Tuberculosis, Cutaneous

COPENHAGEN, Denmark, April 2, 2024 – Bavarian Nordic A/S (OMX: BAVA) announced today that JYNNEOS®, the only FDA-approved mpox vaccine, is now commercially available in the U.S., marking a significant expansion for access to JYNNEOS® by establishing additional pathways for vaccine procurement, distribution, and reimbursement by both public and private payers. Since 2022, in response to the global mpox outbreak, JYNNEOS has been made available through public health channels for individuals at risk of mpox infection. This was made possible through Bavarian Nordic’s long-standing partnership with the U.S. government to supply the vaccine for the national stockpile and enabled by interim guidance from the Centers for Disease Control and Prevention (CDC), recommending pre- and post-exposure use of the vaccine for individuals at risk during the outbreak. These recommendations were updated in October 2023 by unanimous vote by the CDC's Advisory Committee on Immunization Practices (ACIP), and JYNNEOS is now recommended for routine use in individuals 18 years and older with certain risk factors1. While mpox no longer constitutes a public health emergency, infections are still occurring throughout the U.S., with around 200 cases every month on average and transmission of the virus having been reported across most of the states in 2024 to-date2. Since the beginning of the outbreak in 2022, more than 32,000 cases have been reported in the U.S., representing a third of all cases reported globally3. According to estimates from the CDC, two (2) million U.S. individuals are eligible for vaccination against mpox4. Recent data shows 60% of this population remains completely unvaccinated, and 15% have received only one dose of the vaccine5. Real-world data show that protection against mpox disease is superior in vaccinees who received the full schedule of two vaccinations as recommended by the CDC, compared to those who are unvaccinated or have only received one dose of the vaccine6. Through its existing nationwide vaccine distribution structure, Bavarian Nordic is now making the mpox vaccine commercially available across the nation. As of April 1, health care providers can order JYNNEOS through their preferred wholesaler and distribution partners to make it available for at-risk individuals at local pharmacies and physician offices in addition to public health clinics. Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic, commented: “From the beginning of the mpox outbreak, almost two years ago, the prompt availability of an approved vaccine combined with a strong public health response have helped to significantly reduce the impact of this debilitating disease, but unfortunately, mpox has not gone away completely. Building on the trust and reliability as a supplier of vaccines to the U.S. government for more than a decade, we are proud to extend our commitment to improving the nation’s public health by making our mpox vaccine widely available to at-risk individuals through the regular channels. We look forward to working with healthcare providers across the nation to increase awareness and availability of the mpox vaccine.” Brian Hujdich, Executive Director, National Coalition for LGBTQ Health, commented: “The expanded availability of JYNNEOS is a vital step toward ensuring equitable access to healthcare for the LGBTQ+ community and marks a significant stride in preventing the spread of mpox. We must continue to advocate for equitable policies that protect and support the health and well-being of all individuals and encourage those at risk to consult with their healthcare providers regarding vaccination.” About mpox Visit the CDC website for comprehensive information about mpox: About Bavarian Nordic Bavarian Nordic is a fully integrated vaccine company with a mission to protect and save lives through innovative vaccines. We are a global leader in travel vaccines and a preferred partner with governments on vaccines for public preparedness. For more information visit . About JYNNEOS® JYNNEOS® (Smallpox and Monkeypox Vaccine, Live, Nonreplicating) is approved for the prevention of smallpox and mpox disease in adults 18 years of age and older determined to be at high risk for smallpox and mpox infection. The vaccine was developed in collaboration with the U.S. government originally to ensure supply of a smallpox vaccine for the entire population, including immunocompromised individuals who are not recommended vaccination with traditional replicating smallpox vaccines. JYNNEOS was approved by the U.S. Food and Drug Administration (FDA) in 2019 and in 2021, ACIP voted to recommended JYNNEOS for pre-exposure vaccination of people at occupational risk for orthopoxvirus exposures. In 2022, the CDC issued interim guidance, enabling pre- and post-exposure use of JYNNEOS during the mpox outbreak and an Emergency Use Authorization (EUA) was issued allowing the use of JYNNEOS in people under 18 years. In October 2023, the CDC updated its guidance for use of JYNNEOS, and now recommends routine use of the vaccine for at risk individuals 18 years and older. Important safety information Appropriate medical treatment must be available to manage possible anaphylactic reactions following administration of JYNNEOS. Anyone who has experienced a severe allergic reaction following a previous dose of JYNNEOS or following exposure to any component of JYNNEOS may be at increased risk for severe allergic reactions. Syncope (fainting) has been reported following vaccination with JYNNEOS. Procedures should be in place to avoid injury from fainting. Immunocompromised persons, including those receiving immunosuppressive therapy, may have a diminished immune response to JYNNEOS. Vaccination with JYNNEOS may not protect all recipients. In smallpox vaccine-naïve healthy adults, the most common (>10%) solicited injection site reactions were pain (84.9%), redness (60.8%), swelling (51.6%), induration (45.4%), and itching (43.1%); the most common solicited systemic adverse reactions were muscle pain (42.8%), headache (34.8%), fatigue (30.4%), nausea (17.3%) and chills (10.4%). In healthy adults previously vaccinated with a smallpox vaccine, the most common (>10%) solicited injection site reactions were redness (80.9%), pain (79.5%), induration (70.4%), swelling (67.2%), and itching (32.0%); the most common solicited systemic adverse reactions were fatigue (33.5%), headache (27.6%), and muscle pain (21.5%). The frequencies of solicited local and systemic adverse reactions among adults with HIV infection and adults with atopic dermatitis were generally similar to those observed in healthy adults. Across all studies, a causal relationship to JYNNEOS could not be excluded for 4 serious adverse events (SAEs), all non-fatal, which included Crohn’s disease, sarcoidosis, extraocular muscle paresis and throat tightness. Cardiac adverse events of special interest (AESIs) considered causally related to study vaccination were reported in 0.08% of subjects who received JYNNEOS and included tachycardia, electrocardiogram T wave inversion, electrocardiogram abnormal, electrocardiogram ST segment elevation, electrocardiogram T wave abnormal, and palpitations. None of the cardiac AESIs considered causally related to study vaccination were considered serious. To report SUSPECTED ADVERSE REACTIONS, contact Bavarian Nordic at 1-844-4BAVARIAN or the US Department of Health and Human Services by either visiting or calling 1-800-822-7967. Please see full Prescribing Information Contacts – investors Rolf Sass Sørensen, Vice President Investor Relations, Tel: +45 61 77 47 43 Graham Morrell, Paddock Circle Advisors (US), graham@paddockcircle.com, Tel: +1 781 686 9600 Contact – media Michelle Trasatti, michelle.trasatti@syneoshealth.com, Tel: +1 443-528-7427 Media are also encouraged to visit for additional background information and media kit, including photos and b-roll. References 1 Persons at risk include gay, bisexual, and other men who have sex with men, transgender or nonbinary people who in the past 6 months have had one of the following: A new diagnosis of ≥ 1 sexually transmitted disease; More than one sex partner; Sex at a commercial sex venue; Sex in association with a large public event in a geographic area where mpox transmission is occurring, sexual partners of persons with the aforementioned risks, and persons who anticipate experiencing any of the aforementioned. 2 CDC, weekly data. Accessed April 1, 2024. . 3 CDC. Ongoing 2022 Global Outbreak Cases and Data. Accessed April 1, 2024. . 4 CDC. JYNNEOS Vaccine Coverage by Jurisdiction as of September 26, 2023. 5 6 CDC. 2022/2023 Mpox outbreak: situational awareness and updates (October 25, 2023, ACIP meeting presentation). Accessed April 1, 2024. Attachment 2024-04-02-en

CHICAGO, Dec. 27, 2023 /PRNewswire/ -- The Skin of Color Society (SOCS), the global leader in skin of color dermatology, reports that 2023 was a year of exceptional progress in support of its mission to change the landscape for people of color through research, education, mentorship and advocacy. Several signature SOCS programs and newer initiatives that took place this year made uniquely important contributions to the field, as follows. Continue Reading SOCS Presidents united, pictured from left: Drs. Andrew F. Alexis (current SOCS President) with Past Presidents through the years: Drs. Rebat Halder, Valerie M. Harvey, Valerie D. Callender, Founder Susan C. Taylor, Amy McMichael, Lynn McKinley-Grant, Seemal R. Desai and President-Elect Victoria Barbosa. 2023 Highlights December 2023: The SOCS Meeting the Challenge Summit: Population Descriptors in Dermatology Research Studies—Continuing in its commitment to increase diversity in dermatology research studies and clinical trials, SOCS presented its second Meeting the Challenge Summit in December 2023, this time focusing on population descriptors that best describe various populations under study. As the second in a series, the Summit convened an esteemed, diverse group of 116 stakeholders, including skin of color dermatology leaders, researchers, clinicians, regulators, dermatologists-in-training, industry representatives, geneticists, dermatology journal editors, and an anthropologist. Co-chaired by Valerie M. Harvey, MD, MPH, FAAD and Valerie D. Callender, MD, FAAD, the 2023 Summit further advanced the broader work of the SOCS Diversity in Dermatology Clinical Trials Task Force, which introduced the inaugural Meeting the Challenge Summit in 2022—a groundbreaking gathering that led to the development of the nation's first Diversity in Clinical Trials Mentorship Program, presented in 2023 in collaboration with the National Medical Association. In addition, this SOCS Task Force is in the process of developing a comprehensive, evidence-based review of the use and misuse of the current scales used to measure skin tones. The 2023 Meeting the Challenge Summit was made possible with thanks to the support of the following sponsors: Johnson & Johnson Health Care Systems, Inc. and L'Oréal Research & Innovation (Champion Level); Bristol Myers Squibb, Eli Lilly, Inc., and Incyte Corporation (Ally Level), and AbbVie, Arcutis Biotherapeutics, Google Health, and Sanofi-Regeneron (Partner Level). The 3rd SOCS Meeting the Challenge Summit will take place in 2025. October 2023: My Best Winter Skin Campaign— On October 24, 2023, SOCS launched a new national health awareness day known as My Best Winter Skin Day, (MBWS), kicking off an annual seasonal campaign built around public education, volunteerism and giving. While raising awareness about winter skin— a common skin condition that affects people of all ages, skin types and tones in the colder months of the year— funds raised through this public educational campaign go to the SOCS Foundation to help support innovative research and mentorship in skin of color dermatology. The world's first MBWS Day rolled out with two successful community outreach events held in Chicago, IL and Washington, D.C., led by teams of SOCS members, dermatology residents and medical students from Northwestern University and Howard University respectively. Participating SOCS volunteers shared educational tips for managing winter skin that were developed by members of the SOCS Patient Education Committee, and distributed free moisturizers generously donated by MBWS campaign sponsors, La Roche-Posay and CeraVe. Campaign support was also provided by Restore Hair. Since the MBWS Day events, a total of 36 SOCS members in 18 U.S. states and Washington, D.C. have volunteered to conduct additional outreach events in their communities and on local college campuses, resulting in the distribution of 5,000 educational tips and donated moisturizers to the public. Hundreds of medical school students, Resident and Fellow members have participated in this inaugural outreach to date. Plans are underway for an expanded MBWS campaign in 2024. August 2023: Dermatology Foundation and SOCS Partner to Deliver Impactful Opportunity to Advance Health Equity in Dermatology—For the first time, the Dermatology Foundation (DF) and SOCS have partnered to deliver new DEI research support for 2024, with a one-million-dollar grant generously provided by Sanofi-Regeneron. The Sanofi-Regeneron Diversity, Equity and Inclusion Mid-Career Award was developed especially for the exceptional mid-career investigator with an established trajectory of excellence in basic, clinical or translational science and will expand the understanding of dermatological issues impacting underrepresented or underserved groups in medicine. This substantial award adds a critical piece to the pathways of investigators working to address healthcare disparities. Supported research projects are expected to yield novel results that will provide urgently needed preliminary data and will serve as a springboard for obtaining larger research grants. Administered and promoted by the DF/SOCS Collaborative, this unique award leverages the DF's experience and infrastructure in award development and management, along with the SOCS's expertise in DEI and deep reach into the community of DEI investigators. Applications are closed for the 2024 Award cycle. Recipients will be announced in March 2024. July 2023: The first-ever SOCS Scientific Session at the World Congress of Dermatology (WCD)–SOCS was pleased to present its first WCD Scientific Session at the 25th World Congress of Dermatology in Singapore. Organized by the International League of Dermatological Societies, of which SOCS is a proud member, the WCD is one of the largest dermatology meetings in the world. Featuring expert presentations on inflammatory disorders, cultural beauty around the world, lichen planopilaris in South Africa, facial pigmentation and less-known facets of cutaneous tuberculosis, the SOCS Scientific Session was co-chaired by Drs. Victoria Barbosa and Ginette A. Okoye, under the leadership of SOCS President Dr. Andrew Alexis. This well-attended program was made possible by an educational grant from Pfizer. June 2023: The SOCS Educational Video Series—In its continuing dedication to physician, patient and public education, SOCS released an innovative educational video series in June 2023, consisting of the "MelanatED" series of eight short-form videos and ten longer-form SOCS Identity videos. Covering pertinent, high-interest topics ranging from cultural competency, inflammatory diseases, hair loss, and sunscreen in skin of color to patient safety, dermatologic differences in darker skin, the importance of early detection, how to find "Dr. Right" and much more, this enlightening collection addresses many issues of importance to patients of color and the physicians who care for them. Drawn from the 6th Annual SOCS Media Day initiative, held in March 2023, these insightful videos feature nationally and globally recognized SOCS leaders, including: Drs. Susan C. Taylor, Andrew F. Alexis, Valerie M. Harvey, Candrice R. Heath, Janiene Luke, Corey L. Hartman, Shawn Kwatra, and Nkem Ugonabo. This initiative was made possible thanks to the support of: Johnson & Johnson Health Care Systems, Inc., Procter & Gamble, Senté, Bristol Myers Squibb, Arcutis Biotherapeutics and Dove. The 7th Annual SOCS Media Day, "Changes, Challenges and Choices in Skin of Color: What SOCS Experts Say in an Era of Opportunity and Promise," will lead to a new series of educational videos, featuring SOCS leaders who will share their insights on a range of timely and relevant topics of importance to patients of color. March 2023: The 19th Annual SOCS Scientific Symposium—Held in March 2023, the 19th Annual SOCS Scientific Symposium, "Where Science, Innovation and Inclusion Meet," showcased the latest skin of color dermatology research and insights from emerging researchers and leading experts from around the US and the world. A record 179 scientific abstracts were submitted, with 128 poster abstracts and five oral abstract presentations accepted for inclusion in the program. Experienced by an international audience of 511 attendees, the Symposium featured 16 invited speakers, including a keynote address, who shared their insights through presentations, moderated panels and oral abstracts, along with an expansive range of iPosters on display for viewing. This informative program was co-chaired by Victoria Barbosa, MD, MPH, MBA, FAAD and Ginette A. Okoye, MD, FAAD. The 19th Annual SOCS Scientific Symposium was supported by AbbVie, Arcutis, AVITA Medical, Beiersdorf, Bristol Myers Squibb, Dermavant Sciences, Eli Lilly, Evolus, Incyte Johnson & Johnson Health Care Systems, Inc., OrthoDermotologics, Sanofi-Regeneron, Sente, Strata Skin Sciences, UCB, and Unilever/Dove/Vaseline. The 20th Annual SOCS Scientific Symposium, "Pathways to Equity: Advancing Advocacy, Research, and Clinical Excellence," will take place on Thursday, March 7, 2024, at the Marriott Marquis in San Diego. The upcoming Symposium is co-chaired by Nada Elbuluk, MD, MSc, FAAD and Chere Lucas Anthony, MD, FAAD. 2023 By the Numbers: SOCS Signature Programs and Activities Membership is growing globally, with 505 new SOCS members added from 30 countries. 11 SOCS Observership Grants awarded, supported by EltaMD, L'Oréal and many SOCS members who have made voluntary contributions through the SOCS Foundation. 5 SOCS Research Grants awarded, supported by Bristol Myers Squibb, L'Oréal and Pfizer. 3 SOCS Career Development Grants awarded, supported by Bristol Myers Squibb and Pfizer. 2 SOCS Early Career Innovations Awards given, supported by SOCS member Dhaval Bhanusali, MD, FAAD. 8 Travel Grants to the SOCS Meeting the Challenge Summit awarded to Dermatology Residents, supported by Summit sponsorships. 128 SOCS Mentee applications for the SOCS Mentorship program received 48 SOCS Mentor-Mentee pairings in the SOCS Mentorship program were facilitated, thanks to individual donations made to the SOCS Foundation. A total of 150 SOCS members and dermatology colleagues participated in SOCS Networking & Educational Symposia held in Chicago, Boston, New York, San Antonio, Philadelphia and San Francisco during 2023. These events were supported by Pfizer. "As we usher in our 20th Anniversary milestone in 2024, we're deeply grateful to so many SOCS leaders, members, supporters and collaborators who have helped make 2023 an extraordinary year of remarkable progress," comments SOCS President Andrew F. Alexis, MD, MPH, FAAD. About the Skin of Color Society The Skin of Color Society (SOCS) is an international professional dermatologic organization dedicated to achieving health equity and excellence in patient care through research, education, mentorship and advocacy. SOCS is committed to increasing diversity and inclusion in dermatology to advance patient care. Established in 2004 by Susan C. Taylor, MD, SOCS includes members from more than 30 countries around the world. Learn more: . SOURCE Skin of Color Society

Phase IIa clinical trial evaluated Aurase Wound Gel in patients with venous leg ulcers Former Smith+Nephew CMO, Andy Weymann joins as Chairman to support progression of further Phase II clinical trials CAMBRIDGE, England--(BUSINESS WIRE)-- SOLASCURE Ltd (SolasCure), a biotechnology company developing a hydrogel containing tarumase (provisional INN), a recombinant enzyme derived from maggots, and which aims to accelerate wound debridement and contribute to wound bed preparation & healing, today announced the results of its proof-of-concept, first-in-human, Phase IIa safety study. The CLEANVLU trial evaluated the Company’s first investigational product, Aurase Wound Gel, for use in chronic venous leg ulcer patients over 12 applications of the product (dosed every 3 days). SolasCure’s CLEANVLU Phase IIa clinical trial observed a strong safety pro Aurase Wound Gel, with no evidence of systemic availability, no antibody generation to the enzyme and no effects on systemic coagulation pathways. In addition, no local tolerability issues (erythema, oedema, induration, or bleeding) and no pain from application of the gel was observed. The trial also indicated a dose-dependent effect on wound debridement with higher concentrations of enzyme resulting in more complete debridement, a faster rate of debridement, and an improved wound healing trajectory. The study was performed at centres in the US, UK, and Hungary. SolasCure’s Aurase Wound Gel, a hydrogel containing an enzyme cloned from medical maggots, aims to facilitate debridement, reduce bacterial biofilm, and promote wound bed preparation and healing. Aurase Wound Gel is due to enter further Phase II trials to further evaluate its efficacy across a larger and more diverse patient group than the Phase IIa study, with the positive safety data obtained from the Phase IIa trial allowing for higher concentrations of the gel to now be explored. Chronic wounds are a huge unmet medical need with treatment costs accounting for approximately 1-3% of total healthcare expenditure in developed countries. With over 40 million chronic wounds requiring debridement each year globally, the need for better debridement, wound bed preparation and healing is a growing and urgent problem, currently without safe, pain-free, and effective solutions. Strengthening SolasCure’s leadership team as it moves towards further Phase II clinical trials, medical expert Andy Weymann has been appointed as Chairman of the Board. Andy Weymann M.D., newly appointed Chairman of the Board, SolasCure, said: “I am delighted to join the SolasCure team, especially at such an exciting phase of growth. The positive safety and proof-of-concept data from the Phase IIa trial represents a huge milestone for the Company, accelerating its mission to provide a disruptive wound care product that could significantly improve outcomes for patients with chronic wounds globally. I look forward to working alongside the team as we now focus on developing the efficacy of Aurase Wound Gel in subsequent Phase II trials.” Andy Weymann is an orthopaedic surgeon with 25 years’ experience in the medical device and regenerative medicine industries. Andy has held several global executive and Board roles throughout his career, including Chief Medical Officer and Senior Vice President of Scientific, Clinical and Medical Affairs at Smith+Nephew. Andy completed his Masters in Human Medicine at the University of Zurich, Switzerland, an MBA at the Simon Business School, University of Rochester, NY, and his Board Program at Harvard, Boston, MA. Rob Kirsner, M.D., PhD, Head of Medical Advisory Board at SolasCure, Chairman and Harvey Blank Professor of Dermatology at the University of Miami, added: “SolasCure’s Aurase Wound Gel is an innovative technology, harnessing an enzyme cloned from medical maggots to accelerate wound cleaning, and therefore healing. We have a shared vision to deliver a meaningful solution for patients with chronic wounds, and the positive data observed in the CLEANVLU Phase IIa trial brings us another step closer.” Further validating SolasCure’s innovative approach to wound care, the Company was recently selected for the EIC Accelerator Horizon grant which recognises the potential impact the innovative technology could have on the lives of patients suffering from chronic wounds without adequate solutions. For more information about SolasCure, please visit: . View source version on businesswire.com: Contacts Esmé Walters Zyme Communications Email: esme.walters@zymecommunications.com Source: SolasCure View this news release online at: