^® (brodalumab)

• Observational study to assess the real-life descriptive effectiveness in patients with moderate to severe plaque psoriasis treated with Brodalumab stratified by patients with BMI>30 and patients with BMI ≤ 30. The BROACTIVE Study. 2 years – results.
  
  Author: Juan Escalas
  
  Poster ID: P3205
  
  ePoster presentation

• Long-term management outcome assessment of adult patients with moderate-to-severe plaque psoriasis treated with brodalumab in Greece: The ReSOLVE study.
  
  Author: Pantelis Panagakis
  
  Poster ID: P3102
  
  ePoster presentation

Temtokibart

• Targeting IL-22RA1 with temtokibart in patients with moderate to severe atopic dermatitis induces fast clinical and molecular responses, distinct from dupilumab
  
  Author: Christine Bangert
  
  Presentation ID: D2T01.3A
  
  LB presentation: Thursday, 26 Sep, 14:15 – 14:30
  
  Location: Auditorium

• Individual responses to IL-22RA1 inhibition in Asian patients with moderate-to-severe atopic dermatitis in Phase 1 and 2a clinical trials
  
  Author: Diamant Thaçi
  
  Poster ID: P0691
  
  ePoster presentation

In addition to the abstracts and poster presentations, LEO Pharma will also present 3 symposiums at the meeting:

• A New Era in Atopic Dermatitis
  
  Speakers: Prof. Melinda Gooderham, Prof. April Armstrong and Prof. Marjolein de Bruin-Weller
  
  17:45–19:15 CEST on Thursday the 26th of September in Room 7.1, RAI Amsterdam

• Plaque psoriasis and obesity — a double burden for patients?
  
  Speakers: Prof. Dr med. Khusru Asadullah and Dr Matteo Megna
  
  11:15-12:00 CEST on Thursday the 26th of September in Amtrium 1, Hall 4, RAI Amsterdam

• Chronic Hand Eczema Breaking the Silent Conversation
  
  Speakers: Prof. Swen Malte John, Prof. April Armstrong, Dr Marie-Louise Schuttelaar
  
  13:00-14:00 CEST on Friday the 27^th of September in Room 7.3, RAI Amsterdam.

About Chronic Hand Eczema

Chronic hand eczema (CHE) is defined as hand eczema (HE) that lasts for more than three months or relapses twice or more within a year.^29,30 CHE is one the most common skin disorder of the hands with a prevalence rate of approximately 4.7%.³¹ In a substantial number of patients, HE can develop into a chronic condition.³² CHE is a fluctuating disorder characterized by itch and pain, and patients may experience signs such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures on hands and wrists.³³

CHE has been shown to cause psychological and functional burdens that impact patient quality of life,³⁴ with approximately 70% of individuals who live with severe CHE admitting to problems in performing everyday activities, and suffering disruption in their daily life due to the condition.³⁵ Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE.³⁶

About Atopic Dermatitis

Atopic dermatitis is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions.³⁷ Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.³⁸ Type 2 cytokines, including IL-13, play an important role in the key aspects of atopic dermatitis pathophysiology.^37,38 Excessive IL-22 production is also known to contribute to the pathogenesis of AD.³⁹

About Psoriasis

Psoriasis is a chronic, systemic inflammatory disease that primarily affects the skin in 125 million people worldwide.^40,41 Psoriasis is the result of skin barrier cell proliferation and the activation of cytokines (a family of proteins involved in immune responses) that cause inflammation.⁴² About 80% to 90% of patients are affected by plaque psoriasis, the most common clinical form of psoriasis.⁴³ The symptoms of plaque psoriasis are itchy or painful raised scaly and inflamed plaques. Plaques may appear anywhere on the body, but often appear on the scalp, knees, elbows and torso.⁴³

About Anzupgo^® (delgocitinib) cream

Anzupgo^® (delgocitinib) cream 20 mg/g is a topical pan-Janus kinase (JAK) inhibitor for the treatment of moderate to severe CHE. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE.⁴⁴ The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome.⁴⁵ Anzupgo is currently approved in the European Union for the treatment of moderate to severe chronic hand eczema (CHE) in adults for whom topical corticosteroids are inadequate or inappropriate. In 2014, LEO Pharma A/S and Japan Tobacco Inc. (JT) entered into a license agreement in which LEO Pharma gained exclusive rights to develop and commercialize delgocitinib cream for topical use in dermatological indications worldwide, excluding Japan, where JT retains rights.

About Adtralza^® (tralokinumab) / Adbry ^® (tralokinumab-ldrm)

Adtralza^® (tralokinumab), which is marketed under the tradename Adbry^® in the U.S., is a high-affinity fully human monoclonal antibody developed to bind to and inhibit the interleukin IL-13 cytokine, which plays a role in the immune and inflammatory processes underlying atopic dermatitis signs and symptoms.^38,46 Adtralza^® specifically binds to the IL-13 cytokine, thereby inhibiting interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2).⁴⁷

Adtralza^® is approved for the treatment of moderate to severe AD in adult and adolescent patients 12 years and older in the European Union, Canada, Great Britain, the United Arab Emirates, and South Korea. Adtralza^® is approved for use in adults with moderate to severe AD in the U.S., Switzerland, Saudi Arabia, and Japan.

About Kyntheum^® (brodalumab)

Kyntheum^® (brodalumab) is a recombinant fully human monoclonal immunoglobulin IgG2 antibody that binds with high affinity to human IL-17RA and blocks the biological activities of the pro-inflammatory cytokines IL-17A, IL-17F, IL-17A/F heterodimer, IL-17C and IL-17E (also known as IL-25), resulting in inhibition of the inflammation and clinical symptoms associated with psoriasis. IL-17RA is a protein expressed on the cell surface and is a required component of receptor complexes utilized by multiple IL-17 family cytokines. IL-17 family cytokine levels have been reported to be increased in psoriasis. IL-17A, IL-17F and IL-17A/F heterodimer have pleiotropic activities including the induction of pro-inflammatory mediators such as IL-6, GROα, and G-CSF from epithelial cells, endothelial cells and fibroblasts that promote tissue inflammation. IL-17C has been shown to induce similar responses as IL-17A and IL-17F in keratinocytes. Blocking IL-17RA inhibits IL-17 cytokine-induced responses resulting in normalization of inflammation in the skin.⁴⁸

Kyntheum^® is indicated in the European Union, Great Britain, the United Arab Emirates, and Brazil for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy.

About temtokibart

Temtokibart (LEO 138559) is an investigational monoclonal antibody that targets the IL-22RA1 receptor subunit, currently in Phase 2 development for the potential treatment of moderate to severe atopic dermatitis.⁴⁹ It blocks the IL-22RA1 subunit and thereby inhibits the effects of the IL-22 cytokine, and potentially also to some extent the effects of IL-20 and IL-24.⁴⁹ Temtokibart does not bind to the IL-22 cytokine itself.⁴⁹ LEO Pharma has obtained a worldwide exclusive license to develop and commercialize temtokibart from argenx.

About LEO Pharma

LEO Pharma is a global company dedicated to advancing the standard of care for the benefit of people with skin conditions, their families and society. Founded in 1908 and majority owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, and today, the company offers a wide range of therapies for all disease severities. LEO Pharma is headquartered in Denmark with a global team of 4,200 people, serving millions of patients across the world. In 2023, the company generated net sales of DKK 11.4 billion.

References

1. Giménez-Arnau AM, Pinter A, Sondermann W et al. DELTA FORCE trial: A 24-week head-to-head phase 3 trial comparing the efficacy and safety of topical delgocitinib cream with oral alitretinoin capsules in adults with severe chronic hand eczema. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. Oral Presentation. D1T01.1F.
2. Bisonnette R, Schliemann S, Gooderham M, et al. Treatment response of delgocitinib cream according to Chronic Hand Eczema (CHE) subtypes in adults with moderate to severe CHE: results from the Phase 3 DELTA 1, DELTA 2, and DELTA 3 trials. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. Oral Presentation. FC07.04
3. Giménez-Arnau AM, Bewley A, Molin S, et al. Patient characteristics and comorbidities in moderate-to-severe CHE: Results from the RWEAL study. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P2559
4. Fargnoli MN, Molin S, Bewley A, et al. The multifactorial and heterogenous nature of Chronic Hand Eczema in clinical practice: Results from the RWEAL study. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0608.
5. Worm M, Jiang L, Litman T, et al. Topical pan-JAK inhibition with delgocitinib restores the molecular signature of lesional skin in patients with Chronic Hand. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. Oral Presentation. P0572.
6. Bewley A, Molin S, Crepy MN, et al. Health-related quality of life in people with Chronic Hand Eczema – Findings from the multi-national CHECK study. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P3443.
7. Mohandas P, Devani AR, Baranowski K, et al. Clinical trial exit interviews in patients with moderate to severe Chronic Hand Eczema: perspectives on disease burden and its impact on quality of life from participants in the phase 3 DELTA 1 trial. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0532.
8. Pezzolo E, Cork M, Beecker J, et al. Real-world effectiveness of tralokinumab in adults with atopic dermatitis: Interim data on improvements in physician-assessed disease severity after up to 9 months of follow-up in the TRACE study. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0689.
9. Costanzo A, Becherel PA, Serra E, et al. Real-world effectiveness of tralokinumab in adults with atopic dermatitis: Interim data on improvements in patient-reported outcomes after up to 9 months of follow-up in the TRACE study. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0690.
10. Escalas J, Armesto S, Abalde T, et al. Observational study to assess the real-life descriptive effectiveness in patients with moderate to severe plaque psoriasis treated with Brodalumab stratified by patients with BMI>30 and patients with BMI ≤ 30. The BROACTIVE Study. 2 years – results. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P3205.
11. Panagakis P, Chasapi V, Kalapothakou K, et al. Long-term management outcome assessment of adult patients with moderate-to-severe plaque psoriasis treated with brodalumab in Greece: The ReSOLVE study. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P3102.
12. Thaçi D, Bangert C, Laquer V, et al. Individual responses to IL-22RA1 inhibition in Asian patients with moderate-to-severe atopic dermatitis in Phase 1 and 2a clinical trials. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0691.
13. Blauvelt A, Merola J, Carrascosa JM, et al. Long-term safety and efficacy of tralokinumab in patients 65 years or older with moderate-to-severe atopic dermatitis. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0479.
14. Bauer A, Schuttelaar ML, Baranowski K, et al. Delgocitinib cream reduces itch and pain in adults with moderate to severe Chronic Hand Eczema: pooled analyses of the Phase 3 DELTA 1 and 2 trials. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0564.
15. Schuttelaar ML, Bisonnette R, Worm M, et al. Efficacy and of delgocitinib cream in adults with moderate to severe Chronic Hand Eczema: pooled results of the Phase 3 DELTA 1 and 2 trials. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0569.
16. Gooderham M, Thaçi D, Damgaard T, et al. Systemic exposure and safety profile of delgocitinib cream in adults with moderate to severe Chronic Hand Eczema in the Phase 3 DELTA 2 trial. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0581.
17. Molin S, Gooderham M, Bisonnette R, et al. Long-term safety and efficacy of delgocitinib cream for up to 36 weeks in adults with Chronic Hand Eczema: results of the Phase 3 open-label extension DELTA 3 trial. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0565.
18. Crepy MN, Molin S, Giménez-Arnau AM, et al. Association and impact of Chronic Hand Eczema on occupational and household/leisure activities– results from the multinational CHECK study.

Contacts

Melissa Borland
LEO Pharma, Senior Manager Communications, North America

647.241.1475

MQBCA@leo-pharma.com

Jes Broe Frederiksen
LEO Pharma, Senior Manager, Global Product and Data Communications

Tel: +45 53 60 59 48

Email: jebfe@leo-pharma.com

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