Epileptic Encephalopathy, Childhood-Onset

VANCOUVER, British Columbia, Aug. 08, 2023 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused biopharmaceutical company, today announced two new appointments to its Board of Directors: Dr. Gillian M. Cannon and Mr. Justin Gover. Dr. Cannon has more than 30 years of experience in the pharmaceutical industry, where she served in business and commercial leadership roles at Merck and Co., UCB, Otsuka and Roivant. Mr. Gover served as founding Chief Executive Officer and as a director of GW Pharmaceuticals from inception in 1999 until its sale to Jazz Pharmaceuticals for $7.2 billion in May 2021 and brings nearly twenty-five years of experience in leadership positions in the biotechnology industry with a focus on epilepsy. Mr. Ian Mortimer, Xenon’s President and Chief Executive Officer, stated, “On behalf of our Board of Directors, I am delighted to welcome Gillian and Justin to our Board. Gillian brings a vast knowledge of commercializing novel medicines and leading successful neuroscience franchises at large pharmaceutical companies. In addition to his leadership acumen in the biotechnology industry, Justin brings a depth of understanding of the epilepsy space, with his background as founding CEO at GW Pharma and ongoing advocacy efforts at organizations such as CURE Epilepsy. These Board appointments are particularly timely given our continued efforts in advancing XEN1101 in multiple Phase 3 epilepsy trials and our preparation for commercialization as well as nearing a topline readout of our XEN1101 Phase 2 X-NOVA clinical trial in major depressive disorder. I am proud that both Gillian and Justin are lending their expertise to Xenon and look forward to their valued contributions and counsel.” Gillian M. Cannon, Ph.D. brings more than 30 years of experience in the pharmaceutical industry, where she has served in leadership roles at multiple prominent global pharmaceutical companies including Merck and Co. Inc., UCB Inc. and Otsuka Pharmaceuticals. Serving more than 25 years at Merck, Dr. Cannon held a variety of senior positions, including Global Vice President for Commercial Operations at Merck’s start-up biosimilar business, Merck BioVentures; Business Unit Head for Merck’s specialty products franchise, and Global Commercial Head of Merck’s neuroscience franchise. More recently, Dr. Cannon was the President of North American Operations for UCB Inc. from 2015 to 2017. In 2018, Dr. Cannon joined Roivant Sciences, a biotechnology company, serving initially as COO for Alyvant and subsequently as Head of Commercial Innovation for Roivant. Dr. Cannon currently serves on the Board of Directors for Corcept Therapeutics, a publicly traded clinical-stage biopharmaceutical company; Affibody AB, a Swedish biotechnology company; Edinburgh Innovations, the commercial arm of Edinburgh University; and Our Future Health Trading Board, the largest UK health research program. She also serves as a lecturer in the Drug Discovery Master’s program at Drexel University, PA. Dr. Cannon received her B.Sc. from the University of Edinburgh and Ph.D. in Health Administration from Temple University. Justin Gover brings nearly twenty-five years of experience in leadership positions in the biotechnology industry in the UK and the U.S. Mr. Gover served as founding Chief Executive Officer and as a director of GW Pharmaceuticals plc from the company’s inception in 1999 until its sale to Jazz Pharmaceuticals plc for $7.2 billion in May 2021. Mr. Gover led GW from London, UK from 1999 to 2015, at which time he relocated to San Diego, CA to open the company’s US headquarters. At GW, Mr. Gover led the development and commercialization of Epidiolex® (cannabidiol), which is approved in the U.S. and Europe in the field of childhood onset epilepsy. From 2018 to 2021, Mr. Gover served on the Board of Directors of the Biotechnology Innovation Organization (BIO). Mr. Gover currently serves on the Board of Directors for CURE Epilepsy and Rady Children’s Institute for Genomic Medicine. Mr. Gover holds an M.B.A. from the INSEAD business school in France and a B.Sc. (Hons) from Bristol University, UK. About Xenon Pharmaceuticals Inc. Xenon Pharmaceuticals (NASDAQ:XENE) is a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit . Safe Harbor Statement 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, and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical fact, and include statements regarding our management and directors and their contributions and our prospects; the potential efficacy, safety profile, future development plans, addressable market, regulatory success and commercial potential of our and our partners’ product candidates; our ability to successfully develop and achieve milestones in our XEN1101 and other development programs; our ability to successfully develop and obtain regulatory approval of XEN1101 and our other product candidates; and anticipated enrollment in our clinical trials and the timing thereof. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events, or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of any of our or our collaborators’ product candidates; promising results from pre-clinical development activities or early clinical trial results may not be replicated in later clinical trials; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; any of our or our collaborators’ product candidates, including XEN1101, may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; the impact of new or changing laws and regulations; the impact of pandemics and other health crises on our research and clinical development plans and timelines and results of operations, including impact on our clinical trial sites, collaborators, regulatory agencies and related review times, and contractors who act for or on our behalf; the impact of unstable economic conditions in the general domestic and global economic markets; adverse conditions from geopolitical events; as well as the other risks identified in our filings with the Securities and Exchange Commission and the securities commissions in British Columbia, Alberta, and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements. “Xenon” and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner. Investor/Media Contact: Jodi Regts Xenon Pharmaceuticals Inc. Phone: 604.484.3353 Email: investors@xenon-pharma.com

First patient receives brain-responsive neuromodulation for LGS, a severe and disabling childhood-onset epilepsy MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)-- NeuroPace, Inc. (Nasdaq: NPCE), a commercial-stage medical device company focused on transforming the lives of people living with epilepsy, today announced that the first patient with Lennox-Gastaut Syndrome (LGS) was treated in its feasibility investigational device exemption (IDE) study. LGS is a devastating form of childhood onset epilepsy characterized by cognitive dysfunction and frequent generalized onset seizures that often lead to injury. The study uses the RNS® System, which has demonstrated safety and effectiveness of brain-responsive stimulation for treating medically intractable focal onset seizures in people 18 and older, to test whether brain-responsive neurostimulation can also be used to treat LGS. The first procedure took place at Emory Healthcare in Atlanta and was performed by Robert E. Gross, MD, PhD, the MBNA Bowman Chair in Neurosurgery and Professor and Vice Chair, Emory University Department of Neurosurgery. “An exciting aspect of this study is that the implant location for each patient is based on customized models of their brain connectivity.” NeuroPace received a $9.3 million National Institutes of Health (NIH) grant through the Brain Research through Advancing Innovative Neurotechnologies® (BRAIN Initiative) to evaluate its responsive neuromodulation technology in those who suffer from LGS. Six study sites will enroll a total of 20 patients 12 years of age and older with LGS and drug-resistant generalized onset seizures. “The NIH looks for ideas that could be transformative, with the potential to change how LGS is treated today,” said Martha Morrell, MD, Chief Medical Officer of NeuroPace. “In addition to finding the best detection and stimulation settings for responsive neurostimulation in LGS, we are looking to identify changes in the recorded brain data that indicate whether the therapy is effective. These so-called biomarkers may help clinicians treat LGS and also facilitate future research, including the possibility of a larger clinical study into the mechanisms of the disease and treatment approaches.” Presently, antiseizure medications are the standard of care for treatment of LGS. However, even with multiple medications, seizures are rarely controlled, and it is typical for people with LGS to experience increasing disability over their lifetime. "Overall, treatment is rarely effective in LGS, and the outcome remains very poor," said Tracy Dixon-Salazar, PhD, Executive Director of the LGS Foundation and mother of an adult living with LGS. "Those living with LGS need new treatment options for the many seizures, LGS-associated disorders, and treatment side-effects our loved ones suffer. The impact of LGS extends to the whole family, as we shoulder this unpredictable disease and try to manage the many physical, emotional, and financial burdens. We need better treatments now." Disclaimer: Research reported in this press release was supported by the National Institutes of Health’s Brain Research Through Advancing Innovative Neurotechnologies (BRAIN) Initiative under award number UH3NS109557. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. About Epilepsy One in 26 Americans will develop epilepsy in their lifetime, with approximately 150,000 new cases of epilepsy diagnosed annually. An estimated 3.4 million Americans currently live with epilepsy. Epilepsy is a chronic disorder, the hallmark of which is recurrent, unprovoked seizures. More people live with epilepsy than autism spectrum disorder, Parkinson’s disease, multiple sclerosis and cerebral palsy – combined.[i] About the RNS® System The RNS® System, a paradigm-shifting treatment for drug-resistant focal epilepsy, is the only brain-responsive neuromodulation system approved by the FDA. The closed-loop technology delivers personalized, data-driven treatment targeted to the seizure source by continuously monitoring brain activity, recognizing a patient’s unique seizure pattern, and responding in real-time with imperceptible stimulation to prevent seizures. By recording ongoing EEG data, the RNS System provides physicians with a unique “window to the brain,” enabling them to remotely monitor their patients, gain insights based on brain activity, and use that information to optimize patient care. Long-term clinical studies demonstrate that the RNS System provides significant reduction in seizure frequency and enduring improvements in quality of life and cognition with no stimulation-related side effects. The RNS System is available at most comprehensive epilepsy centers in the United States and is widely covered by insurance. It is currently approved in the United States as an adjunctive therapy for patients 18 years of age and older with drug-resistant focal epilepsy. See important safety information at . About NeuroPace, Inc. Based in Mountain View, Calif., NeuroPace is a commercial-stage medical device company focused on transforming the lives of people living with epilepsy by reducing or eliminating the occurrence of debilitating seizures. Its novel and differentiated RNS System is the first and only commercially available, brain-responsive platform that delivers personalized, real-time treatment at the seizure source. This platform can drive a better standard of care for patients suffering from drug-resistant epilepsy and has the potential to offer a more personalized solution and improved outcomes to the large population of patients suffering from other brain disorders. Forward Looking Statements In addition to background and historical information, this press release contains “forward-looking statements” based on NeuroPace’s current expectations, forecasts and beliefs, including NeuroPace’s expectations and beliefs about future growth and indication expansion, commercialization efforts, expected returns, growth plans and revenue expectations, as well as our assumptions underlying these expectations. These forward-looking statements are subject to inherent uncertainties, risks, and assumptions that are difficult to predict, including the possibility of delays or failures associated with implementation, regulatory actions, failure to maintain or renew key customer and other business relationships, failure to maintain competitive offerings, the possibility of unfavorable results, and other risks associated with our commercialization efforts or business. You should not put undue reliance on these statements or the information presented. These and other risks and uncertainties include those described more fully in the section titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its public filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on March 10, 2022 and its quarterly report on Form 10-Q filed with the SEC on November 8, 2022, as well as any reports that it may the SEC in the future. Forward-looking statements contained in this announcement are based on information available to NeuroPace as of the date hereof. NeuroPace undertakes no obligation to update such information except as required under applicable law. These forward-looking statements should not be relied upon as representing NeuroPace’s views as of any date subsequent to the date of this press release and should not be relied upon as a prediction of future events. In light of the foregoing, investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of NeuroPace. [i]Epilepsy Foundation. “Facts about Seizures and Epilepsy.”

Data from six abstracts to be presented, including new long-term Phase 3 results and two real-world analyses of U.S. caregiver-reported seizure and non-seizure outcomes in patients prescribed Epidiolex ®(cannabidiol) DUBLIN, Nov. 28, 2022 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that six company-sponsored Epidiolex® (cannabidiol) oral solution presentations, including three late-breaking abstracts, will be shared at the upcoming 2022 American Epilepsy Society (AES) annual meeting, which will be held December 2-6, 2022, in Nashville, TN. "We understand the significant, lifelong implications of severe, childhood-onset epilepsy on both patients and their families. We continually strive to improve patient outcomes and are proud to present data that includes caregiver-reported insight into Epidiolex's effects on seizure and non-seizure outcomes in both children and adults living with Lennox-Gastaut Syndrome and Dravet Syndrome," said Kelvin Tan, MB BCh, MRCPCH, senior vice president and chief medical officer of Jazz Pharmaceuticals. "In addition, we are sharing long-term Phase 3 trial findings which demonstrate Epidiolex's ability to reduce tuberous sclerosis complex-related seizures over the course of three years of treatment – further underscoring that Epidiolex is an important treatment option in an area with significant unmet patient need." Epidiolex, a pharmaceutical formulation of highly-purified cannabidiol (CBD), is the first prescription, plant-derived cannabis-based medicine approved by the U.S. Food and Drug Administration (FDA). It is indicated for the treatment of patients with seizures associated with Lennox-Gastaut Syndrome (LGS), Dravet Syndrome (DS) and tuberous sclerosis complex (TSC) in patients aged 1 year and older. Presentation highlights include: Two Late Breaker Abstracts Featuring Subgroup Analysis of BECOME (BEhavior, COgnition, and More with Epidiolex) Caregiver Survey Results: While onset of LGS and DS is typically in infancy or childhood, these conditions are lifelong diseases with symptoms that evolve over time. The BECOME survey is a global outcomes survey of caregivers of patients with LGS or DS that characterized and quantified the seizure and non-seizure outcomes of Epidiolex treatment. The results from both poster presentations demonstrate that a substantial proportion of the caregivers of people with LGS or DS treated with Epidiolex reported improvements in many patients' seizure and non-seizure outcomes, regardless of age group (patients aged <18 years and >18 years).1,2 Long-term Safety and Efficacy of Add-on Cannabidiol (CBD) for Seizures Associated with Tuberous Sclerosis Complex (TSC): 3-Year Results From GWPCARE6 Open-Label Extension (OLE): Final data from the Phase 3 trial GWPCARE6 OLE evaluates the long-term efficacy and safety of add-on Epidiolex in patients with TSC-associated seizures across three years. Findings suggest that long-term, add-on Epidiolex treatment was well tolerated and demonstrated sustained reductions in TSC-associated seizures in patients for up to 156 weeks.3 REST LGS TOOL: Real World Use to Screen for LGS and Improve Access to Care: LGS is frequently undiagnosed in the adult population due to the lack of transfer of prior medical history to adult providers and the evolution of the symptoms of LGS over time. The Refractory Epilepsy Screening Tool for LGS patients (REST-LGS) was designed to improve identification and treatment of patients with LGS. This retrospective chart review of 100 patients aged 18 and older with drug-resistant epilepsy (DRE) and Intellectual and Development Disabilities (IDD) sought to further validate the REST-LGS. Using REST-LGS, this study identified that over half of the individuals without a previous LGS diagnosis should be referred for further diagnostic evaluation at a specialized epilepsy center, and further validated the REST-LGS for the identification of potential LGS patients with DRE and IDD.4 The AES abstracts are available online at . A full list of Jazz-sponsored AES presentations follows: About Tuberous Sclerosis Complex Tuberous sclerosis complex (TSC) is a rare genetic condition.5 The condition causes mostly benign tumors to grow in vital organs of the body including the brain, skin, heart, eyes, kidneys and lungs6 and is a leading cause of genetic epilepsy.7 People with TSC may experience a variety of seizure types. One of the most common is infantile spasms that typically present in the first year of life; focal (or partial) seizures are also very common.8 TSC is associated with an increased risk of autism and intellectual disability9 and the severity of the condition can vary widely. In some children the disease is very mild, while others may experience life-threatening complications.6 Epilepsy is present in about 85 percent of patients with TSC and may progress to become intractable to medication.8,10,11 More than 60 percent of individuals with TSC do not achieve seizure control12 with standard treatments such as antiepileptic drugs, epilepsy surgery, ketogenic diet, or vagus nerve stimulation8 compared to 30-40 percent of individuals with epilepsy who do not have TSC who are drug resistant.13,14 About Dravet Syndrome Dravet syndrome (DS) is a rare genetic condition that appears during the first year of life with frequent fever-related seizures (febrile seizures). Later, other types of seizures typically arise, including myoclonic seizures (involuntary muscle spasms).15 Additionally, status epilepticus, a potentially life-threatening state of continuous seizure activity requiring emergency medical care, may occur. Children with DS typically experience poor development of language and motor skills, hyperactivity and difficulty relating to others. About Lennox-Gastaut Syndrome Lennox-Gastaut syndrome (LGS) begins in childhood. It is characterized by multiple types of seizures. People with LGS begin having frequent seizures in early childhood, usually between ages 3 and 5.16 More than three-quarters of affected individuals have tonic seizures, which cause the muscles to contract uncontrollably. Almost all children with LGS develop learning problems and intellectual disability. Many also have delayed development of motor skills such as sitting and crawling. Most people with LGS require help with usual activities of daily living. About Epidiolex®/Epidyolex® (cannabidiol) Epidiolex/Epidyolex, the first prescription, plant-derived cannabis-based medicine approved by the U.S. Food and Drug Administration (FDA) for use in the U.S., the European Commission (EC) for use in Europe, the Medicines and Healthcare products Regulatory Agency (MHRA) for use in Great Britain, the Therapeutic Goods Administration for use in Australia, Swissmedic for use in Switzerland, and the Food & Nutrition Services of the Israel Ministry of Health for use in Israel, is an oral solution which contains highly purified cannabidiol (CBD). In the U.S., Epidiolex is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS) or tuberous sclerosis complex (TSC) in patients one year of age and older. Epidiolex has received approval in the European Union under the tradename Epidyolex for adjunctive use in conjunction with clobazam to treat seizures associated with LGS and DS in patients two years and older, and for adjunctive use to treat seizures associated with TSC, in patients two years of age and older. Epidyolex has received Orphan Drug Designation from the European Medicines Agency (EMA) for the treatment of seizures associated LGS, DS and TSC. Important Safety Information & Indications CONTRAINDICATION: HYPERSENSITIVITY EPIDIOLEX (cannabidiol) oral solution is contraindicated in patients with a history of hypersensitivity to cannabidiol or any ingredients in the product. WARNINGS & PRECAUTIONS Hepatocellular Injury: EPIDIOLEX can cause dose-related transaminase elevations. Concomitant use of valproate and elevated transaminase levels at baseline increase this risk. Transaminase and bilirubin levels should be obtained prior to starting treatment, at one, three, and six months after initiation of treatment, and periodically thereafter, or as clinically indicated. Resolution of transaminase elevations occurred with discontinuation of EPIDIOLEX, reduction of EPIDIOLEX and/or concomitant valproate, or without dose reduction. For patients with elevated transaminase levels, consider dose reduction or discontinuation of EPIDIOLEX or concomitant medications known to affect the liver (e.g., valproate or clobazam). Dose adjustment and slower dose titration is recommended in patients with moderate or severe hepatic impairment. Consider not initiating EPIDIOLEX in patients with evidence of significant liver injury. Somnolence and Sedation: EPIDIOLEX can cause somnolence and sedation that generally occurs early in treatment and may diminish over time; these effects occur more commonly in patients using clobazam and may be potentiated by other CNS depressants. Suicidal Behavior and Ideation: Antiepileptic drugs (AEDs), including EPIDIOLEX, increase the risk of suicidal thoughts or behavior. Inform patients, caregivers, and families of the risk and advise to monitor and report any signs of depression, suicidal thoughts or behavior, or unusual changes in mood or behavior. If these symptoms occur, consider if they are related to the AED or the underlying illness. Withdrawal of Antiepileptic Drugs: As with most AEDs, EPIDIOLEX should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus. ADVERSE REACTIONS: The most common adverse reactions in patients receiving EPIDIOLEX (≥10% and greater than placebo) include transaminase elevations; somnolence; decreased appetite; diarrhea; pyrexia; vomiting; fatigue, malaise, and asthenia; rash; insomnia, sleep disorder and poor-quality sleep; and infections. Hematologic abnormalities were also observed. PREGNANCY: EPIDIOLEX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Encourage women who are taking EPIDIOLEX during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. DRUG INTERACTIONS: Strong inducers of CYP3A4 and CYP2C19 may affect EPIDIOLEX exposure. EPIDIOLEX may affect exposure to CYP2C19 substrates (e.g., clobazam, diazepam, stiripentol), orally administered P-gp substrates, or other substrates (see full Prescribing Information). Consider dose reduction of orally administered everolimus, with appropriate therapeutic drug monitoring, when everolimus is combined with EPIDIOLEX. A lower starting dose of everolimus is recommended when added to EPIDIOLEX therapy. Concomitant use of EPIDIOLEX and valproate increases the incidence of liver enzyme elevations. Pneumonia was observed more frequently with concomitant use of EPIDIOLEX and clobazam. Dosage adjustment of EPIDIOLEX or other concomitant medications may be necessary. INDICATIONS: EPIDIOLEX (cannabidiol) oral solution is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in patients 1 year of age and older. Please refer to the EPIDIOLEX full Prescribing Information for additional important information here. About Jazz Pharmaceuticals plc Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases—often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. Within these therapeutic areas, we are identifying new options for patients by actively exploring small molecules and biologics, and through innovative delivery technologies and cannabinoid science. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. Please visit for more information. Caution Concerning Forward-Looking Statements This press release contains forward-looking statements, including, but not limited to, statements related to the Epidiolex for people with tuberous sclerosis complex, Lennox-Gastaut syndrome, Dravet syndrome, including as a potential treatment option in an area with significant unmet patient need, and the potential impact on that community and other statements that are not historical facts. These forward-looking statements are based on Jazz Pharmaceuticals' current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with: pharmaceutical product development; the regulatory approval process, and other risks and uncertainties affecting the company and its development programs, including those described from time to time under the caption "Risk Factors" and elsewhere in Jazz Pharmaceuticals plc's Securities and Exchange Commission filings and reports (Commission File No. 001-33500), including Jazz Pharmaceuticals' Quarterly Report on Form 10-Q for the quarter ended September 30, 2021 and future filings and reports by Jazz Pharmaceuticals. Other risks and uncertainties of which Jazz Pharmaceuticals is not currently aware may also affect Jazz Pharmaceuticals' forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof or as of the dates indicated in the forward-looking statements, even if they are subsequently made available by Jazz Pharmaceuticals on its website or otherwise. Jazz Pharmaceuticals undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made. Media Contact: Kristin Bhavnani Head of Global Corporate Communications Jazz Pharmaceuticals plc CorporateAffairsMediaIn[email protected] Ireland +353 1 697 2141 Investors: Andrea N. Flynn, Ph.D. Vice President, Head, Investor Relations Jazz Pharmaceuticals plc [email protected] Ireland, +353 1 634 3211 References 1 Dixon-Salazar, T. et al. Nonseizure Outcomes With Cannabidiol (CBD) in Pediatric Versus Adult Patients With Lennox-Gastaut Syndrome (LGS) and Dravet Syndrome (DS): Subgroup Analysis of BECOME, a Caregiver Survey. American Epilepsy Society 2022 Annual Meeting. Nashville, TN, United States. . Accessed November 27, 2022. 2 Saurer, T.B. et al. Seizure Outcomes With Cannabidiol (CBD) in Pediatric Versus Adult Patients With Lennox-Gastaut Syndrome (LGS) and Dravet Syndrome (DS): Subgroup Analysis of BECOME, a Caregiver Survey. American Epilepsy Society 2022 Annual Meeting. Nashville, TN, United States. . Accessed November 27, 2022. 3 Thiele, E. et al. Long-term Safety and Efficacy of Add-on Cannabidiol (CBD) for Seizures Associated with Tuberous Sclerosis Complex (TSC): 3-Year Results From GWPCARE6 Open-Label Extension (OLE). American Epilepsy Society 2022 Annual Meeting. Nashville, TN, United States. . Accessed November 27, 2022. 4 Wolf, S. et al. REST LGS TOOL: Real World Use to Screen for LGS and Improve Access to Care. American Epilepsy Society 2022 Annual Meeting. Nashville, TN, United States. . Accessed November 27, 2022. 5 TS Alliance. What is TSC? . Accessed November 9, 2022. 6 NIH Tuberous Sclerosis Fact Sheet. . Accessed November 9, 2022. 7 TS Alliance Website. . Accessed November 9, 2022. 8 Kingswood JC, d'Augères GB, Belousova E, et al. TuberOus SClerosis registry to increase disease Awareness (TOSCA) - baseline data on 2093 patients. 2017;12(1):2. 9 de Vries PJ, Belousova E, Benedik MP, et al. TSC-associated neuropsychiatric disorders (TAND): findings from the TOSCA natural history study. Orphanet J Rare Dis. 2018;13(1):157. 10 Tuberous Sclerosis Alliance. Diagnosis, Surveillance and Management for Healthcare Professionals. . Accessed November 9, 2022. 11 Jeong A, Wong M. Systemic disease manifestations associated with epilepsy in tuberous sclerosis complex. Epilepsia. 2016;57(9):1443-1449. 12 Chu-Shore CJ, Major P, Camposano S, Muzykewicz D, Thiele EA. The natural history of epilepsy in tuberous sclerosis complex. Epilepsia. 2010;51(7):1236-1241. 13 Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000;342(5):314-319. 14 French JA. Refractory epilepsy: clinical overview. Epilepsia. 2007;48 Suppl 1:3-7. 15 Epilepsy Foundation. Dravet Syndrome. . Accessed November 9, 2022. 16 NORD. Rare Disease Database. . Accessed November 9, 2022. SOURCE Jazz Pharmaceuticals plc