Vanderbilt University Medical Center

Data demonstrated people with narcolepsy were significantly more likely to have sleep, mood and pain disordersDUBLIN, Oct. 24, 2024 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, and nference, a health tech company dedicated to making biomedical data computable, today announced the publication of real-world data that identified the demographic characteristics and the top 20 most prevalent comorbidities of people living with narcolepsy. The paper, titled “Demographic Characteristics and Comorbidities of Patients With Narcolepsy: A Propensity-Matched Cohort Study,” was published online in Sleep Advances. These real-world findings were previously presented at the American Neurological Association (ANA) Annual Meeting in October 2022. Results describing demographic characteristics and the top 20 comorbidities were based on a review of deidentified electronic health data from more than 2,000 people with narcolepsy and 2,000 matched controls. The retrospective analysis was conducted through Mayo Clinic Platform, which leverages nference’s AI software to provide access to curated, deidentified electronic health data in a secure, privacy-protected environment. These types of data provide a more comprehensive view of patient information than claims data alone. “This is the first real-world study in narcolepsy to use aggregate electronic health record data,” said Melissa Lipford, M.D., a neurologist at the Center for Sleep Medicine at Mayo Clinic and lead author of the published paper. “We found that people with narcolepsy were more likely to have psychiatric, sleep and pain disorders. Understanding which comorbid conditions are most common should help clinicians better understand the challenges faced by patients with narcolepsy and help them optimize the management of their symptoms with the most appropriate treatment.” “We were proud to collaborate with Mayo Clinic Platform and nference to generate these real-world deidentified data from patients seen at the Mayo Clinic Health System. Narcolepsy is a chronic and complex neurological disorder and understanding the most prevalent comorbidities increased in this patient population may help to inform optimal management,” said Jennifer Gudeman, Pharm.D., Senior Vice President, Medical and Clinical Affairs of Avadel. “In contrast to claims-based studies, cardiovascular disease was not among the top 20 co-morbidities found to be increased in the narcolepsy cohort compared to the matched cohort.” About Avadel Pharmaceuticals plcAvadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company focused on transforming medicines to transform lives. Our approach includes applying innovative solutions to the development of medications that address the challenges patients face with current treatment options. Avadel’s commercial product, LUMRYZ, was approved by the U.S. Food & Drug Administration (FDA) as the first and only once-at-bedtime oxybate for the treatment of cataplexy or EDS in patients seven years and older with narcolepsy. For more information, please visit www.avadel.com. Cautionary Disclosure Regarding Forward-Looking StatementsThis press release includes “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. These forward-looking statements relate to our future expectations, beliefs, plans, strategies, objectives, results, conditions, financial performance, prospects or other events. Such forward-looking statements include, but are not limited to, expectations regarding the potential impact of the study on helping clinicians optimize the management of patients’ symptoms with the most appropriate treatment. In some cases, forward-looking statements can be identified by the use of words such as “will,” “may,” “could,” “believe,” “expect,” “look forward,” “on track,” “guidance,” “anticipate,” “estimate,” “project,” “next steps” and similar expressions and the negatives thereof (if applicable). The Company’s forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, the Company’s business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results and the results of the company’s business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in the Company’s forward-looking statements include the risks and uncertainties described in the “Risk Factors” section of Part I, Item 1A of the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the Securities and Exchange Commission (SEC) on February 29, 2024, and subsequent SEC filings. Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. The Company does not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law. About nferencenference is unlocking the potential of healthcare data with AI, delivering real-world evidence, insights, and solutions informed by the most comprehensive multimodal data across all therapeutic areas. Our extensive de-identified, longitudinal data includes decades of clinical notes along with rich patient histories, vitals, lab tests, radiology images, digital pathology, genomics, and electrophysiology waveforms. Our federated data platform, comprised of premier healthcare organizations, including Mayo Clinic, Duke Health, Banner Health, Vanderbilt University Medical Center, and Emory Healthcare, enables advanced research and custom AI model development. With unprecedented access to data from over 40 million patient journeys, our partners can accelerate target discovery, optimize clinical trial design, and enhance lifecycle management. Follow nference on LinkedIn. Visit us at www.nference.com. AvadelInvestor Contact:Courtney MogerleyPrecision AQCourtney.Mogerley@precisionAQ.com(212) 698-8687 Media Contact:Lesley StanleyReal Chemistrylestanley@realchemistry.com (609) 273-3162 nferenceMedia Contact:Andrea SampsonPresident/CEO, Sampson Public Relations Groupasampson@sampsonprgroup.com

The Advanced Research Projects Agency for Health (ARPA-H) has committed $110 million to 23 awardees addressing women’s health, First Lady Jill Biden announced Wednesday at the HLTH 2024 conference in Las Vegas. The funding is part of a program called Sprint for Women’s Health, which is organized by ARPA-H, an agency within HHS, and was first announced in February. It came after the White House launched an initiative on women’s health research in November. The awardees include startups, “global innovators” and universities and are addressing cancer, ovarian health, gynecological care, endometriosis, obstetrics, menopause, lymphatics, pain management, neurological conditions and cardiovascular conditions, according to the announcement. For example, biotech company Gameto was selected to build a novel ovarian therapy to stop disease in menopause, and Vanderbilt University Medical Center was chosen to create an at-home medication for risks during preterm labor. The recipients were chosen based on “their high-impact and novel approaches,” the announcement stated. sponsored content Upcoming Webinar: Battle of the Budget: Employers vs. Rising Healthcare Costs Gain valuable knowledge and practical insights on how employers are addressing an increasingly complex healthcare budget landscape. By Personify Health “ARPA-H is de-risking investments in these big ideas, so that answers can get to the women who need them now,” Biden said. “The potential in this space is too great to ignore. In 2021, the Boston Consulting Group estimated that the size of the women’s health market would grow from $9 billion to $29 billion in just eight years, because of the growing momentum from funders and founders to address the unmet health needs of women. I know you see these opportunities in your day-to-day work.” The awardees are also split up between two tracks: Spark and Launchpad. The former is for early-stage research, while the latter track is for later-stage development that will bring new treatments and products to market within two years. In total, ARPA-H received more than 1,700 submissions for funding across 45 states and the District of Columbia and 34 countries. About 30% of the recipients have never received government funding and 39% have fewer than 50 employees, according to the announcement. In addition, 70% of the awardees are women-led. During a panel discussion at HLTH, Renee Wegrzyn, Ph.D., ARPA-H director, noted that the 1,700 applications represent more than $8 billion of applications. presented by Sponsored Post The Promise of Value-Based Care and MedTech Innovation Monica Vajani, Executive Director for mHUB’s MedTech Accelerator, discusses how mHUB is helping innovators transition healthcare towards value-based care. By Monica Vajani - mHUB “There’s a lot out there that is still left to be invested in,” Wegrzyn said. “There’s a lot of momentum there.” Although women represent about half of the population, women have historically been underrepresented in research. It wasn’t until 1993 when the U.S. Congress passed a law that required women to be included in NIH-sponsored clinical trials. During her speech, Biden argued that because of a lack of investment in women’s health research, many medications, treatments and health products are based on men. Biden also called on the audience to take action to further advance the women’s health space. “Any time I get together with my sisters and friends, we have conversations about our health,” she said. “We ask each other: should I be taking hormone therapy for symptoms related to menopause? How is it possible that my heart attack was almost missed? “It’s time for investors, researchers, and business leaders to have those conversations too, not as an afterthought but as a first thought,” she urged. “Those kinds of questions belong in your research proposals, in your laboratories, in your pitch decks. There is incredible momentum behind women’s health right now. What are you going to do to make sure this energy is unstoppable?”

NEW YORK, NY, USA I October 22, 2024 I SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company and leader in infectious diseases, today announced that it entered into an agreement with Vanderbilt University to obtain a license to a portfolio of preclinical fully human monoclonal antibodies (mAbs) which could be used as potential treatments for a broad range of orthopoxviruses, including smallpox and mpox. Under the agreement, SIGA has exercised its option to license the exclusive rights to develop, manufacture, and commercialize these mAbs globally. “SIGA has cultivated deep expertise in orthopoxvirus, and we are thrilled to expand our pipeline with Vanderbilt’s human monoclonal antibodies, which nicely complement our best-in-class TPOXX ® franchise. We believe these antibodies hold the potential to treat a broad spectrum of orthopoxviruses, both as a therapeutic and a prophylactic measure. By leveraging our unique capabilities in clinical development and our long-standing partnerships with U.S. Government agencies, we are well-positioned to maximize the impact of these potential new therapies,” said Diem Nguyen, SIGA Chief Executive Officer. “This license marks a step forward in our strategy to leverage our existing capabilities to create new opportunities for growth over the long term.” Developed by James Crowe, Jr., M.D., Professor of Pediatrics, Pathology, Microbiology and Immunology at Vanderbilt University Medical Center, these mABs have demonstrated promise in preclinical models and could potentially be used as standalone treatments or in combination with TPOXX ® . The U.S. Department of Defense is currently funding the development of these mAbs as potential orthopoxvirus treatments through Phase 1 clinical trials under a contract awarded to a contract manufacturing organization with biologics expertise. “Given the need for additional orthopoxvirus treatments in these unsettling times of recurring poxvirus outbreaks, my team and I are excited to work with SIGA in its future efforts to advance the development of these innovative antibodies,” said Dr. Crowe. The financial terms of the transaction were not disclosed. About SIGA SIGA is a commercial-stage pharmaceutical company and leader in global health focused on the development of innovative medicines to treat and prevent infectious diseases. With a primary focus on orthopoxviruses, we are dedicated to protecting humanity against the world’s most severe infectious diseases, including those that occur naturally, accidentally, or intentionally. Through partnerships with governments and public health agencies, we work to build a healthier and safer world by providing essential countermeasures against these global health threats. Our flagship product, TPOXX ® (tecovirimat), is an antiviral medicine approved in the U.S. and Canada for the treatment of smallpox and authorized in Europe and the UK for the treatment of smallpox, mpox (monkeypox), cowpox, and vaccinia complications. For more information about SIGA, visit www.siga.com . SOURCE: SIGA